New NIOSH Report On Nano-technology

Updating their previous draft report from July 2006, NIOSH is about to produce a final report to provide an overview of what is known about the potential hazards of nanoparticles and how workplace exposure to nanoparticles can be minimized and monitored.

Nanotechnology—the manipulation of matter on a near-atomic scale to produce new structures,
materials, and devices—offers the promise of unprecedented scientific advancement for many sectors, such as medicine, consumer products, energy, materials, and manufacturing. Nanotechnology has the power not only to improve existing technologies, but to dramatically enhance the effectiveness of new applications. Research on the potential applications of nanotechnology continues to expand rapidly worldwide. New nanotechnology consumer products emerge at a rate of three to four per week. Over the course of the next decade, nanotechnology could have a $1 trillion impact on the global economy and employ two million workers—half of them residing in the U.S. While nanomaterials present seemingly limitless possibilities, they bring with them new challenges to understanding, predicting, and managing potential safety and health risks.

The report analyzes several animal and epidemiologic studies, hypothesizing that effects of inhaled nanoparticles are similar to ultrafine particles with similar characteristics or may be predicted by surface area, composition, and particle number. Noting the potential for chronic respiratory effects such as inflammation and tumor development, NIOSH emphasizes that exposure assessment should be conducted for environments where nanomaterials are manufactured or used as part of a manufacturing process. They recommend several methods for measuring and characterizing nanomaterial air concentrations including aerosol sampling, airborne surface area analysis, and particle number measurement.

The NIOSH report notes several challenges for implementation of successful nanoparticle monitoring strategies, including lack of current standards and complexity/uniqueness of individual nanoparticle types. Because health risk information and monitoring strategies are limited at this time, they emphasize use of a variety of engineering control techniques, implementation of a risk management program in workplaces where exposure to nanomaterials exists, and use of good work practices to help to minimize worker exposures to nanomaterials.

DRI Products Liability Conference - It's Not Easy Being Green

DRI's product liability committee is holding its annual conference with a focus on "green" issues. This program will highlight emerging issues in product liability law associated with increasing environmental awareness and health concerns. The "green" movement will impact a product liability practice and this seminar presents opportunities to learn to help clients navigate the new terrain. As environmental concerns mount and consumers and companies seek to minimize their impact on the planet, new opportunities and risks arise for product manufacturers. Manufacturers are inventing new products using cutting-edge technologies. Consumers are becoming nervous about the use of traditional chemicals in products, but also question newer approaches. The government is involving itself by threatening to more heavily regulate a variety of areas, including product labeling.

Details
Product Liability Conference
Hilton San Diego Bayfront One Park Blvd. San Diego, CA 92101
4/14/2009 - 4/17/2009

SIGN UP HERE

Topics include:
􀁴 Litigation arising from the use of phthalates and nano materials
􀁴 New claims emerging from the use of “green” building materials
􀁴 Preemption in the area of product liability
􀁴 How to meet new sustainability standards
􀁴 What new “green” regulatory standards are being considered in Europe and America
􀁴 New rules enacted by the Consumer Products Safety Commission

(Your faithful blogger is vice-chair of DRI's Mass Torts & Class Actions SLG)

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Eleventh Circuit Affirms Exclusion of Expert Testimony on General Causation

The 11th Circuit has affirmed a trial court’s exclusion of key expert causation proof in a suit against the manufacturer of Remicade, finding the expert evidence was not adequately supported by scientific studies or literature. Goldstein v. Centocor Inc., 2009 WL 275322 (11th Cir. 2/05/09).

Plaintiff-appellant contended that the prescription medication Remicade caused his pulmonary fibrosis, requiring a bilateral lung replacement. The trial court excluded plaintiff’s expert testimony on general causation, pursuant to Fed.R.Evid. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). The court of appeals reviews a trial court's Daubert rulings under an abuse of discretion standard. McClain v. Metabolife Intern'l, Inc., 401 F.3d 1233, 1238 (11th Cir.2005).

Plaintiff’s expert did not rely on any epidemiological studies that connect Remicade with pulmonary fibrosis. This is not necessarily fatal, said the 11th Circuit, but it makes a plaintiff’s task to show general causation more difficult. See Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1198 (11th Cir.2002).

In the absence of epidemiological studies, the expert reviewed four sources to make his general causation assessment. The first category, plaintiff's lung and bowel pathology reports, was not relevant to general causation; its focus on the plaintiff made it relevant to specific causation. See McClain, 401 F.3d at 1239 (“General causation is concerned with whether an agent increases the incidence of disease in a group and not whether the agent caused any given individual's disease.”). The second category, MedWatch case reports submitted by doctors who observed possible reactions to Remicade, have a limited weight. Such reports are made without medical controls or scientific assessment, and while they may support other proof of causation, alone they cannot prove causation. Id. at 1199. (putting aside an expert’s reliance on such reports, they are hearsay and do not fall within any of the exceptions to the hearsay rule; also, the prejudicial effect of these reports outweighs their probative value.)

The third category, a review of medical textbooks, revealed no relevant general causation information, only extended analogies. The fourth category, a review of abstracts of four articles linking Remicade with pulmonary fibrosis, is relevant to general causation but provided only very limited information.

A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. General Elec. Co. v. Joiner, 522 U.S. 136, 146, (1997). The district court did so here, and the 11th Circuit found no abuse of discretion in its determination.
 

Members of Congress to Re-introduce Medical Device "Safety" Bill

Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Medtronic, which held  that the Medical Device Act Amendments of 1976 specifically pre-empt product liability lawsuits against makers of FDA-approved class III medical devices. The FDA approval process for such devices is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective. The bills would permit lay juries to second-guess regulatory decisions of the FDA resulting from that process.

Sponsors of the planned legislation include Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone, head of its health subcommittee, and Senators Edward M. Kennedy and Patrick J. Leahy.  The lawmakers claim that the Supreme Court’s decision has left patients legally powerless against what they criticize as incomplete oversight of products by the FDA. Of course, if there is concern about the FDA’s efficacy, the answer is to increase the agency's resources, as the FDA is the appropriate body to set nationwide safety standards; allowing juries to second-guess such decisions would stifle product innovation. Such a bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with. What the sponsors may really want is to restore the trial lawyer lotto that can net jackpot jury awards while wreaking havoc on national standards.
 

Similar legislation, the Medical Device Safety Act of 2008, was introduced last session to overturn the Supreme Court’s decision in Reigel v. Medtronic.  H.R. 6381 garnered 62 co-sponsors last time.  Officials for the "American Association for Justice" f/k/a ATLA,  recently released a legislative agenda for 2009 and cited as their top priority efforts to pass this pro-litigation legislation.

Federal Court Predicts Delaware Would Recognize Medical Monitoring In Device Context- But Why?

Two recent, related federal court opinions illustrate just how unsettled the law of medical monitoring continues to be. Molly Guinan V. A.I. Dupont Hospital For Children, 2009 WL 311113 (E.D.Pa. Feb. 6, 2009); Molly Guinan V. A.I. Dupont Hospital For Children, 2009 WL 307019 (E.D.Pa. Feb. 6, 2009).

Plaintiff is one of several infants who had what the court called a “controversial” procedure to correct a congenital heart defect performed on her by doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware. Cardiologists implanted a covered stent manufactured by NuMed, Inc., a New York corporation that is one of the few developers of pediatric medical devices in the United States. The stent had not been approved by the Food and Drug Administration when implanted. Plaintiff developed serious conditions that were allegedly side effects of the treatment, and there were factual disputes surrounding the treatment plaintiff received when her injuries first began manifesting themselves.

Plaintiffs sued the doctors, hospital, and device maker. Plaintiff articulated two different theories of negligence against the treaters: (1) medical negligence premised on malpractice; and (2) lack of informed consent. (The plaintiff parents claimed they weren’t told anything, and the defendant doctors claimed they told the parents everything.) At bottom, Guinan is another of an increasing number of cases in which what are in reality malpractice cases are being twisted into product liability litigation. Even worse when they get stretched into medical monitoring claims. Multiple summary judgment motions were filed.

The first question was choice of law. Plaintiffs were residents of New Jersey, and the complained-of surgery occurred in Delaware. Plaintiffs sued in the Eastern District of Pennsylvania, where the child was then being treated for the complications. The aspect of most interest for readers of MassTortDefense is not the malpractice claim, but the medical monitoring claim. The court noted that Pennsylvania and New Jersey recognize medical monitoring as a cause of action. However, there are differences between the laws of the two states that created a conflict. See In re Paoli R.R. Yard PCB Litig. (Paoli II), 35 F.3d 717, 787-88 (3d Cir.1994) (identifying potential conflict between Pennsylvania and New Jersey medical monitoring causes of action). In Delaware, the court said that it is not clear whether medical monitoring is an independent tort or whether medical monitoring is simply a remedy. However, while some Delaware decisions have mentioned medical monitoring, Mergenthaler v. Asbestos Corp. of Am., 480 A.2d 647, 651 (Del.1984), the state has never adopted medical monitoring.

The court concluded that Delaware had the greatest interest in seeing its law applied to this action and thus Delaware law would control. Again, Delaware has never recognized medical monitoring as a legally cognizable cause of action. See Mergenthaler, 480 A.2d at 649 (affirming Delaware Superior Court's dismissal of plaintiffs' “claim for the expenses of medically required surveillance ... where there [was] no present physical injury,”). Going through an Erie analysis, the district court predicted that the Delaware Supreme Court would permit a claim for medical monitoring if it were confronted with the facts of this case. Such a prediction seems in direct contrast to 3d Circuit guidance on the issue. E.g., Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003) (federal court in a diversity case should be reluctant to expand the common law); Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)(court should opt for the interpretation that restricts liability, rather than expands it).

Several considerations militated in favor of allowing plaintiff to proceed with a medical monitoring claim, said the court. It is undisputed that plaintiff has a Class III medical device in her body. Moreover, it is undisputed that the device did not have premarket approval from the FDA. The FDA, NuMed, and the Institutional hospital defendants have all suggested that plaintiff should receive follow-up care to monitor the stent. “This is compelling, if not conclusive, evidence that medical monitoring is appropriate in this case.”

The court rejected any countervailing policy considerations. See, e.g., Metro-North Commuter R.R. Co. v. Buckley, 521 U.S. 424, 443-44, 117 S.Ct. 2113, 138 L.Ed.2d 560 (1997) (discussing potential for a “ ‘flood’ of less important cases” that could “entail systemic costs without corresponding benefits” if the Supreme Court were to recognize a “full-blown” medical monitoring tort in the context of the Federal Employers' Liability Act (FELA). In sum, considerations of fairness, efficiency, and deterrence favored recognizing a cause of action for medical monitoring, according to the court.

The second, companion opinion’s choice of law analysis included New York, NuMed's state of incorporation. The court found again that Delaware has the greatest interest. And while Delaware has not expressly adopted a medical monitoring claim, for the same reasons as above, the court again predicted that the Delaware Supreme Court would adopt a claim for medical monitoring.

The surprisingly simplistic analysis boils down to bad facts make bad law (or bad predictions of the law). The plaintiff's novel theory that a tort claim for medical monitoring can be applied to medical procedures and devices raises serious policy issues that the court never analyzed. In a case involving HRT, Vitanza v. Wyeth, Inc., 2006 WL 462470 (N.J. Super. Ct. 24 Jan. 2006), claimants sought class certification of a group defined as all persons in New Jersey who had taken the drug Prempro and were not suffering from breast cancer, but who wanted medical monitoring for an alleged increased risk of future cancer. The court dismissed the claim, noting that the state's recognition of medical monitoring came in the unique context of manifest exposure to toxic substances in environmental tort actions, and is to be applied sparingly. The policy reasons applicable to the environmental exposure context (including the difficulty in proving exposure levels and duration, and even the identity of the chemicals at issue) are not present in the prescription drug context where claimants have access to relevant information through the label, pharmacy records, and their prescribing physician. The need to deter polluters, perceived to be present in the toxic tort context, does not apply to life sciences companies. See also Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *5, n.6 (D.N.J. 14 Jan. 2008)(applying similar reasoning to device context). See generally Sinclair v. Merck & Co., 195 N.J. 51, 948 A.2d 587 (N.J. 2008)(plaintiffs could not maintain an action for medical monitoring in a pharmaceutical product liability action). That the device was not approved yet for this use doesn't change the fact that the FDA has primary responsibility for regulating use of the product.

Moreover, from a doctrinal perspective, medical monitoring requires an underlying tort or tortious conduct. Redland Soccer Club, Inc. v. Department of the Army, 696 A.2d 137, 145 (Pa. 1997); Potter v. Firestone Tire & Rubber Co., 863 P.2d 795, 823 (Cal. 1993) (“as a result of a defendant's tortious conduct”); Meyer v. Fluor Corp., 220 S.W.3d 712, 717 (Mo. 2007); (“consequences of the defendant’s tortious conduct”); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993) (“which exposure was caused by the defendant’s negligence”); (“through the tortious conduct of the defendant”); Bower v. Westinghouse Electric Corp., 522 S.E.2d 424, 432 (W. Va. 1999); Petito v. A.H. Robins Co., 750 So.2d 103, 106 (Fla. App. 1999) (“caused by the defendant’s negligence”). Here, the negligence claim was dismissed for lack of any viable expert opinion on either liability or damages. There was no viable product defect claim, because of the experimental product. There was no proof of fraud. Bottom line, there was no tort upon which to predicate medical monitoring. Was the court predicting that Delaware would not only adopt the claim, but would do so without this essential element?
 

Canadian Court Certifies Another Class Action

The Ontario Court of Justice earlier this month certified a class action against Dell Canada Inc. for alleged damage caused to about 120,000 individuals, corporations, and government agencies by allegedly defective notebook computers. See Griffin v. Dell Canada Inc., Ontario Superior Court of Justice, No. 07-CV-325223D2 (2/3/09). Here at MassTortDefense, we have posted about just how difficult Canada is becoming as a jurisdiction for class actions defendants. Frequently, identical consumer products, drugs, and medical devices are marketed in Canada as well as the U.S.

The court concluded that a class action was the preferred option to address the issues, that it was “fanciful” to think that any claimant could pursue an individual claim in a complex products liability case, and rejected Dell's arguments that an arbitration clause in its terms and conditions of sale precluded direct litigation by its customers.


The court minimized the importance under the Class Proceedings Act of plaintiffs’ obligation to produce a workable litigation plan. Such a plan is necessary to help the court decide whether a class action is the preferable procedure, and whether the litigation is manageable. The more complex the litigation, the more detailed a plan is needed that indicates how to manage the litigation. The court ruled, however, that the plaintiff is not required to show that there is a fair, efficient, and manageable method of resolving the claim, but only that there is a fair, efficient, and manageable method for advancing the claim. Order at para. 95. Who cares about theoretical advancement if the claim cannot efficiently be resolved?  A class proceeding in this case achieved this lesser goal and met the objective of judicial economy, even though plaintiff’s plan provided no detail of the resources the class law firm has to administer a claims process of this dimension to ensure that the interests of class members are protected, and there was no analysis of the resources that will be required to litigate the class members' claims to conclusion. Nevertheless, the court went ahead and certified the action conditionally, subject to the plaintiffs producing an acceptable litigation plan. Order at para. 102.

The court rejected Dell Canada’s argument that the significant individual issues involved in each of the potential claims far outweigh the common issues, as merely a “familiar refrain.” Order at para. 90.  Perhaps it is familiar because it is frequently true? The court concluded that the trial judge will be able to fashion efficient and fair trial plan procedures using the extensive powers and discretion conferred on the court by Sec. 25 of Ontario's Class Proceedings Act. The prospect of individualized mini-trials on whether, and to what extent, other factors contributed to the computer failures did not deter the certification. Nor did potentially difficult issues of causation and damages. Order at para. 90.

Dell did not propose that consumers undertake individual lawsuits, but argued that adjudication through arbitration administered by the National Arbitration Forum, as specified in Dell's terms and conditions of sale, was preferable to a class action. The court found, however, that arbitration was not the kind of process that would be easy for class members to navigate without legal representation. The multitude of individual issues that Dell says precludes class treatment would also lead to more complex and therefore more costly arbitration hearings, said the court. Order at para. 92-93.

“On the other hand, aggregating similar individual actions in a class proceeding avoids unnecessary duplication of fact-finding and analysis, and distributes fixed litigation costs among class members, making it economical to prosecute this claim, thereby improving access to justice.” Order at para. 93.
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More Made In China Products Liability Litigation

A putative class of Florida homeowners recently filed suit against a company that manufactured drywall in China, alleging the material used in their homes emits sulfur compounds that damaged heating and electrical wiring, and created health risks. See Allen v. Knauf Plasterboard Tianjin, No. 09-CV-54-FtM-99 DNF (M.D. Fla., complaint filed 1/30/09). This is just the latest potentially significant suit arising over products made in China. Plaintiffs allege that defendants manufactured drywall that contained fly ash from Chinese coal-fired power plants, causing the product to emit sulfur compounds that create odor and corrode copper in air conditioning units and wiring in homes. At least one home builder has also brought claims over the drywall issues.

Plaintiffs’ attorneys claim that as much as 10 million square feet of such drywall was used in Florida homes due to shortages of American-made drywall between 2004 and 2006. The complaint asserted causes of action including negligence and negligence per se, strict liability, breach of express and implied warranties, fraudulent misrepresentation, and violation of Florida's deceptive and unfair trade practices act. Defendants dispute the allegations and note that any low levels of sulfur compounds present in the air in homes are not a health risk

Regardless of the merits of the case, and clearly such claims are typically inappropriate for class certification because of the individual issues that will be presented by evidence surrounding injury and causation, there is a growing volume of cases over alleged defects in products made in China. Such litigation can also raise insurance coverage disputes. Coverage litigation has erupted concerning the recent heparin drug contamination allegations, for example. What importers tell their insurers about their source of supply; whether subsidiaries are covered; whether importers here are in de facto joint ventures with Chinese suppliers; and similar questions may be front and center in coverage disputes when this type of products litigation hits. Insurance companies seem to be increasingly playing the card that insureds needed to disclose the details of their manufacturing suppliers. The recent China dairy product scandal may have insurers arguing that product defects are the result of intentional, criminal behavior, rather than negligence.

With the Consumer Product Safety Improvement Act of 2008 seeking to place importers on the hook for defects, U.S. companies may be in the market for more coverage. At the same time, Chinese exporters have not felt the need to buy insurance as they feel judgment-proof in U.S. courts. However, importers may want to consider requiring their suppliers to purchase such insurance as part of the bargaining.
 

Two Nano-Technology Support Bills Introduced in House

Rep. Michael Honda (D-Calif.) has introduced legislation that he says will promote the development and responsible stewardship of nanotechnology. His bill, the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R. 820), would expand the federal government's efforts to support the commercialization of products emerging from nanotechnology research. A somewhat similar bill was introduced last month by Rep. Bart Gordon (D-Tenn.), chairman of the House Science and Technology Committee. That bill, the National Nanotechnology Initiative Amendments Act of 2009 (H.R. 554) has 21 co-sponsors so far. The S&T Committee has made ensuring that the U.S. is a leader in the development of nanotechnology a priority for the new Congress.

Gordon's bill aims to reauthorize the multi-agency National Nanotechnology Initiative that Congress formally established in 2003 through the 21st Century Nanotechnology Research and Development Act of 2003. A National Nanotechnology Coordination Office along with the National Research Council of the National Academy of Sciences would supervise a national nanotechnology program. 

While the two bills have much in common, H.R. 820 includes elements like the offering of tax credits for individuals purchasing stock in certain types of nanotechnology firms, such as small or start-up companies. Honda reports that H.R. 820 draws on the work of a Task Force on Nanotechnology that he convened in 2005. That task force highlighted various ways the U.S. government could promote the commercialization of nanotechnology, as other governments already are doing. Accordingly, the NANO Act would authorize up to $100,000 to establish public-private partnerships to advance the commercialization of nano-manufacturing technologies to address critical scientific and engineering needs of national importance.

Gordon's bill, H.R. 554, would encourage nanotechnology research to provide solutions to important problems in such areas as nanoelectronics, energy efficiency, health care, and water remediation and purification. Both bills use various means to support the training of students in nanotechnology to ensure a future workforce.
 

Federal Claims Court Finds Against Plaintiffs On Vaccine General Causation Link To Autism

The U.S. Court of Federal Claims ruled last week in three bellwether cases that thimerosal vaccines do not cause autism in children. Three special masters of the Court ruled against plaintiffs in three separate test cases, finding insufficient evidence of a casual link between autism and the MMR (measles, mumps, rubella) vaccine.


Thimerosal has been widely used for decades as a preservative in a number of biologic and pharmaceutical products, including vaccines. It prevents life-threatening contamination. Increasing concern over the potential toxicity of the chemical has led to the removal or reduction to trace amounts of the preservative in most vaccines routinely given children aged 6 and under.


That same concern is behind numerous legal claims alleging that that routine childhood shots are to blame for the rising incidence of autism. The National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq., governs such claims, requiring plaintiffs to file a special no-fault compensation petition with the Court of Federal Claims, rather than a traditional suit against manufacturers. Part of the policy behind the program is the potential impact on public health of a traditional mass tort type of litigation involving life-saving vaccines, ranging from polio to chicken pox. Approximately 12,000 cases have been filed under the program.

To be eligible for compensation under the Vaccine Act, a petitioner must either demonstrate a "Vaccine Table" injury, to which a statutory presumption of causation attaches, or prove by a preponderance of the evidence that a vaccine listed caused or significantly aggravated an alleged injury. Althen v. Sec’y, HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005).  Autism claims fall in that latter category.  In 2002, the Court set up an Omnibus Autism Proceeding to test the three main theories of general causation: that the vaccines and thimerosal combine to cause autism; that thimerosal-containing vaccines cause autism; or that MMR vaccines can cause autism.


Separate opinions covered the Snyder, Hazelhurst, and Cedilllo test cases, but each represent the first, and major, theory, that the vaccines and thimerosal somehow combine to cause autism. The three cases involved some 5,000 pages of transcripts, 939 medical articles and 50 expert reports. The vast majority of credible scientific studies have shown -- and all federal health agencies have strenuously argued -- that there is no connection between vaccines and autism. And public health officials have repeatedly warned that fewer immunizations will endanger children. Indeed, at least in part because of the scare, about one in 12 children does not receive the MMR vaccine in the United States.


The Cedillos contended that their daughter fell sick a week after she received an MMR shot when she was about 16 months old. Today, at age 14, she requires round-the-clock care, suffers from seizures, has lost nearly all her vision and has constant abdominal pain.The Court found that the Cedillos have been misled by physicians who are guilty, in the Court’s view, of gross medical misjudgment on the issue of causation.


The Snyders argued that the MMR vaccine, or the mercury-based preservative in it, had triggered in their son pervasive developmental disorder -- part of the autism spectrum. But, the Court found that the experts contending there is no link between autism and vaccines were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention.


In the Hazlehurst claim, parents alleged that the MMR vaccine had caused "regressive autism" in their son. Agreeing with the other special masters, the Court found their causation evidence fell short, concluding that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism and therefore, could not have contributed to the development of their child's autism. The weight of the presented evidence that is scientifically reliable and methodologically sound does not support petitioners’ claims.
 

California Jury Returns Defense Verdict In Welding Fumes Trial

Jurors in Oakland, CA., concluded last week that welding products manufacturers were not liable for any neurological impairments suffered by a long-time welder. See Thomas v. A.O. Smith Corp., at al. (Calif. Super. Ct., Alameda Cty.).The trial lasted about 3 weeks, and the Alameda County jury delivered its verdict after approximately three and a half hours of deliberations. Judge Robert B. Freedman presided. Trial defendants included Lincoln Electric Co., ESAB Group, and Hobart Brothers Co.

The Thomas trial marks the first time allegations that a worker became ill from exposure to welding rod fumes has been heard by a California state court jury. Thomas had alleged that welding rod manufacturers knew that welding fumes were toxic and failed to adequately warn of the risk of neurological disorders. As a result of his exposure, Thomas alleged he suffered severe physical and emotional injuries.


On the eve of trial, Judge Freedman had denied defense motions to exclude testimony by Thomas’ medical experts and industrial hygienist, but granted a motion to preclude a plaintiff warning expert from offering an opinion as to whether defendants had a duty to warn or on the effectiveness of defendants’ warning labels.

Judge Freedman also barred plaintiffs from making pejorative references to the “welding industry,” or making plaintiffs' typical, inappropriate comparisons to tobacco or asbestos companies. However, the judge denied a defense motion to prevent plaintiffs from referring to defendants’ lobbying activities.

The jury’s finding was that welding fumes did not cause the plaintiff’s injury, and this seems to support what defendants have contended: there is no sufficient link between welding fumes and Parkinson’s disease. By our count that is 22 of the last 26 verdicts for defendants in this mass tort.
 

Denial of Class Certification Does Not Alter CAFA Jurisdiction

A federal court has issued an opinion on an important aspect of the Class Action Fairness Act, namely whether the denial of class action status deprives a federal court of jurisdiction under the Act. In Kitts v. Citgo Petroleum Corp., 2009 WL 192550 (W.D. La., 1/23/09), the district court declined to remand to state court a personal injury action stemming from an oil spill. Although some district courts have held that post-removal events such as class certification denial can render the court without subject matter jurisdiction under CAFA, the Western District of Louisiana held that the better approach is to retain jurisdiction.

On June 15, 2007, plaintiffs filed a putative class action suit in state court in Louisiana, claiming damages resulting from a 2006 oil spill alleged to have occurred from a facility owned and operated by defendant. Plaintiffs' complaint alleged they suffered injuries from this spill, respiratory problems and illnesses, sinus damage, difficulty breathing, and burning of the throat and nasal passages. Defendant removed, based on CAFA. The federal district court later denied class certification. Plaintiffs then filed a Motion to Remand alleging that remand to state court was appropriate because the refusal to certify this matter as a class action divested the court of subject matter jurisdiction.

The court, however, found compelling the reasoning of those cases finding jurisdiction continues to exist even after denial of the class action. Particularly appropriate was the conclusion reached by the Southern District of Florida in Colomar v. Mercy Hospital, Inc., 2007 WL 2083562, *3 (S.D.Fla.07/20/2007). In support of its denial of a Motion to Remand filed in a case properly removed under CAFA, but after the minimally diverse defendant was dismissed and class certification was denied, the Florida district court stated that the courts considering the issue of whether a federal court retains jurisdiction after class certification is denied have concluded that case developments subsequent to removal do not alter the courts' CAFA jurisdiction, if jurisdiction was proper at the time of removal.

The court quoted from the CAFA legislative history, the Senate Report stating that “once a complaint is properly removed to federal court, the federal court's jurisdiction cannot be ousted by later events.... If a federal court's jurisdiction could be ousted by events occurring after a case was removed, plaintiffs who believed the tide was turning against them could simply always amend their complaint months (or even years) into the litigation to require remand to state court.... [I]f subsequent events could unravel a federal court's jurisdiction, a defendant could prevail on the merits, only to have the federal court conclude that it lacks jurisdiction to enter judgment."  S. Rep. 109-14, 109th Cong., 1st Sess.2005, reprinted in 2005 U.S.C.CA.N. 3, *70-71, *66-67.

Here, the court said that to litigate the case up to the eve of trial, and then to seek remand after adverse rulings have issued and summary judgment is briefed, equates to a forum shopping. Plaintiffs admitted that this matter was properly removed under CAFA. Plaintiffs' efforts to unravel jurisdiction on the eve of trial was forum shopping which the traditional rules of removal and remand are designed to preclude.
 

Daubert Lessons From Two Medical Device Cases

Two recent federal cases illustrate important Daubert principles in the medical device context.

In Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09), the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product.  In contrast, in Jaske v. Zimmer Inc., 2009 WL 150946 (N.D. Ill., 1/20/09), the Northern District of Illinois reversed an earlier decision to exclude two expert witnesses for the plaintiff. On a motion for reconsideration, the court ruled that plaintiff can present testimony from two experts in polymer science as to why his prosthetic knee, manufactured by defendant Zimmer, allegedly failed.


Fuesting alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

Under Rule 702 and the Daubert standard, expert testimony must be both relevant and reliable. The district court must act as a “gatekeeper” making a preliminary assessment of the reasoning or methodology underlying the testimony. Daubert factors include: (1) whether the scientific theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the theory's known or potential rate of error when applied; and (4) whether the technique or theory has been ‘generally accepted’ in the scientific community. 


On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. To bridge the gap, rhe expert needed to show, with respect to Fuesting's implant in particular, what quantum of each variable is required to set the alleged causal chain reaction in motion. That is, the causation opinion must be specific to the plaintiff, and each chain in the causal link must be supported by adequate science. Gaps included how much radiation does it take to cause oxidation, and to what degree? How much oxidation must occur to render polyethylene more susceptible to delamination? And once polyethylene becomes more susceptible to delamination, how then does oxidation affect delamination? Are all forms of polyethylene, including that used by Zimmer (which the company claims to be oxidation-resistant), susceptible to delamination? What effect, if any, does implantation into the human body have on the rate of oxidation?

The expert testimony as to defect also failed. Oxidation can occur in implants sterilized by any method. However, plaintiff’s expert did not know of any peer-reviewed studies or articles that compared oxidation rates for implants sterilized by GIA to those sterilized through other methods. While the prosthesis showed significant oxidation when it was tested, that testing occurred more than six years after the knee joint was explanted, and plaintiff failed to account for oxidation that may have occurred after the joint was removed.

Having granted Zimmer's motion to exclude the expert testimony, the court had no alternative but to also grant the company's motion for summary judgment.

In Jaske, Plaintiff had his left knee replaced with a prosthesis to alleviate recurring pain. When the prosthesis allegedly failed, he filed suit against the manufacturer. Last year, the district court granted defendant's motion to exclude the testimony of two of plaintiff's experts in polymer science, who, while qualified to offer some opinions, used a test as the basis for their opinions that was not reliable. (A Fourier Transform Infrared Spectroscopy (“FTIR”)). Plaintiff moved for reconsideration.


The court had determined that the proffered testimony was unreliable for two reasons. First, the results of the FTIR test may have been skewed because lipids and proteins from Jaske's body had permeated the product. And, second, even if the test results were accurate, they did not determine when the oxidation took place. Originally, plaintiff offered nothing but a naked expert opinion on this issue. On reconsideration, plaintiff presented new evidence that any biological material present would absorb the infrared spectrum used in the FTIR at a different frequency than oxidized polyethylene, and that the FTIR is the accepted standard of the American Society of Testing and Manufacturing for this purpose.

The court had also originally noted that the FTIR test measured the amount of oxidation present in the prosthesis only at the time the test was conducted. It did not provide historical readings. Plaintiff clarified that his experts developed their theory independent of the test results. Instead of relying on the FTIR results to arrive at their theory, they said, the FTIR simply provided support for it. In other words, the results of the FTIR are merely consistent with the theory. The theory that gamma irradiation sterilization in air causes oxidation has been recognized, asserted plaintiff, for some time in the scientific community.


This second case demonstrates one of the potential dangers of the Daubert challenge: if the court is going to give plaintiff a second bite of the apple, the Daubert motion turns into a roadmap for the plaintiff on what holes to fix.  See our post on reasons why you might not file a credible motion.
 

Update on BPA From FDA

The Food and Drug Administration has announced a public meeting on BPA to be held on February 24, 2009, by the Science Board to the FDA. This public advisory committee, whose function it is to provide advice and recommendations to the agency on FDA’s various regulatory issues, will discuss updates from the agency on the continued assessment of Bisphenol A in FDA-regulated products. The Science Board will also hear about the plans for (1) The review of FDA Center’s science programs, (2) the review of each Center’s projects within scientific priority areas.

The meeting will be held at the Hilton Washington DC, North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. FDA intends to make background material available to the public no later than 2 business days before the meeting.

Late last month, the FDA and Health Canada’s Health Products and Food Branch hosted a meeting of representatives of U.S. and Canadian manufacturers and users of food packaging materials containing BPA to discuss what is being done to concerning the potential levels of the chemical in food. The meeting was also part of FDA’s efforts to assist industry in its voluntary BPA related efforts.


The meeting was designed to provide a forum for:
• Updating the industry on the FDA’s and Health Canada’s current activities and planned research to further assess the exposure to BPA and manage any potential risks from the chemical.
• Describing manufacturers’ research activities, their work to refine packaging manufacturing practices to minimize migration of BPA into food, and recent marketplace developments.
• Dialogue by the participants about further information from regulated industry stakeholders that would be helpful to the FDA and Health Canada in updating and refining their BPA risk assessments.
• Dialogue about the different uses of BPA in food contact applications and the variation in possible availability of fully functional and evaluated alternative substances.
• Discussion of the possibility whether, because of availability of alternative products, polycarbonate baby bottles could cease to be a substantial component of the North American market in the future.


With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.


Health Canada’s Health Products and Food Branch has concluded that current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and infants. However, using an extremely precautionary approach, the Government of Canada has taken steps to reduce exposure to BPA for infants and young children.
The FDA is currently preparing a detailed response to the October, 2008 review by the FDA Science Board of the agency's draft assessment of the safety of BPA for use in food contact applications. The draft assessment focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel. For example, the FDA is reviewing research about the potential low-dose effects of BPA. 

District Court Permits Consumer Fraud Putative Class Action to Proceed on "All Natural" Claims

A federal district court recently denied defendant’s motion to dismiss in a putative class action under California's Unfair Competition Law alleging that defendant engaged in misleading conduct by advertising its “Healthy Choice” pasta sauce as “all natural” even though it includes some “high fructose corn syrup.” Lockwood v. Conagra Foods, Inc., 2009 WL 250459 (N.D.Cal. Feb. 3, 2009).

Defendant moved to dismiss on several grounds: arguing plaintiffs' claims were expressly preempted by the Nutrition Labeling and Education Act; were impliedly preempted by comprehensive FDA regulations under the Federal Food and Drug Cosmetic Act; that the court should defer to the FDA under the “primary jurisdiction” doctrine. Finally, defendants asserted that the court should strike the class allegations because plaintiffs cannot prove reliance on a class-wide basis.

Regarding the field preemption argument, the court noted that the purpose of the NLEA was to clarify and to strengthen FDA's authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about the nutrients in foods. Under the Act, states may impose labeling requirements for artificial favors, colors or preservatives only if such requirements are identical to those imposed by the FDCA; any differences are preempted. But, the court held, this provision does not apply to plaintiffs' complaint as currently pled. Plaintiffs did not allege that defendant's pasta sauce contains artificial flavoring, coloring or a chemical preservative; rather, they allege that the “high fructose corn syrup” is not produced by a natural process and therefore the pasta sauce is not “all natural.”  One wonders why the claims of not all "natural" due to the use of an "artificial" flavor isn't squarely in that ballpark.

Turing to implied field preemption, the court noted that NLEA's provisions suggest Congress did not intend to occupy the field of food and beverage labeling. The FDA's policy as to the word “natural” similarly suggested an intent not to occupy the field of food labeling. Under the policy, the agency has considered natural to mean merely that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be there. Although the FDA acknowledges that some consumers may be misled by the use of the term “natural,” it has declined to adopt any regulations governing this term. This inaction is consistent with an intent not to occupy the field. This is especially so given that at the time the FDA declined to formally define “natural” it was aware of and had reviewed state regulation of the use of the term, yet it made no mention of the need for uniformity or a preemptive federal regulation.

On conflict preemption, the court found that the defendant had not proved as a matter of law that plaintiffs' claims, if successful, make compliance with federal law a physical impossibility. A manufacturer could comply, that is, not violate, the FDA's policy as to use of the term “natural” and still comply with state law as articulated by plaintiffs in this case, thought the court. Nor does California law stand as an obstacle to the accomplishment and execution of the objectives of the FDCA. Again, it seems questionable that this type of claim wouldn't risk imposing labeling requirements for "artificial" favors, directly in contrast to federal regulations.

Regarding primary jurisdiction, the court found application of the doctrine was not appropriate here. At a minimum, various parties have repeatedly asked the FDA to adopt formal rulemaking to define the word natural and the FDA has declined to do so because it is not a priority and the FDA has limited resources. Moreover, the court did not feel this was a technical area in which the FDA has greater technical expertise than the courts. Finally, plaintiffs' claims were based on state law and, thus, federal law would not dispose of plaintiffs' state law claims.

Finally, the court declined to strike the class allegations at this juncture, finding that if a misrepresentation is material an inference of class-wide reliance may be inferred under the California law. MassTortDefense has posted about the growing trend of plaintiffs to use consumer fraud act claims in place of traditional product theories. Plaintiffs continue to believe that claims based on unfair and deceptive trade practices acts are somehow easier to certify as class actions because of differing notions of reliance and causation.
 

Second Circuit to Hear Appeal of Class Certification Decision in Zyprexa RICO Case

The U.S. Court of Appeals for the Second Circuit recently agreed to hear Eli Lilly’s appeal of a federal district court's orders granting class certification and denying summary judgment in litigation over its anti-psychotic medication, Zyprexa. See In re Zyprexa Products Liability Litigation, 08-4685-mv (2d Cir. 1/15/09).

Judge Jack B. Weinstein of the the Eastern District of New York had granted class certification last fall to a group of third-party payers, including insurance companies, who were suing Eli Lilly for alleged overpayment after the company allegedly exaggerated the benefits of the drug and supposedly failed to disclose certain side effects. The 2d Circuit has now granted the 23(f) motion for leave to appeal.

Readers of MassTortDefense may recall that the 2d Circuit just last year in McLaughlin v. American Tobacco Co., 522 F.3d 215 (2d Cir. 2008), overruled Judge Weinstein's certification of a class of “light” cigarette smokers, finding that individualized issues regarding reliance, loss causation, damages and injury all precluded a finding that common issues predominated over individualized ones as required by Federal Rule of Civil Procedure 23(b)(3). The Zyprexa class claim was brought under the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. § 1964, as plaintiffs seek to take advantage of their reading of the U.S. Supreme Court’s ruling in Bridge v. Phoenix Bond & Indemnity Co., 128 S. Ct. 2131 (2008), regarding reliance in a RICO fraud claim.

In certifying the class in Zyprexa, Judge Weinstein applied his take on the reasoning in Bridge, finding that third-party payers had colorable claims based on the allegedly fraudulent statements made to and relied upon by doctors who prescribed the drugs (not parties). As warned of in our post here last year, the Supreme Court had appeared to reject the defense argument that the proximate cause requirement inherent in the “by reason of” language of the RICO statute demands that a civil RICO plaintiff asserting a claim based on fraud establish his reliance on a misrepresentation by the defendant. In the context of a civil RICO claim predicated on fraud, the required causal link demands a showing that the plaintiff relied on an alleged misrepresentation made to the plaintiff by the defendant. Otherwise, the causal relationship between the alleged injury and the alleged fraud is too attenuated.

The Court appeared to reject petitioners' arguments that under the “common-law meaning” rule, Congress should be presumed to have made reliance an element of a civil RICO claim predicated on a violation of the mail fraud statute. And rejected the argument that a plaintiff bringing a RICO claim based on mail fraud must show reliance on the defendant's misrepresentations in order to establish proximate cause. The Court felt it had no ability to respond to the policy argument that RICO should be interpreted to require first-party reliance for fraud-based claims in order to avoid the “overfederalization” of traditional state law claims. A RICO plaintiff who alleges injury by reason of a pattern of mail fraud cannot prevail without showing that someone relied on the defendant's misrepresentations. But that does not mean, under one reading of Bridge, that the only injuries proximately caused by the misrepresentation are those suffered by the recipient.

The Court’s decision on reliance was based on statutory interpretation, rather than logic or common sense. We predicted that the absence of a clear reliance requirement may in fact make this type of claim even more popular with mass tort plaintiffs. And we are seeing its potential effect on class certification decisions in some district courts.
 

Appeals Court Rejects Bystander Injury Claims

The Sixth Circuit has affirmed the dismissal of claims that a child contracted mesothelioma from exposure to his father's asbestos-laden clothes, finding no evidence that such a “bystander” injury was foreseeable at the time of the alleged exposure. Martin v. Cincinnati Gas and Electric Co., 2009 WL 188051 (6th Cir. 1/27/09).

Claims were brought against the father's old utility company employer and a company that allegedly manufactured asbestos-fireproofing for the utility. The claims were based on asbestos that Martin's father allegedly brought home on his work clothes while working for the utility, CG & E. The district court granted summary judgment for defendants because neither had a legal duty to the plaintiff.

Under applicable Kentucky law, as in most jurisdictions, duty presents a question of law for the judge to decide. Typically, there is a universal duty of care which requires every person to exercise ordinary care in his activities to prevent foreseeable injury. The most important factor in determining whether a duty exists is foreseeability. And foreseeability, in turn, is determined based on what the defendant knew or should have known at the time of the alleged negligence. There was no evidence that either defendant had actual knowledge of the danger of bystander exposure, so the question is whether they should have known: that is, was such a risk foreseeable to them based on “common knowledge at the time and in the community?”

Plaintiff’s expert report did not indicate that the risk was knowable, but in any event, it is insufficient that the danger was merely knowable: the knowledge has to have been available to the defendant. There was an insufficient showing of any general knowledge of bystander exposure in the industry. Plaintiff's expert report concedes that the first studies of bystander exposure were not published until 1965. (Martin's father's exposure to asbestos materials stopped in 1963).

The court rejected the plaintiff’s reliance on several cases from other states where bystander asbestos exposure liability has been upheld; the Sixth Circuit agreed with a number of other cases in which courts have found no duty for secondary asbestos exposure. E.g., CSX Transp. Inc. v. Williams, 608 S.E.2d 208, 210 (Ga. 2005); Adams v. Owens-Illinois Inc., 705 A.2d 58, 66 (Md. Ct. App. 1998); In re Certified Question from Fourteenth Dist. Ct. of Appeals of Tex., 740 N.W.2d at 218-20; In re New York City Asbestos Litig., 840 N.E.2d 115, 121 (N.Y. 2005); and Alcoa Inc. v. Behringer, 235 S.W.3d 456, 462 (Tex. Ct. App. 2007).
 

Summary judgment affirmed.

Sixth Circuit Affirms Denial of Class Certification in Chemical Spill Litigation

The U.S. Court of Appeals for the Sixth Circuit has affirmed the district court's denial of class action status in litigation arising from a 2002 incident in which a Norfolk Southern train derailed, causing a chemical spill.  See Turnage v. Norfolk Southern Corp., No. 07-6033,  2009 WL 140479 (6th Cir. 2009).

While so much of the focus in class actions is on Rule 23 (b) provisions, the court found that plaintiffs had not demonstrated that the number of people allegedly harmed by the spill, but not already fully compensated, was so numerous as to make joinder impractical. While this 23(a)requirement is commonly referred to as a “numerosity” requirement, the real issue is whether the plaintiff seeking class certification has demonstrated impracticability of joinder.

The incident had led to a mandatory evacuation of homes within a 1 mile radius of the site, and a voluntary evacuation of those within a 3 mile radius.  Nevertheless, the class definition, and the number of putative class members, was a moving target throughout the litigation.

The proximity of class members to each other, and the discrete and obvious nature of the alleged harm, made identifying class members easy.  And made joinder easier too. So, while some courts find the proximity of class members a factor in favor of certification under Rule 23 (b), the 6th Circuit noted the opposite effect on the 23(a) factor.

After the incident, the defendant had set up claim centers and reimbursed a vast majority of households within the 1 mile radius for out-of-pocket expenses related to food, clothing, and lodging. Plaintiffs made an insufficient showing that the residents included in their numbers suffered actual damage. Plaintiffs failed to show how many of the 15,000 supposedly uncompensated residents actually evacuated. The excludable group includes those who were out of town during the evacuation, those in the voluntary zone who chose not to evacuate and whose daily routines were little disturbed, and those who were able to relocate temporarily to other quarters with little inconvenience or expense.
 

State Appeals Court Affirms Class Action Trial Victory for Chemical Defendant

An interesting little case: a personal injury class gets certified, defendant stipulates to key elements of liability, and defendant wins the trial anyway.

The Louisiana appeals court has affirmed a lower court ruling in favor of E.I. du Pont de Nemours & Co. in a case involving an accidental chemical release at a DuPont facility in Reserve, Louisiana. See Johnson v. E.I. du Pont de Nemours & Co., 2009 WL 91481 (La.App. 5 Cir. 2009).

The named plaintiffs filed a class action petition in 1994, alleging they were injured by the release of toxic chemicals at a DuPont facility after a small chemical accident. The trial court certified the matter as a class action in September, 1997. DuPont stipulated to certain elements of liability in 2000, but reserved their right to trial on damages, causation, the nature of the chemicals released, and the area affected. The plaintiffs apparently agreed to waive all claims for punitive damages in the stipulation.

At a bench trial in 2006, the trial court ruled in favor of DuPont, finding that the plaintiffs had not met their burden on causation. The plaintiffs failed to show exposure to harmful levels of chemicals, and to show that plaintiffs' injuries were caused by the chemical explosion.

The Louisiana Court of Appeal has agreed, saying that plaintiffs' sole medical expert did not establish that the plaintiffs' injuries— nausea, eye and skin irritation, coughing, and headaches—were caused by the chemical release. Plaintiff’s expert treated the plaintiffs at the time of their alleged injury and had diagnosed them with “fume inhalation,” but based entirely on the history provided by the plaintiffs.

The court also rejected plaintiffs’ challenge to the testimony of a DuPont witness about plaintiffs' alleged injuries, because such testimony was about his observations of plaintiffs' alleged injuries, not testimony as a medical expert. Although he was closer to the incident than plaintiffs, he did not hear any explosion, did not smell anything, and did not experience nausea, headaches, eye irritation, or other symptoms.
 

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.