Third Circuit Affirms Asbestos Dismissals

Readers know that too often the necessary administrative procedures set in place in a mass tort are enforced on a one-way basis, costing defendants money and resources without requiring plaintiffs to comply with necessary discovery in a timely fashion.  The Third Circuit recently affirmed a lower court decision to exclude from an MDL workers allegedly exposed to asbestos at work when these plaintiffs failed to provide full asbestos exposure histories. See In Re: Asbestos Products Liability Litigation (NO. VI), numbers 12-2061-12-2072 (3d Cir. 2013).  

MDL 875 once included more than 150,000 plaintiffs and more than eight million claims. By the time Judge Robreno inherited the MDL in 2009, thousands of cases had been settled or otherwise resolved. Judge Robreno has been overseeing the progress and resolution of the remaining cases since then.  In the asbestos MDL No. 875, the court had issued Administrative Order 12, which required plaintiffs to submit medical diagnoses or expert opinions based on certain data, interpreted to include exposure history. The order was issued in 2007 and was intended to accelerate the handling of the significant numbers of cases in this MDL by screening out cases in which causation cannot be demonstrated, and to avoid unnecessary burdens on defendants by requiring plaintiffs to provide certain medical and exposure information at the outset of the case.

The district court dismissed several cases in 2012, holding that the plaintiffs' submissions regarding their alleged medical conditions did not meet Administrative Order 12.  Specifically, Judge Robreno determined that the Plaintiffs' submissions were fatally flawed in that they failed to include specific histories of Plaintiffs' exposure to asbestos. Plaintiffs' counsel disputed that interpretation of the order as requiring a complete occupational history of asbestos exposure, and offered simply a diagnosis of an asbestos-related disease. At no point did Plaintiffs offer supplemental AO 12 submissions with more complete exposure histories. 

The Third Circuit agreed that the language of AO 12 is broad, but saw no reason not to defer to the District Court's interpretation of AO 12 that requires plaintiffs' submissions to include asbestos exposure history. Based on the language in AO 12 that requires plaintiffs to submit medical diagnoses or opinions based on objective and subjective data, as well as based on statements from reputable medical organizations that emphasize the importance of exposure history, the District Court interpreted AO 12 submissions to include exposure history. And it was not an abuse of discretion – especially given the District Court's experience overseeing the MDL proceedings – to require a complete occupational and environmental exposure history. 

 

JPML Releases MDL Stats

 The U.S. Judicial Panel on Multidistrict Litigation recently released the data on requests for coordination and dispositions in 2012, and some interesting trends can be detected.

Specifically, the Panel has shown an increasingly strict view of MDL requests.  In the early years of the last decade, the Panel routinely granted most requests, and even as recently as 2007-09 the Panel was granting 4 out every 5 requests.  Since then, however, the panel has denied more than 40% of the MDL requests.

One theory for the change is the increase over time in the number of petitions made, but that trend has actually started to level off in recent years.  And the Panel has always maintained it has sufficient able federal judges to mange the MDL's.

Another theory has to do with the feedback received by the Panel from judges and practitioners in a 2010 survey of MDL practice.  Much of that feedback discussed the Panel's ostensible preference for centralization.  The Panel now may have a deeper appreciation for the costs and economics of creating an MDL.

A third theory is that CAFA and federal court scrutiny of class actions has pushed more cases into the MDL stream, and sooner, although it is hard to confirm any rampant prematurity phenomenon.

Another is a possible change in the mix of cases proposed for MDL status.  Recent cases may have smaller numbers of parties, more varied filing dates, differing defendants, and different subject matters -- fewer antitrust matters and more consumer fraud claims, for example.  

 

 

Duke Organizing Special MDL Conference

Here is a conference opportunity worth thinking about for our readers who work on MDLs.

The Director of the Duke Law Center for Judicial Studies notes that they are looking for additional experienced lawyers from diverse areas of practice to attend an invitation-only conference, addressing the “Future of MDL” on May 2-3 in Washington DC area. The Panel on Multi-District Litigation is addressing pressing issues affecting their responsibility and is seeking input from knowledgeable lawyers at the conference.

The conference is to bring together outstanding panels of academics, MDL Panel members, and experienced private practitioners who, along with the other conferees, will critically examine what works and what maybe does not work in MDL procedures. The upcoming conference is designed to give experienced lawyers the opportunity to make a difference by making their views known on pressing issues directly to some of the key officials responsible for administering the MDL system.

Information on the “Future of MDL” conference, including the agenda and faculty, is posted here. All who get invited to register for the conference are expected to actively participate during discussions. If any of our readers are interested in being invited to the conference you can send Ann Yandian at Duke (ann.yandian@law.duke.edu) a short description of your MDL experiences, and indicate your areas of practice, number of years practicing law, and which side of the “v” you typically represent.

As an aside, the Duke Law Center for Judicial Studies has as its mission advancing the study of the judiciary through interdisciplinary scholarship and cooperative thinking from multiple perspectives, including judges, researchers, teachers, theorists, and practitioners.

Panel Rejects MDL Status for Brass Plumbing Claims

We have posted before about the MDL process and the importance of the initial decision by the Panel on ordering coordination. Last week the Judicial Panel on Multidistrict Litigation declined to consolidate the suits by plaintiffs alleging injuries over brass plumbing fittings.See In re Uponor Inc., F1960 Plumbing Fittings Products Liability Litigation, MDL No. 2393 (JPML 9/27/12).

We like to flag for readers, for any insights they may offer, the less common decisions rejecting MDL status, see also here and here.

The plaintiffs alleged in this litigation that high-zinc-content brass components on the plumbing fittings failed, due to corrosion that caused the loss of zinc. This resulted, they said, in various forms of property damage, including the loss of integrity of the components, leaks, loss of water pressure, and other problems.This litigation currently consists of nineteen actions pending in
seven districts, but the Panel was notified of four additional, potentially related actions.

All involved homeowners supported plaintiff’s motion. The Uponor/Wirsbo defendants also supported the motion but  other responding defendants, which are various plumbing and supply defendants,  builders, or installers, opposed the motion and, alternatively, suggested a different transferee forum.

The Panel rejected the motion, noting that "several practical considerations" make the request to centralize unworkable. Most fundamentally, this request rested on a factual assumption – that F1960 fittings are involved in every action – that required the Panel to make a determination not apparent on the face of most complaints. Very few complaints actually mentioned the F1960
standard. Instead, plaintiffs typically framed their complaints as broadly involving high zinc yellow brass fittings and other attendant components. The exceedingly general language that the homeowners employed in most actions to describe the defective components at issue
made it impossible in most cases to transfer “F1960 claims” and then separate and remand, other product claims.

But even assuming that the court could separate and remand the non-F1960 claims, the proposed transfer would still double the forums in which numerous local defendants would have to litigate, or [in an important practical observation]  at a minimum, monitor. Centralization might thus force many local defendants – builders, plumbers, suppliers – to prosecute their indemnity claims against the manufacturer in the MDL, while still having to defend claims that they supplied, built homes with, or installed defective plumbing components elsewhere.

Fragmentation of this litigation, said the Panel, also would increase the risk that the involved
courts will rule inconsistently on identical issues of state law, such as issues of compliance with Nevada’s unique state pre-litigation statute regarding construction defects. The potential inefficiencies and inconvenience associated with centralizing this litigation, separating out F1960 claims etc.,  outweigh any possible benefits of, or added efficiencies to, resolving common claims regarding the F1960 fittings.

"Centralization is not a cure-all for every group of complicated cases."  The actions here were in
distinct procedural postures, and most of the advanced actions seem to be progressing well in the District of Nevada.

Thus, moving parties failed to convince the Panel that Section 1407 transfer of F1960 claims will benefit the parties and witnesses, or that centralization will produce sufficient clarity or efficiency in this already complicated litigation to outweigh the added inconvenience, confusion and cost that would be imposed on numerous parties.
 

 

Challenge to Federal-State Court Coordination Overture Prompts Response

One of the challenges of our system of federalism, and dual jurisdiction between state and federal courts, is the coordination of related cases pending in the two systems.  Perhaps nowhere does this happen more regularly than in the realm of mass torts.  Federal cases may be coordinated in an MDL, and several states, such as New Jersey, have a procedure to centralize mass tort filings in their state court system. See Hermann, et al. Statewide Coordinated Proceedings (2d ed. West 2004). But coordination between the state and federal level has been more difficult, more informal, more experimental. That is, state and federal judges, faced with the lack of a comprehensive statutory scheme, have undertaken innovative efforts to coordinate parallel or related litigation so as to try to reduce the costs, delays, and duplication of effort that can stem from such dispersed litigation. State judges, for example, can bring additional resources that might enable an MDL transferee court to implement a nationwide discovery plan or a coordinated national calendar

Recently, plaintiffs in state court cases in the Actos litigation sent the Actos federal MDL court a letter complaining that the judge improperly "intervened" by discussing the litigation "ex parte" with the state court judge.  The plaintiffs asserted that the federal court persuaded the state court judge to rule in a certain fashion on scheduling issues, including the time for discovery and trial dates. Plaintiffs complained that such "intervention" would prevent them from properly litigating their cases; violated the important policy of comity (citing the Anti-Injunction Act); and raised "objectivity" concerns.  Plaintiffs requested the federal court refrain from such communications in the future with any state court judges handling Actos cases, citing the Canons of Judicial Ethics.  Finally, the letter asked that plaintiffs further be heard on this issue at an upcoming MDL hearing.

At first blush, this seemed like an over-reaction by plaintiffs, and perhaps an attempt to intimidate the court into not doing what seems like a perfectly acceptable thing, informally coordinating litigation which raises similar issues, involves many of the same counsel, and likely will implicate many of the same discovery requests, fact and expert witnesses. We leave it to the loyal readers of MassTortDefense to decide for themselves about the tone of this letter.

So how did the federal court react? Judge Doherty is overseeing the federal multidistrict litigation, In re: Actos (Pioglitazone) Products Liability Litigation (MDL-2299). Her reaction came in the form of a "Memorandum Response." The court read the original letter as possibly alleging improper and unethical conduct by both the federal and state court judges, and doing so by making "completely specious" arguments. On the merits, the court began by noting that the Manual for Complex Litigation recommends cooperation and coordination among federal and state court judges in these mass tort contexts.  So does the state court-focused manual, Managing Mass Tort Cases: A Resource for State Court Judges, published by the Conference of Chief Justices. The important notion of comity was respected because the communication from the MDL court was merely an invitation asking whether state courts might see any benefit in talking about the litigation posture. An invitation to chat is not an "intervention." And any communications were in that same spirit.

The court's memorandum turned to the MDL schedule, its internal logic and consistency, and the ample opportunity all parties had to comment on and object to any of its provisions. The court then points out, logically, that an improper ex parte conversation involves a communication between the court and one , but not all parties -- not a conversation between two independent judges.

The court than labeled a "cautionary tale" those cases that warn attorneys against unsubstantiated allegations that bring the judiciary into disrepute. Finally, the court noted that the letter inaccurately cites the Code of Judicial Conduct. The canons clearly do not prohibit a judge from consulting with other judges to aid the judge in carrying out his or her responsibilities.

The court gave the authors the benefit of the doubt, deciding ultimately to view the letter as over-zealous, ill-advised, poorly thought out, regrettable hyperbole, and empty rhetoric, as opposed to something more troubling.   An interesting read for all our readers, especially those with MDL practices.

 

Court of Appeals Considering Significant Mass Tort Settlement Issue

When a defendant settles a mass tort, it wants to achieve peace; one of the worst things that can happen is for plaintiffs to attempt to pursue claims that were and ought to have been extinguished in the settlement.  An important version of this issue arises in the Vioxx mass tort. See In re: Vioxx Products Liability Litigation, No. 12-30560 (5th Cir. 2012).

Amicus, the Product Liability Advisory Council, weighed in on the issue, emphasizing the policy implications.  Merck entered into a class action settlement in the Vioxx MDL. Afterwards, plaintiffs in Missouri sought to pursue claims that had already been resolved in the settlement. Specifically, the state court plaintiffs sought recovery of alleged economic damages for the price of Vioxx prescriptions that were owned, not by the Missouri plaintiffs, but by the MDL plaintiffs who settled their claims and were paid already.  The MDL court stepped in, issuing an injunction under the All Writs Act, to protect and effectuate its orders regarding the settlement.  The district court concluded that the injunction was necessary to prevent interference with years of effort, at great expense, to reach the massive settlement. Plaintiffs appealed.

PLAC noted that an MDL court has authority and flexibility to decide a case and to manage it, including to effectuate binding settlements that state courts may not frustrate or imperil. Injunctions in aid of the settlement are valid exercises of a federal court's authority under the All Writs Act.

The policy underlying this view is that, otherwise, the finality of virtually any class action involving pendent state claims could be defeated by subsequent suits brought in those states, asserting rights derivative of those already released by class members.  As a practical matter, no defendant in consolidated federal court actions could reasonably be expected to consummate a settlement of the claims if those claims could later be reasserted under state law by different plaintiffs seeking recovery of the money already paid to the federal court plaintiffs.

The "clear and present risk" to the finality of the settlements reached, argued PLAC, was the duplication of effort, the re-litigation of claims that were settled, and a possible double recovery of the damages. The success of any federal court settlement is dependent on the parties' ability to agree to a release of all claims in exchange for fair consideration; if any of those claims can be re-litigated, there could be no certainty about the finality of the federal settlement, nor the amount a defendant will pay.  This would threaten settlement efforts by the district courts, and hamper the utility of the MDL forum.  Indeed, MDL litigation presents a unique opportunity to resolve large numbers of claims in an efficient manner. Parallel state court actions that functionally would require defendants to pay twice on the same claims would severely curtail the incentive to settle.

PLAC argued that the had been careful not to over-reach; the injunction forbids recovery only of the claims that have already been settled.

JPML Declines MDL Status for Surgical Robots

We have posted before about the MDL process and the importance of the initial decision by the Panel on ordering coordination. Last week the Judicial Panel on Multidistrict Litigation declined to consolidate the suits by plaintiffs alleging injuries from da Vinci surgical robots. See In re Da Vinci Robotic Surgical System Products Liability Litigation, MDL No. 2381 (J.P.M.L., , 8/3/12).

We like to flag for readers, for any insights they may offer, the less common decisions rejecting MDL status, see also here and here. Also here. See here.

At the time of the decision there were five cases pending in five different federal courts. Defendant Intuitive Surgical, Inc. also supported the motion. The parties even agreed on centralization in the Northern District of California.

But the Panel was not persuaded that Section 1407 centralization would serve the convenience of the parties and witnesses or further the just and efficient conduct of this litigation. Each action, said the Panel, alleged personal injuries arising out of alleged defects in the da Vinci Robotic Surgical System. These are "relatively straightforward personal injury or wrongful death actions,"   and the litigation may focus to a large extent on individual questions of fact concerning the circumstances of each patient’s alleged injuries.

Given the "minimal number of actions currently pending," the proponents of centralization failed to convince the Panel that any factual questions shared by these actions are sufficiently complex or
numerous to justify Section 1407 transfer. The court noted that the proponents maintained that this litigation may eventually encompass “hundreds” of cases or “over a thousand” cases. But the Panel declined to accept such predictions, and considered voluntary coordination among the parties and the involved courts of these relatively actions to be a preferable alternative to centralization at this time.

Court of Appeals Affirms Exclusion of Plaintiff Expert Testimony

The Sixth Circuit earlier this month affirmed the exclusion of plaintiff expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. See Simmons v. Novartis Pharmaceuticals Corp., No. 11-5053 (6th Cir., 6/5/12).

Simmons developed osteonecrosis of the jaw (ONJ), a bone disease affecting the jaw, allegedly as a result of using the prescription medications Zometa and Aredia. He sued and the Judicial Panel on Multidistrict Litigation transferred the action under 28 U.S.C. § 1407 to the United States District Court for the Middle District of Tennessee and assigned it to Chief Judge Todd Campbell.

To prove specific causation, plaintiff offered two experts. Plaintiff offered Dr. Obeid, a board-certified oral and maxillofacial surgeon who saw the plaintiff, and Dr. Edward Gutman an experienced oral surgeon. Defendant moved to exclude, inter alia, the testimony of Drs. Obeid and Gutman, on the issue of causation. The MDL court granted the motion to exclude any testimony by Dr. Obeid as
to the cause of Simmons’s injury, and by a separate order the district court granted defendant’s motion to exclude Dr. Gutman’s causation testimony. The court then granted defendant’s motion for summary judgment on all of plaintiff’s claims because plaintiff no longer had proof of an essential element of a product-liability claim under Maryland law, i.e., specific causation. Plaintiff appealed.

The court of appeals noted that a treating physician’s testimony is subject to Daubert. See Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419, 426 (6th Cir. 2009). Plaintiff was therefore required to demonstrate that Dr. Obeid’s reasoning or methodology was scientifically valid and that he properly applied that reasoning or methodology to the facts at issue. Plaintiff relied on Dr. Obeid’s statement that he found “a very close association” between ONJ and the class of drugs. However, Dr. Obeid also specifically acknowledged that he “didn’t establish causation” in evaluating Simmons’s ONJ.  Readers know that association is not causation.  Furthermore, Dr. Obeid agreed that the current level of evidence did not support a cause-and-effect relationship between bisphosphonate exposure and ONJ. While there were references to the medication in Dr. Obeid’s medical records, even if this was a "diagnosis," a diagnosis is merely a hypothesis, which does not satisfy Daubert and Rule 702. Moreover, nowhere in his testimony did Dr. Obeid rule out other conditions as the sole cause of Simmons' ONJ.

As to Dr. Gutman, the court noted that he had no knowledge of the etiologies of ONJ prior to meeting Simmons, and then gained only a limited familiarity based on literature supplied to him by plaintiff’s counsel. He had never treated any patients who were taking Aredia or Zometa or any other bisphosphonate, had never diagnosed a patient with ONJ, or determined a cause of
a patient’s ONJ.  Dr. Gutman admitted that he was not an expert on Zometa, Aredia, bisphosphonates, or ONJ, except as to Simmons’s case. He had no independent expertise from any other source other than six medical articles plaintiff’s counsel gave him; other than these
articles, there was no other "methodology" supporting his opinion.

The district court also did not abuse its discretion in excluding Dr. Gutman’s specific causation
opinion as unreliable because it was not derived from scientifically valid principles but
rather relied exclusively on the scientific literature provided by counsel. Dr. Gutman
made no attempt to verify this information, such as by doing his own research for other articles, and then drawing an independent conclusion. Courts view with special caution expert testimony prepared solely for purposes of litigation, rather than flowing from an expert’s line of scientific or technical work.  

Exclusions upheld; summary judgment affirmed.

Court of Appeals Affirms Dismissal of FEMA Trailer Claims

The Fifth Circuit recently upheld the dismissal of putative class actions filed by Mississippi and Alabama residents against the federal government alleging trailers provided to Hurricane Katrina-impacted citizens contained hazardous levels of formaldehyde. See In re: FEMA Trailer Formaldehyde Products Liability Litigation (Mississippi Plaintiffs), No. 10-30921, and In re: FEMA Trailer Formaldehyde Products Liability Litigation (Alabama Plaintiffs), No. 10-30945 (5th Cir. 2012).

Plaintiffs-Appellants brought this Federal Tort Claims Act action against the United States for injuries allegedly related to their exposure to elevated levels of formaldehyde contained in the component materials of the Emergency Housing Units (“EHUs”) provided to them by the Federal Emergency Management Agency (“FEMA”) after Hurricanes Katrina and Rita. Readers will recall we have posted about various aspects of this litigation before. In October 2007, the United States Judicial Panel on Multidistrict Litigation created MDL No. 07-1873 (In re: FEMA Trailer Formaldehyde Products Liability Litigation), and assigned the complex litigation to the United States District Court for the Eastern District of Louisiana.

The key facts: After the hurricanes, FEMA activated its Individual and Household Assistance Program and, from September 2005 through May 1, 2009, the agency supplied disaster victims with EHUs, at no cost, to use as temporary shelter. The EHUs were taken from FEMA’s preexisting inventory, which had been purchased from public retailers as well as directly from manufacturers. The EHUs were small, portable, and usually placed at the disaster victims’ home sites. The trailers were installed by government contractors who placed the units on blocks or piers, anchored them to the ground using straps or bolts, and connected them to public sewer and water lines.

In March 2006, when FEMA began receiving formaldehyde-related complaints, it encouraged shelter occupants to ventilate their EHUs by opening the doors and windows. In June 2006, FEMA prepared an informational brochure informing EHU occupants of the potential risks of formaldehyde exposure, encouraging them to ventilate their units, and urging them to seek medical help if they developed health problems related to formaldehyde. In September 2006, FEMA began working with the Environmental Protection Agency to test the EHUs for formaldehyde, and also developed various new mitigation techniques.  In July 2007, FEMA distributed another informational brochure to EHU occupants, set up a hotline and a dedicated call center to field formaldehyde complaints from occupants, and continued to assist occupants in locating alternative housing. FEMA subsequently entered into an agreement with the CDC to conduct additional testing, the findings of which were compiled in a third informational brochure and distributed to EHU occupants in early 2008.

The federal government filed various motions to dismiss the claims against it, or in the alternative for summary judgment, based on the FTCA’s discretionary function exception.The district court denied the motions and held that the FTCA’s discretionary function exception might not apply to some or all of appellants’ claims, the determination of which would be driven by the facts of each individual case.  The district court then denied class certification and scheduled a series of bellwether trials in the MDL, but none of the FTCA claims brought by the bellwether plaintiffs against the Government advanced to the trial stage.

The Government then moved under Federal Rule 12(b)(1) to dismiss Appellants’ FTCA claims for lack of subject-matter jurisdiction on the grounds that no analogous private liability existed under the Mississippi and Alabama emergency statutes.  The district court granted the Government’s motion and dismissed appellants’ FTCA claims. Plaintiffs appealed to the Fifth Circuit.

 A plaintiff may only sue the United States if a federal statute explicitly provides for a waiver of sovereign immunity. The United States must consent to be sued, and that consent is a prerequisite to federal jurisdiction. Delta Commercial Fisheries Ass’n v. Gulf of Mex. Fishery Mgmt. Council, 364 F.3d 269, 273 (5th Cir. 2004). Waivers of sovereign immunity are narrowly construed in favor of the United States. In re Supreme Beef Processors, Inc., 468 F.3d 248, 253 (5th Cir. 2006). The FTCA is recognized as providing a waiver of sovereign immunity and provides the sole basis of recovery for tort claims against the United States. See 28 U.S.C. § 1346 and § 2671, et seq.; In re Supreme Beef Processors, 468 F.3d at 252 n.4. But the Act provides that the United States shall be liable in the same manner and to the same extent as a private individual under like circumstances. See
28 U.S.C. § 2674.

The "same manner" analysis is a mix of federal and state law. The FTCA requires the  Government's liability to be measured in accordance with the law of the state where the alleged act or omission occurred, so here the Appellants’ FTCA claims were limited by the relevant provisions set forth in Mississippi and Alabama tort law. See 28 U.S.C. § 1346(b)(1); Richards v. United States, 369 U.S. 1, 11-14 (1962); Cleveland ex rel. Cleveland v. United States, 457 F.3d 397, 403 (5th Cir. 2006). Whether a private person in “like circumstances” would be subject to liability is also a question of sovereign immunity and, thus, is ultimately a question of federal law. See United States v. Olson, 546 U.S. 43, 44 (2005). Because the federal government could never be exactly like a private actor, a court’s job in applying the standard is to find the most reasonable analogy. LaBarge v. Cnty. of Mariposa, 798 F.2d 364, 366-69 (9th Cir. 1986). Inherent differences between the government and a private person cannot be allowed to disrupt this analysis. The Fifth Circuit has consistently held that the government is entitled to raise any and all defenses that would potentially be available to a private citizen or entity under state law. Camacho v. Tex. Workforce Comm'n, 445 F.3d 407, 410 (5th Cir. 2006). Therefore, if a private person under “like circumstances” would be shielded from liability pursuant to a state statute, lower courts must decline to exercise subject matter jurisdiction in a case like this.

Because, here, the Mississippi and Alabama emergency statutes abrogate the tort liability of a private person who, (1) voluntarily, (2) without compensation, (3) allows his property or premises to be used as shelter during or in recovery from a natural disaster, the Government’s voluntary, cost-free provision of the EHUs to disaster victims, in connection with Hurricanes Katrina and Rita, was
also immunized conduct under the statute.  Despite plaintiffs' arguments, the Government’s provision of the government-owned EHUs, as implemented by FEMA, was voluntary because it was under no contractual or legal obligation, under any federal legislation, to provide the EHUs to disaster victims in response to the disasters. The Government did not receive compensation from the disaster victims in exchange for letting them use the EHUs. (The collection of taxes by the Government was not comparable to the traditional quid pro quo compensation contemplated by the statute.) In addition, the Government’s actions relating to the EHUs fell within the time frame contemplated by the statute as “during or in recovery from” a major disaster, since FEMA’s temporary emergency housing program ran from the hurricanes up to May, 2009.

Because Mississippi and Alabama emergency laws would protect those private individuals who shelter natural disaster victims from tort liability, the federal government's voluntary provision of the trailers was likewise immunized, the court concluded.

As an alternative, the appellants asked the Fifth Circuit to certify questions to the state supreme courts of Alabama and Mississippi regarding the meaning of the state emergency statutes, but the appeals court agreed with the district court that these questions did not warrant certification. Dismissals affirmed.

MDL Status Denied in Beverage Litigation

The Judicial Panel on Multidistrict Litigation declined to consolidate the suits brought by plaintiffs attacking the marketing of beverages as “all natural” even though they allegedly contained a preservative. In re Skinnygirl Margarita Beverage Marketing and Sales Practices Litigation, No. 2306 (JPML 12/14/11).

The central allegation was that Skinnygirl Margarita beverage was marketed as being all natural
despite some level of sodium benzoate. Pursuant to 28 U.S.C. § 1407, plaintiffs sought  centralization of actions pending in six districts. Plaintiffs sought centralization in the Central District of California or, in the alternative, the District of New Jersey. 

The Panel was not persuaded that Section 1407 centralization was necessary for the convenience of the parties and witnesses or for the just and efficient conduct of this litigation at this time, even if these putative nationwide class actions may share some factual questions regarding the defendants’ alleged marketing. It appeared that the common, material disputed facts may be limited in number. In addition, centralization would not prevent either conflicting or multiple rulings, because plaintiffs brought their claims under the laws of different states. Under some state laws, for example, the state of mind or reliance by individual purchasers may be a critical factor; in others it may not. These issues would not thus involve common discovery.

Finally, that all defendants uniformly opposed centralization was a factor which is quite influential where other factors do not strongly favor centralization. 

The order cited to the precedents that earlier this year, the Panel denied centralization in MDL No. 2248 – In re: Nutella Marketing and Sales Practices Litigation even though the common defendant, and eventually all plaintiffs, supported centralization. See In re Nutella Mktg. and Sales Practices Litig., 2011 WL 3648485, (J.P.M.L. Aug. 16, 2011). Similarly, the Panel denied centralization in MDL No. 2026 – In re: AriZona Beverage Co. Products Marketing and Sales Practices Litigation. The Panel found that the factual questions surrounding whether the defendants deceptively marketed their beverage products as being all natural when those beverages contain high fructose corn syrup did not appear to be sufficiently complex or numerous to warrant centralization. See In re AriZona Beverage Co. Products Mktg. and Sales Practices Litig., 609 F. Supp. 2d 1369 (J.P.M.L. 2009). A similar outcome was  deemed  appropriate here.



 

Class Certification Denied in BPA Litigation

A Missouri federal court last week denied the class certification motion of consumers suing defendants in the multi-district litigation over the use of bisphenol-A in baby bottles and sippy cups. In re: Bisphenol-A Polycarbonate Plastic Products Liability Litigation, No. 4:08-md-01967 (W.D. Mo.).

As we have posted before, the federal judge in the MDL involving BPA in baby bottles refused last Summer to certify three proposed multistate classes in this multidistrict litigation. In re: Bisphenol-A Polycarbonate Plastic Products Liability Litigation, No. 08-1967 (W. D. Mo. July 7, 2011).   That decision offered an interesting discussion of choice of law, and of the notion of commonality after Dukes v. Walmart, and included an important reminder that while individual issues relating to damages do not automatically bar certification, they also are not to be ignored. E.g., In re St. Jude Medical, Inc., 522 F.3d 836, 840-41 (8th Cir. 2008) (individual issues related to appropriate remedy considered in evaluating predominance); Owner-Operator Independent Drivers Ass’n, Inc. v. New Prime, Inc., 339 F.3d 1001, 1012 (8th Cir. 2003), cert. denied, 541 U.S. 973 (2004) (individual issues related to damages predominated over common issues); see also In re Wilborn, 609 F.3d 748, 755 (5th Cir. 2010).

The court gave plaintiffs an opportunity to show that a class of Missouri-only consumers should be certified, and plaintiffs then moved for certification of three classes of Missouri consumers. Plaintiffs alleged three causes of action: violation of the Missouri Merchandising Practices Act (MMPA), breach of the implied warranty of merchantability, and unjust enrichment.

The court focused first on standing. A court may not certify a class if it contains members who lack
standing. In re Zurn Pex Plumbing Products Liability Litigation, 644 F.3d 604, 616 (8th Cir. 2011). Plaintiffs’ proposed classes here could not be certified because they included individuals who had not suffered an injury-in-fact.  Individuals who knew about BPA’s existence and the surrounding controversy before purchasing defendants’ products had no injury. There was a potential for the proposed classes to include a large number of such uninjured consumers. Plaintiffs admitted that parents often carefully research baby care product purchases, and defendants submitted proof that information regarding BPA was in the media (including popular press such as "20/20") as early as 1999.

The opinion also offers an instructive discussion of reliance. Plaintiffs argued the issue of knowledge goes only to consumers’ reliance on defendants’ alleged nondisclosure, and plaintiffs always contend reliance is not an element of their consumer fraud claims. The court explained that the hypothetical posed by the question of reliance – whether the plaintiff would have purchased the product if she/he had known – presupposes the consumer did not know the relevant information. Thus, the question of knowledge logically precedes the question of reliance.

Even consumers who were unaware of BPA when they purchased defendants’ products may not have suffered an injury. Consumers who fully used defendants’ baby bottles and other products without physical harm before learning about BPA suffered no injury, and could not assert a claim under consumer protection statutes or for breach of warranty. Plaintiffs asserted that none of the proposed class members received what they intended to obtain, because plaintiffs were not provided material information before making their purchases. But plaintiffs were bargaining for baby products at the time of transaction, not for a certain type of information. Those who fully used the products before learning about BPA would have received 100% use (and benefit) from the products.

In the Rule 23 analysis proper, the court also noted that plaintiffs’ proof of what defendants failed to disclose would not be common for all class members, at least with respect to the scientific debate concerning BPA. Class-wide evidence cannot be used to show what defendants knew or should have known because their knowledge and the available information about BPA changed during the
class period. Plaintiffs' proposed trial plan stated they intended to show defendants' alleged awareness and nondisclosure of various scientific studies from 1997 to at least 2006.

The court's observation on materiality is also worth noting. A material fact for state consumer fraud liability includes a fact which a reasonable consumer would likely consider to be important in making a purchasing decision.  Even if this is an objective inquiry, that does not mean it can always be proven with class-wide evidence. A 2006 study allegedly showing BPA's effect on the endocrine systems of snails, even if material, would not be probative of defendants' liability in 2002. Similarly, a reasonable consumer may be less likely to consider a scientific study from 1997 significant if that consumer learned that federal agencies over the years – the FDA in particular – considered that study, and nevertheless still concluded BPA could be safely used to make baby products.

Finally, the court considered superiority and manageability, with a key issue of concern how to determine who was in the class (some courts do this analysis under the ascertainability rubric). Identifying himself or herself as a purchaser would not prove a person is in the class. A plaintiff in a typical case is not allowed to establish an element of a defendant’s liability merely by completing an affidavit swearing the element is satisfied, and this should be no different for a class action.  Defendants would be entitled to cross-examine each and every alleged class member regarding his or her memory and story.

For all these reasons, class certification denied.

Gulf Oil Spill MDL Court Issues Trial CMO

The court managing the Gulf oil spill MDL recently entered an important case management order defining the structure and scope of the upcoming trial on the Deepwater Horizon oil spill.  That Trial of Liability, Limitation, Exoneration, and Fault Allocation is scheduled to commence, as previously ordered in CMO No. 1 and CMO No. 2, on February 27, 2012.  See In re: Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico, on April 20, 2010, MDL No. 2179 (E.D. La., Order 9/14/11).

Readers know we have been keeping an eye on this signficant litigation since the MDL was created. CMO No. 3 notes that the trial will address all allocation of fault issues that are to be tried to the bench without a jury, including the negligence, gross negligence, or other bases of liability of, and the proportion of liability allocatable to, the various defendants, third parties, and non-parties with respect to the issues, including limitation of liability.

The trial will be conducted in three phases.

Phase One [the Incident Phase] of the trial will address issues arising out of the conduct of various parties, third parties, and non-parties allegedly relevant to the loss of well control at the Macondo Well, the ensuing fire and explosion on the Deepwater Horizon vessel, the sinking of the Deepwater Horizon on April 22, 2010, and the initiation of the release of oil from the Macondo Well or Deepwater Horizon.

Phase Two of the trial will address Source Control and Quantification of Discharge issues. Source Control issues consist of issues pertaining to the conduct of various parties, third parties, and non-parties regarding stopping the release of hydrocarbons stemming from the Incident from April 22, 2010 through approximately September 19, 2010. Quantification of Discharge issues refer to  issues pertaining to the amount of oil actually released into the Gulf of Mexico as a result of the Incident from the time when these releases began until the Macondo Well was capped on approximately July 15, 2010 and then permanently cemented shut on approximately September 19, 2010.

Phase Three [Containment Phase] of the trial will address issues pertaining to the efforts by various parties, third parties, and non-parties aimed at containing oil discharged as a result of the Incident by, for example, controlled burning, application of dispersants, use of booms, skimming, etc. Phase Three of the trial will also address issues pertaining to the migration paths and end locations of oil released as a result of the Incident as carried by wind, currents, and other natural forces.

CMO No. 3 also addresses the sequence of proof for Phase One: first plaintiffs, then Transocean, then the other defendants. At the end of each Phase of the trial and after consideration of the parties' submissions, the Court may decide to issue partial Findings of Fact and  conclusions of Law for that Phase if it deems the record adequately developed. The Court said it anticipates that discovery and other pretrial proceedings for Phase Two of the trial and possibly for Phase Three of the trial will likely need to be conducted concurrently with pretrial proceedings for and the conduct of Phase One of the trial.

 

 


 

MDL Court Rules on Availability of Punitive Damages in Gulf Oil Spill Litigation

The MDL court overseeing the claims arising from the 2010 Gulf of Mexico oil spill has ruled that plaintiffs can seek punitive damages against allegedly responsible parties in economic loss and property damage suits. In Re: Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico on April 20, 2010, No. 2:10-md-02179 (E.D. La., 8/26/11).

Readers may recall that this MDL consists of hundreds of consolidated cases, with thousands of claimants, arising from the April 20, 2010 explosion, fire, and sinking of the Deepwater Horizon  mobile offshore drilling unit, which resulted in the release of millions of gallons of oil into the Gulf of Mexico before it was finally capped approximately three months later. In order to efficiently  manage this complex MDL, the court consolidated and organized the various types of claims (e.g., personal injury, environmental, property, and economic damages) into several “pleading bundles.”  One such pleading bundle includes all claims for private or non-governmental economic loss and property damages.  There are in excess of 100,000 individual claims encompassed within this bundle.

The court recently ruled on several pending motions to dismiss the claims by this sub-group of plaintiffs, but let's focus on the punitive damages claims. The court's analysis began with the Oil Pollution Act of 1990: the OPA is silent as to the availability of punitive damages. So the issue became whether plaintiffs who could assert general maritime claims pre-OPA enactment could still plausibly allege punitive damages under general maritime.  The court concluded they could.

First, punitive damages have long been available at common law, and the common-law tradition of punitive damages extends to maritime claims. The court reasoned that Congress had not occupied the entire field of oil spill liability in light of the OPA provision preserving admiralty and maritime law, “except as otherwise provided.” OPA does not mention punitive damages; thus, while punitive damages are not available under OPA, the court did not read OPA’s silence as meaning that punitive damages are precluded under general maritime law. The MDL court observed that Congress knows how to proscribe punitive damages when it intends to, as it did in the commercial aviation exception under the Death on the High Seas Act, 46 U.S.C. § 30307(b) (“punitive damages are not recoverable”).
 

Second, the court saw nothing to indicate that allowing a claim for punitive damages in this context would frustrate the OPA liability scheme. All claims against the allegedly Responsible Party must comply with OPA’s procedure, regardless of whether there is also cause of action against the Responsible Party under general maritime law. However, the behavior that would give rise to punitive damages under general maritime law–gross negligence–would also break OPA’s limit of liability. See 33 U.S.C. § 2704(a). Thus, the imposition of punitive damages under general maritime law would not, according to the court, circumvent OPA’s limitation of liability.

Finally on this issue, the court noted that some courts had held that the Trans-Alaska Pipeline Authorization Act (“TAPAA”), which provided “the liability regime governing certain types of Alaskan oil spills, imposing strict liability but also capping recovery,” did not restrict the availability of punitive damages.  OPA, like TAPAA, creates a liability regime governing oil spills, imposes strict liability on the Responsible Parties, includes liability limits, and is silent on the issue of punitive damages.

Thus, the court concluded, the OPA does not displace general maritime law claims for those plaintiffs who would have been able to bring such claims prior to OPA’s enactment. 


 

MDL Panel Declines to Coordinate Spread Litigation

The Judicial Panel on Multidistrict Litigation declined recently to consolidate three suits by plaintiffs who alleged Ferrero U.S.A. Inc. misrepresented Nutella hazelnut spread as a healthy and nutritious food. In re Nutella Marketing and Sales Practices Litigation, MDL No. 2248 (J.P.M.L.,  8/16/11).

We are always interested when the Panel declines to coordinate cases, but also have to admit that this is a favorite product in the MassTortDefense household.  The spread, in its earliest form, was created in the 1940s by Mr. Pietro Ferrero, a pastry maker and founder of the Ferrero company. At the time, there was very little chocolate because cocoa was in short supply due to World War II rationing. So Mr. Ferrero used hazelnuts, which were plentiful in the Piedmont region of Italy, to extend the chocolate supply. The region is mostly mountains and hills, on the north-western border of Italy with France and Switzerland.

A plaintiff in the District of New Jersey action sought consolidation, arguing that the cases made similar allegations challenging Ferrero's marketing and advertising practices. Interestingly, movants and respondents both recommended centralization because the actions contained "similar allegations" concerning Ferrero’s advertising, marketing and sale of Nutella spread and its alleged misrepresentations of Nutella as a healthy and nutritious food. All parties disagreed only as to the appropriate choice for transferee district.

However, the Panel noted that it has an institutional responsibility that goes beyond simply accommodating the particular wishes of the parties. See In re: Equinox Fitness Wage and Hour Empl’t Practices Litig., 764 F. Supp. 2d 1347, 1348 (J.P.M.L. 2011) (denying unopposed motion for centralization of two actions).

Here, the Panel was not persuaded that Section 1407 centralization was necessary for the convenience of the parties and witnesses or for the just and efficient conduct of this litigation. The actions may have shared some factual questions regarding the common defendant’s marketing
practices, but these questions did not appear complicated to the Panel. Indeed, the parties did not persuade the Panel that any common factual questions were sufficiently complex or numerous to justify Section 1407 transfer.  Instead, said the Panel, cooperation among the parties and deference among the courts should minimize the possibility of duplicative discovery and inconsistent pretrial rulings. See, e.g., In re: General Mills, Inc., Yoplus Yogurt Prods. Mktg. and Sales Practices Litig., 716 F. Supp. 2d 1371 (J.P.M.L. 2010).

 

Interesting Case Management Issue in Welding MDL

We have posted about the welding fumes MDL before. Call it case management by option-- as the court has worked through the bellwether trials, it is interesting that the MDL court gave the next-up plaintiff (in the Street trial) a choice.  Plaintiff could either (1) maintain his existing trial date of June 1, 2011, at which trial he may not offer the opinions of his expert Dr. Sanchez-Ramos; or (2) postpone the starting date for trial of his case until on or about November 1, 2011, and the Court would conduct a Daubert hearing on the admissibility of Dr. Sanchez-Ramos’s opinions during the summer of 2011.

Plaintiff Street chose the second option. Accordingly, the MDL Court has set the Daubert hearing to begin on August 24, 2011, with the expectation the hearing will last two days. The parties were directed to negotiate a schedule for briefing, expert depositions, and so on, and provide it to the Special Master as soon as possible. The schedule will include a deadline of April 5, 2011, for provision by Dr. Sanchez-Ramos of a supplemental expert report and literature review list.


Trial of the Street case was accordingly postponed to November 1, 2011. The Court said it will
discuss trial preparation deadlines with the parties during the next case management teleconference.  In re Welding Fume Products Liability Litigation,  No. 1:03-CV-17000 (N.D. Ohio, 3/25/11).  

Negligence Ruling in Florida Chinese Drywall Litigation

The judge overseeing one part of the litigation involving Chinese drywall -- the Florida class action -- has issued an important ruling on the negligence claims. Bennett v. Centerline Homes Inc. et al., No. 2009-ca-014458 (Palm Beach County, Fla.)

Defendants moved to dismiss the negligence claims, arguing they had no duty to protect the plaintiffs from the unknown and unforeseeable harm of the drywall.  The court found that there was no duty to inspect or test the drywall for a latent defect, and thus to warn the plaintiffs.  Florida law does not impose a duty to inspect a product for a latent defect, or to warn others about a latent defect, unless the product is inherently dangerous (which drywall is not).

Home builders, installers or suppliers of allegedly defective Chinese drywall could only be held negligent if it is established that the companies were aware that the drywall was defective, through actual or implied notice.  But the issue whether a defendant had notice of a defect must be
determined on an individual, case-by-case basis.  Thus, the court declined to grant the motion on an omnibus basis. 

As we have noted before, according to the allegations of the litigation, a shortage of drywall made in the U.S. caused many builders to use imported Chinese drywall during Florida's construction boom between 2004 and 2006. Much of the drywall was used in construction after Hurricane Katrina.  Lawsuits filed over the drywall issues allege that excessive sulfur levels in the Chinese-made products are causing health effects and problems with air conditioning systems, appliances, internal wiring and other electrical systems. The U.S. Judicial Panel on Multidistrict Litigation consolidated the lawsuits in the U.S. District Court for the Eastern District of Louisiana.  Other defendants, including building supply distributors, general contractors and installers, face  litigation in state courts, like this one.

New Report on Asbestos and Silica Litigation in Texas

The Texas Civil Justice League has released a new report, "A Texas Success Story: Asbestos and Silica Lawsuit Reform."

Established in 1986, the Texas Civil Justice League is a non-partisan, statewide business coalition committed to legal reform and public policy research. The League makes legislative recommendations in vital issue areas, such as administration of the courts, general business liability, mass torts, and products liability.

The purpose of this special report is to document the current state of asbestos and silica litigation in Texas state courts. Part one provides a brief history of asbestos and silica litigation in the United States and an overview of the legislative efforts in Texas to address abuses in asbestos and silica litigation.  The report then offers a description of asbestos and silica litigation in Texas’s two multidistrict litigation courts handling asbestos and silica cases, and the impact of reform legislation (S.B. 15) on the state MDLs.

The report then turns to recent issues in asbestos litigation, specifically to the science-based evidentiary standards required by the Texas Supreme Court’s decision in Borg-Warner Corp. v. Flores.

Next are the issues relating to asbestos claimant compensation, starting with the role of bankruptcy trusts in compensating asbestos claimants; the bankruptcy trust payment system can provide substantial compensation to asbestos victims, but is a “black box” system that remains hidden from public scrutiny.

Lots of good info, worth a read.

New Report on Asbestos and Silica Litigation in Texas

The Texas Civil Justice League has released a new report, "A Texas Success Story: Asbestos and Silica Lawsuit Reform."

Established in 1986, the Texas Civil Justice League is a non-partisan, statewide business coalition committed to legal reform and public policy research. The League makes legislative recommendations in vital issue areas, such as administration of the courts, general business liability, mass torts, and products liability.

The purpose of this special report is to document the current state of asbestos and silica litigation in Texas state courts. Part one provides a brief history of asbestos and silica litigation in the United States and an overview of the legislative efforts in Texas to address abuses in asbestos and silica litigation.  The report then offers a description of asbestos and silica litigation in Texas’s two multidistrict litigation courts handling asbestos and silica cases, and the impact of reform legislation (S.B. 15) on the state MDLs.

The report then turns to recent issues in asbestos litigation, specifically to the science-based evidentiary standards required by the Texas Supreme Court’s decision in Borg-Warner Corp. v. Flores.

Next are the issues relating to asbestos claimant compensation, starting with the role of bankruptcy trusts in compensating asbestos claimants; the bankruptcy trust payment system can provide substantial compensation to asbestos victims, but is a “black box” system that remains hidden from public scrutiny.

Lots of good info, worth a read.

Panel Creates Vitaminwater MDL

The U.S. Judicial Panel on Multidistrict Litigation last week ordered the coordination of the litigation against Coca-Cola Co. alleging it misled the public about the nutritional benefits of its Vitaminwater.  In re: Glaceau Vitaminwater Marketing and Sales Practices Litigation, MDL No. 2215 E.D.N.Y.).

Common defendants The Coca-Cola Company and Energy Brands Inc. moved, pursuant to 28 U.S.C. § 1407, for coordinated pretrial proceedings of this litigation filed in three federal districts. (Two tag along districts emerged as well.) Some plaintiffs supported the motion; some opposed.  The parties opposing centralization variously argued, that (1) some of the actions named local retailers as defendants, and the claims against them presented unique
issues of fact; (2) questions of law were unique to the various jurisdictions in which actions have been filed; (3) only three actions were pending, alleging discrete multi-state or statewide classes of consumers.

The Panel found that these arguments had "some merit," but on balance, were outweighed by the benefits of centralization. Though only three actions were before the Panel, and they do not allege overlapping putative classes, the Panel was persuaded that centralization was appropriate. The relatively small number of cases was sufficient: the Eastern District of New York action consisted of five prior actions that were voluntarily consolidated, and it involves proposed classes of consumers from three states. Two additional related actions were pending.

These actions shared factual questions arising out of allegations that defendants misrepresented their VitaminWater product as a healthy alternative to soft drinks though it contains almost as much sugar, said the order. Section 1407 does not require a complete identity or even a majority of common factual or legal issues as a prerequisite to transfer. See, e.g., In re Gadolinium Contrast Dyes Prods. Liab. Litig., 536 F. Supp. 2d 1380, 1382 (J.P.M.L. 2008). Nor does it require an identity of common parties.

Centralization would eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary. Creation of an MDL will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation, the Panel concluded.

The Eastern District of New York was deemed to be the most appropriate transferee district. The action in that district had been pending for two years, and is more advanced than any other action in this litigation. The court has ruled on a motion to dismiss, and discovery is underway. Both some plaintiffs and some defendants supported centralization in this district.

Partial Settlement Proposed in FEMA Trailer Litigation

Defendants and certain plaintiffs in the FEMA TRAILER FORMALDEHYDE PRODUCTS
LIABILITY LITIGATION, MDL NO. 07-1873(E.D. La.) have filed a joint motion seeking approval of a partial settlement of the litigation.

Readers may recall from our previous posts that plaintiffs had filed claims against the United States and several manufacturers alleging that they were exposed to high levels of formaldehyde contained in emergency housing provided to them by FEMA in the aftermath of Hurricane Katrina. The plaintiffs proposed litigating the claims in six subclasses, including four subclasses for residents divided by state (Louisiana, Alabama, Texas, and Mississippi), a medical monitoring (“future medical services”) subclass, and an economic loss subclass.  The court denied the personal injury class, and then the medical monitoring class.   The court then adopted a bellwether trial approach.  We posted on the federal jury in Louisiana returning a defense verdict in just such a bellwether plaintiffs' suit over alleged exposure to formaldehyde fumes while living for several months in a FEMA-provided trailer.  Indeed, all three bellwether trials have resulted in losses for plaintiffs. There are currently two appeals pending from previous bellwether trial verdicts. The MDL court also found last year that FEMA itself could not be held liable for the alleged formaldehyde in the trailers.
 

Now, several maker of the emergency mobile homes used after hurricanes Katrina and Rita have agreed to pay approximately $2.6 million to settle certain claims that plaintiffs were allegedly sickened by levels of formaldehyde in the homes.  The proposed settlement covers FEMA mobile homes issued to victims of the hurricanes, not the travel trailers, which actually formed the majority of emergency housing made available after the hurricanes. 

Under the proposed settlement, a whopping 48% of that total will be set aside for plaintiff attorneys' fees.  According to the settlement agreement, the size of the potential settlement class is more than 1,000.  In addition to the trial results, the joint motion makes reference to the MDL court ruling that precluded plaintiffs from arguing for liability under varied (and higher) state standards, rather than a uniform federal level.

Dismissal of FEMA Trailer MDL Bellwether Plaintiff Affirmed

With the recognition by many courts of the inappropriateness of the use of the class action device for personal injury claims, the use of other methods to manage mass torts has emerged.  One approach frequently seen within MDLs is the bellwether trial.  Only a proportion of the cases are selected for case specific discovery; only a fraction of them go into a trial pool; and only a percentage of them are selected for trial, to serve as bellwethers for the remaining cases. The hope is that the trial-selected cases provide sufficient information, about claims and defenses, and case values, to inform and propel the disposition of the remaining cases. Such trials may force plaintiffs' counsel to prepare their standard trial package, and the trials may give some sense of how sound that package is. The bellwether trials may give the court a context to resolve legal questions that arise at a trial as witnesses begin to take the stand. Bellwether trials may test the expert witnesses and theories, and give both parties a sense of how much it costs to try a case to verdict. In theory, test trials are to produce valuable information that will allow the parties to assess the strength and settlement value of all the related cases. Accordingly, which cases go first, from among the hundreds or thousands in the mass tort can be extremely significant.

The process for selection of the bellwether cases is crucial.  If plaintiffs are permitted to handpick their best cases to go first, the process works only if plaintiffs lose their best cases; if they win their best cases, that comes as no surprise to anyone.  Ideally the court would pick truly representative cases. 

A significant, although less well recognized issue, is what happens when a bellwether plaintiff cannot or will not go to trial.  Plaintiffs often adopt this tactic to replace a plaintiff whose claim turns out to be, after discovery, not as strong as originally expected.  In the FEMA trailer formaldehyde MDL, the Fifth Circuit recently confirmed that plaintiffs cannot play fast and loose with the procedure, dropping plaintiffs from the line for trial without some sanction. The court of appeals refused to resuscitate a bellwether claim that was dismissed with prejudice after the plaintiff said he could not go forward with trial. In re: FEMA Trailer Formaldehyde Products Liability Litig., No. 09-31131 (5th Cir. 12/14/10).

Raymond Bell and his mother, like thousands of other plaintiffs, filed suit against multiple defendants who participated in the government’s program to supply temporary housing for victims of the devastating 2005 hurricanes. These cases were assigned by the Multi-District Litigation Panel for pretrial management by Judge Engelhardt in New Orleans. The MDL court set dates in 2009 and 2010 for four bellwether cases, each to be prosecuted by a plaintiff against one of the four trailer manufacturers estimated to have the most units at issue in the suits. The case of Diana Bell, Raymond’s mother, was identified as the bellwether case against Keystone RV, manufacturer of the trailer in which her family had lived.  Diana then dropped out, and voluntarily dismissed her case with prejudice. After consulting with counsel, the court promptly selected Raymond Bell as the next bellwether plaintiff in order to maintain the benefit of trial preparation concerning the particular trailer they both had lived in. The next Bell, however, also moved to substitute a new bellwether plaintiff or obtain a continuance of the 2010 trial date.

He made three arguments in support of this dual motion. He asserted he could not take two weeks off from his job to attend trial;  he could not afford to forego at least one week of income; and the trial dates would interfere with his participation in Community College classes at the beginning of the spring semester.

The trial court concluded that Raymond Bell really did not want to go to trial. He moved for a dismissal without prejudice and attached an affidavit asserting as fact the arguments noted above. He expressed doubt about the curative impact of the judge’s proposed instruction if he were to be absent from part of the trial.  The MDL court noted that plaintiffs’ counsel should take notice that all plaintiffs who assert claims in an MDL have to be ready and willing to serve as bellwether plaintiffs, if called upon to do so. The claims of those plaintiffs who refuse to do so, when called upon, will be dismissed with prejudice.

The reasoning was that the parties had expended much time, effort, and money into readying the case involving the Bell trailer for trial. Based on the decisions of the plaintiffs, all the pre-trial work and discovery relating to the Bell trailer was rendered utterly useless. All of the resources spent in preparing this case for trial had been wasted. Because the parties had to choose another bellwether plaintiff, which will involve conducting discovery on an entirely different trailer and readying a completely different case for trial, the claims of Mr. Bell, like those of Mrs. Bell, should be dismissed with prejudice.   Not doing so would possibly cause other bellwether plaintiffs to “jump ship” at the last minute; this is obviously a tactic that any MDL court does not wish to encourage.

On appeal the Fifth Circuit found that it was not hard to justify the court’s decision to deny the plaintiff's alternative motions. Raymond Bell’s attempt to withdraw as plaintiff or to continue seemed contrived, especially in light of his mother’s less than diligent prosecution of a claim bearing on the same trailer. Nothing in his motion papers distinguished Bell’s inconvenience in going forward with trial from the inconvenience that any plaintiff may suffer from having to try the case he has filed. The case had been pending for months, the parties had been actively preparing for trial.

Plain legal prejudice would have accrued to defendants from an unconditional dismissal of Raymond Bell’s case without prejudice. The court would have to realign Keystone RV with a new bellwether plaintiff who resided in a different trailer and whose suit would almost surely add a different group of subsidiary defendants. Not only would Bell be able to refile his suit, but the appellees were in no way spared the continuing costs of legal defense. Defendants'  investment in trial preparation for Bell’s case was wasted. Moreover, other plaintiffs in the FEMA trailer formaldehyde litigation were disadvantaged by the tactics employed on Bell’s behalf as they were delayed in acquiring trial information important for their cases. The size and scope of this multiparty litigation inescapably heightened the prejudice from Bell’s motion to dismiss.

Bottom line is that Bell wanted to have his cake and eat it too by withdrawing from a bellwether
trial and then sitting back to await the outcome of another plaintiff’s experience against the appellees. When a plaintiff files any court case, however, sitting back is no option. He must be prepared to undergo the costs, psychological, economic and otherwise, that litigation entails. That the plaintiff becomes one of a mass of thousands pursuing particular defendants lends urgency to this reality. Courts must be exceedingly wary of mass litigation in which plaintiffs are unwilling to move their cases to trial. Any individual case may be selected as a bellwether, and no plaintiff has the right to avoid the obligation to proceed with his own suit, if so selected.

 

 

Update on Deepwater Horizon MDL

Judge Carl Barbier recently presided over the November status conference in the MDL involving the Gulf oil spill litigation.  In re: Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico on April 20, 2010, MDL No. 2179 (E.D. La.).

Liaison counsel reported on the number of cases, now up to roughly 300, and on the status of the related 17 or so cases in state courts. 

A major topic was the entry of an order regarding preservation of evidence recovered from the seabed or otherwise. The order also noted the equipment related to the Deepwater Horizon explosion that must be turned over to the government's Joint Investigation Team as it is recovered. The government reported that forensic testing had begun on the Blow Out Preventer, with a report estimated to be available in March, 2011. Counsel for the Justice Department also reported to the Court that a sample of cement from the site had been turned over to the Marine Board and was being held in a climate-controlled area while the parties discuss protocols for physical testing of the cement. (The Marine Board is the joint investigation by the U.S. Coast Guard and the Bureau of Ocean Energy Management, Regulation, & Enforcement.)

Defense counsel reported that the Gulf Coast Claims Facility  (GCCF) has paid out nearly $1.9 billion in claims so far, to 395,000 claimants, with about 150,000 other claims awaiting additional documentation.

The deadline for submission of Plaintiff Profile Forms is this month, and it is expected that the Forms will be used to help identify appropriate test cases.  The first trial slot is for February, 2012.

The parties reported that written discovery and depositions will begin in January, 2011.

The next status conference was set for December 17th.

 

  

Lone Pine Order Adopted in Avandia MDL

In the right case, we are big fans of the "Lone Pine" order as a tool of case management.  Named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986), Lone Pine orders are designed to handle the complex issues and potential burdens on the parties and the court in mass tort and toxic tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).   The term refers to case management orders that require the plaintiffs to make a showing regarding causation, injury, and/or damages to demonstrate, typically at an early stage, some minimal level of evidentiary support for the key components of their claims which will be in dispute.

While the 1986 New Jersey Superior Court case involved traditional toxic tort claims, the device has gotten good use in drug cases as well.  E.g., In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010). After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement.  The order required non-settling plaintiffs to notify their health-care providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply eventually resulted in dismissal of several of the plaintiffs' claims with prejudice.

And the federal judge overseeing the MDL for Celebrex and Bextra found that a “Lone Pine” order was appropriate for managing the claims of the remaining, non-settling plaintiffs. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No. M:05-cv-01699 (N.D. Cal.) (Pretrial Order No. 29, Aug. 1, 2008).

In the drug context, a Lone Pine order might require plaintiffs to submit a case-specific expert report on the issue of medical causation; or to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and/or proof of dosage in relation to the injury. The benefit to the court of requiring plaintiffs to supply this information is that the parties will not have to engage in protracted discovery in hundreds or thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence is simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Requiring plaintiffs to identify basic information about injuries and causation is not unreasonable given the costs that mass tort claims have on the legal system, and on defendants in particular. Lone Pine orders allow courts to weed out the frivolous suits where there is insufficient exposure, or no sufficient scientific connection between injury and exposure. Accordingly, Lone Pine orders can be effective when entered early in the game. Early disposal of frivolous claims allows the parties to focus their attention on the serious cases. Ideally, the order will actually phase discovery, and motions practice as well, with the Lone Pine issues pushed up front.

But the device also has a role later in mature mass torts when, as seen above, a chunk of the litigation has settled and there still remain numerous claims of questionable strength.

In the MDL involving the the diabetes medication Avandia, In re Avandia Marketing, Sales Practices, and Products Liab. Litig., MDL No. 1871 (Pretrial Order No. 121)(E.D. Pa. Nov. 15, 2010), the federal court has recently adopted a Lone Pine order.  The court found that many of the remaining claims lacked sufficient support or detail even after submission of the Plaintiff Fact Sheets.  Thus, additional detail about the plaintiffs' claims was necessary in furtherance of settlement agreements, for the selection of cases for bellwether trials, and for the timely remand of cases to the transferor courts for resolution.

The court's overriding concern was having sufficient information to objectively identify which of the many thousands of remaining plaintiffs have injuries that could credibly be linked to the drug usage.  The order calls for information that the court said the plaintiffs should have had before filing their claims.

Specifically, plaintiffs have to have a licensed physician identify the plaintiff's Avandia usage, the alleged injury, the time lag between drug usage and injury, and a certification that the drug usage caused the injury.

Failure of a plaintiff to submit these required expert certification (and supporting documents) in a timely fashion may result in the dismissal of that plaintiff's claims with prejudice.

A defendant in such litigation should not bear the burden of winnowing cases that never should have been filed, nor should the court be saddled with consideration of claims that would not have survived reasonable pre-complaint investigation.

 

MDL Court in Peanut Butter Litigation Grants Multiple Summary Judgments For Defense

The MDL court overseeing the coordinated federal litigation stemming from a 2007 peanut butter recall recently granted summary judgment to the defendant manufacturer ConAgra Foods in multiple cases.  See Southern v. ConAgra Foods Inc., MDL 1845, No. 09-1544  (N.D. Ga. 9/29/10).

Readers may recall that in 2007, ConAgra Foods Inc. recalled jars of Peter Pan and Great Value peanut butter that were made at its Georgia plant, after the CDC and FDA observed a possible association between these products and reports of salmonella poisoning.  As part of the recall, ConAgra instructed consumers to discard the jar but to save the lid, which contained the product code identifying when and where the peanut butter was manufactured.  After the recall, multiple consumers sued ConAgra, alleging they had contracted salmonella after eating either Peter Pan or Great Value peanut butter. The lawsuits were consolidated in an MDL in the Northern District of Georgia.

To prove causation, each plaintiff must show that it is more likely than not that contaminated peanut butter caused his or her illness. The best way to show that peanut butter is contaminated with Salmonella is to test the peanut butter itself, said the court. The fact that the peanut butter was recalled here does not mean that it was contaminated. In fact, most of the recalled peanut butter was completely free of Salmonella contamination. During discovery, accordingly, ConAgra asked the plaintiffs to provide the product code for the peanut butter that allegedly caused their illnesses. It also asked the plaintiffs whether they submitted a blood, urine, or stool sample to a doctor for testing. Because the symptoms of Salmonellosis are similar to those of other common gastrointestinal illnesses, these samples were important in determining causation, said defendant.

Here, the 19 plaintiffs could not establish causation, as a matter of law. First, they could not show that the peanut butter they ate was manufactured by ConAgra at the Sylvester plant during the outbreak.  Plaintiffs did not know the product codes from their peanut butter. Without these numbers, which indicate when the peanut butter was manufactured, it was impossible to know whether the peanut butter was at risk of contamination.

Second, the plaintiffs did not provide enough evidence to show that they contracted Salmonellosis shortly after eating the peanut butter. Symptoms alone are not enough to permit a reliable diagnosis of this disease because the symptoms of Salmonellosis – usually diarrhea, abdominal cramps, and fever – are more commonly associated with viruses, parasites, fungi, other bacteria, toxins, and various chronic diseases. Indeed, the CDC estimates that nearly 300 million cases of diarrhea and related gastrointestinal symptoms occur each year of other causes. A positive blood, urine, or stool sample is the best way to show that Salmonella caused a plaintiff’s illness. A proper differential diagnosis by a physician who examined and treated a plaintiff during his illness may also support a finding of causation in some cases, said the court.  

But none of the plaintiffs here provided evidence of a differential diagnosis or a positive blood, urine, or stool culture. None of the plaintiffs' available medical records indicated that the plaintiffs’ doctors considered and excluded other causes or performed any form of differential diagnosis or diagnostic tests. To the contrary, the records showed that most plaintiffs did not even visit the doctor until several months after eating the allegedly contaminated peanut butter.

Without more, concluded the court, no reasonable jury could find that it was more likely than not that
contaminated peanut butter caused the plaintiffs’ alleged illnesses.

 

 

Oil Spill MDL May Appoint Special Master

The judge overseeing the Gulf oil spill  MDL has given notice of its intent to appoint Duke Law Professor Francis McGovern, as a special master to help the parties address several complex issues arising from the Deepwater Horizon accident.  In re: Oil Spill by the Oil Rig "Deepwater Horizon" in the Gulf of Mexico, on April 20, 2010, MDL No. 2179 (E.D. La.).

In the order last week, the court accordingly, pursuant to Rule 53 of the Federal Rules of Civil
Procedure, provided notice to the parties of its intention to appoint a special master.  In mass tort litigation, courts often appoint special masters to assist in managing the matters, especially the discovery. Rule 53 permits the court to appoint a master for pretrial matters that cannot be addressed effectively or in a timely manner by the court. Appointment of a special master to supervise discovery may be appropriate where the financial stakes justify imposing the expense on the parties, and where the amount of activity required would impose undue burdens on a judge.

The Manual for Complex Litigation says that it is preferable for the court to appoint the special master with the parties' consent, and here the court is giving the parties an opportunity to weigh in.  The success of the special master in the role the court assigns depends in the first instance on the person selected.  Prof. McGovern is well known to our readers, having served as special master or mediator in dozens of major mass torts, including several asbestos matters, DDT toxic exposure litigation, the Dalkon-Shield controversy, and silicone gel breast implant litigation.  As an academic, he has advocated for enhanced roles for court appointed special masters as "case managers" and "settlement masters." As a practicing case manager, he has helped courts to organize the pretrial administration of a case, and used ADR techniques to help the parties agree on efficient discovery approaches and schedules. (But note the Manual for Complex Litigation advises against referral of extensive pretrial management to a special master, at Section 10.14). His role as settlement master in some cases has required that he develop innovative ways to implement potential settlements. In the Dalkon Shield litigation, he helped organize and administer the distribution of the $2.4 billion trust established to compensate 100,000 women who had sued the maker of the device.

He is also a prolific author on mass torts issues, including A Model Mass Tort: The PPA Experience, 54 Drake Law Review 621-638 (2006); A Model State Mass Tort Settlement Statute, 80 Tulane Law Review 1809-1826 (2006); and A Proposed Settlement Rule for Mass Torts, 74 UMKC Law Review 623-636 (2006).

The final order appointing the special master will specify the scope of the reference, the circumstances under which ex parte communication will be deemed appropriate, and other relevant details.  Ordinarily, the special master will produce a report on the matters in his or her charge, with findings of fact and conclusions of law which would be reviewed by the district court.

 

Update on Gulf Oil Spill Litigation

Couple of interesting issue being debated in the Gulf Oil Spill Litigation.  In re: Oil Spill by the Oil Rig "Deepwater Horizon" in the Gulf of Mexico on April 20, 2010, MDL-2179 (E.D. La.).

The first concerns control over the testing of key components of the rig, once they are recovered.  Readers know how important such testing can be in supporting or refuting causation theories. But the very act of testing, even if not destructive, potentially alters the condition of the product.  Who goes first; what tests get run in what order; who does the testing; how tests are done... all of these can be vitally important issues in accident investigation and product liability litigation.

Defendant Transocean Ltd. unit has asked the judge in the MDL to grant a motion for a protective order that would block the government's apparent plan to unilaterally control testing of the oil rig's blowout preventer. Press reports suggest the blowout preventer could be recovered from the Gulf floor in the near future. Transocean Offshore Deepwater Drilling Inc. and several other defendants thus filed a motion last week in the U.S. District Court for the Eastern District of Louisiana for an expedited hearing on the protective order covering the blowout preventer.

The federal government has indicated that it wants to take exclusive control of the blowout preventer, transport it to a government site, and then contract for forensic testing and analysis. The motion argues that while the government has solicited input from other parties on testing protocol, it never said it would pay attention to any of those suggestions.

The second issue is a battle between Transocean and co-defendant BP over document discovery. Transocean attorneys are claiming that BP has been withholding documents and limiting Transocean's access to sensitive information connected to the accident, including records of tests on the blowout preventer, lab reports on components of the rig such as the well cement mix, and data on equipment used to keep well pipes in place during cementing.  BP, for its part, calls the claim a "publicity stunt” designed to divert attention from Transocean's alleged role in the accident.  BP claims it has already turned over thousands of pages of documents, including materials on the initial exploration plan, lab tests and daily drilling reports, and mud log reports.

Third, the American Petroleum Institute and other parties who are defendant-intervenors have asked the MDL judge to remand one of the many coordinated cases.  Gulf Restoration Network et al. v. Salazar et al.  This one is the suit brought by environmental groups against the federal government, and the argument is that it is fundamentally different from the other cases because it focuses on administrative law issues regarding the government’s approval of offshore drilling plans.

The Gulf Restoration Network, along with the Sierra Club, accused the U.S. Department of the Interior of ignoring environmental regulations when it allegedly waived safety regulations to allow BP and Transocean to conduct offshore drilling exploration in the Gulf of Mexico.

The discovery for negligence claims at the core of the MDL, these moving parties assert, will not materially assist or advance a case that stems from the legal issue whether the federal government took proper steps in granting the companies the offshore drilling exploration permits.  In fact, the argument goes, keeping Gulf Restoration in the MDL would unreasonably delay what would normally be a quick resolution to an administrative law action.

 


 

Drywall Litigation Update

The Georgia Superior Court has preliminarily approved a $6.5 million settlement between the Lowe's home improvement stores and a nationwide proposed class of drywall purchasers. Vereen v. Lowe's Home Centers Inc., SU10-CV-2267B (Ga. Super. Ct., Muscogee Cty.).

The proposed resolution of this piece of the drywall litigation would provide Lowe's gift certificates ranging from $50 to $2,000 to any consumer who purchased drywall (not just from China), as well as cash awards of up to $2,500, if the claimant can provide documentation of damages and proof of purchase. That is, plaintiffs who provide proof of purchase of drywall from Lowe's but have no proof of actual damages would receive gift cards valued up to $250. Class members unable to provide a proof of purchase would receive $50 gift cards.

Under the settlement, Lowe's also agreed to pay attorneys' fees and expenses up to 30% of the class fund, as well as $1 million to the plaintiff attorneys for administration of claims. The settlement purports to release Lowe's from all drywall claims.The Georgia court conditionally certified a settlement class and set a final fairness hearing for November 19th.

But the proposed settlement has apparently drawn objections from participants in the federal Chinese drywall multidistrict litigation, who are arguing that the settlement fund is too small and that the settlement would interfere with federal jurisdiction.  The plaintiffs' steering committee for the Chinese drywall multidistrict litigation in the Eastern District of Louisiana went so far as to move to enjoin the state court from moving ahead with the settlement, arguing that the benefit to the class is too small, and the attorneys' fees too large. Ironically, these plaintiff attorneys assert that the form of the class benefit, i.e.,  a gift card, is also improper.

The MDL lawyers assert that the parties involved in the MDL have been negotiating towards a global settlement, and allowing the state court, one-defendant settlement to go forward would simply undermine those efforts.  They called on the federal court, pursuant to the Anti-Injunction Act, to enjoin state court proceedings where, as here, it is allegedly necessary in aid of its jurisdiction or to protect or effectuate its judgments.

Readers will recall that after Hurricanes Katrina and Rita in 2005, drywall was imported from China to address a shortage of drywall required for repairs and new construction. After the drywall was installed, homeowners began to complain of smells, gas emanations, corrosion of appliances and electrical fixtures, and other alleged property damage. The lawsuits typically allege that sulfur compound levels in the drywall are too high, causing issues with air conditioning systems, electrical appliances, internal wiring, and other electrical systems in homes. Plaintiffs also allege the drywall produces a rotten egg-like stench and causes a variety of respiratory and other health problems for those who live in the affected homes.

So far, a few bench or jury bellwether trials have been completed, with mixed results.
 
 

JPML Orders Gulf Oil Spill MDL to Eastern District of Louisiana

The Judicial Panel on Multidistrict Litigation yesterday selected New Orleans as the site of the oil spill litigation MDL. The Panel ordered coordination, and transferred 77 lawsuits to the Eastern District of Louisiana before U.S. Judge Carl J. Barbier (and referred to more than 200 potential tag along actions). In Re: Oil Spill by the Oil Rig "Deepwater Horizon" in The Gulf of Mexico, MDL No. 2179 (Aug. 10, 2010). 

In its order, the Panel found that the cases indisputably share factual issues concerning the cause (or causes) of the Deepwater Horizon explosion/fire and the role, if any, that each defendant played in it. Centralization under Section 1407 would eliminate duplicative discovery, prevent inconsistent pretrial rulings, including rulings on class certification and other issues, and conserve the resources of the parties, their counsel, and the judiciary. Interestingly, the Panel noted that centralization may also facilitate closer coordination with Kenneth Feinberg’s administration of the BP compensation fund.

Over some objections, the Panel also concluded that it made sense to include the personal injury/wrongful death actions in the MDL. While these actions will require some amount of individualized discovery, in other respects they overlap with those that pursue only economic damage claims, found the Panel. The Order notes that the transferee judge has broad discretion to employ any number of pretrial techniques – such as establishing separate discovery and/or motion tracks – to address any differences among the cases and efficiently manage the various aspects of this litigation. See, e.g., In re Lehman Brothers Holdings, Inc., Securities & Employee Retirement Income Security Act (ERISA) Litigation, 598 F.Supp.2d 1362, 1364 (J.P.M.L. 2009). 

In terms of where the cases should be coordinated, the Panel noted that the parties advanced sound reasons for a large number of possible transferee districts and judges. They settled upon the Eastern District of Louisiana as the most appropriate district for this litigation. Without discounting the spill’s effects on other states, the Panel concluded that "if there is a geographic and psychological center of gravity in this docket, then the Eastern District of Louisiana is closest to it."

In selecting Judge Barbier, the Panel expressly declined the suggestion made at oral argument that, given the litigation’s scope and complexity, it should assign the docket to multiple transferee judges. "Experience teaches," said the Panel, that most, if not all, multidistrict proceedings do not require the oversight of more than one judge, provided that he or she has the time and resources to handle the assignment. Moreover, Judge Barbier has at his disposal all the many assets of the Eastern District of Louisiana which is accustomed to handling large MDLs. Judge Barbier may also, found the Panel, choose to employ special masters and other case administration tools to facilitate certain aspects of the litigation. See Manual for Complex Litigation, Fourth §§ 11.52, 11.53 (2004).


 

JPML Hears Oral Argument In Gulf Oil Spill MDL

The U.S. Judicial Panel on Multidistrict Litigation heard oral argument last week on the issue of consolidating the hundreds of cases arising from the Gulf oil spill. In re: Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico,  MDL No. 2179.

The MDL panel met this time in Boise, Idaho, and suspended the usual rule limiting oral
argument to 20 minutes.  Multiple attorneys representing the various parties in the pending cases addressed the panel.  Most defendants urged the cases be coordinated in the Southern District of Texas, while most plaintiffs, including some of the restaurant owners and fishermen affected by the spill, argued for the Eastern District of Louisiana, asserting that much of the injury/damages is centered there. A  few other plaintiffs pushed for the cases to be coordinated in Mississippi, Alabama, or Florida courts.

BP argued that the Texas forum was appropriate because this defendant's headquarters, documents, and key fact witnesses are all located there. The government wants the cases consolidated in New Orleans. But one issue is that 8 federal judges, including several in Louisiana, have recused themselves from the spill cases.  This led to discussion whether potential judicial conflicts should compel the panel to bring in a judge from outside the Gulf states. In New Orleans, the Eastern District of Louisiana has consolidated its 50+ oil spill cases before Judge Carl J. Barbier, who has issued interim case management orders and appointed interim liaison counsel for plaintiffs and defendants.  Some have argued this has effectively created an administrative framework that could be utilized were the Panel to send the MDL to New Orleans.

At last look, federal cases were spread around the country, including in New York and California and Illinois.  However, the busiest oil spill dockets are in the Eastern District of Louisiana, Southern District of Texas, Southern District of Alabama, and the three Florida district courts, each with more than 10 cases. 

As noted here, the litigation involves a wide variety of claims, from personal injury, to property or environmental damages, lost profits, and securities-based economic injury.  The panel asked whether the cases, even if consolidated, should be put in separate groupings.  Some plaintiffs' attorneys  argued it was particularly important to set up a separate track for personal-injury claims.  

 

Court Rebuffs Forum Shopping - But Shoppers Get Bargain Anyway?

A federal court recently ordered the transfer of an action involving an allegedly defective pain pump from Minnesota to plaintiffs' home state of North Carolina, in an apparent rebuff of attempted forum-shopping. Powell v. I-Flow Corp., No. 10-1984 (D. Minn. 7/14/10).

This case is one of thousands of product liability actions filed in recent years in the District of Minnesota by plaintiffs who have no connection to Minnesota against defendants who have no connection to Minnesota regarding events that did not occur in Minnesota and that had
no impact within Minnesota.  Here, defendants are  Delaware corporations with their principal places of business in California. Plaintiff underwent shoulder surgery in North Carolina in 2001, and he and his wife sued defendants for damage to his joint that allegedly resulted from the treatment of his post-surgical pain with a pain pump made by the defendants. In short, this case had no discernible connection to Minnesota.

Presumably the plaintiffs did not file this action in North Carolina — where they live,
where the pain pump was implanted, and where plaintiffs' alleged injuries occurred —
because it is too late to sue the defendants there.  Indeed, observed the court, the vast majority of these kinds of unconnected actions have been filed in this district because, if they were filed by the plaintiffs in their home states (or almost anywhere else), they would be dismissed under the applicable statutes of limitations. The Minnesota Legislature has, however, enacted unusually long statutes of limitations, and the state court has applied them to cases such as this.  See Fleeger v. Wyeth, 771 N.W.2d 524, 525 (Minn. 2009).

The federal court noted that such forum shopping imposes heavy burdens on the District Court and
diverts the court’s limited resources away from litigants and cases that have much stronger
connections to the District of Minnesota.

Defendants moved to transfer. Section 1404(a) provides: “For the convenience of parties and
witnesses, in the interest of justice, a district court may transfer any civil action to any other
district or division where it might have been brought.” 28 U.S.C. § 1404(a). Deciding whether
to order a transfer under § 1404(a) requires a case-by-case evaluation of the particular
circumstances at hand and a consideration of all relevant factors. See Terra Int’l, Inc. v. Miss.
Chem. Corp.
, 119 F.3d 688, 691 (8th Cir. 1997). The relevant factors fall generally into three
categories: (1) the convenience of the parties; (2) the convenience of the witnesses; and (3) the
interests of justice.

All these factors, said the court, overwhelmingly favor transfer. Because none of the parties is located in Minnesota, none of the relevant events occurred in Minnesota, none of the alleged injuries has been suffered in Minnesota, and none of the evidence is present in Minnesota, Minnesota does not appear to be convenient for anyone — including the Powells, who live in North Carolina.  In fact, any state with any connection to this lawsuit would be more convenient than Minnesota.  It is true that, as a general rule, courts afford some deference to a plaintiff’s
choice of forum; but this deference “is based on an assumption that the plaintiff’s choice of forum will be a convenient one.” In re Apple, Inc., 602 F.3d 909, 913 (8th Cir. 2010). When that assumption does not hold — when, as here, the plaintiff has chosen an inconvenient forum — the plaintiff’s choice of forum fades in importance.

The plaintiffs also argued that keeping all of the pain-pump cases like this one in Minnesota would further the interests of justice because the cases could be litigated more efficiently if they were all
litigated in the same district. But by this logic, plaintiffs’ lawyers could routinely force a “de facto” MDL on a district simply by filing enough similar cases in that district. This would allow plaintiffs’ lawyers to sidestep the MDL process — the very mechanism that federal courts have implemented for handling mass-tort actions.  In fact, the JPML has twice declined to consolidate pain-pump cases into an MDL. See In re Ambulatory Pain Pump-Chondrolysis Prods. Liab. Litig., MDL No. 2139, 2010 WL 1790214 (JPML May 5, 2010); In re Shoulder Pain Pump-Chondrolysis Prods. Liab. Litig., 571 F. Supp. 2d 1367 (JPML 2008).

One interesting tidbit, even though transferred, because the plaintiffs originally filed suit in Minnesota, the Minnesota statutes of limitations may travel with this case.  That is, if, under Minnesota’s choice-of-law rules, the Powells are entitled to the benefit of Minnesota’s statute of limitations, they may retain that benefit in the Eastern District of North Carolina. See Ferens v. John Deere Co., 494 U.S. 516, 523 (1990) ( § 1404(a) transfer does not change the law applicable in a diversity case); Eggleton v. Plasser & Theurer Export Von Bahnbaumaschinen Gesellschaft, MBH, 495 F.3d 582, 586 (8th Cir. 2007) (after a § 1404(a) transfer, “the transferee court applies the
choice-of-law rules of the state in which the transferor court sits”).  Thus, it may have been a rewarding shopping trip.

Toyota MDL Judge Issues Discovery Order

The judge overseeing the Toyota unintended acceleration MDL has issued an order permitting expanded discovery. In Re: Toyota Motor Corp. Unintended Acceleration Marketing, Sales Practices, and Products Liability Litigation, Case No. 8:10ML2151 JVS (Order No. 5: Phase I Discovery Plan, July 20, 2010).

Judge Selna (C.D. Calif.) noted that the Phase I Discovery Plan being promulgated was intended solely to educate the parties about foundational issues involved in the litigation, including the identification of the proper parties to this litigation, the identity of relevant third-parties, organizational structure, the identify of relevant witnesses, and identity, nature, and location of relevant documents. The court expects that discovery on foundational issues during Phase I will enable the parties to develop a more narrowly tailored discovery plan for subsequent phases of the litigation and to be more focused, economical and efficient in subsequent phases of discovery. In addition to the foundational information to be provided to plaintiffs by Toyota, Phase I will also provide Toyota the opportunity to obtain foundational, threshold information from plaintiffs, the class representatives, and relevant third-parties.

Phase I Discovery will last for 100 days, and the parties agreed the Phase I discovery plan needs to be coordinated to the extent feasible with related cases pending in state courts.

Under the order, the Toyota Defendants are to produce witnesses pursuant to Rule 30(b)(6) to testify concerning the twenty-one issues, including:

• organizational structure,
• the roles and responsibilities of each of the various Toyota companies with respect to the design, manufacture and sale of Toyota vehicles,
• the identity, nature, location and retention of documents related to the design, evaluation, manufacture, and testing of the ETCS system and any modifications or adaptations of the ETCS system for Toyota vehicles,
• the identity of the persons and departments involved in the design, evaluation, testing and manufacture of the ETCS and its components,
• the identity, nature, location and retention of documents related to information Toyotas has received about speed control, surge, and SUA events in Toyota and Lexus vehicles, including specifically warranty records, customer complaints, claims and lawsuits,
• procedures employed for investigating and responding to complaints of unintended acceleration by owners or operations of any Toyota vehicles, and
• the internal decision-making process by the Toyota Defendants about what and when to inform Toyota customers, governmental agencies and the public about SUA events and the identities of the persons and departments involved in that decision-making process and the identity of the persons and departments involved in that process.

The court ruled that during this litigation the parties must endeavor to avoid duplicative depositions or repetitive questions and to avoid deposing any witness more than once on the same subject matter. But it held off on ruling on Toyota’s position that no Toyota witness deposed during Phase I
would be deposed again in subsequent phases of this litigation on the same subject matter, except by agreement of the parties. Plaintiffs did not agree with Toyota’s position.

Plaintiffs are to provide completed Plaintiff Fact Sheets and Class Representative Fact Sheets, including the production of any documents responsive to the fact sheets. Fact Sheet Responses to information requests are deemed interrogatory responses pursuant to FRCP 33 and may be treated as such at time of trial, under the order. Responses have to set forth all information known or reasonably ascertainable to the party and/or their counsel. The parties are obligated to make a reasonable search and diligent inquiry for information or documents responsive to the request.
Fact Sheet Responses to document requests and the production of documents are deemed responses and production under FRCP 34. 

Additionally, the Toyota Defendants shall be permitted to conduct inspections of the subject vehicles.  Plaintiffs and class representatives have to identify whether the subject vehicle exists, and if so, its current location, general condition, and vehicle identification number, if known.  The parties agreed that vehicle inspections would be permitted commencing in Phase I. The protocol for vehicle inspections will apparently be determined on a case-by-case basis. 

 

New Empirical Study of MDL Transfers

From time to time, we try to note interesting articles worth a look from our readers.  In Williams, Margaret S. and George, Tracey E., Deciding Who Decides: Consolidating Multidistrict Litigation (July 1, 2010), the authors share the preliminary results of an empirical investigation of the MDL process. 

The United States Judicial Panel on Multidistrict Litigation may transfer factually related actions filed in different federal districts to a single judge for consolidated pretrial litigation. This transferee judge has significant discretion over the management of the litigation, and nearly all cases are resolved without returning to the original district court. Thus, as a practical matter, the Panel controls where most of  these disputes will be finally litigated.

The authors note that the Panel has substantial discretion in making that decision. In its forty years of existence, the Panel has transferred roughly 325,000 lawsuits including high-profile securities and derivative lawsuits (the collapse of Lehman Brothers and the Ponzi scheme of Bernie Madoff), consumer claims (Countrywide Mortgage’s lending practices), and mass torts ranging from the Vioxx litigation to the Union Carbine disaster in Bhopal to the bombing of Pan Am Flight 103. Motions are pending to consolidate and transfer more than 100 Gulf of Mexico oil spill suits filed against BP in the various districts along the Gulf coast to the Southern District of Texas.

This study provides an analysis of an empirical investigation of the Panel’s decision to transfer and consolidate pending federal civil lawsuits, examining the rationale for transfer and for the selection of a specific district court and judge to handle the consolidated litigation. The results provided here represent a sample from an ongoing data project which ultimately will include all Panel orders, say the authors. One preliminary conclusion was that more recommendations for a district by the parties and the representation of the district on the Panel increase the likelihood of a transfer
to that district.
 

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Welding Fume MDL Court Releases "Trial Template"

The Judge overseeing the Welding Fume Products Liability MDL Litigation has issued a “Trial Template” to assist transferor courts in handling the 3,900 remaining cases in the future.  In re: Welding Fume Products Liability Litigation, MDL No. 1535 (N.D. Ohio).

The document outlines the proceedings that have occurred in this MDL since its 2003 inception,
and summarizes the court’s pretrial rulings applicable to every MDL case. (All of this MDL court's written Orders cited in the document are available through the MDL court’s site.)  The stated purpose of the document is to assist trial judges in transferor courts who may preside over the trial of an individual welding fume case, after the Judicial Panel on Multi-District Litigation remands the
case from the MDL court back to the transferor court.

(Another good source on this mass tort for the interested reader is Jowers v. Lincoln Elec. Co., 608 F.Supp.2d 724 (S.D. Miss. 2009), in which the court reviewed all of the parties’ evidence in the context of resolving defendants’ post-judgment motions, filed after the jury reached a rare plaintiff’s verdict in the fourth MDL bellwether trial.)

Key points: since the MDL was created in the U.S. District Court for the Northern District of Ohio in June 2003, more than 9,800 cases have been transferred from other courts, and 2,700 have been removed to or directly filed with the court. Voluntary dismissals, remands and other events have reduced the number of pending cases to approximately 3,900. The gravamen of the complaint in each of these cases is that manganese contained in the fumes given off by welding rods has caused the plaintiff to suffer neurological injury, and the defendant manufacturers of these welding rods failed to warn of this hazard. At trial, defendants typically interpose some or all of the following fact-based defenses: (1) the warning language defendants used was adequate; (2) the plaintiff did not prove he used a particular defendant’s welding rods; (3) the plaintiff did not prove he saw a particular defendant’s warnings; (4) the plaintiff did not prove his neurological condition was caused by exposure to welding fumes; (5) the plaintiff’s neurological condition is not manganese-induced "Parkinsonism," it is something else (e.g., psychogenic movement disorder); (6) the defendants are immune pursuant to their role as government contractors; (7) the defendants are not liable because the plaintiff’s employer was a learned intermediary; (8) the defendants are not liable because the plaintiff was a sophisticated user; (9) the plaintiff did not prove that a better warning would have made any difference; (10) the plaintiff is, to some degree, responsible for his own injuries under the theories of contributory negligence, comparative negligence, or assumption of the risk; and (11) punitive damages are not available because the plaintiff did not present clear and convincing evidence of gross negligence.

The MDL court presided over six bellwether trials and is now in the process of suggesting remand to transferor courts of cases that have become close to trial-ready, the judge said. The court has so far applied the laws of five states in MDL bellwether trials: Mississippi, Texas, South Carolina, California, and Iowa. The parties sometimes, but not always, have agreed on which state’s law applies. In cases of disagreement, the choice-of-law analysis a transferor court will have to apply is likely to be fact-specific.

The court has granted summary judgment to certain defendants (MetLife & Caterpillar) in all welding fume cases. Further, the Court entered a “Peripheral Defendant Dismissal Order,” dismissing without prejudice all defendants in every case except those against whom a given plaintiff is most likely to proceed at trial. Still remaining as defendants in virtually every case are five of the biggest welding rod manufacturers: (1) Lincoln Electric Company, (2) BOC Group (formerly known as Airco) (3) ESAB Group, (4) TDY Industries (formerly known as Teledyne Industries and Teledyne McKay), and (5) Hobart Brothers Company. Defendant-specific discovery in each case may lead to dismissal of some of these five defendants, and possibly to renaming of some previously-dismissed defendants, the court observed. 

Regarding discovery, the parties have engaged in huge amounts of generic discovery directed at
information potentially relevant to every case. This includes, for example, the defendants’ alleged historical knowledge of the hazards posed by welding fumes, the warnings defendants provided to welders over time, and the state of medical and scientific knowledge regarding neurotoxicity of manganese in welding fumes. For the most part, the parties have completed all general discovery. To prepare for trial in a specific welding fume case, the parties must engage in substantial case-specific discovery directed at information relevant to the individual plaintiff’s particular claims and circumstances. This discovery typically will address the plaintiff’s employment history, medical history, and welding experiences. The court observed that at least some of this plaintiff-specific discovery may not occur until after the MDL court has remanded the case to the transferor court. Accordingly, a transferor court may need to oversee some aspects of case-specific discovery.

As to plaintiffs, about ten years ago, the national plaintiffs’ bar engaged in a concerted effort to notify welders that, if they suffered from a movement disorder, their neurological injury might be caused by exposure to welding fumes. The MDL court then imposed several obligations on plaintiffs’ counsel to ensure they intend to actually try the cases they filed. These additional obligations include the filing of: (1) a “Notice of Diagnosis” of neurological injury, signed by a medical doctor; and (2) a “Certification of Intent to Try the Case,” to be submitted by plaintiff’s counsel following initial medical records discovery. These obligations have winnowed the plaintiffs’ cases substantially, so the MDL court believes that there is some likelihood that a case remanded to a transferor court will go to trial.

On the expert front, the parties sought to introduce at trial testimony from a plethora of experts in a number of fields, including neurology, neuro-pathology, neuro-psychology, neuro-radiology, epidemiology, bio-statistics, industrial hygiene, industrial engineering, chemistry, materials science, toxicology, warnings, corporate ethics, military specification and procurement, economics, government lobbying, and ancient corporate documents. Early in this MDL, the court held a multi-day Daubert hearing to determine the admissibility of opinions offered by these experts. Further, the court engaged in additional analyses of the admissibility of expert testimony prior to each MDL
bellwether trial.

Before each MDL bellwether trial, the parties filed numerous motions in limine addressing the admissibility of various pieces of evidence, ranging from critical documents to relatively short comments made by witnesses. The court reviews each of those rulings in this latest document.  Similarly, the court had ruled on a number of motions for summary judgment as a matter of state and federal law. These motions are also described in the document.  For example, to prevail on his product liability claims against a particular manufacturing defendant, a welding fume plaintiff must show he actually used that manufacturer’s products. Because many plaintiffs worked as welders for a variety of employers in different locations over many years, and because welding rods are somewhat fungible, the discovery of product identification evidence can be difficult, and the results less than clear, said the court. Whether a given defendant is entitled to judgment as a matter of law based on lack of product identification is a highly fact-specific question, and the answer as to certain defendants in certain cases may not become clear even until after trial.

Finally, the court provides a number of useful appendices and charts, including MDL Bellwether Trial Result Summary and MDL Bellwether Trial Witness Chart.

Digitek Class Action Denied in MDL

The federal judge in the multidistrict litigation concerning the heart drug Digitek has denied class certification in the MDL's six remaining class actions.  In re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W. Va.).

Quick history. Digitek® is a trade-name for a drug called digoxin. Digoxin was approved by the FDA to treat various heart problems. At some point, a handful of non-conforming dose tablets were found in a lot of 4.8 million tablets.  Defendant initiated a voluntary Class I nationwide product recall.  A flood of civil actions were instituted in state and federal courts across the country. The plaintiffs claimed a variety of injuries and losses resulting from the recalled Digitek®. In 2008, the Judicial Panel on Multidistrict Litigation established an MDL proceeding.

The MDL court addressed several overlapping motions for class certification. The class representatives each sought some kind of economic loss class certified pursuant to Federal Rule of Civil Procedure 23. Two of the class complaints sought only a single-state class. Others sought a nationwide class of all persons residing in the United States who purchased Digitek® pursuant to prescription, during the time period when the recalled Digitek® was manufactured, or sold, who suffered economic losses, including, but not limited to, payments for recalled Digitek®, out-of-pocket expenses for diagnostic testing, medical visits, and/or new prescriptions, as a result of having received recalled Digitek®.

Generally, the plaintiffs focused not on the distinct and highly individualized alleged injuries to the class, but -- as is typical -- on defendants’ alleged misconduct that led to the recall.  In doing so, the plaintiffs tried to paint New Jersey as the nerve center for certification purposes. In fact, they said New Jersey law should control all of the potentially hundreds of thousands of class members’ claims and recoveries throughout the United States. They thus downplayed the individual issues that would arise, including choice of law. They stressed instead that the damages  allegedly suffered by each individual class member were modest and, absent a certified class, millions of consumers would be left without remedy.

The court first addressed the choice of law issues in a nationwide class, as the state in which each claimant was injured has an overriding interest in having its laws applied to redress any wrong done to its citizens.  For example, state consumer protection laws vary considerably, and courts must respect these differences rather than just apply one state's law to sales in other states with different rules.  In re St. Jude Medical, Inc., 425 F.3d 1116, 1120 (8th Cir. 2005).  See generally Kanner, Consumer Class Actions After CAFA, 56 Drake L. Rev. 303, 334 (2008).  Unjust enrichment law varies considerably throughout the United States as well.  Tyler v. Alltel Corp., 265 F.R.D. 415, 422 (E.D. Ark. 2010).  The court reached the same conclusion with the express and implied warranty claims.  See, e.g., Walsh v. Ford Motor Co., 807 F.2d 1000, 1016-17 (D.C. Cir.1986).  The differences impact the class certification factors of typicality, predominance, and manageability.

Putting aside the choice of law issue (that is, assuming a class of New Jersey residents alone and applying only New Jersey law to their claims), the court found that common issues still did not predominate. Violation of the NJ Consumer Fraud Act is subject to proof of a number of
elements, including that plaintiff suffered an ascertainable loss as a result of the unlawful conduct; and a causal relationship between the unlawful practice and the loss sustained.  That is, the New Jersey Consumer Fraud Act affords a right to monetary relief only if there has been an  ascertainable loss in consequence of the consumer receiving something other than what he bargained for, and losing the benefits of the product which he was led to believe he had purchased.  Plaintiffs' contention here that everyone in the class sustained an ascertainable loss presumes that the drug was worthless. But the drug was enormously beneficial to many patients; most got the right dose. Those patients presumably got their money's worth and suffered no economic injury. And the question whether an individual class member got his or her money's worth is inherently individual. Indeed, it involves very much the same questions as would a claim for money damages for personal injury.

This was seen in the differences between the class representatives: one returned Digitek® following the recall. But he received, in return, replacement digoxin at no charge. Another wanted a co-payment for a doctor visit that he had post-recall. He admitted, though, that the appointment was scheduled pre-recall. If certification were granted, this type of fact-intensive investigation and specific explanation would likely be necessary for all claimants to assure that their claims were compensation worthy.

The individual questions also proliferate to the extent the jury is ultimately required to determine which class members received defective Digitek® and which did not. In other words, it may ultimately be inappropriate, said the court, to treat all the recalled Digitek® as a single “defective” product for purposes of making the determination of whether it was unsafe.  Thus product identification would have individual, as opposed to collective, hallmarks.

Another individual issue was the vast array of individualized damages the representatives were seeking. The plaintiffs tried to sweep this concern aside. But even if not controlling,  individualized damage determinations cut against class certification under Rule 23(b)(3).  Ward v.
Dixie Nat. Life Ins. Co.
, 595 F.3d 164, 180 (4th Cir. 2010).

Finally, the court confronted the individualized process of sorting out those potential class members who were already fully compensated by the defendants' refund process. Mitigation was  another highly individualized matter.  Certification appropriately denied. 

Update on Chinese Drywall Litigation

The Consumer Product Safety Commission last week announced the results of testing performed by the Lawrence Berkeley National Laboratory on allegedly defective drywall samples.  Among the findings, most of the drywall that has allegedly caused personal injury and corroded electrical components in various homes throughout the U.S. was indeed manufactured in China;  specifically,  the most reactive sulfur-emitting drywall samples were all produced in China, according to the CPSC.  The worst-testing samples of the Chinese drywall showed emission rates of hydrogen sulfide 100 times greater than non-Chinese drywall samples.

CPSC released the names of the 10 worst-performing samples, including those of Knauf Plasterboard (Tianjin) Co. Ltd. for drywall manufactured in 2005, Taian Taishan Plasterboard Co. Ltd. for drywall manufactured in 2006, Shandong Taihe Dongxin Co. for drywall manufactured in 2005, Beijing New Building Materials for drywall manufactured in 2009.  Drywall samples manufactured in the United States in the same period contained low or no detectable emissions of hydrogen sulfide, according to the agency. 

At the U.S.-China Strategic and Economic Dialogue meetings in Beijing May 24-25, U.S. officials reportedly pressed the Chinese government to facilitate a meeting between CPSC and the Chinese drywall companies whose products were used in U.S. homes, and which exhibit the emissions identified during the testing procedures. The Strategic and Economic Dialogue represents the highest-level bilateral forum to discuss a broad range of issues between the two nations.

Federal cases concerning the drywall products are coordinated in multidistrict litigation pending in the U.S. District Court for the Eastern District of Louisiana. More than 7,000 plaintiffs have claimed that Chinese-made drywall in their homes emits sulfide gases that corrode electrical wiring and/or cause personal injury such as nasal damage and other respiratory problems.  In the first trial, the court ordered Taishan Gypsum to pay $2.6 million to seven plaintiffs last April. In the second trial, the court ordered Knauf Plasterboard to pay a plaintiff family $164,000.  In re: Chinese-Manufactured Drywall Products Liability Litigation, MDL No. 2047 (E.D. La.).

Cases are also pending in state court, and a state trial court in Miami recently certified a class in this litigation. Harrell v. South Kendall Construction Corp. et al., No. 09-008401 (11th Judicial Circuit, Fla.). Following a hearing last Thursday, Judge Farina granted class certification, the first Chinese drywall case to be certified. The class consists of approximately 150 claimants who were purchasers of homes in three subdivisions of the Keys Gate community there. The class alleged that those homes were built using Chinese drywall. Defendants are home builder Kendall Construction Corp., Palm Isles Holdings LLC, broker Keys Gates Realty Inc, and supplier Banner Supply Co.

The court found that a predominating common issue in each class member's case is whether the drywall installed in his or her house was defective. The trial court found that the alleged defect, the potential to emit sulfur gases that can cause damage, is inherent in the physical characteristics of the product and thus has a uniform nature. With one supplier and one builder allegedly involved, the court distinguished the case from other product defect cases in which individual issues are typically found to predominate.

The opinion noted that differences among proof of damages has typically not defeated class certification. The court stressed that if individual class member homeowners were to file their own separate actions, the court would be confronted with a multiplicity of lawsuits that would unnecessarily burden the court system and create the risk of inconsistent rulings and contradictory judgments.

While the court was clearly influenced by the belief that the issues surrounding the allegedly defective product were "unaffected by outside variables," like the way the product was used, its analysis of predominance is quite questionable.  For example, it concluded that a common issue was whether the defective drywall damaged the homes of the putative class members, and thus that the issue of injury (whether the drywall damaged all the homes) could be proved with class-wide evidence.  The fact is that enough of the drywall was imported to damage more than 50,000 homes; yet only a small percentage of that has been observed. Thus, it may be that any number of factors may be impacting the damage drywall is or is not causing in a particular house. Moreover, it is far too simplistic to talk about the injury or "damage" being caused, when there are hotly debated issues about whether there is injury to, or the need for remediation of, non-problem drywall, insulation, flex duct, molding, encapsulated wiring, counter tops, and a whole host of house components. Similar issues will relate to the causation of corrosion of a home’s electrical wiring or AC system.  

Proposed BPA Ban Undermines Food Safety Bill

Sen. Dianne Feinstein (D-Calif.) announced last week that she would seek to ban the chemical bisphenol-A in food and drink containers as part of an amendment to the proposed Food Safety Modernization Act (S.510). That move has the double distinction of lacking in scientific merit and threatening to undermine the bipartisan support for the good parts of the pending bill.  The Grocery Manufacturers of America and the Chamber of Commerce had expressed support for the food safety bill, but may oppose it if the bill contains language banning the chemical. The food safety bill is expected to come up after Congress returns from its Memorial Day break.

The Senator's ill-supported approach by-passes the safety review that belongs with the FDA, and is ongoing, with a re-review assessment due in 2011. NIH has also launched a study on the safety of low level exposure to BPA.  World-wide regulatory agencies who have reviewed BPA have thus far concluded that BPA is safe for use in canned products.  The European Food Safety Authority has announced a delay in delivering its own latest BPA report, needing more time to review the body of research on the chemical.

Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf stable foods and beverages.  The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic.  What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.

Even though there is no persuasive scientific evidence that BPA causes the type of harm the politicians speculate about, litigation is well underway in both the Western District of Missouri (MDL 1967) and the Western District of Kentucky (MDL 2137). The former involves class action suits against manufacturers of baby bottles and sippy cups. The claims include alleged violation of state consumer protection acts, fraud, breach of warranty, unjust enrichment, strict product liability, and negligence. MDL 2137, on the other hand, involves suits against an aluminum bottle manufacturer claiming that the manufacturer marketed its product as an alternative to BPA-containing plastic even though its metal bottles were allegedly lined with an epoxy resin containing BPA.  

 

Expert on "Ethics" Rejected in Device MDL

The federal court overseeing the MDL concerning an allegedly defective stress urinary incontinence device has issued a number of rulings on defendant Mentor Corp.'s motions to exclude various plaintiff experts. The one we want to focus our readers on is the order granting the company's motion to exclude the testimony of a so-called "business ethicist," who was proffered to testify about the supposed inappropriateness of Mentor's conduct relating to the warnings about the ObTape device.  In re Mentor Corp. ObTape TransObdurator Sling Prods. Liab. Litig., 2010 WL 1727828 (M.D. Ga. Apr. 27, 2010).

Mentor developed a device called ObTape Transobturator Tape (“ObTape”), which was used to treat women with stress urinary incontinence. Plaintiffs contended that the allegedly defective design of ObTape caused complications that resulted in significant injuries, including serious infections and erosion of the tape. Of course, every ObTape package included an FDA-approved Product Insert Data Sheet which listed vaginal erosion, urethral erosion, and infection as possible complications associated with ObTape. The Judicial Panel on Multidistrict Litigation transferred the several federal products liability cases to the Middle District of Georgia in 2008. Ahead of the upcoming trials in the bellwether cases, both parties filed various motions in limine to exclude the other's expert  witnesses.

Plaintiffs intended to offer Professor Ann Buchholtz, Ph.D., as an "ethics" expert. Prof. Buchholtz proposed to opine about defendant's alleged ethical duty to protect the safety of patients and its ethical duty to provide information to physicians and patients. Specifically, she asserted, based on a review of selected internal Mentor documents, that certain information about ObTape should have been reported to the FDA and to physicians and patients. Mentor contended that Prof. Buchholtz’s ethics opinions should not be permitted because (1) the opinions would not assist the jury, (2) the opinions are unreliable, and (3) Prof. Buchholtz is not qualified to render the opinions.

For an expert’s testimony to “assist” the trier of fact, the evidence must have a valid scientific connection to the disputed facts in the case. A court may exclude expert testimony that is imprecise and unspecific, or whose factual basis is not adequately explained. Cook ex rel. Tessier v. Sheriff of Monroe County, Fla., 402 F.3d 1092, 1111 (11th Cir. 2005).  Expert testimony is generally only admissible if it concerns matters that are beyond the understanding of the average lay person. Proffered expert testimony generally will not help the trier of fact when it offers nothing more than what lawyers for the parties can argue in closing arguments.

And that is the precise problem with so-called business ethics experts who testify merely to highlight plaintiff counsel's interpretation of cherry-picked internal documents; to testify as to ethical standards that are not legal standards at issue in the case; to invade the province of the jury by substituting the witness' conclusions about the appropriateness of the defendant's conduct; and to work the jury into a lather with a subjective, supposedly expert view of that conduct. See generally In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531 (S.D.N.Y. 2004). Personal views on corporate ethics and morality are not expert opinions. See In re: Diet Drugs Prod. Liab. Litig., 2001 WL 454586 at *9 (E.D.Pa. Feb. 1, 2001); see also In re Trasylol Products Liab. Litig., MDL-1928, 2010 WL 1489793 (S.D.Fla.Feb. 24, 2010).  Expert testimony about a company's "intent" is merely conjecture based on the expert's impressions of the physical evidence, and must be excluded as not based on any reliable methodology or scientific principle. J.B. Hunt Transport, Inc. v. Gen. Motors Corp., 243 F.3d 441, 444-45 (8th Cir.2001); In re Baycol Products Litigation, 532 F.Supp.2d 1029.  Similarly, an expert cannot be presented to the jury solely for the purpose of constructing a factual narrative based upon record evidence.  In re Diet Drugs Prods. Liab. Litig., MDL No. 1203, 2000 WL 876900, at *9 (E.D.Pa. June 20, 2000); see also In re Fosamax Products Liab. Litig., MDL 1789, 645 F.Supp.2d 164 (S.D.N.Y.July 27, 2009).

Here, the court found the expert was not qualified to render an opinion regarding what information Mentor should have disclosed to the FDA or to physicians and patients. Prof. Buchholtz is not a physician, a medical researcher, or a medical ethicist. She had no expertise in the fields that would
qualify a witness to testify about what scientific information should be reported to the FDA or to testify about medical device industry standards for warning physicians and patients about potential adverse effects of a medical device.  Therefore, she was not qualified to offer an opinion about the appropriateness of Mentor’s conduct regarding its alleged failure to warn the FDA, physicians, and
patients about certain risks associated with ObTape.

Beyond the qualification issue, the court went on to note that even if the “Code of Ethics” that Prof. Buchholtz relied on was somehow relevant to a medical device company’s standard of care in the context of product development and marketing, anyone who reads and understands the English language can interpret and apply the principles underlying that “Code of Ethics.” So Prof. Buchholtz’s testimony on the subject was unnecessary, and not beyond the understanding of a lay jury. 

Parties File Joint Report in Toyota MDL

The three attorneys serving as interim plaintiffs' counsel in the Toyota multidistrict litigation have filed a joint Preliminary Report, pursuant to the Court’s April 14, 2010 CMO No. 1. See  In re Toyota Motor Corp. Unintended Acceleration Marketing, Sales Practices, and Products Liability Litigation, No. 8:10-ml-02151-JVS-FMO (C.D. Cal.,  4/30/10).

Among the topics covered were many of the basic MDL structural issues, including the proposed structure and roles of designated counsel.  The parties recommended 18 attorneys to serve in leadership positions. More than 80 law firms and attorneys had filed applications by the May 3rd deadline to serve as lead counsel or in some other leadership role in this MDL.

The plaintiffs' attorneys also recommended establishment of a core discovery committee led by the co-lead counsel for the two types of cases, personal injury and economic loss.  Plaintiffs’ outlined their Core Discovery (types of information and documents, and types of discovery). Proposed core discovery  included: (i) Floor Mat,  (ii) Pedal, and (iii) Electronic Throttle systems issues. Plaintiffs' core discovery includes probing allegations of the existence of a defect in Toyota vehicles responsible for alleged sudden unintended acceleration; and the design and manufacture process for the engine throttle control system (including pedals, floor mats, electronic control systems, accelerator pedals, throttle bodies, etc.).  They also outlined proposed document discovery, as far back as the 1990s, claiming that design of that system began in the 1990s and that it was put in place in some vehicles as early as model year 1998.

Similarly, defendants outlined their proposed discovery in personal injury cases and economic loss cases. A key issue for them is the preservation of the vehicles in testable condition.

The parties offered a brief statement of the facts and legal issues, including class certification issues, standing issues, the application of the economic loss rule, choice of law, and the statute of limitations. Defendants’ specifically requested coordination with state court proceedings. There are now reportedly about 100 cases in 22 states.

Toyota has previously announced that it had retained an outside engineering and scientific consulting firm to conduct a comprehensive, independent analysis of Toyota and Lexus vehicles using the ETCS-i system (Electronic Throttle Control System with intelligence) for concerns related to unintended acceleration.

Toyota has provided members of Congress with an interim, first phase report from this expert on its evaluation of the ETCS-i system, consistent with the company’s commitment to transparency regarding the quality and safety of its vehicles

JPML Denies MDL Status to Pain Pump Litigation- Again

For the second time, the JPML has declined to consolidate the federal product liability cases involving pain pumps. In re Ambulatory Pain Pump-Chondrolysis Products Liability Litigation, J.P.M.L., MDL No. 2139 (4/14/10).

In the litigation, plaintiffs allege that they developed chondrolysis, i.e., damage to their joint cartilage, after pumps were used to directly send anesthetic into their shoulder joints following surgery.

In August, 2008 the Panel had denied the motion for centralization in MDL No. 1966, at at time the  docket involved a total of thirteen actions, as well as eighteen potential tag-along actions.  At that point, the panel noted that an indeterminate number of different pain pumps made by different manufacturers were at issue, as were different anesthetic drugs made by different pharmaceutical companies. Moreover, not all of the then-thirteen constituent actions involved pharmaceutical company defendants, and many defendants were sued only in a minority of those actions.

When the litigation grew to 102 actions in 26 districts, and 70 tag-alongs, the plaintiffs tried again. Most defendants opposed the renewed effort. But although the number of related actions had certainly grown, the Panel found that the issues that weighed against centralization in that earlier docket remain. An indeterminate number of different pain pumps made by different manufacturers are still at issue, as are different anesthetics made by different pharmaceutical companies. Most, if not all, defendants are named in only a minority of actions; and several defendants are named in but a handful of actions. Many actions involve no anesthetic manufacturers at all.

In the current litigation, individual issues of causation and liability continue to appear to  predominate, and remain likely to overwhelm any efficiencies that might be gained by centralization. Pain pumps come in different sizes and designs, with differing volume, duration, and flow capacities. The same anesthetic was not used in all surgeries. Plaintiffs have different medical histories (indeed, some have undergone more than one surgery involving a pain pump).

Third, said the Panel, the constituent actions are at widely varying procedural stages. In many, fact
discovery is either over or nearly over. The record showed that expert discovery is underway or has
been completed in a number of actions. It was also noted that while most plaintiffs supported the motion, others requested exclusion on the ground that their cases were too far advanced.

Thus, the Panel was not convinced that centralization would serve the convenience of the parties or promote the just and efficient conduct of the litigation taken as a whole.


 

Informal Discovery Leads to Dismissal in MDL

The court in the welding fume MDL litigation has dismissed the claims of the  plaintiff who had been chosen for the seventh bellwether trial in this national consolidated welding fume products liability litigation. In re: Welding Fume Products Liability Litigation [Ernest Ray, No. 04-18252], MDL 1535, No. 03-17000, N.D. Ohio.

Plaintiff Ray had moved to dismiss his claim, with prejudice, last November. Thousands of claims have been dismissed in this litigation, so why post about this one?  A reminder to readers of MassTortDefense to travel all lanes of the information superhighway in doing fact investigation, including the so-popular social media hubs.

It appears that plaintiffs were forced to move to dismiss the Ray case after plaintiff’s claims of severe disability were refuted by Internet (specifically Facebook) photos discovered by defendants that appeared to show plaintiff competing in strenuous high-speed powerboat races.

In 2006, the MDL Court implemented a new case evaluation process to try to ensure that only “trial-worthy” cases reached the later stages of pre-trial litigation. This process, which required medical records collection and a certification by plaintiffs’ attorneys that cases were trial‐worthy, prompted plaintiffs to dismiss thousands of cases.  Even with that, this is about the sixth trial-ready case plaintiffs have been forced to dismiss due to revelations in discovery.

Appropriate review of public web sites requires no disclosure to opposing counsel, and can be done relatively cheaply. Today's technology, via the Internet, can result in a wealth of information on the opposing party or witness.  Web sites like the popular myspace.com and facebook.com can now provide a profile of a witness or opposing party, or, like here, information on interests and activities. An individual might have posted comments about his condition, as well. Good luck surfing!

MDL Court Addresses Ex Parte Communication With Treating Physicians

A recent federal court  decision explores a seemingly small but potentially crucial issue involving a product liability plaintiff's treating physicians.  In Re: Ortho Evra Products Liability Litigation, No. 1:06-40000, MDL Docket No. 1742 (N.D. Ohio).

Many product liability suits turn on a battle of the experts on issues of injury and causation.  In many cases, a key set of witnesses, therefore, are the plaintiffs' treating physicians. When the views of the treater are on the side of one party, that party will typically emphasize the "neutral" status of the witness and the fact that the treater has had more and closer contacts with the plaintiff.  Whichever side disagrees with the treater will try to emphasize that the doctor is not the "world class" expert on the relevant scientific issues, and that his or her real function was to treat the injury/illness, not figure out whether a particular product caused it.  Accordingly, the deposition of treating physicians -- and the preparation for those depositions -- can be a critical stage of products liability litigation.

In this MDL, defendants moved to regulate ex parte contacts with plaintiffs’ treating physicians. Defendants sought to prevent what many see as an unfair advantage by plaintiffs lobbying their theories of liability and causation upon the treating physicians during such ex parte contact -- often on the eve of deposition. 

Defendants asserted that this issue had been taken up by the New Jersey court in the Zometa/Aredia Litigation litigation.  In that New Jersey litigation, Gaus v. Novartis Pharmaceuticals Corp., No. MID-L-007014-07-MT (New Jersey, Oct. 29, 2009), the court emphasized the “unique set of practical concerns presented in mass tort cases” as well as the number of plaintiffs in determining that the court’s resources would be impaired by a flood of discovery disputes regarding each treating physician. To ensure the same right of access and promote an efficient discovery process, the court there ordered all parties to proceed by way of formal deposition of plaintiffs’ treating physicians. See also In re NuvaRing Products Liability Litigation, 2009 WL 775442 (E.D. Mo., 2009).

Here, the MDL court allowed plaintiffs’ counsel to have ex parte contact with treating physicians with an important limitation. Specifically, plaintiffs’ counsel can meet ex parte to discuss the physicians’
records, course of treatment and related matters, but not as to liability issues or theories, product warnings, defendant's research documents, or related materials. Violations of this approach, the court said, will result in sanctions.

 

 

 

 

MDL Court Rejects Consolidation of Bellwether Trials

Readers of MassTortDefense know how significant the earliest few trials in any mass tort can be, influencing later trials and shaping settlement strategies.  Accordingly, which cases go first, from among the hundreds or thousands in the mass tort, and how they are tried, can be extremely significant.  The federal court overseeing the MDL concerning the antibiotic Levaquin recently denied plaintiffs' motion to consolidate three bellwether cases for the first trial. In re Levaquin Products Liability Litigation, MDL No. 08-1943, (D. Minn.). 

In the Order, the court noted that it had initially selected fifteen cases for evaluation and initial case-specific fact discovery in the bellwether-selection process. Directed by the court to meet and confer on an ordering of these cases for the first trials, the parties narrowed the field to seven remaining bellwether cases for selection for trial. Plaintiffs then moved to consolidate three of the cases for the first trial.  They asserted that the cases share similar characteristics that are central to this litigation and that consolidation would promote judicial efficiency and the interests of justice, while testing the merits of plaintiffs’ arguments. Defendants opposed the motion, arguing that plaintiffs had not met their burden of showing that a consolidated trial’s benefits would outweigh individual
issues in the case. Specifically, defendants argued that individual issues – including each
plaintiff’s unique medical history, each prescribing physician’s knowledge of warnings in the Levaquin package insert, and each plaintiff’s alleged injuries – precluded consolidation.

Federal Rule of Civil Procedure 42(a)(2) affords a court broad discretion to consolidate for trial actions involving common questions of law or fact. The party seeking consolidation bears the burden of showing that consolidation would promote judicial convenience and economy. Consolidation is inappropriate, however, if it leads to inefficiency, inconvenience, or unfair prejudice to a party.

Plaintiffs also argued that judicial economy would be served by consolidation because common sources of evidence established the supposedly common facts. For example, the same generic
expert witnesses would testify on behalf of each individual plaintiff, and the regulatory and
corporate history of the drug is the same for each plaintiff. Because of these alleged commonalities and claimed efficiencies, plaintiffs argued that consolidation of the three cases would save the court twenty trial days, not insignificant.
 
In opposition, defendants argued that individual issues, including what dose of Levaquin each physician prescribed to treat each plaintiff’s infection, and each individual plaintiff’s medical history, including their various risk factors for the injury alleged such as age, concomitant medication use including corticosteroids, prior injury, and other factors, all made consolidation inappropriate.

Moreover, defendants argued that consolidation would be prejudicial to them because there are complicated causation issues in each case, and multiple plaintiffs would testify regarding similar injuries, which could cause jury confusion. See In re Consol. Parlodel Litig., 182 F.R.D. 441, 447 (D.N.J. 1999) (“A consolidated trial . . . would compress critical evidence of specific causation and
marketing to a level which would deprive [the defendant] of a fair opportunity to defend itself.”).

At this stage of the MDL, the court concluded, consolidation was not merited. With respect to
the consolidation of cases, the Manual for Complex Litigation notes, “If there are few prior verdicts, judgments, or settlements, additional information may be needed to determine whether aggregation is appropriate. The need for such information may lead a judge to require a number of single-plaintiff, single-defendant trials, or other small trials.” Manual for Complex Litigation § 22.314, at 359 (4th ed. 2004). In the mass tort involving breast implants, the courts noted that that “[u]ntil enough trials have occurred so that the contours of various types of claims within the . . .
litigation are known, courts should proceed with extreme caution in consolidating claims.” In re Bristol-Myers Squibb Co., 975 S.W.2d 601, 603 (Tex. 1998).

To date, there are over 240 federal court cases in this MDL and just under 100 state court cases addressing claims similar to those brought by the bellwether plaintiffs. Indeed, this is a still growing MDL, found the court, the exact factual and legal contours of which are still undefined. The parties continue to conduct critical discovery, including deposing plaintiffs’ prescribing physicians. The merits of the parties’ arguments have not been tested at trial or in dispositive motions.

The court recognized that "the stakes are high" because the initial bellwether trials in this MDL may serve as the basis for the parties’ resolution of remaining, pending cases. Thus, although plaintiffs
appear to have demonstrated some commonalities in fact and law among the three
individual plaintiffs’ cases, this motion was denied at this time. 

Digitek MDL Update

Recent developments in the Digitek MDL.  The presiding judge in the federal Digitek multidistrict litigation has selected five bellwether cases to be tried.  Readers of MassTortDefense know that an increasingly common case management technique in consolidated or coordinated litigation is the use of bellwether trials, with the hope that early verdicts will impact the resolution of cases down the line.  Judge Goodwin issued Pretrial Order (PTO) No. 47, which assigned the following five cases for trial, in this order:

 • David Kelch, et al. v. Actavis Totowa, LLC, et al., 2:08-cv-01282

 • William J. Young, et al. v. Actavis Totowa, LLC, et al., 2:09-cv-00498

 • Jacquelyn K. Fox, et al. v. Actavis Totowa, LLC, et al., 2:09-cv-00389

 • Karen Sheahan, et al. v. Actavis Group, et al., 2:08-cv-01051

 • Scottie Vega, et al. v. Actavis Group hf., et al., 2:09-cv-00768

Readers may recall that the federal Digitek product liability cases, alleging that Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC released Digitek tablets containing more than the appropriate dosage to the public in 2008, were transferred to an MDL  last August. The plaintiffs allege that the tablets can cause digitalis toxicity in patients with renal failure. This condition can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

The MDL court also recently ordered the plaintiffs to file their class certification motion and brief in support of their "economic loss" class by Jan. 20, 2010.  Defendants’ response brief shall be filed and served thirty days after the filing of such class certification motion and accompanying brief, said the order.

The court also entered amended PTO #48 (Joint Hearing to Address Challenges to Scientific and Technical Evidence). In the spirit of cooperation and collegiality evident since the inception of this MDL, said the court, several distinguished state judicial officers presiding over certain consolidated Digitek actions have graciously agreed to conduct a joint hearing to address the scientific and technical issues presented in this litigation for resolution pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its federal and state progeny. Those issues are best addressed, said the MDL court,  through coordinated proceedings, albeit with each presiding judicial officer giving separate and individualized attention, and disposition, to the evidence and arguments as they relate to his or her assigned consolidated civil actions. The court recognized that each state may have its own standards and procedures for expert testimony designed to ensure the reliability and relevance of evidence based upon scientific, technical and other specialized knowledge.  That joint hearing is scheduled for October, 2010.

This is just the latest step in efforts for such coordination. Pretrial Order (PTO) No. 11 concerned state and federal coordination. It ordered lead and liaison counsel for the plaintiffs and defense to endeavor to coordinate activities between the federal and state litigation. It also ordered the creation of a joint document depository for use by parties in the federal-state litigation. The Order provided a mechanism for cross-noticing depositions. The next status conference is scheduled for Thursday, February 11, 2010 at 9:00 a.m.
 

 

 

Update on Chinese Drywall MDL

A quick update on the Chinese Drywall MDL.  With the recent filing of an omnibus complaint, approximately 3,000 plaintiffs are now involved in the product liability litigation over Chinese-made drywall, against approximately 600 defendants. In re: Chinese-Manufactured Drywall Products Liability Litigation, MDL No, 2047 (E.D. La.).  Plaintiffs allege generally that sulfur levels in the Chinese-made products are abnormally high, causing problems with air conditioning systems, appliances, internal wiring and other electrical systems, as well as personal injuries.  

The drywall imported from China could have been used throughout the United States in as many as an estimated 300,000 recently built or renovated homes. The U.S. Consumer Product Safety Commission reported on studies linking Chinese drywall installed in homes to elevated levels of hydrogen sulfide and the potential corrosion of metals.

Recently, the MDL court appointed Michael K. Rozen of Feinberg Rozen, LLP as a Special Master in this proceeding under Federal Rule of Civil Procedure 53. Pursuant to the order of the Court, Special Master Rozen shall carry out those tasks he deems appropriate to fully explore opportunities for an ultimate resolution between the various parties. 

At the December status conference, the court explored issues relating to the various profile forms: Plaintiff Profile Form, a Defendant Manufacturers’ Profile Form, a Contractor/Installer Profile Form, a Builder Defendant Profile Form and a Defendant Distributor Profile Form, and the Importer/Exporter/Broker Profile Form. And how to handle a party's failure to complete the required form. Another agenda item was prioritizing the many pending motions. The parties addressed some discovery disputes, including ESI.

An important issue also discussed was the the Court's general plan to establish initial  “bellwether” trials. The Court has further advised the parties that any such trials will be limited to property damage only. The parties have been discussing the protocol and procedure for selecting bellwether trial candidates. The Plaintiff Steering Committee has suggested a sufficient representative sample of cases be selected with regard to geography, concentration of properties, distinctive facts and certain legal issues. The defendants suggest that the selection of bellwether plaintiffs must be limited to the plaintiffs that have submitted profile forms where personal injuries are not claimed. A list of these plaintiff properties has been made available to the PSC and the Court. The parties were directed to continue to discuss the selection of bellwether trials.

It is already clear that the drywall litigation will be complicated. Homeowners are suing builders, installers, distributors and manufacturers. There are multiple levels of insurance litigation, as in some states plaintiffs may also bring direct actions against the insurers for any of those categories of defendants; some homeowners are also in dispute with their carriers as to coverage. Several defendants have sued their carriers. In some cases, insurance companies have already filed declaratory judgment actions on these issues. Moreover, there are cross-claims among categories of defendants, as builders are suing distributors, manufacturers, and their insurers.

As noted here before , a major issue is product identification, i.e., the identification of the maker and seller of the drywall in each plaintiff's building. Plaintiffs in the MDL have already identified 28 foreign labels that they allege may be involved.  Class action motions remain pending, among the difficult case management issues.  Indeed, some of the cases may end up being resolved as part of bankruptcy proceedings.

MDL Status Denied in Pharma Case

The JPML has denied centralization of the litigation accusing a drug maker of fraudulently promoting and allegedly misrepresenting the safety of 11 prescription drugs including Viagra
and Zoloft.  In re: Pfizer Inc. Marketing and Sales Practices Litigation, MDL Number 2115.

The Panel said that these actions do, on their face, share some allegations that defendants engaged in a fraudulent scheme to promote different prescription drugs: Geodon, Zyvox, Lyrica, Aricept, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec. According to
plaintiffs, the company (1) promoted the drugs to physicians by offering them inducements, (2) promoted the drugs at doses or for durations of use that were not medically safe or efficacious, (3) made false representations about the safety and efficacy of the drugs, and (4) promoted certain of the drugs for non-indicated “off-label” uses.

But, the named plaintiffs allege that they themselves each took only one of those eleven drugs, and that they did not take the same drugs.  Given that each of the eleven drugs necessarily has a different clinical, regulatory, medical, and promotional history, and that it is at least questionable whether a plaintiff can prosecute claims regarding drugs that he or she never actually took, the Panel was not convinced that centralization under Section 1407 was appropriate.

The cases thus seemed to fall in that category of litigation which the Panel may be less likely to centralize because the underlying actions raise primarily individual, not common, issues, as when they involve many different defendants, diverse plaintiffs, or different modes of exposure to the allegedly offending products.
 

 

BPA Litigation Update- Part I

In the BPA MDL, Judge Ortrie D. Smith granted in part and denied in part defendants’ motions to dismiss various claims. In re: Bispehnol-A Polycarbonate Plastic Products Liability Litigation, MDL No. 1967 (W.D. Mo.).

Readers of MassTortDefense will recall that last year the Judicial Panel on Multidistrict Litigation centralized fourteen cases; since then, the Panel has continued to transfer cases from around the country, so now about thirty-eight cases have been transferred. In addition, approximately ten cases have been filed in the MDL District and have become part of the consolidation. Defendants roughly fall into two categories: the Bottle Defendants and the Formula Defendants. Generally, the Bottle Defendants make baby bottles, sippy cups and similar products for infants and toddlers, and/or sport bottles. The Formula Defendants sell infant formula packaged in metal cans.

Most of the complaints assert, on behalf of consumers, various causes of action including: (1) violation of state consumer protection laws, (2) breach of express warranty, (3) breach of the implied warranties of merchantability and fitness for a particular purpose, (4) intentional misrepresentation, (5) negligent misrepresentation, and (6) unjust enrichment.

In one Order the court began by addressing the motions to dismiss claims for fraud, misrepresentation and breach of express warranties. The MDL court had previously, mindful of Rule 9, required plaintiffs to identify defendants’ alleged statements that form the basis for their claims of fraud, misrepresentation, and breach of express warranties. Plaintiffs’ continued failure to do so was, said the court, now fatal to these claims. Likely because they were unable to comply, and perhaps because they recognized what compliance would do to their already slim chances for class certification (because of the individual issues that a response would highlight), plaintiffs responded to the aforementioned requirement by saying that they had not identified any advertisements or other media because the allegations are not based on any particular representations. A misrepresentation claim not based on any misrepresentation. Rather, plaintiffs’ allegations are based on defendants’ supposed “overall course of conduct” in marketing and selling the products at issue. Taken as a whole, defendants’ alleged “overall course of conduct” somehow deceptively conveyed the impression or message that the products at issue are safe and healthy for use by infants and children.

By disclaiming reference to any particular fraudulent act, plaintiffs had disclaimed one of the essential elements of a fraud or misrepresentation claim. All states require proof of reliance and causation. For a statement to be relied upon and thus cause a purchaser’s injury, the statement must have been heard by the purchaser. Plaintiffs’ theory – that the placement of a product in a stream of commerce alone somehow conveys a sufficient representation about the product’s safety that can serve as grounds for fraud liability – is a rule that has not been demonstrated to exist in any of the fifty states.

Allowing the mere sale of products to convey an affirmative representation regarding safety would eviscerate the law of warranty and be contrary to the rationale supporting the limited circumstances in which actions constitute representations, noted the court.  Plaintiffs’ failure to identify any expressions made by defendants to them about their products precludes any claim that an express warranty was made, let alone violated. Given the absence of any “affirmation of fact or promise,” (see UCC Article 2-313), plaintiffs cannot allege an express warranty was made. The Supreme Court’s decision in Iqbal requires a plaintiff to identify the basis for, if not the content of, the alleged warranty. And, in a related issue, plaintiffs’ were thus unable to allege how the supposed, non-existent, warranties became “part of the basis of the bargain.”  A representation cannot be part of the “bargain” if the other party to the bargain did not know the representation was made! Merely alleging a representation became part of the bargain does not satisfy Iqbal. If one party (here, the buyer) is not aware of the statement, that party cannot claim the statement became a part of the parties’ bargain.

The court declined to dismiss the claims for fraudulent omissions, based on what it called a “common-sense” view of Rule 9 under which it was unnecessary to require plaintiffs to specifically identify who failed to disclose information and each occasion upon which they failed to disclose it. Rule 9 is satisfied, said the court, with respect to a claim of fraudulent omissions if the omitted information is identified and “how or when” the concealment occurred.

The claim for breach of implied warranty of fitness for a particular purpose was dismissed because while the ordinary purpose for baby bottles can be described as to allow babies and toddlers to drink liquids, a plaintiff cannot rely on this ordinary purpose to support a claim that there was a warranty of fitness for a particular purpose; they must point to some other purpose that is not “ordinary” in order to support their claim.

The court put off ruling on the claims for breach of the implied warranty of merchantability because defendants’ arguments (including lack of privity, untimeliness, and failure to provide notice), seemed premised on the unique characteristics of various states’ laws. Thus, they seemed more amenable to analysis at the time of any class certification decision, which will inevitably raise choice of law issues. A similar deferral was applied to dismissal of all unjust enrichment claims. Many of defendants’ arguments seemed to depend on unique aspects of various states’ laws, found the court.

Defendants also made a strong argument that the claims, at bottom, were improper “no injury” claims. The court agreed as to the category of plaintiffs who disposed of or used up the products before learning about BPA. They received all the benefits they desired and were unaffected by defendants’ alleged concealment. Importantly, the court recognized that while they may contend they would not have purchased the goods had they known more about BPA, these plaintiffs received 100% use (and benefit) from the products and have no quantifiable damages. In this instance, plaintiffs’ position “leads to absurd results.”  These buyers obtained the full anticipated benefit of the bargain. While they may not have paid the asking price, had they allegedly known, offset against this is the fact that they received the full benefits paid for – leaving them with no damages. Plaintiffs here may allege they would not have purchased those products had they supposedly known the true facts, but, again, they obtained full use of those products before learning the truth: the formula was consumed or the children grew to an age where they did not use bottles and sippy cups, so they were discarded. These consumers thus obtained full value from their purchase and have not suffered any damage. These plaintiffs are relegated to the unjust enrichment claim.

The court distinguished, however, those plaintiffs who learned about BPA’s presence and potential effects and either still have the goods or subsequently replaced or disposed of them. Defendants’ argument does not apply to this category, found the court.

That left before the court only plaintiffs’ claims that defendants made fraudulent omissions, violated various state consumer protection statutes, breached the implied warranty of merchantability, and that defendants were unjustly enriched. With these remaining claims pending, the court, in a second order, granted in part defendants’ motion to dismiss on the basis of preemption and denied their motion to dismiss on the ground of primary jurisdiction.

Defendants’ preemption and primary jurisdiction arguments were generally alike in that they both contend their use of BPA should only be subject to regulation by the FDA. Indeed, FDA has issued regulations prescribing the conditions for “safe” use of resinous and polymeric coatings, allowing the coatings to be formulated from “optional substances” that may include “[e]poxy resins” containing BPA. Thus, BPA’s presence in some resinous and polymeric coatings and in polycarbonate resins is subject to regulation by the FDA. It is also a fair reading of FDA’s regulations authorizing BPA’s use that the FDA thinks that food additives containing BPA could be used safely without labeling requirements.

The doctrine of primary jurisdiction applies when enforcement of a claim that is originally cognizable in the courts requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body. The FDA clearly has specialized expertise and experience to determine whether BPA is “safe.” However, said the court, the ultimate issues in these cases, as alleged by plaintiffs, are whether defendants failed to disclose material facts to plaintiffs and thus, for example, whether defendants breached the implied warranty of merchantability through the sale of products containing BPA. FDA’s decision that BPA is “safe” is not determinative of any of those issues, said the court. This conclusion seemed to give insufficient attention, in our view, to the argument that plaintiffs have predicated their claims on proof that BPA is allegedly unsafe: the undisclosed facts are not material unless BPA is not safe. The products are not unmerchantable unless BPA is unsafe, Since plaintiffs base their claims on such evidence, the claims seemed to fall within the primary jurisdiction of the FDA.  The MDL court did not agree.

Turning to the preemption issue, the court first rejected the claim of implied preemption. While noting that FDA has approved BPA use in food additives and noting the agency’s decision not to require labeling, the court concluded that the FDA’s approval of BPA as safe without labeling requirements establishes only a regulatory minimum; nothing in these regulations either required or prohibited defendants from providing the disclosures sought. The court cited Wyeth v. Levine for the proposition that that there is no preemption when federal law did not prevent the drug manufacturer from strengthening its drug label as necessary to comply with the standard to be imposed by state law.

However, the Formula Defendants also raised express preemption; they asserted that the FDA regulations exempt Formula Defendants from having to disclose the presence of BPA in their products. Express preemption exists when a federal law explicitly prohibits state regulation in a particular field. With respect to food labeling, federal law generally prohibits states from establishing any differing requirements for the labeling of food. Thus, plaintiffs’ claims are expressly preempted because they would impose disclosure requirements concerning BPA, the exact opposite of the exemption. Now, here is the interesting twist: plaintiffs asserted that Congress also provided an exception to express preemption under the law for “any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.”  But, the court noted, plaintiffs cannot have it both ways.  If their claims are based on warnings about the safety of food, then their claims would have been subject to dismissal under the primary jurisdiction doctrine because the determination whether BPA is “safe” is solely the province of the FDA, and the FDA has concluded that the use of BPA in epoxy liners is “safe” so long as the manufacturer abides by the FDA’s prescribed conditions. See 21 C.F.R. § 175.300 (2009).  If the claims against the Formula Defendants are not subject to primary jurisdiction, as plaintiffs argued, then they are subject to express preemption analysis.

It may seem clear to readers of MassTortDefense that even with respect to those claims the court concluded should not be dismissed on the pleadings, the court's analysis highlights several issues that may make it difficult for the plaintiffs to proceed as a viable class action. 

 

Developments in Proposed Class Actions in China Drywall MDL

In the Chinese Drywall  MDL, certain plaintiffs recently moved for leave to amend their Class Action Complaint to expand the class definition as to defendant Taishan Gypsum, from a Virginia state-wide class to a national class of all persons allegedly impacted by defective drywall made by that defendant. Plaintiffs assert that there will be no undue delay nor prejudice to defendants from the change; the amendment does not alter the proposed sub-classes as to other defendants who are the builders and installation contractors who allegedly installed the product. The amendment would also include new assertion of a violation of the consumer fraud acts of the various states. In re: Chinese-Manufactured Drywall Products Liability Litigation, No. 09-md-02047 (E.D. La.).

An Omnibus [Proposed] Class Action Complaint is to be filed in the MDL on or before December 9, 2009 by the plaintiffs against another defendant, Knauf Plasterboard (Tianjin) Co., Ltd (“KPT”) and other defendants who were involved in the manufacture, sale, importation, brokerage, distribution, construction and installation of homes containing KPT drywall, and any others who were involved in the stream of commerce for the KPT drywall. In order to assist in the consolidation and efficient handling of claims by affected homeowners, defendant KPT has apparently agreed to accept service of process for homeowner plaintiffs who are to be named in an Omnibus Amended Complaint, and waive its right to demand service of process through the Hague Convention. (We have posted about the issues related to suits against foreign defendants before.) However, to be eligible for inclusion in this Omnibus [Proposed] Class Action Complaint and the service waiver, homeowners must provide, by no later than December 2, 2009, sufficient indicia that the homes in question contain KPT drywall (e.g., photographs, samples, visual inspections or reports identifying KPT markings on drywall in the home), and must also submit by December 14, 2009, a fully completed and executed Plaintiff Profile Form, in accordance with PTO #11. The complaint will not be amended to include additional named plaintiffs after it is filed, the court has indicated.


 

Update on Digitek Litigation

In the Digitek MDL, the parties have been wrangling over the defense motion for a Lone Pine order. See generally Lore v. Lone Pine, No. L-336006-85, 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986).

Dozens of product liability cases alleging that defendants Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC marketed Digitek tablets containing double the appropriate dosage were transferred to an MDL assigned to Chief Judge Goodwin of the Southern District of West Virginia last summer. In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.).
 

Defendants recently moved for a Lone Pine order under which each plaintiff must submit an "affidavit from a medical expert in each case establishing that there is medical evidence of digoxin toxicity." Readers of MassTortDefense recognize this important and logical procedural tool for management of mass toxic tort litigation.  When the major factual battles will be over injury and causation, it may make sense to focus discovery on these issues, and prior to resorting to expensive and time-consuming discovery, to require plaintiffs to come forward with some prima facie showing of injury and specific causation, or as the court put it, "some evidence of certain elements of their claims, e.g. medical causation, to support a credible claim."

The plaintiffs in the federal Digitek multidistrict litigation filed a brief opposing the motion, arguing that the discovery in the MDL is still in its "incipient stages."  As they typically do, the plaintiffs argued that such orders "effectively function as untimely and unjust summary judgment devices and violate the discovery rules for expert witness disclosures and reports." They also argued that they have provided significant case-specific discovery in the form of Plaintiffs' Fact Sheets and records authorizations.

The court entered PTO #43 (Order re Request for Lone Pine Order), saying the motion is taken under advisement pending completion of basic fact discovery of Group 1 cases. Under the latest schedule, Plaintiff shall serve their reports from liability experts no later than March 15, 2010.  The parties shall complete their depositions of Plaintiffs’ liability experts no later than May 28, 2010.  Defendants shall serve their reports from liability experts no later than June 15, 2010. The parties shall complete their depositions of Defendants’ liability experts no later than August 31, 2010. 

At the November 20, 2009, conference each party is to present to the court their choice of five cases that they believe to be representative plaintiffs for trial in accordance with PTO #38, governing the creation of a trial pool upon completion of basic fact discovery, including but not limited to the depositions of plaintiffs, plaintiffs’ physicians who prescribed Digitek® to them, physicians who treated Plaintiffs for alleged digoxin toxicity, and pharmacists who filled plaintiffs’ prescriptions for Digitek®.
 

Chinese Drywall Update

On the eve of the 3rd biennial United States--China Consumer Product Safety Summit, to be held in China, the head of the Consumer Product Safety Commission reported she will press Chinese officials on whether new regulatory standards need to be set for drywall composition. CPSC Chairwoman Inez Tenenbaum said she also would inquire whether the Chinese were willing to provide compensation for the damage from tainted drywall.

In its latest status report on the Chinese drywall issues, the CPSC noted that it had received 1192 consumer complaints, from 24 different states. The majority of the reports continue to be from Florida, Louisiana, and Virginia. The focus of the federal drywall team has remained pursuing the scientific bases of the possible problems, and tracing the chain of commerce of the drywall.

CPSC reports it has completed principal field work for a 50 home indoor air sampling program, coordinated the state and federal response to allegations of radioactive phosphogypsum in Chinese drywall, and completed 75 in-depth site investigations, with another 20 in progress. Long-term air sampling tests will be completed later this month. The evaluation of the results is expected to be complete before November. (Phosphogypsum is a gypsum that has elevated levels of naturally occurring potassium, thorium and uranium radionuclides and decay products.) The CPSC coordinated testing and reporting results for radioactive phosphogypsum contamination in drywall with the Florida Department of Health and the EPA National Air and Radiation Environmental Laboratory. The results of the technical review showed that no radiological hazard was present. EPA is conducting elemental analyses of 15 drywall samples. EPA expects to complete its analyses of drywall samples in the next few weeks.

CPSC continues to analyze the information received from consumers, builders, importers, manufacturers, and suppliers of drywall to determine how much imported drywall may be affected and where that drywall has been installed. To date, CPSC staff has confirmed that during 2006, 6,997,456 sheets of Chinese drywall were imported into the U.S.

As readers of MassTortDefense know, litigation has been filed over the drywall issues, alleging that sulfur levels in the Chinese-made products are abnormally high, causing problems with air conditioning systems, appliances, internal wiring and other electrical systems.  Approximately 200 cases are pending in the MDL. In re: Chinese-Manufactured Drywall Products Liability Litigation, No. 09-md-02047 (E.D. La.).

In the MDL , the next status conference is scheduled for Thursday, November 19, 2009. Recently, the court  issued an order regarding a "Revised Exporter, Importer, or Broker Defendant Profile Form.”  All defendant drywall exporters, importers, or brokers must complete this Profile Form.  The form, inter alia, requires information on exemplar transactions concerning the exportation/importation/brokering of Chinese Drywall for import/export to the United States between 2001 and 2009, including but not limited to purchases, sales, consignments, shipments, transfers, deliveries, receipts, or other distributions.  The form requires information to identify any markings on the Chinese Drywall product (e.g., lot number, batch number, serial number, color markings, UPC codes, etc.) involved in this transaction; a list all trademarks of the product, and any markings or means of identification employed to track or identify the Chinese Drywall.

The issue of linking the specific product that allegedly harmed a plaintiff to the defendants who made and sold that particular product -- often termed "product identification" -- is an essential aspect of the cause in fact inquiry and is often problematic in toxic tort litigation.

 

 

MDL Created For Zicam Litigation

The Judicial Panel on Multidistrict Litigation has decided to consolidate multiple federal cases arising from the Zicam product line.  IN RE: ZICAM COLD REMEDY MARKETING AND SALES PRACTICES LITIGATION, MDL No. 2096.  Plaintiffs moved, pursuant to 28 U.S.C. § 1407, for coordinated or consolidated pretrial proceedings of multiple proposed class actions.  By the time the Panel issued its Order, there were 40 related actions pending in 26 federal districts.

Many of the pending cases were consumer fraud class actions against Matrixx Initiatives, Inc., and its subsidiaries Zicam, LLC, and Zicam Swab, LLC.  Plaintiffs opposed centralization of any actions alleging personal injury claims. But the Panel found that both kinds of actions involved sufficient common questions of fact, and that centralization of the actions under Section 1407 would serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. The actions share factual questions regarding, inter alia, the marketing and sale of three Zicam nasal cold remedy products, and alleged injuries sustained by the use and/or purchase of those products, particularly whether the products cause anosmia (the loss of sense of smell). Centralization under Section 1407, the court found, would eliminate duplicative discovery, prevent inconsistent pretrial rulings (particularly with respect to class certification), and conserve the resources of the parties, their counsel and the judiciary.

The Panel declined to separate purported consumer class actions from other actions alleging personal injury. Centralization of all actions in this docket would, said the court, allow a single judge to structure pretrial proceedings to accommodate all parties’ discovery needs while ensuring that the common parties and witnesses are not subjected to discovery demands that duplicate activity that will or has occurred in other actions.

The court chose the District of Arizona as the appropriate transferee forum. The defendants are based within the District of Arizona, and relevant documents and witnesses are likely found there, observed the Panel. In addition, centralization in the District of Arizona will allow for coordination of the federal actions with related litigation pending in Arizona state court.

 

Partial Summary Judgment Granted in Genetically Modified Rice MDL

The judge overseeing the federal MDL involving genetically modified rice has granted partial summary judgment to the defendants, dismissing several claims, including a public nuisance allegation. In re: Genetically Modified Rice Litigation, No.4-md-1811 (E.D. Mo. 10/9/2009). 

This multi-district litigation relates to the claims of U.S. long-grain rice producers, and others in the rice business, who allege that certain defendants contaminated the U.S. rice supply with non-approved genetically modified strains of rice. The first of a series of bellwether trials will begin in November; this first trial involves Missouri farmer plaintiffs, and the court's Order rules on only the portions of the motions directed to the claims of the Missouri plaintiffs.

The Missouri plaintiffs are seeking damages under a variety of theories, including negligence,  public and private nuisance, negligence per se, and the North Carolina Unfair Trade Practices Act. The plaintiffs are suing to recover allegedly lost income they claim resulted from the drop in market price for rice; following the announcement of the contamination in 2006, some rice companies around the world banned the importation of U.S. rice, which allegedly caused a dramatic drop in the U.S. market price for rice.

Judge Catherine Perry of the U.S. District Court for the Eastern District of Missouri issued an opinion on a host of summary judgment  issues, most notably granting defendants’ motion for summary judgment on plaintiffs’ claims under the North Carolina Unfair Trade Practices Act and on plaintiffs’ claims for public nuisance and negligence per se.

Defendants asserted first that the economic loss doctrine bars all the common-law claims.  The economic loss doctrine bars recovery of purely pecuniary losses in certain tort cases if there is no personal injury or physical damage to property other than the property at issue in the case – usually an allegedly defective product in a products liability case. A plaintiff suing over damage to a product he contracted for is limited to his contract remedies. Many states have adopted the economic loss doctrine for products liability cases, and some states have applied the doctrine to other torts
as well. Here, however, the court found that the alleged damages were not to any property that was the subject of a contract, and the plaintiffs were not claiming damage to any property that is alleged to be defective. Rather, they claim market losses and damage to other property, including equipment, land, and rice. Because they alleged damage to other property, the doctrine does not
apply, concluded the MDL court.

Defendants fared better with plaintiffs' attempt to rely on the more pro-plaintiff North Carolina statute.  The court noted that plaintiffs are not suing based on contracts with Bayer, and although some of Bayer’s decision-making occurred in North Carolina, the claims of plaintiffs cannot be said to arise mainly from those North Carolina activities.  Although there was some conflicting authority, the court concluded that the better reasoned cases require an in-state injury to a plaintiff’s in-state business operations. In other words, the North Carolina Unfair and Deceptive Trade Practices Act is intended to protect the North Carolina consumer.  Plaintiffs had not shown that their claims here had a sufficient effect on North Carolina business for them to benefit from this act intended to protect North Carolina commerce.

Third, in Missouri, a public nuisance is an offense against the public order and economy of the state that violates the public’s right to life, health, and the use of property, while, at the same time annoys, injures, endangers, renders insecure, interferes with, or obstructs the rights or property of the whole community, or neighborhood, or of any considerable number of persons. Bayer was able to show that, as matter of law, plaintiffs cannot recover for public nuisance. There is no evidence in the record showing the sort of public harm or negative effect on the entire community that public nuisance law was developed to remedy.

A private nuisance, on the other hand, is the unreasonable, unusual, or unnatural use of one’s property so that it substantially impairs the right of another to peacefully enjoy his property.  Plaintiffs’ private nuisance claim survived summary judgment because factual disputes remain regarding whether contamination of plaintiffs’ crops may interfere with their enjoyment of their land. The focus of a private nuisance claim, said the MDL court,  is on defendant’s unreasonable interference with the use and enjoyment of plaintiff’s land.  A genuine issue of fact remains regarding whether plaintiffs can prove a private nuisance.

Defendants were entitled to summary judgment on plaintiffs’ negligence per se claim, to the extent it relied on a violation of federal Animal and Plant Health Inspection Service regulations. This is because they are more in the nature of performance standards that do not provide a standard of
care.  So, for example, if a building code says a stair riser must be six inches tall, that is a precise directive that a builder can follow, and if someone is injured because the riser is taller or shorter, negligence per se might apply.  A building code that says the stair riser should be of a sufficient height not to be dangerous or so that a person will not fall could not provide a basis for a negligence per se claim because the question of what is reasonable was not answered by the building code regulations.

We will keep an eye on the first bellwether case for our readers.

Jury Returns Defense Verdict in FEMA Trailer Trial

Last week a federal jury in Louisiana returned a defense verdict in a plaintiffs' suit over alleged exposure to formaldehyde fumes while living for several months in a FEMA-provided trailer. In Re: FEMA Trailer Formaldehyde Products Liability Litigation, Age v. Gulf Stream Coach Inc., No. 09-02892, E.D. La.). The government had made the trailer available after Hurricane Katrina destroyed the plaintiffs' home in 2005.

Plaintiffs sued manufacturer Gulf Stream Coach Inc. and installer Fluor Enterprises Inc., alleging that elevated levels of formaldehyde aggravated family members' asthma and increased their risk for getting cancer.  (FEMA was dismissed as a defendant in the lawsuit because of the two-year statute of limitations in cases brought against the federal government.)  They argued that Gulf Stream Coach, in expediting production of the housing units following Hurricanes Katrina and Rita, used substandard materials and/or unsafe practices during the manufacturing process, which allegedly resulted in the temporary housing units containing higher than normal levels of formaldehyde. Plaintiffs alleged that Fluor's installation methods contributed to greater formaldehyde exposure.  They further charged that the FEMA trailer deviated from government safety specifications and that Gulf Stream failed to warn the government about the dangers of formaldehyde, which is found in construction materials as well as in glues and adhesives used in the manufacture of the units.

The claim is one of many hundreds of suits filed that are now part of the MDL, and one of the first five bellwether cases selected for trial. Readers of MassTortDefense will recall how Hurricane Katrina devastated much of the Gulf Coast in 2005. The total damage of Hurricane Katrina has been estimated at $75 billion, while not-much-later Hurricane Rita caused $10 billion in damage. The government, through FEMA, moved individuals whose homes were lost or deemed uninhabitable into makeshift housing provided by the agency. Plaintiffs generally allege that the trailers had components that exposed them to dangerous and excessive levels of formaldehyde.

The defense here presented alternative causation evidence on the alleged respiratory issues, and noted that formaldehyde is found in safe levels in many products, including cosmetics, foods and shampoo. The defendants sold this trailer to the most sophisticated purchaser in the world, the United States government, argued the defense, and there is no duty to warn someone about something they know about already. The defense argued that Gulf Stream wasn't obligated to build a "perfect product."

The jury of five men and three women, after 8 days of testimony, decided that the trailer made by Gulf Stream Coach Inc. was not an “unreasonably dangerous” product under Louisiana law. Judge Kurt D. Engelhardt presided over the trial.  A likely issue on appeal will be the MDL court's decision to allow certain defendants to assert the government contractor defense.

Motion To Dismiss Filed in Combination Aspirin MDL

Bayer Healthcare LLC moved last week to dismiss the master complaint in the federal MDL involving combination aspirin products. In Re: Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litigation, No. 1:09-md-02023 (E.D. N.Y.). Aspirin has been sold in the United States for more than a hundred years; a daily regimen of low-dose aspirin is widely recognized as useful in preventing heart attacks and strokes.

Plaintiffs are consumers who claim to have purchased Bayer combination aspirin and dietary supplement products. They do not claim that they were injured by these products or that the products were ineffective. Instead, plaintiffs seek damages because they say they would not have purchased these products if they had known that Bayer, instead of submitting a New Drug Application (“NDA”) for each of these combination products, relied on the preexisting separate regulatory review of aspirin and the supplements. Plaintiffs allege that Bayer misled and deceived
consumers into believing that the products had been proven to be safe and effective for their marketed purposes.
 

The Motion argues that plaintiffs’ claims fail, first, because they are, in essence, private attempts to enforce the FDCA, 21 U.S.C. §301 et seq.  MassTortDefense notes that courts have repeatedly refused to construe such private attempts to enforce the FDCA as valid state law causes of action like the plaintiffs have brought in this litigation. Under the FDCA, the United States government has the exclusive power to enforce the FDA’s regulatory requirements (which include provisions relating to the approval of new prescription and over-the-counter drugs, as well as regulation of dietary supplements and food additives). The FDCA provides that “[a]ll such proceedings for the enforcement, or to restrain violations, of this Act, shall be by and in the name of the United States.” 21 U.S.C. § 337(a) (2009).

Even if a state were to recognize it, a cause of action based on a failure to obtain FDA approval would be preempted as interfering with the FDA’s approval processes. Courts have repeatedly held that private plaintiffs fail to state a claim where they, in essence, seek redress for a violation of the FDCA. Courts have applied this doctrine to dismiss a variety of causes of action, from RICO and the Lanham Act, to state law unfair competition and consumer fraud act claims. See, e.g., Mylan Labs. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993) (dismissing Lanham Act claim); In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp. 2d 1282, 1290 (C.D. Cal. 2008) (dismissing state consumer fraud and false advertising and RICO claims); Ethex v. First
Horizon Pharm. Corp
., 228 F. Supp. 2d 1048, 1055 (E.D. Mo. 2002) (dismissing deceptive trade practices claims and Lanham Act claim).

Additionally, defendant argues that plaintiffs, who do not claim harm or that their products did not work, have not alleged a cognizable injury. Accordingly, plaintiffs have not stated a claim for any of the causes of action they have brought. Under Fed. R. Civ. P. 12(b)(6), a complaint must be dismissed if it fails to articulate grounds upon which relief can be granted. Under Rule 8(a), a plaintiff’s obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do. Bell Atlantic Corp. v. Twombly, 550 US 544, 555 (2007).   The Supreme Court recently reaffirmed these principles in Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009).

These standards apply to injury and loss requirements as well as to other elements of a claim. As the Second Circuit recently explained, to state a claim for relief, a plaintiff must do more than simply allege an injury or loss – that theory must be “plausible.” McLaughlin v. American Tobacco Co., 522 F.3d 215, 227 (2d Cir. 2008). Legally cognizable theories of injury must also not require a court to “engage in a series of speculative calculations to ascertain whether, or in what amount, plaintiffs suffered a loss.” Id. at 230.  Like many convoluted consumer fraud actions, plaintiffs' claims here fail to allege a plausible theory that is open to private plaintiffs.
 

 


 

 

Motion For Default Filed in China Drywall MDL

An Alabama construction company that is a party in the multidistrict litigation over allegedly tainted Chinese-made drywall has asked for a default judgment against a foreign manufacturer/seller of gypsum drywall. Mitchell Co. Inc., et al. v. Knauf Gips KG, et al., No. 09-cv-4115 (E.D. La.).

Mitchell filed a motion last week  in the U.S. District Court for the Eastern District of Louisiana asking for a default judgment against China-based Taishan Gypsum Co. Ltd.  The motion alleges that Taishan has not responded to the plaintiff's complaint nor entered an appearance.  Mitchell filed its original complaint back in March, in the Northern District of Florida, seeking to represent a class of plaintiffs who allege they incurred expenses stemming from defective drywall.  The complaint names several drywall makers and sellers.  The case was later transferred with related actions to the MDL in front of Judge Fallon. In re: Chinese-Manufactured Drywall Products Liability Litigation, No. 09-md-02047 (E.D. La.). 

Interestingly, the motion comes as the Congress debates a bill that would make it easier for foreign manufacturers to be sued when their products allegedly injure U.S. consumers, the Foreign Manufacturers Legal Accountability Act of 2009.

MassTortDefense has posted about the alleged problems with Chinese imported drywall. In litigation over the issues, Lennar Corp., the U.S.' second largest home-builder (by volume), has sued more than two dozen manufacturers, suppliers and installers.  As noted here before, Sens. Bill Nelson, D-Fla., and Mary Landrieu, D-La., have introduced legislation tied to Chinese drywall.  Also, the CPSC reports that it has now received a total of 810 reports related to the allegedly defective drywall, including complaints from two additional states, Pennsylvania and South Carolina. That means the Commission (criticized in some circles for its work on this issue)has received reports from homeowners in 23 states and the District of Columbia. The majority of the reports continue to be from Florida, Louisiana, and Virginia. About 6.2 million sheets of Chinese drywall were imported into the U.S. during 2006.

 

Digitek MDL Plaintiffs Ordered To Respond To Discovery

The federal court has ordered plaintiffs in the MDL concerning the heart medication Digitek to respond to discovery relating to whether the individuals in each identified case had sufficient evidentiary support to justify filing their claim.  The decision is also interesting for all those in mass torts struggling with plaintiffs' typically inadequate responses to initial fact discovery and Plaintiff Fact Sheets. In re: Digitek Products Liability Litigation, MDL-1968 (S.D. W.Va.).

In April, 2008, the FDA announced a recall of the drug Digitek® (Digoxin) distributed by Mylan Bertek Pharmaceuticals, Inc. and UDL Laboratories, Inc. The recall stated that certain lots of the tablets may have contained more than the approved level of the drug’s active ingredient, thereby exposing patients with renal failure who consumed the drug to the risk of digitalis toxicity. Soon thereafter, the plaintiffs filed civil actions against the defendants in state and federal courts across the country. In August, 2008, the Judicial Panel on Multidistrict Litigation entered an order establishing a multidistrict litigation proceeding, which consolidated federal Digitek® related actions for joint case management. The plaintiffs generally allege that the defendants manufactured, marketed, tested, promoted, and/or distributed Digitek® with inconsistent amounts of the active ingredient.

As is fairly typical, plaintiffs were required to fill out basic fact information about their use of the drug and alleged injuries in Plaintiff Fact Sheets.  Such fact sheets are often used instead of  interrogatories, and allow the parties and the court to assess the various types of cases in the mass tort. They can be crucial to decide on trial plan, the scope and timing of additional discovery, and even settlement analysis. 

Defendants served three requests for admission in 39 individual cases, seeking information relating to whether the plaintiff in each identified case had sufficient evidentiary support to justify filing a claim. The requests at issue asked the plaintiff or their counsel  to "admit that you did not serve Defendants with any of Plaintiff’s medical records when you served the Plaintiff Fact Sheet;"  to "admit that you did not have any of Plaintiff’s medical records or pharmacy records in your possession when you filed the Complaint in this case;" and to "admit that you did not have Plaintiff’s medical records or pharmacy records in your possession when you served Defendants with the Plaintiff Fact Sheet."

The Plaintiffs’ Steering Committee in the MDL submitted the plaintiffs’ master objections to the defendants’ requests. They argued that the discovery was premature: before the parties may begin
discovery on an individual case, that case must be selected for inclusion in a trial group. Second, they allege that the defendants are attempting to cure deficient Plaintiff Fact Sheets with the
requests, rather than through the deficiency process outlined in previous pre-trial orders.  Third, in a preemptive strike, they argued that since the Plaintiff Fact Sheets constitute discovery responses,  defendants cannot pursue sanctions for them under Rule 11.  Finally, plaintiffs also asserted that the requests were not reasonably calculated to lead to the discovery of admissible evidence, and alleged that the targeted information is protected by the attorney-client privilege and/or the work product doctrine.

The court noted that the defendants have expressed serious concerns about the merits of many of the cases filed in the MDL. They believe that a large number of cases lack sufficient evidentiary support demonstrating that the identified plaintiffs exhibited digitalis toxicity as a result of ingesting nonconforming Digitek® tablets. The defendants are attempting to determine whether the plaintiffs served with the requests possessed their medical and pharmacy records at the time their complaints were filed and the Plaintiff Fact Sheets were submitted. The defendants suspect they were not. If their suspicions prove true, the answers to the requests may be used to support future Rule 11 motions for sanctions.

The court first held that the provisions and stipulations contained in previously entered pretrial orders do not prohibit the defendants from serving requests for admission on individual plaintiffs at this time.

Next, regarding the deficiency process, the court noted that the defendants were not seeking information that must be contained in a Plaintiff Fact Sheet. Rather, they are seeking Rule 11 information relating to whether the plaintiffs had a sufficient evidentiary basis to file suit. The requests specifically target information concerning whether the plaintiffs possessed their medical and pharmacy records at particular times. This information is outside the scope required to be disclosed in a Plaintiff Fact Sheet. The deficiency process described in pretrial orders has no application in determining whether the defendants’ requests for admission are proper.

Third, while the plaintiffs are correct that Plaintiff Fact Sheets are considered discovery responses according to the case management order, their argument about Rule 11 is premature because the defendants have not yet filed a Rule 11 motion for sanctions. Even so, the plaintiffs again missed the point of the defendants’ requests. The defendants were not attempting to discover whether the plaintiffs committed sanctionable conduct in their Plaintiff Fact Sheets. Instead, they were trying to gather information as to whether there were appropriate Rule 11 prefiling investigations.

Also, the court found that the requests were specifically aimed at discovering information relevant
to the defendants’ defense. If the plaintiffs in the 39 cases in fact failed to comply with Rule 11, serious issues arise as to the merits of those plaintiffs’ claims. The defendants would
be able to use the information gathered from the requests to support a defense that the claims lack
evidentiary basis. Thus, the information sought by the defendants is within the scope of discoverable material under Rule 26(b)(1).

Finally, the court acknowledged that information relating to Rule 11 may raise potential privilege
and conflict issues. However, if the information received by an attorney from a client is relevant to
whether a complaint is well-founded, it probably will eventually be disclosed, either in a pleading
or in later discovery. Schwarzer, Sanctions Under the New Federal Rule 11--A Closer Look, 104
F.R.D. 181, 199 (1985). Thus, the fact that information may be incorporated into work product does
not immunize it from disclosure.

In summary, based upon the allegations contained in the complaints, a prefiling investigation without first obtaining medical and pharmacy records would be reasonable only in an extremely
limited set of circumstances. The records would be essential in determining whether the plaintiffs
have a colorable claim. Rule 11 applies to the same extent in mass tort and multidistrict litigation as it does in more conventional disputes.The defendants’ requests for admission were sufficiently and narrowly tailored to reveal whether the plaintiffs were in possession of the relevant records at the time suit was initiated. The requests would not cause the plaintiffs any undue burden or hardship as the information necessary to answer the requests should be readily ascertainable. 

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Plaintiffs' Causation Expert Excluded in Viagra MDL

The federal judge overseeing the multidistrict litigation involving the erectile dysfunction drug Viagra has decided to exclude the testimony of the plaintiffs' key expert witness on causation. In re: Viagra Products Liability Litigation, case number 06-md-01724 (D. Minn. 8/19/09).

The litigation stems largely from an announcement in July, 2005 by the FDA that it was updating its labeling requirements for Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to nonarteritic anterior ischemic optic neuropathy (NAION), an eye condition that can result in partial or total blindness.  An MDL consolidated hundreds of product liability lawsuits alleging a link between Viagra and NAION.
 

Judge Paul Magnuson of the U.S. District Court for the District of Minnesota had ruled last year that the general causation opinions of three of  the plaintiffs' experts should be excluded.  This motion related to plaintiffs' sole remaining general causation expert, Dr. Gerald McGwin.  This expert had authored a study, published in the British Journal of Opthalmology, which indicated that male Viagra users with a history of heart attacks had a statistically significant increased risk of suffering NAION. The court had originally denied Pfizer’s Daubert challenge to Dr. McGwin, largely because his study was peer-reviewed, published, contain[ed] known rates of error, and seemingly resulted from generally accepted epidemiological research.  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1081 (2008). In January, Judge Magnuson ruled that Pfizer could seek additional discovery related to McGwin's study, and in July, the judge denied the plaintiffs’ motion to have McGwin provide live testimony at a Daubert rehearing.
 

That additional discovery revealed that the study contained discrepancies that raised “serious concerns” about its reliability. In fact, the study contained numerous “acknowledged inaccuracies,” chief among them the inclusion of numerous patients in McGwin's data-set who had not taken Viagra until after they were diagnosed with NAION.  Dr. McGwin acknowledged that the statistics
in his study would have been different had those individuals (11 of 27 patients who
reported drug use) been coded as unexposed rather than as exposed. The discrepancies between the dates of first use on the original survey forms and in Dr. McGwin’s later electronic data set weaken the McGwin study’s assessment of temporality, thereby impair the study’s ability to contribute meaningfully to Dr. McGwin’s opinion about general causation.

Second, the statistical methods actually used to produce the numbers in the McGwin study as published were not the statistical methods that the study said were used. Even if a later reanalysis purportedly confirmed  the findings of the original study, the fact that the methodologies described in the study were not the actual methodologies used clearly also undermines the reliability of the McGwin study as published.

Third, the study was unreliable because it mischaracterizes one of its main findings—that men with a personal history of myocardial infarction and drug use have a significantly higher risk of NAION. The patients were actually asked whether they had a family history of myocardial infarction; no one was asked about personal history. These mis-codings regarding myocardial infarction added yet another layer of unreliability to the McGwin study as published.

The judge concluded that "Almost every indicia of reliability the Court relied on in its previous
Daubert Order regarding the McGwin Study has been shown now to be unreliable. Peer
review and publication mean little if a study is not based on accurate underlying data."

Lastly, Judge Magnuson denied the plaintiffs' motion for leave to file a supplement to McGwin's expert report, which included a reanalysis of the data, concluding that the report's untimely
submission was neither harmless nor justified. The reanalysis lacked even the basic indications of reliability — peer review and publication — that the original had seemingly had, and it had also been produced simply in response to concerns raised in the litigation.

Update On Chinese Drywall Litigation

The Consumer Products Safety Committee has reported that it has received approval from the Chinese for a visit to China in connection with the drywall issues, and that CPSC staff is working with the Chinese government to arrange an investigative visit beginning later this month.  The CPSC has asked to visit several sites of interest in its investigation of issues related to the tainted drywall, which we have posted about before.

The CPSC reports that it has now received a total of 810 reports related to the allegedly defective drywall, including complaints from two additional states, Pennsylvania and South Carolina. That means the Commission has received reports from homeowners in 23 states and the District of Columbia. The majority of the reports continue to be from Florida, Louisiana, and Virginia.  About 6.2 million sheets of Chinese drywall were imported into the U.S. during 2006.

As part of its investigation, the Commission notes the:
• Start of the Lawrence Berkeley National Laboratory chamber testing of various drywall samples to isolate specific emissions.
• Start of a 50 home indoor air sampling program.
• Site visit to a synthetic drywall manufacturing facility.
• Completion of testing for radioactive phosphogypsum contamination in drywall, in coordination with the Florida Department of Health and the EPA National Air and Radiation Environmental Laboratory. 

The EPA is conducting elemental analyses of 15 drywall samples, with a tentative date for completing its analyses of drywall samples by late August. The CPSC's engineering staff has visited seven homes in Florida, Louisiana and Virginia to gather samples of electrical, plumbing and safety systems. CPSC also has hosted a call among attorneys general of impacted States to coordinate and exchange information about State-level efforts.

Lawsuits filed over the drywall issues allege that excessive sulfur levels in the Chinese-made products are causing health effects and problems with air conditioning systems, appliances, internal wiring and other electrical systems. In June, the U.S. Judicial Panel on Multidistrict Litigation consolidated the lawsuits in the U.S. District Court for the Eastern District of Louisiana. More than 90 suits were on the docket as part of the MDL as of last week. Plaintiffs have asked the court to certify the matter as a class action. In re: Chinese-Manufactured Drywall Products Liability Litigation, MDL 2047.

The monthly status conference in the MDL was held last week before Judge Fallon. At the conference, the court considered issues raised by Liaison Counsel, including pre-trial orders, property inspections, Plaintiff and Defendant profile forms, an evidence preservation order, state court settings, state/federal coordination, discovery issues, Freedom of Information Act/ public records requests, trial settings in federal court, tolling agreement/suspension of prescription, plaintiffs' request for a class action, insurance issues, service of pleadings electronically, and the master complaint. A full report can be found here. 

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Defense Jury Verdict In Welding Rod Trial

A jury in Mason County, W.Va., issued a unanimous verdict last week for welding industry defendants, rejecting claims that injuries to former welder John Belcher were caused by their products. Adkins, et al v. Airco, et al., No. 06-103 (W.Va. Cir. Ct., Mason Cty.)

Apparently jurors deliberated for only a couple hours after an eight-day trial before Circuit Judge David W. Nibert.  Defendants at the trial included Lincoln Electric Company Inc., Hobart Brothers Inc. and The BOC Group Inc. The Circuit Court had entered a gag order before trial to avoid prejudicing potential jurors, so there wasn’t much press on this one.

Defendants have won about 85% of the trials so far in this mass tort. And along with numerous defense verdicts like this one, this litigation has seen the dismissals of thousands of cases. The total number of pending welding fume cases has dropped by more than one half since January 2006. In the MDL in Cleveland, the plaintiffs recently dismissed more than two thirds of the cases they had certified as "ready for trial. "

The next bellwether trial in the federal MDL in front of  Judge O'Malley is set for September. Plaintiff Cooley, a long time welder from Iowa, alleges manganese neuro-toxicity, which defendants contend is not actually a recognized disease. Both sides have recently filed motions to knock out the other's expert opinions under the Daubert doctrine.

 

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Guide for Multidistrict Litigation Transferee Judges Published By FJC

The Judicial Panel on Multidistrict Litigation and The Federal Judicial Center have recently released a new publication, "Ten Steps to Better Case Management: A Guide for Multidistrict Litigation
Transferee Judges."

As readers of MassTortDefense well know, Section 1407 empowers a transferee judge to exercise all the powers of the transferor court, with the exception of actually conducting the trial of the case (except in special circumstances). The stated purpose of this Guide is to briefly introduce some of
the “best practices”  -- in  the authors' view -- that transferee judges have developed over the years. It is designed as a complimentary piece to the guidance in the Manual for Complex Litigation (4th ed.), which addresses some of difficult management, intellectual, and legal challenges posed by MDL cases. 

The advice includes the suggestion to identify and appoint liaison counsel who are vigorous advocates, constructive problem-solvers, and also civil with their adversaries, because the judge cannot manage an MDL entirely alone. "To a large extent, you [judge] must rely upon lead counsel to assist you."

Another welcome suggestion: Rulings should be prompt and disciplined; scholarly
perfection is not required on all issues.  In particular, resolving discovery disputes expeditiously is important to avoid undue delay in any case, but particularly in an MDL, says the Guide.

In MDL litigation with parallel state cases, judges are urged to reach out to their state court colleagues "from the outset" to try to forge constructive working relationships with them. One way of doing this is to establish an MDL-specific website so that federal orders and rulings are readily available to state courts.

Worth a look for defense counsel with MDL practices.

 

Sanctions Against Plaintiffs in HRT Litigation

The judge in charge of multidistrict litigation involving Wyeth Pharmaceuticals' hormone replacement pill, Prempro, has decided to sanction a law firm representing hundreds of plaintiffs, for its failure to timely produce completed client fact sheets. In re: Prempro Products et al., No. 4:03-cv-01507 (E.D. Ark.). 

Judge Wilson of the U.S. District Court for the Eastern District of Arkansas recently granted Wyeth's motion for sanctions against a Texas-based firm, although he declined to dismiss the plaintiffs.

Readers of MassTortDefense know the role plaintiff fact sheets (PFT) play in mass tort litigation, replacing some aspects of basic fact discovery; allowing defendants to gather information for early case assessment; beginning the process that winnows the number of cases that will be subjected to fuller case-specific fact discovery and expert discovery; and eventually informing the pool of cases available for initial trials if the case management process includes bellwether trials. 

The information requested on the PFT is often a negotiated topic, but typically includes information that any plaintiff's attorney who has done a good faith, Rule 11 assessment of the claim should have, or could readily access. The Manual for Complex Litigation notes that in lieu of interrogatories, questionnaires directed to individual plaintiffs in standard, agreed-on forms were used successfully in the breast implant and diet drug litigation.  It also includes sample case management orders regarding, inter alia, plaintiff fact sheets. (For other examples of plaintiff fact sheets, see In re Baycol Products Litigation, MDL 1431, Pretrial Order No. 10 (D. Minn. Mar. 18, 2002) and In re Phenylpropanolamine (PPA) Products Liability Litigation, MDL No. 1407, Case Management Order No. 6 (W.D. Wash. Mar. 21, 2002)).

Wyeth showed the court that the plaintiff firm missed several court deadlines to serve completed fact sheets for each of its clients. Wyeth first argued in 2008 that plaintiffs represented by the firm had repeatedly submitted incomplete fact sheets in which they provided merely a “will supplement” answer to several questions. Judge Wilson agreed and issued an order on Dec. 17, 2008,
directing the firm to produce completed fact sheets by Feb. 2, 2009.  In February, defendant again complained to the court that hundreds of fact sheets had not been served by the deadline and that many of those that had been produced remained incomplete, with plaintiffs replacing “will supplement” with the vague language that plaintiffs do "not recall and do not have reasonable access to the information that would be responsive to this question without undue burden or cost.”
Plaintiffs were then given until April 13 to resubmit the fact sheets in accordance with the order, and the responses led Wyeth to renew its bid for sanctions including dismissal.

The judge directed the firm to pay $5,000 to Wyeth to partially compensate it for the time and effort involved in seeking adequate fact sheets.  The firm must also assign an associate or paralegal to immediately contact all plaintiffs identified by Wyeth as still having insufficient fact sheets and to have the documents filled out by August 5th.

The court warned that it was likely that additional sanctions — and perhaps considerably more severe sanctions — will be imposed if substantial effort is required to review the adequacy of fact sheets filed by Aug. 5, 2009. 

The court indicated it had seriously considered dismissing all the affected cases without prejudice, and with the proviso that if a case was refiled it must have a reasonably accurate fact sheet attached and that sanctions against counsel would likely be imposed if additional fact sheets were attached with non-answers.  Only the administrative burden of dealing with amended complaint filings prevented this.

iPhone MDL Created

The U.S. Judicial Panel on Multidistrict Litigation has issued an order consolidating 12 putative class actions alleging that Apple Inc.’s iPhone 3G did not perform as fast as promised on AT&T Mobility LLC’s 3G data network.  In re: Apple IPhone 3G Products Liability Litigation, MDL No. 2045.

Plaintiffs allege that iPhone owners paid extra for the supposedly superior functionality and high-speed data network used by the phone. They further allege that because the phone is typically used for e-mail and on-line activities, many purchasers subscribe to a data plan that uses AT&T’s 3G network. But, they assert, the phone does not function as fast as promised and often performs at slower speeds than other 2G and 3G phones. In the litigation thus far, plaintiffs' complaints conspicuously seem to omit one critical condition precedent to their causes of action: an allegation that they contacted Apple to seek a repair of the alleged defects or a replacement iPhone 3G under Apple's one-year limited warranty.

In the order issued last week, the JPML said that centralizing the lawsuits in the U.S. District Court for the Northern District of California was appropriate. All actions involve common factual questions arising from the performance of Apple’s iPhone 3G on AT&T’s 3G network. Specifically, the actions share allegations that Apple and, where named, AT&T, misrepresented to the public the speed, strength and performance of the iPhone 3G on AT&T’s 3G network. Centralization under Section 1407 will eliminate duplicative discovery; prevent inconsistent pretrial rulings, particularly with respect to class certification; and conserve the resources of the parties, their counsel and the judiciary.

The Northern District of California stands out as an appropriate transferee forum, said the panel. The headquarters of the common defendant, Apple, are located within this district; accordingly, relevant witnesses and documents will likely be found there. Eight actions are already pending in the district. Other cases are in the Southern District of Florida, the District of New Jersey, the Eastern District of New York and the Eastern District of Texas.

Update on FEMA Trailer MDL

A federal judge has decided an that an advisory jury can hear evidence on claims against the U.S. government in bellwether trials in the MDL concerning alleged formaldehyde-laden trailers. In re: FEMA Trailer Formaldehyde Products Liability Litigation, MDL 1873 (E.D. La.)

Readers of MassTortDefense will recall how Hurricane Katrina devastated much of the Gulf Coast in 2005. The total damage of Hurricane Katrina has been estimated at $75 billion, while not-much-later Hurricane Rita caused $10 billion in damage. The government, through FEMA, moved individuals whose homes were lost or deemed uninhabitable into makeshift housing provided by the agency.  Plaintiffs allege that the trailers had components that exposed them to dangerous and excessive levels of formaldehyde.

The court has decided that it will hold bellwether trials in the MDL. But the defendants include both private entities and the government. The government moved to strike the jury demand and requested that a jury not be involved in any manner in determining its liability. The federal government argued that, because the plaintiffs have filed claims under the Federal Torts Claims Act (“FTCA”), 28 U.S.C. §§ 2671-2680 and 28 U.S.C. § 1346(b), the use of any jury is precluded under 28 U.S.C. § 2402 which states that “[a]ny action against the United States under section 1346 shall be tried by the court without a jury. . .”  The Plaintiffs’ Steering Committee (“PSC”) and the nongovernmental defendants both opposed the motion. Indeed, both the PSC and the non-governmental defendants contended that it is both permissible and sensible for the court to utilize an advisory jury who will hear evidence of the Government’s alleged fault in order to properly apportion liability to all parties. The government claimed that any use of even an advisory jury contravenes the statute and congressional intent to have FTCA cases decided by the court without a jury.

Rule 39(c) of the Federal Rules of Civil Procedure states, in pertinent part, “[i]n an action
not triable of right by a jury, the court, on motion or on its own . . . may try any issue with an
advisory jury.”  The court found that it has the power to make use of an advisory jury in this case. Because of the purely advisory function that a jury empaneled under Rule 39(c) has, the use of an advisory jury is not precluded under 28 U.S.C. § 2402. The court concluded it will empanel a jury to hear the bellwether plaintiffs’ claims against the non-governmental defendants in the bellwether trials and will exercise its discretion to use that jury in an advisory capacity to hear the claims against the government in those same trials.

This advisory jury will not be asked or allowed to make a binding factual determination on the plaintiffs’ FTCA claims; instead, it will be allowed to hear the case and, through the verdict, advise the court, who will remain free to consider the same evidence and completely disregard such findings. The court determined that utilizing an advisory jury will alleviate jury confusion that would result if jurors are expected to listen to all the evidence against all the defendants - including FEMA - but then are instructed to ignore any evidence pertinent to the government.
 

 

Defense Experts Pass Daubert Test in Stand 'n Seal MDL

In the multidistrict product liability litigation over "Stand ‘n Seal," a federal judge is allowing, over plaintiffs' objections, testimony from the defendants' causation experts.  Judge Thomas W. Thrash of the U.S. District Court for the Northern District of Georgia has ruled that three experts, who opined that Stand ‘n Seal does not emit sufficient amounts of the chemical which plaintiffs allege caused their injuries, including chemical pneumonitis, may testify. In Re Stand ‘N Seal Products Liability Litigation, MDL NO. 1804 (N.D. Ga.).

Plaintiffs in the roughly 200 personal injury actions in the MDL assert that Stand ‘n Seal  manufactured with Flexipel S-22WS caused respiratory problems. Stand ‘n Seal is a consumer product used to seal ceramic tile grout in kitchens, bathrooms, and similar areas. The advertised advantage of Stand ‘n Seal was that users can easily stand and spray the sealant onto the grout without the strain of using a brush and manually applying the sealant. The plaintiffs say that the
problems with Stand ‘n Seal began when the manufacturer changed its chemical components to include Flexipel.

Part of the defense has been the dose-response issue that plaintiffs could not have inhaled a harmful amount of the chemical while using Stand ‘n Seal as directed. The plaintiffs urged the court to exclude this expert testimony of Drs. Mark Rigler, William Longo, and Mitchell Sauerhoff.  Rigler and Longo, industrial hygiene experts, tested samples of Stand ‘n Seal and concluded that plaintiffs did not inhale an “analytically detectable” concentration of Flexipel, the specific chemical at issue.  They did not, contrary to plaintiffs' arguments, opine that users of Stand ‘n Seal had absolutely no exposure to Flexipel.  Instead, they have said that users of Stand ‘n Seal were not exposed to “any significant” or “analytically detectable” amounts of Flexipel. In other words, there is a range between zero and the detection limit of their testing, but they believe that range is insignificant.

Instead, said the defense experts, the users of Stand ‘n Seal had a much higher probability of inhaling significant levels of Isopar-G, a solvent used in various formulations of grouting. Defendants intend to offer expert testimony from Mitchell Sauerhoff that overexposure to Isopar-G can cause respiratory injury.  Judge Thrash concluded that the experts’ opinions were admissible. 

“The plaintiffs' experts disagree with Sauerhoff’s opinions, but that disagreement by itself does not make Sauerhoff’s or Rigler and Longo’s testimony inadmissible.”  The court noted that "none of these [potential alternative] explanations seems especially conclusive."  But the alleged generality of the defense experts’ alternate explanations for the cause of the plaintiffs’ injuries affect the weight, not the admissibility, of the expert testimony.”   MassTortDefense notes that plaintiffs often forget that the defendant does not have the burden to disprove causation.  So defense evidence of alternative causes can be admissible even if such evidence would be insufficient when offered by a plaintiff who has the burden of proof on causation.

 

JPML Declines to Consolidate Metoclopramide Litigation

Some have expressed the sentiment that the the Judicial Panel on Multidistrict Litigation always grants requests for MDL status.  In reality, that is not the case, although opposition to MDL status can be an uphill battle in burgeoning mass torts. (FYI Volume 82, Number 6 (June 2008) issue of the Tulane Law Review is devoted to "The Problem of Multidistrict Litigation." )

The JPML recently declined to consolidate federal litigation involving the heartburn medication metoclopramide, finding that the pending actions do not share sufficient factual issues concerning whether the drug causes neurological injuries. (In re Reglan/Metoclopramide Products Liability Litigation, MDL No. 2049, 6/3/09).

The Panel was not persuaded that Section 1407 centralization would serve the convenience of the parties and witnesses or further the just and efficient conduct of this litigation at the present time. The eleven actions at issue did share some factual issues as to whether the drug metoclopramide causes neurological injuries (principally, tardive dyskinesia). But there is no single common defendant, and some entities, are named in only one or two actions. Moreover, several of the actions appear to be substantially more advanced (five were commenced in either 2006 or 2007). Metoclopramide litigation thus has a somewhat lengthy history, and the record indicates that a significant amount of the common discovery has already taken place in some cases. The proponents of centralization failed to convince the Panel that any remaining common questions of fact among these actions are sufficiently complex and/or numerous to justify Section 1407 transfer at this time. Alternatives to transfer exist that may minimize whatever possibilities there might be of duplicative discovery and/or inconsistent pretrial rulings, concluded the Panel. 

MDL Created for Chinese Drywall Litigation

The U.S. Judicial Panel on Multidistrict Litigation has consolidated a number of lawsuits brought over Chinese-made drywall installed in U.S. homes. See In re: Chinese-Manufactured Drywall Products Liability Litigation, MDL-2047 (JPML).

The motion for consolidation encompassed ten actions, four actions in the Southern District of Florida, three actions in the Middle District of Florida and one action each in the Northern District of Florida, Eastern District of Louisiana, and Southern District of Ohio. The panel said it was aware of 67 related lawsuits that were pending in federal courts around the country. Those suits and any other related actions will be treated as potential tag-along actions.

The Panel found that all actions share factual questions concerning drywall manufactured in China, imported to and distributed in the United States, and used in the construction of houses; plaintiffs in all actions allege that the drywall emits smelly, corrosive gases. Centralization under Section 1407 will eliminate duplicative discovery, including any discovery on international parties; prevent inconsistent pretrial rulings, particularly those with respect to class certification issues; and conserve the resources of the parties, their counsel and the judiciary, said the Panel.

As is sometimes the case, no district was a clear focal point of this litigation. The common manufacturing defendant and its affiliates are foreign entities without a major presence in any of the suggested transferee districts. Most actions also name local entities, such as builders and suppliers, as defendants. Several parties suggested different districts, and all of the suggested districts, particularly those in the southeastern region, have a nexus to the litigation through allegedly affected houses built with the drywall at issue. On balance, the panel was persuaded that the Eastern District of Louisiana is a preferable transferee forum for this litigation. Centralization in this district permits the Panel to effect the Section 1407 assignment to a judge who has "extensive experience in multidistrict litigation as well as the ability and temperament to steer this complex litigation on a steady and expeditious course." That would be the Honorable Eldon E. Fallon of the Eastern District of Louisiana.

As posted on MassTortDefense before, the lawsuits allege that sulfur compound levels in the drywall are too high, causing issues with air conditioning systems, electrical appliances, internal wiring and other electrical systems in homes. Plaintiffs also allege the drywall produces a rotten egg-like stench and causes a variety of respiratory and other health problems for those who live in the affected homes. The lawsuits filed so far have named Chinese-based manufacturers, as well as importers, developers and builders, contractors, suppliers and others. Companies facing suits include Knauf Gips KG, Knauf Plasterboard Tianjin Co., Taishan Gypsum Co., L&W Supply Corp. and USG Corp. Lennar Corp., a major home builder, has brought in more than 20 manufacturers, suppliers and installers.  Some legislators have been critical of the CPSC's handling of the issue.  And bills have been introduced to ban the product.

FEMA Trailer MDL Decision on Preemption

The federal court overseeing the MDL involving trailers issued by the U.S. government following Hurricane Katrina has dismissed some of the plaintiffs' state law claims against mobile home manufacturer defendants, on the basis of the federal preemption doctrine. In Re: FEMA Trailer Formaldehyde Products Liability Litigation, MDL No. 1873 (E.D. La.)

As readers of MassTort Defense know, Hurricane Katrina impacted much of the Gulf Coast in August 2005, and Hurricane Rita followed in September 2005, causing extensive damage along the Louisiana and Texas coasts. In the wake of the hurricanes, many individuals whose homes were lost or damaged moved into temporary housing provided by FEMA. Plaintiffs allege that these trailers exposed residents to high levels of the chemical formaldehyde, about which they were not warned. The Judicial Panel on Multidistrict Litigation consolidated a number of suits against defendants, including the federal government and several trailer manufacturers, over the alleged formaldehyde exposure in 2007.

Judge Kurt Engelhardt of the U.S. District Court for the Eastern District of Louisiana last week granted the manufacturer defendants' motion to dismiss certain state law claims. The defendants asserted that the construction of these mobile homes was regulated by the Manufactured Home Construction and Safety Standards Act, 42 U.S.C. § 5401 et seq., (“the MHA”) and the regulations promulgated by the United States Department of Housing and Urban Development (“HUD”), pursuant to 24 C.F.R. § 3280 and § 3282 (“the HUD Code”). Pursuant to the MHA, HUD established the Manufactured Home Construction and Safety Standards (“MHCSS”), 24 C.F.R § 3208 et seq., which govern the standards for formaldehyde emissions from materials used in manufactured homes. This regulation expressly and specifically dictates the maximum level of formaldehyde gas that component products in mobile homes can emit. The regulations also specify that a health notice on formaldehyde emissions shall be temporarily displayed in the kitchen of each manufactured home.Accordingly, the defendants asserted that the federal statutes and regulation in the MHA and the HUD Code explicitly and impliedly preempt plaintiffs’ state law claims against them.

As several courts have previously noted, the MHA does not explicitly preempt state causes of action. Turning to implied preemption, the court noted that implied preemption exists when state law regulates conduct in a field Congress intended the Federal Government to occupy exclusively (also referred to as “field preemption”), or when state law actually conflicts with federal law (also referred to as “conflict preemption”). Conflict preemption exists in two scenarios: (1) when compliance with both a state and federal law is impossible, and/or (2) when the state law conflicts with the federal law such that it stands as an obstacle to the achievement of the federal law’s purposes and objectives.

After analyzing the statute and regulations, the MDL court concluded that if plaintiffs in the instant case were allowed to go forward with their state product liability claims raising the ambient air standard, then defendants in the mobile home industry would essentially be required to deviate (in ways variable from state to state) from those federal standards so carefully and thoroughly crafted by HUD. The MHA clearly states that if states want to regulate safety matters that federal law already covers (like formaldehyde emissions), those regulations must be “identical.” 42 U.S.C. § 5403(d). Furthermore, it was noteworthy that the plaintiffs contend that the moving defendants should have adhered to the ambient air standard, which differs from the HUD-accepted component products standard. Thus, cases that present situations where the plaintiffs are not arguing that the defendants should have adhered to a standard higher than, or different from what the MHA imposes, are inapplicable.

The court concluded similarly that any such claims relating to inadequate warnings of exposure
to purportedly high levels of formaldehyde contained in the units, that require more than the federal
label standards, should be dismissed. However, any of plaintiffs’ state law claims that advance non-compliance with federal formaldehyde regulations (to the extent that such claims exist) are considered to be parallel claims, are not preempted and, thus, are not dismissed. See Riegel v. Medtronic, Inc., 128 S.Ct 999, 1011 (2008).

Court Refuses To Consolidate Class Action Into Lexapro MDL

A federal court last week rejected an attempt to consolidate a newly filed proposed class action over Lexapro and Celexa with the multidistrict litigation involving the drugs. In Re: Celexa and Lexapro Products Liability Litigation, MDL No. 1736 (E.D. Mo.).

Judge Rodney W. Sippel said in his ruling that plaintiffs had not demonstrated that consolidation would be appropriate. The MDL is currently comprised of 42 cases brought by individual plaintiffs who claim Lexapro or Celexa caused or induced a suicide or suicide attempt. In originally creating this MDL in 2006, the Judicial Panel on Multidistrict Litigation noted that the actions shared allegations relating to the safety of Celexa or Lexapro and the adequacy of Forest's warnings concerning the possible adverse effects of using the drugs, in particular, the potential for each product to induce its users to commit, or attempt to commit, suicide. The JPML recently declined to transfer two personal injury cases to the MDL because they involved injuries other than suicide.

The new suit, Universal Care, Inc., et al. v. Forest Laboratories, Inc., et al., on the other hand, involves allegations relating to Forest Laboratories Inc.'s marketing of the drugs, and economic damages allegedly caused from the sale of Celexa or Lexapro. Specifically, the new suit alleges violations of the Missouri Merchandising Practices Act and makes claims for unjust enrichment,  fraudulent concealment , and misrepresentation. The plaintiffs in this case claim that Forest engaged in improper promotional activities, causing third-party payors to reimburse patients and health care institutions for prescriptions of Lexapro and Celexa that were written for patients for whom the drugs were not indicated.

Moreover, the cases pending in the MDL are individual actions, not a putative class actions. The extensive discovery and motion practice relating to the alleged appropriateness of class-wide treatment and the adequacy of the class representatives are not part of the current MDL. These factors could significantly delay the progress of the MDL proceedings, prejudicing both the MDL plaintiffs and Forest. A final factor is that the MDL is already more than 2 years old, with significant pretrial proceedings already haven taken place.

Even in the MDL context, Rule 42 applies, and the court has discretion to assess the impact of allegedly common questions.  Consolidation is inappropriate if it causes confusion or leads to delay, inefficiency, inconvenience, or unfair prejudice to a party. E.g., EEOC v. HBE Corp., 135 F.3d 543, 551 (8th Cir. 1998).

Daubert Ruling In Zyprexa: A Lesson For Mature Mass Torts

Zyprexa is a mature mass tort, as the defendant has settled approximately 31,000 individual product liability lawsuits over the drug, which was widely used in the treatment of psychiatric disorders. The federal court overseeing the multidistrict litigation over Eli Lilly and Co.'s product has made an important ruling on a Daubert challenge to a plaintiff expert in 13 cases involving 20 of the remaining claimants. In re Zyprexa Products Liability Litigation, MDL No. 1596 (E.D.N.Y. May 12, 2009).

Plaintiffs proposed to call an expert to establish the specific causal relationship between the Zyprexa taken and the onset or worsening of their diabetes. After briefing and an extensive evidentiary hearing, Senior Judge Jack B. Weinstein granted Eli Lilly's motion to disqualify Dr. Stephen J. Hamburger, M.D. While the expert met the necessary educational and experiential qualifications warranting the admissibility of his expert opinions, the court found his testimony lacked sufficient scientific reliability.

The court noted that in longstanding and highly complex litigation (read mass tort), particular emphasis must be placed on the reliability and scientific validity of the expert's opinions. Particularly in a mature mass tort ("advanced stage" described the court) when the issues of the benefits and risks of the drug have been a focus of the scientific community for some time, precision with respect to the relevant scientific knowledge and its application to the facts of the individual cases is expected, said the court.

The record demonstrated to the court that this expert's opinions relied on "a subjective methodology, a fast and loose application of his scientific theories to the facts, and conclusion-driven assessments on the issues of causation in the cases on which he proposes to testify,” the order said. In particular, the court pointed to the opinion that Zyprexa supposedly has a direct adverse effect on cells essential to the body's production of insulin, even in cases in which there was no documented weight gain. This opinion was not based on sufficient facts or data, nor was it the product of a reliable method.

In applying this theory to the facts of the cases (the "fit" required by Daubert), the expert had been, in the view of the court, “shockingly careless” about the scientific facts in these cases, including whether weight gain preceded or followed the plaintiffs' use of Zyprexa, and whether there was any weight gain at all. When confronted with these issues, he merely "shrugged off" factual discrepancies in his analyses or shifted to new theories on the fly.

Significantly, the court correctly observed that other mass torts had been subject to a kind of junk science, and it it could not "permit a major pharmaceutical litigation to become the subject of the kind of 'rubber-stamp' expert opinions that have so marred mass litigations such as those involving asbestos and breast implants.”

Latest Update on Digitek MDL

The Digitek MDL Judge, on March 5th,  entered PTO # 16, which details important case management and scheduling deadlines in this mass tort. 

For those interested in some of the nuts and bolts of managing an MDL: the Order  requires that within 45 days, each defendant named in the Master Complaint shall file a Master Answer or a Fed. R. Civ. P. 12 motion in response to the Master Complaint.

The Order sets deadline for plaintiffs to request and brief class certification of any wrongful death, personal injury or medical monitoring putative class in September, 2009.

Plaintiffs are required to fill out and sign Plaintiff Fact Sheets, providing basic fact discovery.  It sets up a process for handling deficiencies in the responses.

Plaintiffs are to provide signed undated authorizations for the gathering of medical records, and addresses for each health care provider, including hospitals, clinics and outpatient treatment centers, and any other custodian of records identified in a plaintiff’s Fact Sheet.

Plaintiffs are ordered to produce medical and pharmacy records in their  possession establishing that the plaintiff was prescribed Digitek and the date(s) on which each prescription issued.

The Order set up a procedure for governing the oft-debated ex parte contact by defendants of treating physicians.

Defendants are ordered to provide organizational chart information as well as QC/QA structures. Also specifications, instructions, test methods and standard operating procedures relating to the manufacture of  Digitek;  quality assurance/control and testing records for Digitek, and any of its component ingredients, including but not limited to records related to batch sampling, post-manufacturing testing and finished goods testing. 

The Order establishes a procedure for privilege logs. The parties were directed to reach an agreement concerning a document production protocol to include the production format of paper and electronic documents, objective coding and metadata, privilege logs and any other applicable issues. In the event the parties cannot agree, the issues will be presented to Magistrate Judge Stanley for resolution.

The PTO also sets deadlines for service of interrogatories, document requests, and company witness depositions. As to expert discovery: Plaintiffs shall serve their reports from liability experts no later than January 1, 2010. The parties shall complete their depositions of Plaintiffs’ liability  experts no later than March 12, 2010.  Defendants shall serve their reports from liability experts no later than March 31, 2010.  The parties shall complete their depositions of Defendants’ liability experts no later than June 11, 2010.

To efficiently manage discovery for all currently pending and future cases in the MDL, the cases will be divided into groups, with each group having a separate scheduling order. Following completion of the first wave of Plaintiffs’ Fact Sheets the Court shall schedule a hearing for purposes of  selecting the initial trial pool of cases (“Group 1”). No later than 5 days before the hearing, Plaintiffs shall select 15 cases and the Defendants shall select 15 cases, and each side shall exchange lists of such selections and submit them to the Court.  Within 10 days after the scheduled hearing, the Court shall select a total of no more than twenty of the proposed trial pool cases to constitute Group 1.

Case specific discovery is set up by Group, with staggered dates of initial discovery (DID),  corresponding discovery deadlines, and Daubert and dispositive motions deadlines 310 days after  DID.

State Appellate Accutane Decision Reverses Verdict

The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week.  See  McCarrell v. Hoffman-La Roche, Inc., And Roche Laboratories, Inc., 2009 WL 614484 (N.J.Super.A.D.) (March 12, 2009).

Plaintiff alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease ("IBD"). The IBD allegedly led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his product liability claim against Roche, but not on his consumer fraud claim, and awarded him compensatory damages.

By order dated May 2, 2005, the state Supreme Court had designated all pending and future statewide actions involving Accutane as a mass tort.  Thus, all Accutane cases, including plaintiff's lawsuit, were transferred to Atlantic County to be heard on a coordinated basis. Discovery in the state cases proceeded in tandem with discovery in the federal Accutane multidistrict ("MDL") litigation.

On appeal from the jury verdict, Roche specifically argued, inter alia, that the trial court erred in admitting the opinion testimony of plaintiff's causation expert Dr. Sachar because his methodology was unreliable and thus improper under  N.J.R.E. 702; and that the trial court denied Roche a fair trial in admitting the testimony about causality assessments based on Accutane ADEs, but in restricting the defense in presenting competing quantitative proofs to put the ADEs in context, including the actual number of Accutane users.

On the issue whether Dr. Sachar's causation testimony was sufficiently reliable in the field of scientific research to be admitted, the court noted that in New Jersey the standard of review of such
rulings under Rule 702 is a narrow one. "In reviewing a trial court's evidential ruling, an appellate court is limited to examining the decision for abuse of discretion."

On the merits, the defendant objected to the expert's heavy reliance on animal studies. The NJ  Supreme Court has previously recognized that animal studies can be an accepted scientific method to study the safety and efficacy of drugs.  Even though the dose administered in the animal studies was far different than the medicinal dose, "trained experts commonly extrapolate from existing data." Gen. Elec. v. Joiner, 522 U.S. 136, 146 (1997). In assessing the results of animal studies, which frequently involve high doses, experts should be careful to consider the dose-response differential between animals and humans. Magistrini v. One Hour Martinizing
Dry Cleaning
, 180 F. Supp. 2d 584, 593 (D.N.J. 2002), aff'd, 68 Fed. App'x. 356 (3d Cir. 2003). (Readers also know that the biological differences between commonly used animals such as rats and humans make the models inappropriate for many comparisons, regardless of dose.)

Defendants also challenged the use of anecdotal case reports as a basis for the causation opinion. The court recognized that "[c]ausal attribution based on case studies must be regarded with caution." Federal Judicial Center, Reference Manual on Sci. Evidence 497 (2d ed. 2000).
That is so because case reports typically reflect reported observations, and do not themselves contain scientific analyses. For instance, case reports may lack controls, may fail to screen out alternative causes, and may omit relevant facts about the patient's condition that can be pertinent to a causation assessment. Consequently, a number of courts have concluded that anecdotal case reports are not a scientifically reliable basis for an expert's opinion on causation.

Nevertheless, some other courts have allowed consideration of case reports as an acceptable basis for trying to show causation, particularly when accompanied by other reliable scientific evidence. New Jersey courts have previously upheld the admission of expert testimony that has relied, at least in part, upon case reports or comparable anecdotal evidence. The court also found significant that the case reports here included dechallenge and rechallenge reports. Dechallenge and rechallenge reports are a type of case report. Dunn v. Sandoz Pharms. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003). Such reports have limitations, but have been considered useful in some contexts in ascertaining causation because they measure a patient's reaction to a drug, said the appellate court.  (Readers will note that the dechallenge/rechallenge concept appears to make little sense when the effect of the drug is supposedly a permanent disease!)

The New Jersey court recognized it was issuing a causation decision contrary to the ruling in the Accutane MDL.  The state court declined to follow the federal court's decision because (1) the causation expert in the federal case was not Dr. Sachar, and that particular expert's methodology was not as "demonstrably sound" as that of Dr. Sachar; (2) the standards for expert admissibility under N.J.R.E. 702 are not identical to F.R.E. 702; and (3) the testimonial record in this case, having proceeded to trial, was more developed than it was in the Florida case on a pretrial motion, lending greater confidence to a conclusion to sustain the trial judge's decision to admit Dr. Sachar's testimony.

Defendant also challenged the expert's testimony about the company's alleged intent and motive and mind-set, a typical plaintiffs' tactic in mass torts.  Totally improper, highly prejudicial, and ignored by some courts because they seem overwhelmed by the plaintiff's characterization of the defendant's conduct.  Well-reasoned opinions exclude such testimony. See In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1053 (D.Minn. 2007) (observing that "[p]ersonal views on corporate ethics and morality are not expert opinions"); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (holding that the objected-to opinions of expert witnesses on intent, motives, or state of mind of a corporation had no basis in any relevant body of knowledge or expertise).  Here, the court seemed not to understand the impact and purpose of this improper testimony, finding that although Dr. Sachar's testimony sharply criticized Roche, his criticisms did not rise to "such an inflammatory level" that would cause the appeals court to find an abuse of discretion by the trial court in not excluding it.  The issue is not only a Rule 403 prejudice issue; there is a fundamental relevance issue, and a serious issue about fit, foundation, and reliability.

Finally, there was what has been described as the "numbers" issue. The issue refers to the fact that the trial court allowed plaintiff's witnesses and counsel to refer, on repeated occasions, to the number of adverse incidents reported from Accutane users or from other sources while, at the same time, the court restricted Roche's attempt at trial to place those adverse numbers into any larger quantitative context. Specifically, the judge precluded Roche witnesses from more
fully informing the jury about the large number of persons who had taken Accutane before it was prescribed to plaintiff in 1995, and the comparative significance of those figures.

The court ultimately concludes that it was unfair to Roche for the trial court to have precluded such "numbers" counter-proof and that the court abused its discretion on this evidentiary issue. Had Roche been allowed to present the statistics showing five million Accutane users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's actions in changing its label. "Principles of completeness and fairness warranted the presentation of this contextual information to the fact-finder."

 

 

Digitek MDL Court Issues Federal-State Coordination Order

An important aspect of mass tort case management involves the level of coordination between cases in a federal MDL and those cases in state courts involving the same product. The MDL judge in the Digitek products liability multidistrict litigation, In Re: Digitek Products Liability Litigation, MDL No. 1968, No. 08-md-1968( S.D. W.Va.), issued an order coordinating activities between the federal litigation and the mass tort litigation recently coordinated before the state court in West Virginia's Circuit Court. In Re: Digitek Litigation, No. 08-C-5555, (W.Va. Cir., Kanahwa Co.).

Readers of MassTortDefense will recall the nationwide recall of Digitek products, involving tablets with higher dosage than called for which may have been released to the public. Approximately 60 cases arising from the recall were transferred last August to a multidistrict litigation assigned to Chief U.S. Judge Joseph R. Goodwin of the Southern District of West Virginia. Later in the Fall, multiple Digitek stats court cases were coordinated in the Kanawha County Circuit Court.


Pretrial Order (PTO) No. 11 concerns state and federal coordination. The court found that the state and federal litigation share common issues and will involve common discovery.  The court said proper coordination will avoid unnecessary conflicts and expense, conserve judicial resources, and expedite the disposition of all the cases. 

He ordered lead and liaison counsel for the plaintiffs and defense to endeavor to coordinate activities between the federal and state litigation. He also ordered the creation of a joint document depository for use by parties in the federal-state litigation. The Order provides a mechanism for cross-noticing depositions.  Also, counsel in the West Virginia state litigation who obtain confidential documents are subject to the confidentiality/protective order issued in the MDL.


Chief Judge Goodwin also said he is prepared to conduct "consolidated hearings and status conferences with the presiding state judicial officers, and to enter joint rulings, except to the extent that differences may be mandated by different laws or rules governing this court or justified by particular circumstances of the cases before this court." 

Update on Digitek Litigation

As posted by MassTortDefense, the Digitek MDL judge late in 2008 issued a pretrial order regarding multi-plaintiff complaints. In Pretrial Order No. 7, the court ordered the severance of most multi-plaintiff cases (other than spouses). In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.). The court noted that several complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they allegedly ingested the drug at issue. Other MDL judges have noted the case management, tracking, and other difficulties often accompanying that joinder practice, citing Vioxx and diet drugs.

Plaintiffs’ Co-Lead Counsel were to submit to the court a report identifying multi-plaintiff actions docketed prior to this Order that are subject to severance, and submit a suitable proposed severance order. One of the reasons plaintiffs resist such severance is the need to pay separate filing fees for all the separate claims filed, but the Order required the fees.


The plaintiffs in the Digitek multidistrict litigation then identified five class actions that they say meet the court's requirements for severance under Pretrial Order No. 7. The plaintiffs said that the five cases they identified have multiple class representatives, but  -- despite the order -- they propose that they be continued with multiple class representatives until "class certification issues are addressed and determined by the Court to ascertain suitability and typicality of the class representatives' claims."  These kinds of personal injury claims are typically inappropriate for class treatment.  Individual issues of causation, injury, and damages predominate over any alleged common issues.  Choice of law issues can make the class device unmanageable.

MassTortDefense also posted before about defendants' proposal to centralize the cases filed in New Jersey, and plaintiffs' proposal to designate the New Jersey cases as a mass tort.

New Jersey state court Digitek cases have now been designated a mass tort by a New Jersey Supreme Court Order, and have been assigned to the Bergen County Superior Court. The centralized mass tort docket has been assigned to Judge Jonathan N. Harris.

The state’s mass tort website states that Digitek is a medication used to treat heart failure and abnormal heart rhythm. The NJ complaints seek damages, medical monitoring and other relief due to the purchase or ingestion of allegedly defective Digitek tablets which the plaintiffs claim were released with as much as twice the appropriate thickness. The complaints further allege that patients were thus taking twice the intended dosage. A Class I recall was initiated by the defendants after receiving some reports of illness and injuries consistent with potential overdoses of Digitek. It is alleged that this condition is dangerous especially among individuals suffering from renal failure because the Digitek may accumulate in the body of such individuals, rather than be excreted normally in urine. 

The pattern of federal case MDL and mass tort treatment of multiple filings in a given state's court has been seen in numerous other pharmaceutical cases, including Vioxx and Seroquel.
 

Preemption Found In Medtronic MDL

The federal judge in the Medtronic Sprint Fidelis Leads MDL has ruled that all claims in the plaintiffs' master consolidated complaint are preempted. In Re: Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 35467 (D.Minn. 2009).

The Judicial Panel on Multidistrict Litigation transferred related cases involving Medtronic Inc.'s recalled Sprint Fidelis defibrillator leads to the District of Minnesota last February. The leads were recalled in late 2007, because of the potential for fracture, which can potentially cause unnecessary shocks or failure, possibly resulting in injury. 

Relying on the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), the MDL court noted that Congress has decided to limit medical-device manufacturers' liability in order to spur innovation. Plaintiffs' remedy, therefore, lies with Congress, and not with the courts. 

Every medical device intended for human use is placed into one of three categories by the FDA, based on the risks of injury or illness the device presents; each category is subjected to a different level of FDA scrutiny. Devices that either support or sustain human life or present a potential unreasonable risk of illness or injury” are categorized as “Class III” devices. Class III devices are subject to the greatest level of FDA scrutiny and “must complete a thorough review process with the FDA before they may be marketed.”  Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001). Through this process, known as pre-market approval (“PMA”), a device maker must provide the FDA with “reasonable assurance” that its device is both safe and effective.

The PMA process is “a rigorous one.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. When analyzing that information, the FDA weighs the probable benefit to health from the use of the device against any probable risk of injury or illness from such use. Accordingly, the FDA sometimes grants PMA to potentially life-threatening devices, if they offer great benefits in light of available alternatives. Riegel, 128 S.Ct. at 1004.

Here, the MDL court rejected arguments that a recall of the leads invalidated their premarket approval. Medtronic correctly noted that the PMA process is governed by a completely separate statutory and regulatory regime than that governing withdrawal of a PMA. Also, the PMA for the leads was in place at the time they were implanted, a crucial fact because liability under plaintiffs' various legal theories hinges upon whether the leads were defective at that time. More fundamentally, the federal interest that preemption is designed to protect is the PMA process, and preemption necessarily looks backward (to the time of PMA) rather than forward.

The court also rejected the plaintiffs' claims that they have asserted "parallel" claims and therefore preemption does not apply. For example, plaintiffs purported reliance on Good Manufacturing Practice or Quality Control guidance did not save the claims. In the absence of any specific requirement in the CGMPs/QSR that Medtronic weld the Sprint Fidelis leads in a certain fashion [that was plaintiffs' beef], holding Medtronic liable for such a welding “defect” would have imposed requirements “different from, or in addition to” those under federal law. This is equally true of plaintiffs' allegation that Medtronic used inadequate testing and quality-assurance methods. Plaintiffs simply could not identify any specific requirements in the CGMPs/QSR that were purportedly violated by Medtronic.

It is noteworthy that the court found dismissal with prejudice was appropriate. This complaint was filed after extensive preparation by the Plaintiffs' Steering Committee, which is made up of lawyers who are experienced in federal preemption litigation. In the MDL Court's estimation, if plaintiffs were aware of sufficient facts in order to avoid preemption, they would have already pleaded them.
 

MDL Court Permits ESI Discovery

Readers of MassTortDefense are aware of the significant risks that plaintiff e-discovery tactics pose in product liability and toxic tort contexts. Rather than a device to uncover relevant facts for the litigation, e-discovery often is about plaintiffs’ attempt to find some alleged misstep by the defendant that will bring sanctions.

In multi-district litigation arising out of the manufacture of allegedly defective plumbing fittings, the U.S. District Court for the District of Minnesota recently ordered the defendant to name a witness to be deposed on whether it preserved evidence dating back to its notice of likely litigation, before a putative class suit was filed. In re: Zurn Pex Plumbing Products Liability Litigation, D. Minn., MDL No. 08-1958.

Plaintiffs allege that the defendant erred in its document preservation efforts three years before any litigation was actually filed, claiming that the number of warranty claims to the company somehow triggered a duty to preserve. However, in late October 2007, the parties were ordered to engage in focused discovery on the issue of class certification, and discovery of electronically stored information was limited, absent a showing of easy accessibility at an affordable cost.

Plaintiffs moved to compel a Rule 30(b)(6) deposition and identification of a 30(b)(1) deponent as they sought to depose a corporate representative regarding document retention practices and possible spoliation of evidence. Defendant resisted, arguing that plaintiffs have no reason to believe evidence has been destroyed; the requests are unreasonably burdensome; and the requests violate the prior discovery orders.

The court, however, permitted the deposition limited to determining whether discoverable evidence had been inadvertently destroyed. The court noted that case law requires plaintiffs to designate, with painstaking specificity, the particular subject areas that are intended to be questioned, and that are relevant to the issues in dispute,” but found somehow that plaintiffs had done so by "circumscribing" their request to information concerning the identified risk of litigation for Zurn Pex, Inc. with respect to its brass fittings.

Yet another cautionary tale from the world of ESI.  It is crucial for defendants to retain counsel who can assess and advise on the e-discovery issues.


 

Severance Ordered In Digitek MDL

The Digitek MDL judge earlier this month issued a pretrial order regarding multi-plaintiff complaints. In Pretrial Order No. 7, the court ordered the severance of most multi-plaintiff cases (other than spouses). In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.). The court noted that several complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they allegedly ingested the drug at issue. Other MDL judges have noted the case management, tracking, and other difficulties often accompanying that joinder practice, citing Vioxx and diet drugs.
 

No later than December 31, 2008, plaintiffs’ Co-Lead Counsel are to submit to the court a report identifying multi-plaintiff actions docketed prior to this Order that are subject to severance, and submit on that same date a suitable proposed severance order. One of the reasons plaintiffs resist such severance is the need to pay separate filing fees for all the separate claims filed, but the Order requires the fees.

MassTortDefense has posted on this MDL.  Defendant initiated a nationwide recall of Digitek products, saying tablets with double the appropriate dosage may have been released to the public, with possible side effects. More than 50 Digitek product liability cases were transferred to Chief Judge Joseph R. Goodwin of the Southern District of West Virginia in August.

Consolidated trials are something most mass tort defendants may want to oppose. The pre-trial severance of multi-plaintiff actions here is without prejudice to any party’s right under Federal Rule of Civil Procedure 42 to request consolidation of severed actions upon future remand to a transferor court for trial. But better that plaintiffs have the burden of putting cases together than defendant have to overcome the "inertia" of cases that have been consolidated since day one.
 

Federal Court Denies Class Certification In Teflon Litigation

The MDL court in the Teflon products litigation has refused to certify 23 proposed statewide consumer fraud class actions. In re Teflon Products Liability Litigation, 2008 WL 5148713 (S.D. Iowa, 2008).

Plaintiffs alleged that in producing and marketing Teflon® and unbranded, non-stick cookware coatings (“NSCC”), defendant DuPont allegedly made misleading representations regarding safety. None of the proposed class representatives alleged that he or she had been injured by the use of DuPont NSCC. Rather, in each of the purported class actions, plaintiffs sought recovery solely for economic damage and injunctive relief. In particular, plaintiffs demanded creation of a fund for scientific researchers to further investigate the potential for adverse health effects from the use of products containing DuPont's non-stick coating; that DuPont discontinue selling cookware containing the non-stick coating; that DuPont stop making alleged misstatements regarding the safety of its product; that DuPont replace and/or exchange all existing cookware containing DuPont non-stick coating possessed by class members with non-hazardous cookware; rescission and restitution; and/or that DuPont provide a new warning label or other disclosure on cookware made with or containing DuPont non-stick coating.

DuPont has steadfastly denied that PFOA's or any other chemicals are released at harmful levels when cookware coated with Teflon is used as intended.


The Class
The court first identified key deficiencies in plaintiffs’ attempt to define an ascertainable class. As they typically do, plaintiffs argued that at this stage, they do not need to show that each class member ultimately will be able to prove his or her membership; rather, the court need only ensure that the appropriate criteria exists to evaluate membership when the time comes. The court felt this argument necessarily depended upon the availability of evidence to establish membership at a later stage of the proceeding. No such evidence existed to be produced in the case. Deposition testimony showed that it is virtually impossible to identify a brand of non-stick coating based on a visual examination of the item of cookware. Testimony from the class members was thus a key component of the product identification and thus class membership issue. But, even after a lengthy discovery period, during which each proposed representative was thoroughly deposed, many class reps were unable to ascertain whether they belonged in the class or a particular sub-class. An “abundance” of proposed representatives had no memory whatsoever of the circumstances surrounding their purchase of the cookware—let alone records to document their purchase. Bottom line, too many infirmities existed in the class definitions to ensure that the court could determine objectively who was in the class, without resort to speculation. For example, many class representatives mistakenly believed their product contained Teflon coating-even when they were informed the particular brand of cookware at issue never used Teflon.

Lastly, membership in this class necessarily required a plaintiff to pinpoint the date on which he or she purchased the item of cookware; the proposed class representatives were unable to recall this information one-fourth of the time.

Typicality, Coherence, Predominance
An analysis of the claims made clear that common issues did not predominate; class reps’ claims were not typical. Plaintiffs built the majority of their claims around statements made and/or marketing practices employed by DuPont regarding its NSCC products. According to plaintiffs, the fact that each cause of action derived from an alleged  “common practice or course of conduct” on the part of DuPont rendered the claims made by a representative plaintiff typical of the claims of all class members. However, the alleged misstatements cited by plaintiffs span a forty-plus-year period, across a wide variety of advertising and promotional media. Each plaintiff was exposed to different representations, at different time periods. Because reliance is a key element of plaintiffs' claim for negligent misrepresentation, and is necessary for recovery under the consumer fraud statutes in many jurisdictions, an individualized inquiry must be conducted not only to pinpoint the representations at issue, but also to determine the extent to which each plaintiff relied upon the particular representations. Due to the widespread nature of DuPont's advertising over the years, however, determining the precise statements each plaintiff heard could only be accomplished through individualized inquiry.

The court also pointed out the varying degrees to which each plaintiff became educated about NSCC prior to purchase.  Even if class members were exposed to the same representation, advertisement, or omission, the court could not presume that each member responded to the representation or omission in an identical fashion. Here, some proposed class representatives who were informed of potential health risks from NSCC stopped using the cookware, but others exposed to similar information continued to use their existing cookware, and others purchased new non-stick cookware.

Finally the court worried that plaintiffs were splitting their cause of action and thus harming absent class members. Under any one of their alternative bases for relief, plaintiffs necessarily must establish first that DuPont's non-stick cookware coating is dangerous to the health of its users. But the class disclaimed personal injury and had abandoned their original claims for medical monitoring. The representative plaintiffs risked a future waiver not only of their own personal injury and medical monitoring claims, but also those of the absent class members.

 

 

Digitek MDL Proceeds And State Mass Tort Designation Looms

Certain plaintiffs in the Digitek litigation have filed for mass tort designation in the State of New Jersey, according to a notice filed on the New Jersey Judiciary mass tort web site. Earlier this year, defendant initiated a nationwide recall of Digitek products, stating that tablets with double the appropriate dosage had possibly been released to the public. It said digitalis toxicity was possible in patients with renal failure.

Previously, some plaintiffs had moved for centralized management, but not mass tort designation, of all New Jersey state-court litigation involving the drug Digitek and assignment of that litigation to Bergen County. Anyone wishing to comment on or object to this second application regarding the Digitek  state-court litigation is to provide such comments or objections in writing, with relevant supporting documentation, to the Administrative Office of the Courts, by December 1, 2008. After that date the N.J. Supreme Court will consider and act on both applications regarding Digitek and any comments received.

At the federal level, the judge in the newly-created Digitek federal multidistrict litigation issued an order appointing lead and liaison counsel for the plaintiffs as well as the Plaintiffs' Steering Committee. See In Re: Digitek Products Liability Litigation, MDL No. 1968, JPMDL.; No. 08-md-1968, S.D. W.Va.). Chief Judge Joseph R. Goodwin of the Southern District of West Virginia appointed Carl N. Frankovitch of Frankovitch, Anetakis, Conatonio & Simon, Fred Thompson III of Motley Rice, and Harry F. Bell Jr. of Bell & Bands, as co-lead counsel for the plaintiffs. Bell is also liaison counsel for the plaintiffs. Previously, Chief Judge Goodwin appointed Rebecca A. Betts of Allen, Guthrie & Thomas as defendants' liaison counsel.


Earlier in the fall, the federal court held a pretrial conference jointly with Magistrate Judge Mary E. Stanley and advised the parties of its intention to coordinate heavily with the judges and counsel involved in the state Digitek cases, especially in West Virginia and New Jersey where a majority of the state cases have been filed.
 

Modified Rice MDL Court Proposes Settlement Master

The federal judge overseeing the MDL involving claims over allegedly mishandled genetically modified rice has appointed a special master to assist with settlement talks. In re Genetically Modified Rice Litigation, MDL No.1811.
 

The order comes as the parties prepare for the process of selecting the bellwether trials currently slated to begin in November, 2009. The parties are to select plaintiff claims from each of 5 affected states for the initial trial pool. The bellwether trial plan approach follows the court's denial of class certification.

The bulk of plaintiffs are long grain rice producers who allege that defendants developed and tested a genetically modified strain of rice that contaminated the U.S. commercial rice supply. When rice importers banned the importation of U.S. rice, prices dropped and plaintiffs sued. Defendants have argued that such damages are too legally remote and speculative to be recovered.

The court noted that it “is important that the parties continue to explore settlement while preparing the cases for trial or remand to the transferor districts.” Because the MDL court did not have time to address settlement in as an effective and timely manner as is needed, the court proposed appointment of Hon. Steven N. Limbaugh, Sr., who has recently retired from the bench, and is available and willing to serve as a settlement special master for this case.

The court is giving the parties notice and an opportunity to be heard, and the opportunity to suggest alternative candidates for appointment. If no party files objections by Nov. 20, any objections will be waived, and the court will enter an order appointing him as Special Master.
 

 

MDL Court Issues Daubert and Summary Judgement Ruling

The MDL court in the Human Tissue mass tort litigation has issued a noteworthy Daubert and summary judgment decision. In re Human Tissue Products Liability Litigation, MDL No. 1763, 2008 WL 4665765 (D.N.J. Oct. 22, 2008). This multidistrict litigation arises from an alleged criminal enterprise to harvest tissue from human corpses without obtaining proper consents and without following appropriate regulations. The plaintiffs in this litigation include the recipients of processed tissue who allegedly suffered harm from the processed tissue product, as well as relatives of the deceased donors.

Certain defendants moved for summary judgment on the issue of general causation of the relevant infectious diseases of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, cancer, and prion disease. General causation, of course, refers to whether a substance is capable of causing a particular injury or condition in the general population. See Perry v. Novartis Pharms. Corp., 564 F.Supp.2d 452, 463 (E.D.Pa.2008); Reference Guide on Medical Testimony, in Reference Manual On Scientific Evidence 439, 444 (Fed. Jud. Ctr., 2d ed.2000).

Defendants argued generally that the tissue at issue was incapable of infecting recipients with certain diseases due to the methods employed by the processing companies to disinfect and sterilize the allografts. But the motion only attacked the potential for the transmission of diseases short of sterilization.

Defendants also moved to exclude the proposed testimonies of several of plaintiffs’ experts. The central conflict among the experts involved time, not capacity. There appeared to be no genuine conflict among the parties that unprocessed bone tissue stored at room temperature can transmit HIV, HBV, HCV, syphilis, and cancer. Rather, the real issue was for what period of time can such bone tissue transmit these diseases-- is it a matter of hours, days, months, or years? Defendants contend that the transmission of disease cannot occur after thirty days, and plaintiffs have sought to extend the period of transmission beyond thirty days. After a comprehensive review of the scientific literature, including epidemiology, animal, and in vitro studies, the court struck plaintiffs' proposed expert testimony where they sought to opine that: (1) unprocessed bone tissue kept at room temperature for thirty days or longer can transmit HIV, HBV, HCV, syphilis, or cancer; (2) unprocessed bone tissue is a transmitter of prion diseases; and (3) the incubation periods of hepatitis and HIV are longer than six months.

Plaintiffs’ expert opinions regarding unprocessed bone tissue stored at room temperature for thirty days or more did not appear to meet the second and third parts of the Daubert and Fed.R.Evid. 702 inquiry-- reliability of methodology and “fit.” The court noted that the opinions were derived from a literature review. When proposed expert testimony is not based upon the expert's own independent research, but instead on such a literature review, the party proffering such testimony must come forward with other objective, verifiable evidence that the testimony is based on scientifically valid principles. The court did not question the reliability of the underlying studies, but rather the plaintiffs’ extrapolations from those studies to the ultimate conclusion. The extrapolations from these studies were not tested, were not subject to peer review, and had no known rate of error. The theory that these studies suggest the existence of general causation as framed in this litigation has not been generally accepted. Without plaintiff's expert evidence, there was no evidence supporting plaintiffs' theories of causation.

In an observation of special interest to readers of MassTortDefense, the court addressed the claim that the science was still evolving and an MDL court should not truncate the mass litigation before it develops. Multidistrict litigation courts are often confronted with evaluating limited or evolving scientific and medical theories and evidence. The absence of definitive scientific or medical knowledge is, said the court, a reality in some cases. Nevertheless, district courts are charged with the role of gatekeeper and can only allow presently reliable evidence. As courts have recognized, the Rules of Evidence may, on occasion, prevent the jury from learning about promising or potential clinically relevant information. See In re Reuzulin Products Liability Litigation, 369 F.Supp.2d 398, 438 (S.D.N.Y.2005). The Rules of Evidence, however, cannot be disregarded even if at a future date, medical and scientific literature proves the contrary. As Judge Richard Posner put it, “the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”  Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996).
 

While MassTortDefense does not typically blog about non-legal or personal issues, we cannot help but say Congratulations to our Philadelphia Phillies, 2008 World Series Champions

Discovery Battles Continue In Zyprexa MDL

Two interesting developments in the ongoing discovery battles in the Zyprexa MDL, which involves claims by several states and health entities alleging that defendant Eli Lilly made misleading statements about the medication. The states allege that they would not have funded Medicaid patients taking Zyprexa had they known about the risks of the drug...But don't seem eager to prove it.

First, the magistrate judge denied defendant’s motion for sanctions against Montana, New Mexico, Louisiana, and Mississippi, but ordered the states that have not yet produced their complete Medicaid databases as requested to do so on pain of sanctions.

Second, the court ordered the states to produce non-party medical records requested by Lilly. The defendant, not surprisingly, wanted to be able to compare the records of other antipsychotic medications in the relevant periods. As the court said, "the records are in fact relevant to Lilly’s defenses. For example, as Lilly notes, the use of a statistically significant sample of Medicaid patient records can help to explain information obtained from Medicaid databases, and may provide information on potential confounding variables."

The states argued that their respective physician-patient privilege laws prohibited discovery of the patient medical records. It is axiomatic that state privilege laws do not govern in federal question cases. Although several of the plaintiff states did not allege violations of federal law in their
complaints, and each has vigorously challenged the basis for federal jurisdiction, Judge
Weinstein has held that jurisdiction lies under federal law. 

The court also felt that the states’ doctor-patient privilege argument was not well taken, because the order was for the production of de-identified medical records with patient names redacted. Federal statutes and regulations make clear that de-identified health information is discoverable in litigation in federal court, with or without patient consent, and it appears that the states’
respective privilege laws would not apply to de-identified information either.

The court also denied the states' request that Lilly subpoena the records, as a step that would needlessly prolong discovery.  Significantly, Lilly does not know the identities of the patients whose medical records it seeks. Moreover, the states are in a better position to ensure that the medical records produced are a randomly selected, statistically significant sample. If Lilly were constrained to subpoena the medical records, it would likely target only certain records, which would inevitably lead to protracted argument over whether the records subpoenaed represent a statistically significant sample, said the court.

MassTortDefense has posted on this litigation before. It continues to be an excellent example of the type of attenuated and indirect injury claim that requires in-depth and detailed discovery to defend. Also an example of plaintiffs who are more willing to assert complex damages theories than to provide the evidence to test those claims.
 

JPML Denies MDL Status in Pain Pump Litigation

The U.S. Judicial Panel on Multidistrict Litigation has rejected requests for MDL status for litigation involving injuries allegedly caused by pain pumps that directly delivered anesthetics to joint tissue following surgery. See In re Shoulder Pain Pump--Chondrolysis Products Liability Litigation, MDL No. 1966 (8/11/08).

On the surface, the denial may have seemed surprising in that suits had been filed in eight different federal district courts, and the plaintiffs all claimed that the direct delivery systems caused the degeneration of joint tissue, leading to a condition called chondrolysis. The cases involve high volume pain pumps that deliver pain medication directly to afflicted areas through flexible plastic catheters. Physicians temporarily implant the catheters into patients following surgery to manage postoperative pain. A 2007 study published in the American Journal of Sports Medicine apparently spurred the litigation.

In denying the motion, the panel said it was not persuaded that centralization would serve the convenience of the parties and witnesses, or further the just and efficient conduct of this litigation at the present time. Although these personal injury actions seemed to have some commonality, a number of different pain pumps made by different manufacturers are at issue, as are different anesthetic drugs made by different pharmaceutical companies. Moreover, not all of the thirteen constituent actions involve pharmaceutical company defendants, and many defendants are sued only in a minority of those actions.

Because of this, the proponents of centralization could not convince the panel that the efficiencies that might be gained by centralization would not be overwhelmed by the multiple individualized issues (including ones of liability and causation) that these actions present.

MassTortDefense notes that whether the JPML grants or denies a motion to centralize cases can have a significant effect on product liability litigation. The vast majority of motions in products cases are granted. But it is not unheard of for the panel to deny MDL status when the underlying actions raise primarily individual, not common, issues, as exemplified by many defendants, diverse plaintiffs, or different kinds of exposure to the relevant product. Here, the panel pointed out, for example, that five pharmaceutical defendants were each named in only one of the underlying actions. And the panel noted that that none of the underlying actions was a class action, implying the presence of numerous individual issues.
 

MDL Court Rejects Class Action In Genetically Modified Rice Litigation

The MDL court overseeing the litigation arising from alleged contamination of the U.S. rice supply by genetically modified strains has declined to certify a proposed class. In re Genetically Modified Rice Litigation, MDL No.1811, 2008 WL 3539879 (E.D. Mo. August 14, 2008).

Plaintiffs, U.S. long grain rice producers, alleged that the defendants contaminated the U.S. rice supply with non-approved genetically modified strains of rice, thereby affecting the market price for plaintiffs' crops. Plaintiffs alleged that the U.S. market price for rice dropped dramatically as a result of defendant's alleged contamination of the rice supply. (The United States is one of the leading producers in the world of rice, accounting for approximately 13% of the worldwide rice trade. Nearly half of the U.S. rice supply is exported to other countries.)


Mass Accident
While plaintiffs' primary claim for damages was that the defendants' activities caused a market loss injury to the U.S. rice market, the complaint asserted statutory and common law claims of public nuisance, private nuisance, negligence, products liability, and strict liability for ultra-hazardous activities. Thus, the court observed that, in many respects, the alleged widespread contamination of U.S. rice is akin to a “mass accident” mass tort - the sort of case that the Advisory Notes to Rule 23 say should rarely be afforded class treatment. A mass tort resulting in injuries to numerous persons is ordinarily not appropriate for a class action because of the likelihood that significant questions, not only of damages but of liability and defenses to liability, would be present, affecting the individuals in different ways. In these circumstances an action conducted nominally as a class action would degenerate in practice to multiple lawsuits separately tried. See Pruitt v. Allied Chemical Corp., 85 F.R.D. 100, 111 (E.D.Va.1980) (denying class certification for all plaintiffs who claimed to be injured as a result of defendant's pollution of a river, as the pollution affected various groups of plaintiffs in significantly different ways).


Damages Key on Predominance
MassTortDefense notes how significant the issue of damages was to the certification decision, and in particular the predominance inquiry balancing individual issues and alleged common issues. The court observed that, ordinarily, variation in individual damage amounts is not a bar to class certification. Even wide disparity among class members as to the amount of damages suffered does not necessarily mean that class certification is inappropriate. See Bell Atlantic v. AT & T Corp., 339 F.3d 294, 306 (5th Cir.2003). However, class certification “may not be suitable where the calculation of damages is not susceptible to a mathematical or formulaic calculation, or where the formula by which the parties propose to calculate damages is clearly inadequate.” Bell Atlantic, 339 F.3d at 306 (citing Broussard v. Meineke Discount Muffler Shops, Inc., 155 F.3d 331, 342-343 (4th Cir.1998)).


Here, plaintiffs argued that they could show on a class-wide basis the total amount of economic harm caused by the contamination. Plaintiffs argued they could show the total quantity of long-grain rice affected. Using these two market-based figures, plaintiffs would supposedly calculate damage on a per-hundredweight basis. This figure will be used to calculate each individual plaintiff's damages. Each class member would attest to the quantity of rice sold, and that figure would be multiplied by the per-hundredweight loss.

But the court was not persuaded that the calculation of damages in this case was a common issue. What plaintiffs have proposed was a convenient shorthand calculation that might represent an estimate of some damages for some plaintiffs. It might be a reasonable basis on which to reach a settlement of some claims, mused the court. But plaintiffs' proposed method for calculating damages does not represent an actual adjudication of any one plaintiff's claims. Rather, calculation of actual damage is an individual issue specific to each plaintiff in this case, involving a unique inquiry into the time, place, and manner in which each plaintiff both priced and sold the rice.


For example, some rice producers entered pools or cooperatives to sell their rice. Others sold rice through booking contracts, where a quantity of rice to be delivered or a price to be paid might be set far in advance. Rice producers using basis contracts or hedge-to-arrive contracts employed yet more complicated methods for pricing and selling their rice. An accurate, true assessment of any plaintiff's damages would require an extensive inquiry involving the circumstances of that particular plaintiff. This case was therefore more like those cases where class certification was denied because individual damages issues predominated over common elements. This individual inquiry on damages predominated over the common issues allegedly raised in the class action complaint.


Superiority Lacking
The class method was not superior either. The claims process would devolve into an endless series of “mini-trials” that would fail to meet the goals of class certification. Also, hundreds of plaintiffs had shown significant interest in prosecuting their own claims. While plaintiffs argued that to deny class certification in this case would result in hundreds of full-scale individual trials across five states, all dealing with the same issues, the court noted that there are many options available to resolve the hundreds of cases in this MDL. The parties can propose a collection of “test cases” to be tried to verdict before deciding how other cases should be handled. The MDL court also has the option of going to trial on the claims of the plaintiffs named in the master consolidated complaint that was filed in its home district.

The opinion is thus also instructive on the willingness to look at real world trial plans and alternate methods of moving an MDL forward, beyond class action treatment.
 

MDL Created For BPA Litigation

On August 13th, the JPML created MDL 1967, IN RE: BISPHENOL-A (BPA) POLYCARBONATE
PLASTIC PRODUCTS LIABILITY LITIGATION.

The panel's order found that these actions share factual questions arising out of allegations that various defendants manufactured, sold or distributed polycarbonate plastic bottle products containing Bisphenol-A without disclosing its possible harmful effects. The cases were assigned to Judge Ortrie Smith of the Western District of Missouri.

At the time of the motion to create the MDL, this litigation consisted of fourteen actions pending in eight districts as follows: four actions in the Central District of California; two actions each in the Eastern District of California, the Western District of Missouri, and the Western District of
Washington; and one action each in the Eastern District of Arkansas, the District of Connecticut, the Northern District of Illinois, and the District of Kansas.

While the motion was pending, the Panel was notified that nine additional related actions have been filed: three actions in the Central District of California, and one action each in the Eastern District of Arkansas, the Northern District of Illinois, the District of Kansas, the Western District of Missouri, the Southern District of Ohio, and the Western District of Washington. These actions will be treated as potential tag-along actions.
 

MassTortDefense has posted on BPA and here.  BPA received considerable recent attention due to widespread human exposures and concern for possible reproductive and developmental effects reported in laboratory animal studies. A recent draft report by the Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program (NTP) examined the Food and Drug Administration finding that bisphenol-A is safe when used to line infant formula cans. The CERHR/NTP draft report expressed "some concern" based on animal studies that the chemical might affect the neurological systems and behavior of fetuses, infants, and children.

The NTP Brief on Bisphenol A is not a quantitative risk assessment, nor is it intended to supersede risk assessments conducted by regulatory agencies. The NTP Brief on Bisphenol A does not present a comprehensive review of the health-related literature; it does not include a comprehensive analysis of the issues related to this chemical. The NTP report relies heavily on animal testing, rather than human epidemiology. Regarding the neural and behavioral effects reported in some studies of rats and mice at relatively low BPA doses, the Panel authoring the report also acknowledges that it is not even clear whether these effects should be construed as an adverse toxicological response. The draft report does not conclude that BPA is dangerous. It notes that further research is needed – that’s the right approach to new data or concerns about a product that has been in use for decades. And the key reported low-dose effects are not replicated or corroborated.

The European Food Safety Authority recently concluded a report with a key conclusion that after exposure, the human body rapidly metabolizes and eliminates BPA. This represents an important metabolic difference compared with rats, and suggests certain animal models are not all that useful. That is, people metabolize and excrete BPA far more quickly than rodents. This evidence further limits the relevance of low-dose effects of BPA reported in some rodent studies used for human risk assessment.

 

 

Lone Pine Order Entered in Celebrex MDL

The federal judge overseeing the MDL for Celebrex and Bextra has sided with defendants' view that a “Lone Pine” order is appropriate for managing the claims of the remaining, non-settling plaintiffs. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No. M:05-cv-01699 (N.D. Cal.) (Pretrial Order No. 29, Aug. 1, 2008).

“Lone Pine” orders take their name from a 1986 New Jersey Superior Court case involving toxic tort claims; they refer to case management orders that require the plaintiffs to make a showing regarding causation, injury, and/or damages to demonstrate, typically at an early stage, some minimal level of evidentiary support for the key components of their claims which will be in dispute.

Defendants had first asked the court for a Lone Pine order in late June, arguing that each plaintiff should be required to submit a case-specific expert report on the issue of medical causation. The motion also sought to compel each plaintiff to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and proof of dosage in relation to the confirmed injury. The benefits to the court of requiring plaintiffs to supply this information is that the parties would not have to engage in protracted discovery in thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence was argued to be simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Plaintiffs argued that the proposed order would be overly burdensome, was not needed, and was a retaliation for not settling. Plaintiffs also suggested that Lone Pine orders are generally issued as sanctions against plaintiffs who provide no other information to the defendants about the filed case. But the court disagreed with plaintiffs.

The court appeared mindful of what had happened on the eve of the first trial in the MDL, as the scheduled cases began to disappear. Thus, under the Order, plaintiffs will have 45 days to have a physician or other medical expert offer a case-specific expert report for each plaintiff including a review of the plaintiffs’ medical records, the dates they used Celebrex and/or Bextra, and whether they experienced a myocardial infarction, ischemic stroke, sudden death, or any other injury while taking the medications.

The court observed that all of this information should be already readily available to plaintiffs through the plaintiff fact sheets process. The court apparently expects that cases in which plaintiffs cannot show drug usage, injury, or causation, will drop from the docket before being scheduled for trial. Without threshold proof of Celebrex or Bextra usage, a compensable injury, and a link between usage and an injury, there could have been no good-faith basis for a lawsuit in the first place.

Moreover, requiring plaintiffs to identify basic information about injuries and causation is not unreasonable given the costs that mass tort claims have on the legal system, and on defendants. Lone Pine orders allow courts to weed out the frivolous suits where there is insufficient exposure, or no sufficient scientific connection between injury and exposure. Accordingly, Lone Pine orders can be effective when entered early in the game. Early disposal of frivolous claims allows the parties to focus their attention on the serious cases. Ideally, the order will actually phase discovery, and motions practice as well, with the Lone Pine issues pushed up front.

With their focus on causation, Lone Pine orders are especially useful when multiple plaintiffs claim a variety of different injuries, allege injuries incurred over a long period of time, and/or when plaintiffs allege diverse exposures.

 

Partial Summary Judgment Granted in Aredia MDL

Novartis Pharmaceuticals Corp. has prevailed in a motion to end certain failure-to-warn claims in cases in the MDL relating to its bone cancer drugs Aredia and Zometa. The U.S. District Court for the Middle District of Tennessee granted defendant’s motion for partial summary judgment, dismissing claims of eight Texas-based plaintiffs. In Re: Aredia and Zometa Products Liability Litigation, No. 06-md-01760 (M.D. Tenn.) Opinion found here.

The motion was based upon a Texas statute which protects a defendant from any products liability claims involving failure to provide adequate warnings if the drug at issue and accompanying warnings were approved by the FDA. The statute creates the presumption such warnings were adequate, and then specifically explains how a claimant can rebut this presumption:

(b) The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that: (1) the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury. Tex. Civ. Prac. & Rem. Code Ann. § 82.007(b)(1).

The court noted that plaintiffs were correct that the language of the Texas statute specifically creates a rebuttable presumption that a defendant is not liable for failure-to-warn claims if the warnings provided with the product were approved by the FDA. The Texas Legislature, however, went on to establish certain evidentiary standards for rebutting this presumption. The presumption of adequate warnings, therefore, is unrebuttable unless one of the specific statutory provisions applies.  Here, the only possible exception was the so-called fraud-on-the-FDA exception. However, in Buckman Co. v. Plaintiffs’ Legal Comm., 121 S.Ct. 1012 (2001), the Supreme Court found that the plaintiffs’ state law fraud-on-the-FDA claims conflicted with and were therefore impliedly preempted by the Federal Food, Drug and Cosmetic Act. Noting that policing fraud against federal agencies is hardly a “field which the States have traditionally occupied,” the Court held that it is the FDA’s exclusive responsibility to police fraud or wrongdoing in connection with approval of products before the FDA. Id. at 1017.   The Court stated that fraud-on-the-FDA claims would “inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.” Id. at 1018. In sum, the Court opined, this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore preempted by that scheme. Id. at 1020.

Under the Texas law, in order to rebut the presumption plaintiffs must establish that defendant withheld or misrepresented “required information” to the FDA. The Court found that the task of determining whether certain information was “required” by the FDA would raise the federalism concerns expressed in Buckman.

Second, the Texas statute also requires that the information which was withheld or misrepresented be “material and relevant” to the performance of the product. Because subsection (b) concerns misrepresentations to the FDA, it is reasonable to infer that the information must be “material and relevant” to the FDA. Determining what information would have been important to the FDA would also create the federalism concerns noted by the Court in Buckman.

Finally, the information which was allegedly withheld or misrepresented must, under the Texas statute, be causally related to plaintiffs’ injuries. Unless the withheld information would have resulted in some definite change by the FDA, such as either non-approval of the drug or a labeling change, such withheld information could not be causally related to a plaintiff’s injury. Again, in order to establish that the FDA would have acted differently if defendant had submitted accurate information, plaintiffs would have to “go behind” the FDA processes, raising the concerns sought to be avoided in Buckman.

The Court thus found that the requisite showing under the Texas statute is analogous to and sufficiently equivalent to asserting a claim of fraud on the FDA that the fraud claim/presumption defense/statutory exception is itself preempted under Buckman. For all these reasons, Defendant’s Motion for Partial Summary Judgment was granted.

The ruling on the Texas claims follows the MDL court's April ruling dismissing claims by Michigan plaintiffs. The court had relied on Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), for the proposition that the Michigan fraud exception was also preempted under the U.S. Supreme Court's decision in Buckman.

Grout Sealer MDL Court Denies Summary Judgment Motion

The MDL transferee court has denied the summary judgment motion of the manufacturer of an allegedly toxic ingredient in Stand 'n Seal grout sealer. In re Stand 'N Seal Products Liability Litigation, 2008 WL 2622793 (N.D.Ga.), No. 1:07-MDL-01804 (6/26/08). The motion focused on the apparent inability of 67 plaintiffs to demonstrate exposure to the product, which in turn meant they could not show causation. Proof of exposure is a recurring theme in toxic tort litigation, and MassTortDefense has blogged on it here.

Stand 'n Seal originally contained an ingredient called Zonyl, according to the court’s recitation. The manufacturers substituted one ingredient, Innovative Chemical Technologies, Inc.’s product, Flexipel S-22WS, for Zonyl in 2005; some users then complained of respiratory problems, leading to a recall. Numerous personal injury actions were consolidated in a multidistrict litigation overseen by Judge Thomas W. Thrash of the U.S. District Court for the Northern District of Georgia.

ICT’s motion sought to dismiss the group of 67 plaintiffs on the basis that they could not prove their exposure to the Stand 'n Seal product with Flexipel. Generally, plaintiffs must show that the product that allegedly caused their injuries was, in fact, manufactured or supplied by the defendant in this case.

According to Judge Thrash, some of these plaintiffs lacked a can identification number – typical product identification evidence – because they threw away their cans of Stand 'n Seal. Others, he said, retain a can that contains Zonyl, but claim they used more than one can of Stand 'n Seal. The court found that under applicable Georgia law such plaintiffs could use circumstantial evidence to meet their burden of proving exposure to the ingredient. In an interesting turn of phrase, the court stated that ICT had not presented clear and positive evidence that all of the Plaintiffs used cans containing only Zonyl. Under the summary judgment standard, defendant as the moving party did not have that burden. Rather, defendant needed to show there was genuine issue of fact, and plaintiffs’ lack of relevant evidence was certainly part of that showing.

The court concluded that the plaintiffs subject to this motion should be allowed to present individualized circumstantial evidence that they were exposed to cans containing Flexipel. “Such evidence could include testimony concerning the smell of the product. It could include testimony as to the date and place of the purchase of the product.” In a typical case, the plaintiff would have had to make such a showing to defeat summary judgment. But here, in the MDL. the timing of summary judgment motions can be atypical. Accordingly, the court held that the presentation of such individualized evidence by the plaintiffs could occur following remand to the transferor courts or before bellwether trials in this MDL court.

MDL Court Holds To Pretrial Deadlines For Next Bellwether Case In Welding Fumes

The MDL court in the In re Welding Fume Products Liability Litigation, MDL-1535 (N.D. Ohio) recently issued an interesting Order about mediation. Not ordering mediation. Instead, it came to the Court’s attention that various plaintiff counsel have stated publicly that the Court has ordered the parties to engage in mediation. This statement, in turn, has led to various conjectures and to requests that assorted deadlines be postponed pending mediation. The Court issued an “Order to end inappropriate speculation.” Although the MDL Court did, sua sponte, raise the concept of mediation, the Court has not ordered any mediation in this case. In particular, the Court has scheduled the next MDL bellwether case – Byers v. Lincoln Electric Company – for trial in November of 2008. The Court issued the Order to make “clear here that it expects the parties will pursue all deadlines in their welding fumes litigation accordingly.” Motions in limine are due 9/15. Dispositive motions are due 9/8.

In this mass tort, plaintiffs have moved to dismiss more than 4,000 cases in the MDL. The total number of cases pending against the welding defendants has dropped by over two-thirds. Plaintiffs have been forced to dismiss five trial-ready cases, including three slated for early trials in the MDL. Although plaintiffs secured a significant verdict last December in the Tamraz case, it was the first plaintiff victory in several years, and juries have found for defendants in 20 of the last 23 plaintiffs’ cases tried in this litigation, including consolidated cases that are heavily weighted toward plaintiffs and cases in jurisdictions that are considered plaintiff-friendly.

Bellwether Trials Proposed in Aredia MDL

The MDL

The parties in the MDL concerning the bone cancer drugs, Aredia and Zometa, have proposed 10 bellwether cases for the first round of trials. The MDL court reported last week that it had received the list of cases the plaintiffs and Novartis propose for “Wave 1-A” of the trials. The court set a status conference for May 28 to discuss the list and make further decisions for the first round of trials.

The MDL No. 1760 consists of about 285 cases alleging that the bone-cancer drugs cause osteonecrosis of the jaw, a condition involving the deterioration of the jawbone. The cases were consolidated in the U.S. District Court for the Middle District of Tennessee in April 2006. In October, 2007, the court denied certification of a class of asymptomatic persons treated with Aredia and/or Zometa, seeking medical monitoring. Plaintiffs had alleged that they were at an increased risk for developing osteonecrosis of the jaw because of their treatments with the drugs, and sought periodic dental monitoring, including dental radiographs, which they claimed would help prevent the development the disease. In re: Aredia & Zometa Products Liability Litigation, No. 3:06-MD-1760  (M.D. Tenn. October 10, 2007).

Bellwether Cases

This raises an important issue and gives MassTortDefense the opportunity to make some general observations about bellwether trials.

Particularly in non-class mass tort litigation, such as MDL’s, statewide coordinated proceedings, and large consolidations, judges often resort to use of bellwether trials. Such trials may force plaintiffs' counsel to prepare their standard trial package, and the trials may give some sense of how sound that package is. The bellwether trials may give the court a context to resolve legal questions that arise at a trial as witnesses begin to take the stand. Bellwether trials may test the expert witnesses and theories, and give both parties a sense of how much it costs to try a case to verdict. In theory, test trials are to produce valuable information that will allow the parties to assess the strength and settlement value of all the related cases. Cf. In re Bridgestone/Firestone, Inc. Tires Prods. Liab. Litig., 288 F.3d 1012, 1020 (7th Cir. 2002) (central planning model: one case, one court, one set of rules, one settlement price for all involved, suppresses information that is vital to accurate resolution), cert. denied, 537 U.S. 1105 (2003).

In order for that to occur, however, it is imperative that there be a sufficient number of cases tried, and that the cases selected be representative of the range of cases. Trying one or two cases out of a collection of hundreds, or thousands, certainly doesn't give any statistically significant information about the value of the cases. Test cases should produce a sufficient number of representative verdicts to enable the parties to determine what range of value the cases may have if resolved in the aggregate. Manual For Complex Litigation (4th) § 22.315. If the cases are randomly selected, they will reflect the full range and diversity of the claims at issue, including in terms of factual issues, choice of law, legal theories and defenses, and perhaps counsel as well.

At times, courts have permitted each side to select one-half of the test cases, a practice that will likely not offer a representative sample, but rather a mix of the “best” and “worst” cases for each side. See In re Chevron USA, Inc., 109 F.3d 1016, 1019 (5th Cir. 1997). This approach has an element of fairness, and may offer the benefit of allowing each side to test out issues that are important to its strategy, or which each party feels will be persuasive to the other side once resolved.

And while it would seem self-evident that trial of plaintiffs selected by one side only will not provide meaningful information (unless the other side manages to prevail anyway), it is not unusual for courts to allow plaintiffs to select the “test” cases, as has occurred in aspects of the Vioxx mass tort. In re Vioxx Lit., Case. No. 619 (N.J. Super. Ct., Atlantic Cty.) (ordering plaintiff to select a grouping of eight plaintiffs, with trials consisting of two or more plaintiffs). The danger is, of course, how a few early trial results can have significant unfortunate effects, decreasing rather than increasing the prospects of any early global resolution, raising to unreasonable heights the expectations of the plaintiffs' bar. That plaintiffs secure verdicts in their handful of best cases out of hundreds or thousands, which may bear no resemblance to the best few, should come as no surprise. And may not encourage rational defendants to alter their views about the merits of the bulk of cases.

Even when the court randomly selects bellwethers, or permits the defendants to select some bellwethers, plaintiffs' counsel often seek to exercise control over the process by refusing to go forward with the selected unfavorable cases, either by convincing the client to dismiss or by withdrawing as counsel. This has happened in tobacco, HRT, and Vioxx litigation, for example. Defendants should ask the court to put safeguards in place to minimize plaintiffs’ ability to undermine the selection process, and in no event should plaintiff who dismisses rather than proceed with the selected bellwether have the ability to select the next bellwether. There really ought to be a system to supply substitutes that achieves the same goals as the original selections.

NJ Creates Mass Tort Consolidation of Gadolinium-Based Contrast Agent Litigation

Further procedural developments in the Gadolinium-based contrast agent litigation.

The New Jersey Supreme Court recently ordered all litigation in the state over gadolinium-based contrast dyes centralized as a mass tort in Middlesex County (In re: Gadolinium-Based Contrast Agents Litigation, N.J. Super. Ct., Middlesex Cnty., No. 279, 4/10/08). The cases were assigned to Judge Jamie D. Happas, who scheduled a case management conference for May 13. 

Readers of MassTortDefense are familiar with the MDL Panel. And readers probably know that some, but not all, states have “mini MDL” procedures for coordinating cases in state court systems.  More NJ procedural  info here.

This litigation involves suits by patients who allege harm from exposure to gadolinium-based contrast dyes used in medical imaging. The plaintiffs assert that they developed a medical condition called nephrogenic systemic fibrosis (NSF) or nephrogenic systemic dermopathy (NSD) as a result of having contrast agents injected into their veins during such tests as magnetic resonance imaging.

Litigation apparently was spurred when the FDA issued a health advisory Dec. 22, 2006, noting that gadolinium-based contrast agents have been associated with the development of NSF/NFD in patients with renal insufficiency. Manufacturers added a boxed warning to gadolinium-based agents in September 2007, cautioning against use of these products in patients with kidney disease.

In February, 2008, the Judicial Panel on Multidistrict Litigation consolidated federal cases in the U.S. District Court for the Northern District of Ohio. In Re: Gadolinium Contrast Dyes Products Liability Litigation, MDL No. 1909 (JPML). The Panel rejected the argument of one defendant that the cases do not share common fact issues because each defendant’s contrast agents are chemically and pharmacologically different. Other defendants supported centralization and requested that the Northern District of Ohio be designated as the transferee court. The federal cases are assigned to Judge Dan. A. Polster.  Plaintiffs' Steering Committee has a website.

Such pre-trial consolidations are not surprising, given the courts’ desire for a mechanism to efficiently administer and mange multiple cases raising at least some common issues. However, they do risk the “Field of Dreams” effect: build it and they (plaintiffs) will come. The distortion of the process and the potential impact on defendants’ due process rights is a central and often overlooked aspect to mass tort aggregation.