ACSH Releases Paper On Scientific "Conflicts of Interest"

The American Council on Science and Health has recently published an interesting analysis of an issue of potential importance to all MassTortDefense readers involved in the defense of significant product liability claims. See Bailey, Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest (ACSH 2008). The report can be obtained at  their site.

It is virtually impossible to litigate toxic torts or complex products liability litigation without the benefit of scientific experts. Indeed, most of today’s mass torts, whether they be in the drug or medical devices context, chemicals, or consumer products, implicate significant scientific questions on issues of product defect, warnings, specific causation, general causation, injury and damages. Novel claims such as medical monitoring turn as well on scientific issues such as risk levels, and the availability of scientific tests to early detect diseases.

Defendants in mass torts may face the reality of a gap or hole in the existing science, and confront the issue of whether to sponsor research to fill in the gaps.  Outside litigation, in the ordinary course of business, industry spends billions of dollars on research annually, generating scientific data related to their products' safety and efficacy. Within the court room, Daubert and Frye challenges to experts are a common, and important, feature of many such cases as courts seek to exercise a gate-keeping function to exclude junk science from the courtroom. In that context, as well as in cross examination of experts who are permitted to testify, the search for “bias” that may undermine the validity or credibility of opinions offered by the scientific experts is a crucial undertaking. Insulating one’s own experts from the reach of a bias attack, inoculating the finder of fact from the impact of a bias challenge, is often an important task for defense counsel.

But what is bias? And what should properly be viewed by the jury as a “connection” that fundamentally undermines a proffered expert opinion? As the new ACSH publication notes, for approximately a century, industry has been a powerful motivating force in the creation of new technology and the underwriting of scientific research. Yet, the last two decades have seen the development of a sweeping movement aimed at convincing everyone that any connection with industry taints research or the researcher, and also is aimed squarely at curtailing academic/industry (particularly biomedical) research collaborations and restricting membership on government scientific advisory boards from researchers in any way associated with industry.

Conflicts of interest activists assert that ties between researchers and industry are harming patients and consumers, undermining public trust in research, food safety and environmental regulation and boosting the costs of medicine and other products. The activists seek to demonize researchers whose work receives support from commercial sponsors, especially drug companies and the makers of synthetic chemicals used in agriculture, industry and consumer products. Significantly, it may be that the campaign to purge any experts with industry ties—no matter how slender—from advisory panels is chilling scientific debate and depriving regulators and the public of valuable insights. The problem here is that industry often hires the most qualified and experienced researchers for their advice and research acumen. Those are precisely the people who should be advising.

The paper notes that the intense focus on the alleged effects of financial conflicts of interest ignores how other conflicts can bias scientific research and advice to government agencies. People are influenced by all sorts of interests besides money. “Why should having once consulted with Pfizer or DuPont disqualify a scientist from serving on a government advisory board or writing a review article in a scientific journal, while being a lifelong member of Greenpeace does not? And if owning $10,000 in Dow stock represents a potential conflict of interest, surely $10,000 in funding from the Union of Concerned Scientists does too,” observes the ACSH report.

The paper argues that the current obsession with conflicts of interest is not merely wrong yet harmless. The activists have provoked the development of unnecessary and complex academic regulations and restrictions that are interfering with the speedy translation of scientific discoveries into effective treatments and new products and technologies. Instead of improving public health or making the environment safer and cleaner, the activities of conflict of interest activists are harming them. Researchers are abandoning universities and some are even leaving the country for settings in which academic-industry collaboration is encouraged rather than denigrated and penalized. Government agencies are being denied access to sound scientific advice, which distorts regulatory priorities, risks lives and raises costs.

That is not to say that no mistakes have been found, but private solutions including the advent of permanent online peer-review of scientific studies and the requirement by scientific journals that all clinical trials be registered go a long way to deal with such situations.

There appears to be very little evidence that alleged conflicts of interests are significantly distorting scientific research, harming consumers and patients, or misleading public policy. Most conflicts of interest activists clearly have prior strong ideological commitments against free markets and corporations. They view the conflicts of interest campaign as another tool to attack an enterprise which they already despise on other grounds. 

The paper concludes that this crusade is anti-industry ideology masquerading as a patient safety and consumer advocacy campaign.

Wyeth Files Supreme Court Brief in Levine Case

Wyeth filed its brief yesterday in the U.S. Supreme Court in the Levine case, the closely-watched, much-anticipated, case regarding FDA preemption. The drug at issue is the company’s anti-nausea drug, Phenergan. Levine claims that the drug's labeling should have foreclosed IV push injection of Phenergan because of the risk of injury. Wyeth has argued that the FDA's approval of the Phenergan labels/warnings preempted any such state-law claims over the product.

In October 2006, the Vermont Supreme Court upheld a $7 million judgment for Levine and ordered Wyeth to modify the drug's label to reflect the alleged risk, citing a “presumption against preemption.”

The Supreme Court granted cert in January, and in the brief, Wyeth notes that the FDCA prohibited it from modifying the drug's label in most cases without approval from the FDA. Vermont law, by contrast, imposed a tort-law requirement that Wyeth alter that labeling (to foreclose IV administration) regardless of FDA action.

In the FDCA, Congress established a drug-approval regime in which an expert scientific agency makes uniform, national judgments about the safety and effectiveness of prescription drugs by balancing therapeutic benefits against safety risks ex ante, taking into account the interests of all potential patients. Wyeth argues that FDA struck precisely that type of balance in approving IV administration of Phenergan and in determining what warnings and instructions were appropriate to manage its associated risks.

Plaintiff has until August 1 to file the reply brief.

Florida Appeals Court Rejects Retroactive Application of Asbestos and Silica Compensation Fairness Act

The Florida court of appeals earlier today rejected retroactive application of the state’s Asbestos and Silica Compensation Fairness Act, finding that the many claimants who filed claims prior to the statute’s enactment need not plead or prove that they developed a malignancy or impairment as a result of their exposure. Williams, et al. v. American Optical Corp., et al., No. 4D07-143 (Fla. Ct. App., 4th DCA, May 28, 2008). 

The decision conflicts with the opinion of another Florida court a few months ago, DaimlerChrysler Corp. v. Hurst, 949 So.2d 279 (Fla. 3d DCA 2007), and is of potential significance because of the wave of reform statutes passed in various states recently in an attempt to bring some fairness and justice to the grandfather of all mass torts, asbestos, and its lurking dust cousin, silica. E.g., Ohio Rev. Code Ann. §§ 2307.71-80; 2307.84-90; 2307.901 (including a requirement that claimants meet certain medical criteria establishing impairment before proceeding with their claims); Kansas (Silica & Asbestos Claims Act, S.B. 512); South Carolina (Asbestos & Silica Claim Procedures Act, S.C. Code Ann. § 44-135-10 et seq.); Tennessee (Silica Compensation Fairness Act, Tenn. Code Ann. § 29-34-301 et seq.).

In the spring of 2005, the Florida Legislature passed the Asbestos and Silica Compensation Fairness Act, which not only requires plaintiffs to show they meet certain medical criteria before proceeding with their claims but also requires that plaintiffs be Florida residents before filing claims in Florida courts. See Fla. Stat. Ann. § 774.201-774.209. The Fourth DCA consolidated several appeals from plaintiffs whose claims were dismissed for not complying with the Act. The issue was stated: Can the Florida Asbestos and Silica Compensation Fairness Act be retroactively applied to prejudice or defeat causes of action already accrued and in litigation? And the court held that the Act cannot constitutionally be so applied.

Asbestos Reform

The long and persistent asbestos litigation led the Florida Legislature to enact the Florida Asbestos and Silica Compensation Fairness Act, which became effective in 2005. The Legislature found that the number of asbestos-related claims has increased significantly in recent years. The true victims of asbestos, the truly injured, were in danger of not receiving compensation, as those who were exposed and could point to some minimal indication of impact without any impairment or disability, soaked up all the resources. The Act made significant changes to the cause of action for damages resulting from an exposure to asbestos. Before the Act was adopted, it was not necessary for any plaintiff to establish that any malignancy or physical impairment had resulted from their exposure and their “asbestosis.” Under the Act, however, a claimant bringing an action for damages from exposure to asbestos must now, as an indispensable element, plead and prove an existing malignancy or actual physical impairment for which asbestos exposure was a substantial contributing factor. Plaintiffs’ asbestosis claims were dismissed for failing to meet these requirements.

Retroactive Analysis

Under Florida’s Constitution, one form of intangible property is a cause of action. This is a right grounded in tort, property or contract law to recover a judgment for money or property from another person whose conduct or activity is deemed by applicable law to have caused the claimant to suffer damage or a loss. Retroactive provisions of a legislative act are invalid when they destroy vested rights. When a cause of action accrues it becomes a substantive vested right. In contrast, said the court, when a right to sue is inchoate, a mere prospect, it is merely an expectation that if another person does someday engage in specific conduct or activity causing some injury, and a specific cause of action has then accrued, the person so aggrieved may then be able to bring an action in court to vindicate the claim in money damages. It is well established that the right to sue on an inchoate cause of action — one that has not yet accrued — is not a vested right because no one has a vested right in the common law.

The question therefore became whether before the statute was enacted Florida law recognized a cause of action for damages arising from the disease of “asbestosis” without any permanent impairment or the presence of cancer. The 4th DCA thought the answer was yes, citing Eagle-Picher Industries Inc. v. Cox, 481 So.2d 517 (Fla. 3d DCA 1985), although that was really a negligent infliction of emotional distress case, and Zell v. Meek, 665 So.2d 1048 (Fla. 1995), although in that case the allegation was of serious lung damage, and Willis v. Gami Golden Glades LLC, 967 So.2d 846 (Fla. 2007), which again seemed to focus on alleged emotional effects from exposures.

The appeals court disagreed, implicitly, with the Legislature’s statement that the Act was intended to simply change the form of asbestos claimants' remedies without impairing their substantive rights. And rejected defendants’ argument that plaintiffs can have no vested right in their claimed cause of action because, in the absence of a true injury in the form of malignancy or impairment, it is a mere expectancy. The right to pursue a cause of action is generally considered to have become vested when the cause of action has accrued. A cause of action accrues when “the last element constituting the cause of action occurs.” § 95.031(1), Fla. Stat. (2007). Constitutionally, a new statute becoming effective after a cause of action has already accrued may not be applied to eliminate or curtail the cause of action. In the appealed cases, plaintiffs alleged a previous exposure to asbestos resulting in what they called the disease of asbestosis, which in turn had manifested itself in some way. Thus, for each, the cause of action had passed from an expectation to the accrual of the right to sue for damages.

Conflict With the 3rd DCA

The opinion attempts to distinguish the decision of the Third District in DaimlerChrysler Corporation v. Hurst, 949 So.2d 279 (Fla. 3d DCA 2007), on the grounds that even under the law existing before the Act the result in Hurst might have been sustained because of the lack of any proof that asbestos was a proximate or even concurring cause of lung cancer. However, the court recognized that in the trial courts in the state, Hurst is being applied to dismiss asbestosis cases like the ones on appeal in which there is no cancer injury or any failure to link asbestos to the injury. Accordingly, the 4th DCA certified that a circuit conflict exists with Hurst to the extent that it does stand for a holding that the Act may be validly applied to asbestosis claimants with accrued causes of action for damages but without permanent impairments or any malignancy.

The 4th DCA did not address in any real depth the reasoning of the 3rd DCA, which noted that the legislature in enacting the Act claimed that the Act does not impair vested rights because the Act expressly preserves the right of all injured persons to recover full compensatory damages for their loss. When the plaintiffs filed their asbestos claims, they were pursuing a common law tort theory. A person has no property, no vested interest, in any rule of the common law. Prior to the enactment of the Act, the plaintiffs had, at most, a “mere expectation” that the common law would not be altered by legislation. See generally Wilson v. AC&S, Inc., 169 Ohio App.3d 720, 864 N.E.2d 682 (Ohio App. 12 Dist. 2006)(retroactive application of Ohio reform statute).



This circuit split means the issue will likely wind up before the Florida Supreme Court at some time.

Severability

Finally, the court noted that after giving the entire text of the Act — especially its preamble of purpose — a careful reading in light of these considerations, it is not intellectually possible to disconnect the several provisions of the Act. Thus, the Act, in its entirety, may not constitutionally be applied to deprive asbestos claimants of an accrued cause of action for damages resulting from exposure to asbestos. Tellingly, the language used by the opinion to describe the legislative purpose betrays the court’s view of the legislation: “whose singular purpose is to end litigation by claimants who have been damaged by asbestos exposure without resulting malignancy or physical impairment.”

What the legislature actually said, was that it wanted to give priority to true victims of asbestos and silica, claimants who can demonstrate actual physical impairment caused by exposure to asbestos or silica, while fully preserving the rights of claimants who were merely exposed to asbestos or silica to pursue compensation if they become impaired in the future as a result of the exposure. The Act would also enhance the ability of the judicial system to supervise and control asbestos and silica litigation; and conserve the scarce resources of the defendants to permit compensation to cancer victims and others who are physically impaired by exposure to asbestos or silica while securing the right to similar compensation for those who may suffer physical impairment in the future.

Nevertheless, the court ruled that plaintiff need only show that they suffered an injury from an asbestos-related, non-malignant disease. The trial court decisions to the contrary were reversed.

Medical Monitoring: Is Everyone A Proper Defendant?

The United States District Court for the Eastern District of Pennsylvania issued an interesting medical monitoring ruling last week, which dealt with who is a proper defendant for this type of claim. In Sheridan, et al. v. NGK Metals, No. 06-5510, 2008 WL 2156718 (E.D. Pa. May 22, 2008), the court addressed the potential liability for medical monitoring relief of a unique type of defendant, a consultant hired to sample and monitor air quality. 

The decision is noteworthy in the context of plaintiffs' attempts to expand this non-traditional remedy. (and for another good application of the Twombly pleading decision to a toxic tort context.)

The proposed plaintiff class sought medical monitoring for residents of the Reading, Pennsylvania area who were allegedly exposed to beryllium emitted into the air from one of the defendant’s manufacturing facilities. According to the plaintiffs, members of the proposed class resided and/or regularly worked in close proximity to the Reading Plant at some time during the period from 1950 to 2000.

Defendant Spotts, Stevens & McCoy (SSM) was an engineering firm that, according to the plaintiffs’ Amended Complaint, was involved with testing, sampling, analyzing, and monitoring the air quality and levels of beryllium at the Reading Plant.

The District Court considered SSM’s motion to dismiss, noting that while a complaint need not contain detailed factual allegations, the plaintiff must provide more than labels and conclusions, and more than a formulaic recitation of the elements of a cause of action will not do, under the new Supreme Court guidance in Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1964-65 (2007).

Medical Monitoring

MassTortDefense has posted on this claim before. Medical monitoring is recognized under Pennsylvania law, and a plaintiff must prove:

1. exposure greater than normal background levels;

2. to a proven hazardous substance;

3. caused by the defendant's negligence;

4. as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease;

5. a monitoring procedure exists that makes the early detection of the disease possible;

6. the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and

7. the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.

Redland Soccer Club v. Dep't of the Army, 548 Pa. 178, 696 A.2d 137, 145-46 (Pa.1997).

Negligence Element

As the third element listed indicates, a medical monitoring plaintiff must prove the underlying tort of negligence in Pennsylvania.  And an action in negligence is premised upon the existence of a duty owed by one party to another. Here, plaintiffs alleged that the engineering firm owed them a duty under the notion expressed in Section 324A of the Restatement (Second) of Torts regarding Liability to Third Person for Negligent Performance of Undertaking (the so-called "Good Samaritan" rule).  It states:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to protect his undertaking, if

(a) his failure to exercise reasonable care increases the risk of such harm, or

(b) he has undertaken to perform a duty owed by the other to the third person, or

(c) the harm is suffered because of reliance of the other or the third person upon the undertaking.

Restatement (Second) of Torts § 324A (1977).

Pennsylvania is one of many jurisdictions that has adopted Section 324A. See Cantwell v. Allegheny County, 506 Pa. 35, 40, 483 A.2d 1350, 1353 (1984). It has been interpreted to mean that absent any evidence that a defendant assumed an affirmative duty, there can be no liability for negligently performing that duty. See Wenrick v. Schloemann-Siemag Aktiengesellschaft, 523 Pa. 1, 564 A.2d 1244, 1248 (Pa.1989). Section 324A cannot be invoked to create a duty where one does not exist.

Plaintiffs' Allegations/Response

Plaintiffs alleged that SSM was responsible for advising the other defendants with regard to the air quality and for informing and/or warning the other defendants (the plant owners) about the results of air sampling and testing. Thus, a duty allegedly existed for SSM to act with reasonable care and prevent any increased risk of harm to the plaintiffs. Defendants responded that because the plaintiffs failed to allege that SSM undertook the specific duty to warn the plaintiffs, or that they negligently performed its undertaken tasks, no claim existed. SSM never expressly undertook a duty to warn the plaintiffs of the harmful beryllium exposures at the Reading Plant.

The Ruling: No Claim

The Court noted that the Amended Complaint did not allege that SSM was negligent in performing the testing, sampling, analyzing or monitoring of the air quality in the Reading Plant, or that the engineers failed to report, or were negligent in reporting, the results of its research to the plant owners. The pleading did not allege any circumstances under which such a duty, as a matter of law, could arise “implicitly” or “derivatively.” And absent a duty owed to the plaintiffs here, the Court need not reach the question of whether plaintiffs' alleged injuries were foreseeable.

Plaintiffs also needed to properly allege one of the three subsections of Section 324A, (a) failure to exercise reasonable care that increases the risk of harm, or (b) an undertaking to perform a duty owed by the other to the third person, or (c) the harm is suffered because of reliance of the other or the third person upon the undertaking.

On part (a), plaintiffs confused sins of commission rather than omission when they alleged that SSM allowed beryllium levels at the Reading Plant to rise to unsafe levels. Plaintiffs (discovery was well along) could not allege that SSM assumed or had any control over what caused the beryllium concentrations to rise to excessive levels, or contracted to undertake any corrective action to prevent these excesses from occurring. SSM undertook to test the beryllium emission at the plant, and report those emissions to the plant owners. The Amended Complaint did not allege that Plaintiffs' injuries arose from any alleged negligent testing.

With respect to subsection (b), plaintiffs argue that the engineering firm undertook to perform a duty owed by the plant owners to the plaintiffs. However, SSM agreed to take the steps of merely testing, sampling, monitoring, etc. Mere knowledge of a dangerous situation does not suffice to impose liability under Section 324A(b). Finally, as to subsection (c), plaintiffs failed to allege that they suffered any harm because of their reliance upon SSM undertaking to perform certain tests for the plant owners.

The Court concluded that plaintiffs essentially were advancing the proposition that SSM owed a “social duty” to them, and to the public at large. However, the scope of a good Samaritan’s duty is measured by the scope of his or her undertaking. Section 324A does not impose any “social,” “implied” or “derivative” duty. Rather, Section 324A imposes liability, reaching to third persons, upon a party's breach of a specifically undertaken duty. If a defendant did not undertake to perform a specified task, it cannot be held liable under Section 324A for failing to perform that task.

The medical monitoring claim against the engineers was dismissed.

FDA Launches Sentinel Initiative

On May 22, 2008, FDA launched the “Sentinel Initiative” – a new program with the goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety.


The Sentinel System, once in place, will enable FDA to pose targeted queries (consistent with privacy and security safeguards) of patient registry data, insurance claims data, and other large health care information databases, for information about medical products. FDA says this new system will strengthen the agency's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health.

 
FDA's current post-market surveillance programs generate very important new risk information, but the adverse event reporting system depends on health care professionals and patients first recognizing a potential association between an adverse effect and a medical product, and then report it to FDA or the manufacturer. Some adverse events are never reported.


Once the Sentinel System is up and running, FDA will have the tools to query specific adverse event data in large databases, like the Medicare database and in claims data and electronic health information maintained by private and federal entities who volunteer to participate in the Sentinel System. That is, the System will be created through public-private partnerships. It will rely on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.

Creating an advanced surveillance system like Sentinel was one of the recommendations made by the Institute of Medicine in its 2006 report on ways to improve the safe use of drugs. The Food and Drug Administration Amendments Act of 2007 includes provisions that call for the development of such a system. FDA believes patients will benefit because the agency will be able to identify potential problems sooner, better understand those problems, and ultimately, help health professionals and patients use medical products more safely.

 
The overall initiative is described in an FDA white paper titled, “The Sentinel Initiative—A National Strategy for Monitoring Medical Product Safety.” The report is available at here.

Such a system could also ultimately facilitate data mining and other research-related activities. Researchers have said its full effects would take years to realize, however.


It is interesting to speculate about the potential impact of the system, especially on products liability litigation. Medicare collects data typically only when a medical provider is seeking payment. This claims data is less complete, and potentially less accurate than actual patient health records. Thus, utilizing Medicare data to assess health outcomes of drug use may be problematic. Of course, the new system doesn’t change the reality that sometimes patients suffer adverse events after receiving drugs because they are sick, not because the drug has a problem. And Medicare recipients use an average of 28 prescriptions in a year, compared with an average among all Americans of something like 12 prescriptions. Sorting out which medicine caused any single problem – if any did -- can be difficult.


In mass tort litigation, as readers of MassTortDefense know, plaintiffs frequently will attack defendants’ AER system, the resources devoted, the quality of the reporting. Even more frequently, plaintiffs will allege that the AE reports revealed a “signal” far sooner and far more clearly than the company thought; that the defendant missed or ignored the signal about potential adverse events in order to avoid the financial impact of a new label with a stronger warning. But if the FDA will eventually be able to query databases of tens of millions of patients almost simultaneously, presumably it will no longer have to wait for reports from the field, and the allegations of “missed signals” may lose all force.


To assess the accuracy of the Sentinel system, the FDA will initially conduct studies of drug side-effects that are already well known. And despite the issues, the Pharmaceutical Research and Manufacturers of America supported the FDA initiative, see here,  because it will allow regulators and health care professionals to move from reliance on voluntary reporting of side effects to a more proactive monitoring of medicines. 

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.

Peer Review (Part II)

In yesterday’s post, MassTortDefense began discussion of a peer review issue commented on in this week's New England Journal of Medicine. The editorial comments on two cases in which Pfizer served discovery on the journal, seeking peer-review and other editorial documents on manuscripts concerning Pfizer's Bextra and Celebrex, which of course have been the subject of litigation. Pfizer sought peer-review documents, including the critiques prepared by reviewers for the authors. The logic is that the critiques might help reveal flaws in methodology in the research. This was seen as particularly important given significant imprimatur of the NEJM and the use of its published studies in the cases.

In the case In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation,
2008 WL 859207 (D.Mass. March 31, 2008) the court rejected the discovery, and granted the journal’s motion for a protective order. The court began by noting that the NEJM is the world's oldest and most frequently-cited medical journal. Physicians rely on information presented in the NEJM to follow medical developments and improve patient care. Manuscripts submitted for publication by the NEJM are subject to “peer review,” i.e., to screening and analysis conducted by experts in the subject matter discussed within the submitted articles. Peer reviewers are given a draft manuscript and are asked to provide a confidential, frank, honest evaluation of the manuscript's scientific validity and to provide an overall opinion with respect to a manuscript's “worthiness for publication.” Information from peer reviewers which is communicated to the authors does not reveal the identity of the peer reviewer. The NEJM informs prospective peer reviewers that it will maintain the confidentiality of their identities, unless the reviewer grants specific permission to the contrary. None of the peer reviewers for the eleven Bextra and Celebrex articles published had given the NEJM permission to disclose his or her identity.


The published articles were relevant to the MDL litigation and to plaintiffs’ allegations that Pfizer failed to act upon the results of studies described in the scientific literature, and that it was on notice from those studies of the alleged risks presented by the drugs.

 
At a hearing on the motion, Pfizer apparently narrowed the scope of its request, and withdrew its requests seeking certain documents reflecting the peer reviewer comments which were not shared with the authors, internal editorial comments or processes

Rule 26 and Rule 45 require application of a balancing test looking at whether the information can be obtained from some other source that is more convenient, less burdensome, or less expensive, the burden or expense of the proposed discovery, and its likely benefit, considering the needs of the case, the amount in controversy, the parties' resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues. Specifically here that would include the objector's interest in confidentiality and the potential injury to the free flow of information that disclosure may create. Another factor entitled, said the court, to special weight in conducting this balancing test is that the NEJM was a non-party to the MDL.

The district court concluded that the materials were relevant, but their probative value was limited. The reasoning was that plaintiffs' claims focus on what Pfizer knew, or should have known, via published articles in the scholarly literature. The peer reviewers' confidential comments don’t speak directly to that issue, the court thought. Of course, what a product seller should take from a published article does depend in great measure on the quality of the article, its methodology, is biases, its power, and other aspect peer reviewers are likely to comment upon. But the court felt that Pfizer's own experts were able to review and analyze the articles for flaws in methodology, and the peer reviewer comments contain no new data.


Peer review comments could also potentially be useful to impeach any causation experts of plaintiffs who rely on the studies, and to provide ammunition for defense causation experts. The court however, worried that this reflected a “growing problem” with the use of subpoenas to compel the giving of evidence and information by unretained experts. That seems a somewhat narrow and uniformed view of what defendants typically do when confronted with a mass tort or MDL: they retain as many of the best experts they can find.

Balancing against that probative value, the court analogized the peer review process to the level of protection offered academics engaged in pre-publication research. Because the peer review contributes to the advancement of medicine and science by helping to ensure that faulty, incomplete, or misleading results are not published, and because a journal’s ability to advance medical knowledge in this way might be impaired, resulting in adverse consequences for physicians, patient care, and for society as a whole, the Journal’s objections seemed persuasive to the court. If reviewers thought their names or reviews would be subject to disclosure in unrelated litigation, there would be “chilling effect” on the peer review process and as a result, upon the medical community. The comments are both part of scholarly research efforts as well as part of the editorial process of a print publication. The court concluded that any wholesale disclosure by the NEJM of the peer reviewer comments communicated to authors will be harmful to the NEJM's ability to fulfill both its journalistic and scholarly missions, and by extension harmful to the medical and scientific communities, and to the public interest. Thus the subpoena was quashed.

The Northern District of Illinois, similarly, declined to compel compliance with similar subpoenas served by Pfizer in the same MDL on the Journal of the American Medical Association and the Archives of Internal Medicine. In re Bextra and Celebrex, C.A. No. 08C 402 (N.D.Ill. March 14, 2008). The district court there found that the any probative value of the requested information was outweighed by the burden imposed on the journals in invading the sanctity of the peer review process. In short, it was not unreasonable to believe that compelling production of peer review documents would compromise the process.

But it raises an interesting, perhaps test-able, question whether disclosure of comments would discourage people from submitting articles to the journal, or peer reviewers from commenting on manuscripts.  Isn't a prestigious thing to be able to say "I am a peer reviewer for the NEJM"? After all, a large part of the the academic world involves defending one's scholarly work in public, in symposia, in class rooms, etc.  And scientists frequently publish comments, letters to the editor, publicly critiquing others' work. Wonder if any respected journal conduct peer review in which complete confidentiality is not promised the reviewers?

Yesterday’s editorial commented that confidential peer review is a key component of the manuscript selection process. The Journal’s stand was consistent with the views of the International Committee of Medical Journal Editors. The ICMJE is a group of about 500 general medical journal editors whose participants meet annually and has produced a number of editions of uniform requirements for manuscripts submitted to biomedical journals. See Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication.


In its Uniform Requirements, the ICMJE states that unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Reviewers have rights to confidentiality, which must be respected by the editor. Editors must not disclose information about manuscripts (including their receipt, content, status in the reviewing process, criticism by reviewers, or ultimate fate) to anyone other than the authors and reviewers. “This includes requests to use the materials for legal proceedings.”

It will be interesting to watch and see if the issue arises again in a case in which the party seeking the information -- and might it be plaintiffs under the proper facts? -- can show a higher degree of probative value.

Peer Review, Daubert, and the New England Journal of Medicine

The new England Journal of Medicine weighed in today with an editorial on a topic that should be important for readers of MassTortDefense – peer review. Curfman, et al., Peer Review in the Balance, 358 NEJM 2276 (May 22, 2208).

The editorial weighs in on two recent decisions in the Celebrex litigation involving product liability defendant’s attempts to go beyond the veil of the published article and obtain discovery on information created in the peer review process as manuscripts were assessed. Those manuscripts related to studies of science relevant to the litigation, and the argument was advanced that commentary, discussion, and analysis of those studies by expert peer reviewers likely also contained relevant information about that pertinent science.

Legal Setting

Expert testimony is essential in virtually every mass tort or complex product liability litigation. Under the gate-keeping function of the trial judge, designed to keep junk science out of the courtroom, the Daubert opinion lists important factors to consider in admission of expert testimony, including whether the theory or technique has been subjected to peer review and publication. This factor is relevant, but not dispositive, because sometimes well-grounded but innovative theories will not yet have been published, and sometimes a topic may be of too limited interest to be published. But the Court believed that peer review increases likelihood that substantive flaws will be detected in an article, and publication places the work within the test of the marketplace of ideas. The theory is available to be scrutinized, and has been scrutinized by experts in the relevant field. In essence, submission of the method, theory, reasoning, to scrutiny of scientific community is considered component of good science.


The Daubert Court was aware from amicus briefing of another view of peer review, emphasizing that the peer review system is not a litmus test for truth, not a guarantor of scientific certainty, and does not guarantee that the particular data, research and analytical methodologies, or conclusions of the accepted papers represent the consensus opinion of the relevant community. Brief of Amici Curiae Chubin et al., Daubert, 1992 U.S. S.Ct. Briefs LEXIS 938. But the Court generally rejected this view.


There is some lower court variation in application of Daubert and Frye on peer review; some courts emphasize the mere fact of peer review, Doe v. Ortho-Clinical Diagnostics Inc., 440 F.Supp. 2d 465 (M.D.N.C. 2006)(thimerosal), with others offering a more nuanced view of peer reviewed publication serving as a validity enhancer. The presence of the limited view encourages plaintiffs to seek to get theory published somewhere to “check the box” of peer reviewed publication. The more rigorous view reads the Supreme Court as clearly intending that judges use their own evaluation of peer review and publication as a tool for exploring whether substantive flaws in an expert's methodology have been or could have been exposed. Black v. Rhone-Poulenc, Inc., 19 F.Supp.2d 592 (S.D.W.Va. 1998) (depends upon how the peer review was performed; who did it; plaintiffs failed to provide sufficient information to assess).

Now, before getting into the two recent decisions and the editorial, a brief background on peer review.

Brief History of Peer Review

Modern medical journals came into existence during the 19th century. They were originally a vehicle for personal journalism, with the models for medical editors including the crusading newspaper writer. Publication was a personal vehicle for the editor. Over time, newspapers came to resemble newspapers, with correspondents to cover medicine in different geographic and specialty areas. But in many medical journals, the editors wrote much or all of content. A second type of journal also arose, in addition to those journals that followed the newspaper model, and that was the official publications of research institutes, typically specializing in one kind of research.


In the 19th century editors often could not fill their columns. The problem was finding publishable manuscripts, not turning down original contributions. Editorial board members would help round up material for the editor to publish, rather than review and reject manuscripts. In the 20th century, the supply/demand ratio gradually reversed. The number of passable manuscripts began to increase greatly, so that choosing among good articles became an option. Between 1913 and 1925, the Journal of the American Medical Association received 1500-2000 manuscripts for consideration. And the end of World War II marked the beginning of a dramatic increase in the volume of research and the subsequent reporting of research results. So by the 1990’s, JAMA was receiving 4500 papers/year, plus 5500 letters to editor. Yet JAMA publishes about 500 articles a year. Or the NEJM, which was getting more than 4000 article submissions/year, and publishing less than 10%.

Today there are more than 10,000 medical and scientific journals, and more than 2 million scientific and medical articles published each year. Most are never cited again.

There are examples of historical scientific journals in France and England with well thought-out peer review process to select reports to be published in journals and memoirs. In 1752, the Royal Society of London, a medical society, began publishing Philosophical Transactions and established a "Committee on Papers" to review articles submitted for publication. But in the U.S., most journals were personal fiefdoms of editors. (E.g., James McKeen Cattell, who for 50 years edited (and owned) Science and other major journals at the same time. ) As noted, editors wrote much of the content; they considered themselves as expert as anyone to assess content. The only mechanism that resembled modern peer review, perhaps, was book publishers seeking outside advice regarding textbook manuscripts in technical fields.


Peer review developed in part to deal with situations in which an editor lacked the specialized knowledge to make decisions about highly technical articles. Particularly after WWII, more specialists in subject matter, in terms of technique and, especially, in medicine, and laboratory materials were needed. And when physicians began to specialize in particular fields, it also spawned a demand for specialized journals catering to that specialty.  The supply/demand ratio gradually reversed and there was a growing need to discriminate high-quality articles and turn down others in the growing volume of at least plausibly good submissions that they had to consider.

Fast Forward to Today
An example of rigorous peer review is the New England Journal of Medicine, which publishes less than 10% of the unsolicited manuscripts it receives. There is a multi-step process including an initial screen by and editor; and internal review by an associate editor; submission to at least 2 peer reviewers/referees; presentation of the article to an editorial meeting; a statistical/math review, etc. There is a step for an additional review and revision by the author.


Today, scientific and medical journal have a significant role in shaping the views and behavior of scientists, clinicians, and policy makers. Contrary to the theory that journals act as passive conduits for scientific content, studies show the impact of an article is strongly influenced by which journal published it, and authors know that. There is a potential for a few high-impact journals to shape heavily the use of scientific information. At the same time, the increasing number of biomedical journals, the advent of online publication, and the increasingly interdisciplinary nature and impact of research, are forcing journals to compete for the best research.

With that background, the current controversy in the next posting.

ATRA Report Details Current Tort Reform Battles

In recent years, tort reform efforts have achieved some measure of success, particularly in limiting compensatory and punitive damages, in restricting joint and several liability, regulating class actions, and in reforming venue rules which had concentrated mass tort cases in certain "judicial hellholes" or "magic" jurisdictions.

Where are today's tort reform battlegrounds?  The American Tort Reform Association has issued a report detailing the plaintiff bar's attempts to roll back tort reform successes, and to expand civil liability.  The report is entitled, "Defrocking Tort Deform: Stopping Personal Injury Lawyers From Repealing Existing Tort Reforms And Expanding Rights To Sue In State Legislatures."

The report notes key current issues including:

  • Explicitly Authorizing New Types Of Lawsuits
  • Setting The Stage For Implied Causes Of Action
  • Deputizing/Hiring Private Lawyers To Sue On Behalf Of The State
  • Inflating Limitations On Damage Awards
  • Broadening The Scope Of Consumer Laws
  • Extending Statutes of Limitations/Repose

The report warns that, "Plaintiffs’ lawyers are not only threatening to undo recent progress towards a more stable and predictable civil justice system, but also to expand liability in a drastic
and unprecedented manner. The personal injury bar and its allies are well organized, well funded, and have teamed up with their members and supporters in state legislatures. Rather than play defense, as they have over the past two decades by seeking to overturn rational tort reform measures in the courts, they are now on the offensive with a massive legislative and public relations campaign."

New BPA Study Released

At MassTortDefense we know the importance of well done scientific studies on causation, whether they be epidemiological studies of relevant populations, in vitro studies, or animal toxicology. While we don’t make a habit of posting about individual studies, BPA has been so much in the news, we thought it worth a mention of a recent animal study just published in the journal Toxicological Sciences. Tyl, et al., Two-Generation Reproductive Toxicity Study of Dietary Bisphenol A (BPA) in CD-1 (Swiss) Mice, with an abstract that can be found hereToxicological Sciences is the official journal of the Society of Toxicology and publishes peer-reviewed, hypothesis-driven, original research articles in all areas of toxicology.


The two-generation study exposed mice to a wide range of doses of bisphenol A, and found the chemical did not cause reproductive or developmental harm. The study was funded by the American Chemistry Council, and conducted under the oversight of the EU Bisphenol A Steering Group. That group, which included reproductive and developmental toxicologists from several countries, also had representatives of the World Wildlife Fund on behalf of nongovernmental organizations. The group impacted the study's design and the specific protocols used, and commented on the draft report analyzing the results.

The study was designed to fill in some of the blanks some felt existed in previous animal studies, by utilizing a species of mice particularly sensitive to hormone disruption; exposing the mice to the low doses where some say reproductive and developmental harm would occur; exposing the mice to the chemical in their feed, to mimic route of exposure; and keeping more of the mice alive longer than is typically done.

Clearly the debate over BPA will continue.

Congress Set to Reconcile CPSC Reform Bills

As noted in earlier postings of MassTortDefense, both the House and Senate have passed legislation affecting the Consumer Product Safety Commission. The different versions have to be reconciled.

The House has just named conferees to work on the legislation, including Rep. John Dingell (D-Mich.), chairman of the Commerce and Energy Commission, Rep. Robert Rush (D-Ill.), chairman of the House Subcommittee on Commerce, Trade and Consumer Protection, Reps. Diana DeGette (D-Colo.), Janice Schakowsky (D-Ill.), Henry Waxman (D-Calif.), Joseph Barton (R-Texas), Cliff Stearns (R-Fla.), and Edward Whitfield (R-Ky.).

The Senate conferees were announced two weeks ago, and they include Senate Commerce Committee Chairman Daniel Inouye (D-Hawaii), and Sens. Mark Pryor (D-Ark.), Barbara Boxer (D-Calif.), Amy Klobuchar (D-Minn.), Ted Stevens R-Alaska), Kay Bailey Hutchison (R-Texas), and John Sununu (R-N.H.).


Consumer advocates are lobbying Congress to produce a compromise Consumer Product Safety Reform bill that combines the “strongest protections” of the House and Senate bills, particularly on toy and other children's product safety.

Both House and Senate bills would strengthen CPSC authority and funding, establish new standards on lead content in children's toys, and require third-party certification of testing of certain children's products.

Likely to be more controversial are some of the differences, including the proposal for a publicly accessible database of product safety information. This seems to be of little use to the average consumer, but subject to potential mischief in the hands of plaintiff lawyers. Think about how they attempt to misuse adverse event data in drug litigation.

Another issue is proposed enforcement of the CPSAct by state attorney generals. This proposal risks the creation of uncertainty and inconsistency, with the potential for a patch-work of differing practical rules, rather than a uniform federal standard.

The proposed new “whistle-blower” protections seem both unnecessary and likely to encourage additional litigation.

Congressional Committee Holds Hearing on Preemption

The House Committee on Oversight and Government Reform held a hearing last week entitled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” Chairman Waxman’s opening statement opined that preemption was a "radical legal doctrine" being advocated by the pharmaceutical and device industries and the Food and Drug Administration (FDA). Patients allegedly injured by defective drugs and medical devices would no longer have the ability to seek compensation. “The result is that one of the most powerful incentives for safety - the threat of liability - would vanish.”  Waxman and other Democrats are of the view that FDA approval of drugs and medical devices before they are marketed “does not necessarily guarantee safety.”

Of course, the politicos' simplistic view ignores the fundamental reality that prescription products are typically unavoidably unsafe. Nothing guarantees complete safety.  They are complex products that carry risks, at least to some users. That is why the FDA weighs the risks and benefits for an indicated population, and a learned intermediary – doctor – is needed to obtain the product, someone who can balance the risks with the benefits for the particular patient.

The hearing follows on the Supreme Court decision in Riegel v. Medtronic,128 S. Ct. 999 (2008), and in anticipation of the Court’s decision in Levine v. Wyeth.


The witnesses included some leading opponents of preemption, from actor Dennis Quaid (who has a suit against Baxter), former FDA official David Kessler, and an editor from the New England Journal of Medicine (who editorializes against preemption). No one from the industry was scheduled to appear, apparently. The only two witnesses in favor of preemption were buried in later witness panels.  This led Congressman Christopher Shays (R-Conn.) to note that the hearing was more about plaintiff lawyers than public health. 


Most of the press coverage focused on Quaid (MassTortDefense liked him in “The Rookie”), who urged Congress on Wednesday to preserve patients' rights to sue drug makers for injuries, and recounted the story of his newborn twins’ medical scare – which apparently resulted from human error at the hospital and was unrelated to the safety and efficacy of Baxter's product. "I believe if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats," Quaid said.


The FDA currently and correctly believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not be second-guessed by state court juries.  But should the Supreme Court recognize the role of preemption in the Levine case, this is yet another sign that some in Congress may seek to take action to overturn any ruling in favor of the doctrine.


 

ATSDR Report on Benzene Impacting Litigation

The Agency for Toxic Substances and Disease Registry (ATSDR) issued a report on benzene a few months ago, and it has already begun to have an effect on the litigation.

ATSDR is an agency of HHS and is directed by congressional mandate to perform specific functions concerning the potential effect on public health of hazardous substances in the environment. These functions include public health assessments of waste sites, health consultations concerning specific hazardous substances, health surveillance and registries, response to emergency releases of hazardous substances, applied research in support of public health assessments, information development and dissemination, and education and training concerning hazardous substances.


A Toxicological Profile for Benzene, Draft for Public Comment was released in August 2005, and finalized in August, 2007. An ATSDR toxicological profile characterizes the toxicological and adverse health effects information for the hazardous substance at issue. They are peer-reviewed profiles, and each identifies and reviews the key literature that describes a hazardous substance's toxicological properties. Each profile is supposed to include the following:

(A) summary and interpretation of available toxicological information and epidemiological evaluations on a hazardous substance to ascertain the levels of significant human exposure for the substance and the associated acute and chronic health effects;

(B) determination whether adequate information on the health effects of each substance is available or in the process of development to determine levels of exposure that present a significant risk to human health; and

(C) identification of testing needed to identify the types or levels of exposure that may present significant risk of adverse health effects in humans.

The report notes that benzene, a colorless liquid with a sweet odor, evaporates into air very quickly and dissolves slightly in water. Benzene is found in air, water, and soil. Benzene comes from both industrial and natural sources. Benzene was first discovered and isolated from coal tar in the 1800’s. Today, benzene is made mostly from petroleum. Because of its wide use, benzene ranks in the top 20 in production volume for chemicals produced in the United States. Various industries use benzene to make other chemicals, used in plastics, resins, synthetic fibers. Benzene is also used in the manufacturing of some types of rubbers, lubricants, dyes, detergents, drugs, and pesticides. Natural sources of benzene include gas emissions from volcanoes and forest fires. Benzene is also present in crude oil and gasoline and cigarette smoke.


Everyone is exposed to a small amount of benzene every day, in the outdoor environment, in the workplace, and in the home. Exposure of the general population to benzene mainly occurs through breathing air that contains benzene. The major sources of benzene exposure are tobacco smoke, automobile service stations, exhaust from motor vehicles, and industrial emissions. Vapors (or gases) from products that contain benzene, such as glues, paints, furniture wax, and detergents, can also be a potential source of exposure. Auto exhaust and industrial emissions account for about 20% of the total national exposure to benzene. About half of the exposure to benzene in the United States results from smoking tobacco, according to the report. People living in cities or industrial areas are generally exposed to higher levels of benzene in air than those living in rural areas. Benzene levels in the home are usually higher than outdoor levels. For most people, the level of exposure to benzene through food, beverages, or drinking water is not as high as through air. Drinking water typically contains less than 0.1 ppb benzene. Benzene has been detected in some bottled water, liquor, and food.

Individuals employed in industries that make or use benzene may be exposed to higher levels of benzene. These industries include benzene production (petrochemicals, petroleum refining, and coke and coal chemical manufacturing), rubber tire manufacturing, and storage or transport of benzene and petroleum products containing benzene.

In an unpublished decision, the 5th Circuit relied on the ATSDR report to reverse the dismissal of a toxic tort case involving benzene. See Leblanc v. Chevron USA Inc., 2008 WL 1805448 (5th Cir. April 22, 2008).

Plaintiff alleged that after working as a tanker truck driver for over 30 years transporting products containing benzene, he was diagnosed with myelofibrosis with myeloid metaplasia-MMM, a rare disease. They tendered an expert who supported their claim that the exposure to benzene caused plaintiff's disease. Defendants challenged the expert testimony as unreliable under Daubert. The trial court excluded the testimony and, as is typically the case, because plaintiff had no other evidence on the critical causation issue, the case was dismissed.


At the time the district court issued its order, the ATSDR had issued the draft report on benzene. Because the report was still in draft form and the time for notice and comment had not expired when the district court issued its ruling, the trial court declined to consider it. During the pendency of the appeal, however, the draft received final approval. The Fifth Circuit noted that the ATSDR report on benzene was authored by a number of experts, was reviewed internally by the ATSDR, and peer reviewed by additional experts who collectively have knowledge of benzene's physical and chemical properties, toxicokinetics, key health end points, mechanisms of action, human and animal exposure, and quantification of risk to humans.


Moreover, in the report, the ATSDR concluded that benzene causes a life-threatening disorder called aplastic anemia in humans and animals. In describing a case report of a gasoline station attendant who had been exposed to benzene by inhalation, and probably also through dermal contact, the report calls myelofibrosis a form of aplastic anemia.

Because of this, and the “number and quality of the experts” who participated in the production of the final version of the ATSDR report, the 5th Circuit concluded that this report deserved the careful consideration of the district court before reaching a final conclusion on the reliability of plaintiffs’ expert testimony.

As readers of MassTortDefense interested in toxic torts will know, there is significant litigation surrounding benzene exposures. Some jurisdictions have consolidated cases for pre-trial coordination. E.g., In re: Benzene Litigation, No. 06C-BEN-1 (Del. Super. Ct., New Castle Cty.).

A week ago, a San Francisco jury reportedly awarded $8 million to a benzene plaintiff who claimed that his 17-year employment at SeaRiver Maritime Inc. exposed him to benzene, causing his kidney cancer. See Shelby v. Seariver Maritime Inc., f/k/a Exxon Shipping Co., No. CJC-06-449350 (Calif. Super. Ct., San Francisco Cty.). SeaRiver was the lone remaining defendant at the time of the trial.

Last month, several plaintiffs filed suit contending that they were wrongfully exposed to benzene while working at a Goodyear Tire Plant. Hauptmeier, et al., v. Barton Solvents Inc., et al., No. 08-187 (D. Neb.).

The litigation raises multiple important issues, including product identification, general and specific causation, and important procedural issues as well. In Anderson, et al. v. Crown Central LLC, et al., No. 08-0033 (Texas), plaintiffs are appealing the intermediate appellate court’s severance of their claims, Crown Central LLC v. Anderson, 239 S.W.3d 385 (Tex.App.-Beaumont,2007). Plaintiffs, as is common, prefer consolidated trials in their hand picked venue, with trial plans in which the best case (strongest plaintiff case) elevates the weaker plaintiff claims, despite the fact that often they cannot show their claims arose from the same transactions or occurrences.

Congressional Developments: Hearings and Research Service Weighs in on BPA Issues

The Congressional Research Service has released a report on Bisphenol A (BPA) in Plastics and Possible Human Health Effects. MassTortDefense previously posted on the BPA issues and the National Toxicology Program (NTP) draft report for public comment on BPA.

 The Congressional Research Service (CRS) serves as a sort of shared staff to congressional committees and Members of Congress. CRS staffers assist at the various stages of the legislative process — from bill drafting, through committee hearings and floor debate, to the oversight of enacted laws and various agency activities.

The BPA report is authored by Linda-Jo Schierow, Resources, Science, and Industry Division; and Sara A. Lister, Domestic Social Policy Division, and comes in the immediate wake of legislation proposed in April of 2008, S. 2928, which would prohibit use of BPA in some products intended for use by children. The report notes that the levels of potential exposure to the chemical from plastics is low, although the potential health effects from such exposures is deemed controversial.

In another BPA development, officials from the U.S. Food and Drug Administration and the U.S. Consumer Product Safety Commission both told the U.S. Senate Committee on Commerce, Science and Transportation subcommittee on consumer affairs last week that bisphenol-A did not appear to pose sufficient risks that the product should be banned. Although review is ongoing, at this time those agencies have no reason to recommend that consumers stop using products containing BPA. The FDA's associate commissioner for science said that a large body of evidence indicates that currently marketed products containing BPA, such as baby bottles and food containers, are safe and that exposure levels to BPA from these products are well below those that may cause health effects.

Sen. Chuck Schumer (D-N.Y.) told the subcommittee about the bill he introduced last month to ban BPA from all products for children up to seven years old. But the CPSC official said Congress should be careful not to ban the use of polycarbonate plastic for protective items such as pacifier shields, helmets, goggles and shin guards prematurely. Such products prevent children from receiving serious injuries, and this beneficial use of polycarbonate should be balanced before acting to ban bisphenol-A from children's products. Such a ban could result in less effective protection to children from head, eye or bodily injury, and less net safety.



 

CPSC Reveals New Import Safety Strategy

In an earlier post on the "year of China recalls," MassTortDefense noted legislative changes to the Consumer Product Safety Act and enhanced resources of the CPSC as a response to the spate of recalls.  The commission has announced it is now seeking public comments on a draft report, on Import Safety Strategy.

The Executive Summary notes that imports currently account for about 44 percent of all consumer products sold in the United States today, but they comprise over three-fourths of all product recalls administered by the agency. The value of all imported consumer products under the jurisdiction of the CPSC was an estimated $639 billion in 2007. Last year, approximately 42 percent of these
products were from China, and the value of these imports from China nearly quadrupled from
1998 to 2007.

The report describes a four-pronged strategy to deal with the issue if safety of imported products:

I.  Engage the private sector and foreign governments to foster both compliance with relevant safety standards and adoption of more effective techniques of identifying  potential product hazards;
II.  Build safety assurances into the production processes by promoting the use of safety standards by manufacturers, and verifying compliance through third-party testing and inspections where appropriate;
III.   Prevent unsafe products through strategically redeploying CPSC resources according to  principles of hazard analysis and risk management to target surveillance and inspection of the distribution chain; and
IV.   Identify and remove quickly product hazards in the market and provide real-time
communications to consumers, foreign governments, and the private sector.

Public comments are due  by May 30, 2008, and can be sent  via e-mail to
cpsc-os@cpsc.gov

Recalls of Products Made in China (Part II)

In the previous post, MassTortDefense began exploration of some of the issues associated with the "year of China recalls."  During fiscal year 2007, the CPSC announced 473 recalls, of which 288 were from China.

We continue in Part Two with some practical tips that may be considered to mitigate the risks of using China-based suppliers.

TO DO LIST

U.S. products sellers have to respond with proactive planning:

Testing and Sampling
A report from two Canadian researchers notes that since 1988, a majority of recalls of toys were related to design issues as opposed to poor manufacturing. But, assuming a prudent design, adherence to specifications becomes the focus. US importers have at times in the past chosen products from a showroom, such as in Hong Kong. At other times, products from China are purchased through one or several middlemen, with the ultimate U.S. buyers having little information about the manufacturing or QC of the products.  And importers have relied on purchase orders - a looming battle of the forms scenario -- rather than on a comprehensive contract.

Now, companies may need to turn to be more involved in the process upstream. Random sampling rather than relying on test certificates from their sellers may be wise. Companies may need to negotiate vendor and supply contracts to require those counterparts to test products for compliance with specifications and U.S. regulations. Such a compliance program may include third-party testing and a system to track products in the retail stream of commerce. If self-testing is employed, it may be prudent to have it conducted by a group of employees incentivized to make the testing accurate and thorough.  Companies need to ensure that they have strong process controls at the key risk points of the distribution chain. QC can involve early warning systems, and includes making corrections, documenting results. The timing and scheduling of QC interventions may need to be modified. Even "sealed" products may need to be randomly inspected.

Management

There can be surprisingly high management turnover rates in China, and local management is often the source of fraud when it occurs. Multi-national product sellers may explore returning to use of expatriate management where possible, although they may lack the level of understanding of the local environment.   Importers may also seek to get a better sense of the sub-contracting activities of their suppliers.  Indeed, tracking vendors, subs, and components supplied for the product can be important, even as the supply chain is a moving target.

Note, in this setting, it may be a mistake to leave negotiations and contract management to less senior people. The audit structure employed by management should also be of a design to detect and deter fraud and nepotism at the local management level. This may require not only more inspectors, but a different kind of inspector/on the ground agent.

Risk Sharing
Contracts can be both a risk reduction and dispute resolution mechanism. It is imperative that the contract clearly lay out responsibilities and rights on QC, specifications, delivery, testing, sub-contractors, performance milestones.  U.S. companies are seeking to add arbitration clauses to new contracts, and as existing supply deals expire. Arbitration in a forum that Chinese courts will recognize may be a means to share the burden of a potential recalls, which for the most part has fallen on U.S. importers. China does not generally recognize ad hoc arbitrations. Some importers are looking at CIETAC, the China International Economic and Trade Arbitration Commission as a possibility.  In a CIETAC arbitration, there will still be limited discovery, and short document-focused hearings. Another possibility is the Hong Kong International Arbitration Center.

Companies may think about choice if language provisions in their arbitration clauses, the nationality of the arbitrators, discovery rights, injunctive relief the parties consent to. Choice of law clauses are also key in renegotiated contracts.

Importers are also seeking bonding from their Chinese partners as a way of ensuring financial sharing of the cost of recalls.


The most important kind of risk sharing, however, may be the risk of non-payment, which is only viable when the U.S. importer has good knowledge of the supply chain -- who are the suppliers, and what are they supplying.

It may increasingly make sense to provide for litigation support in the contract, so that the U.S. importer has access to needed records and witnesses should legal issues arise.

Many companies have a crisis management team in place, trained to handle problems with their products, should any arise.  The team may include legal, HR, PR, QC, and regulatory members.

Recalls of Products Made in China (Part I)

The Cook County, Illinois Circuit Court gave preliminary approval recently to a proposed settlement related to RC2 Corporation’s recall of toys tainted with lead. (A hearing on final approval is set for August.) The settlement relates to claims of consumers who purchased a recalled Thomas & Friends Wooden Railway product. This is another step towards resolution of one of the major 2007 recalls of toys made in China.

RC2 Corporation had announced last summer that it was voluntarily recalling five toys from the Thomas & Friends Wooden Railway product line due to levels of lead in surface paint that may exceed U.S. Consumer Product Safety Commission requirements. There have been no reports of illness or injury related to any of the recalled toys.

This is a good reminder to readers of MassTortDefense concerning the risks of outsourcing to China, and an opportunity to comment on mitigation of those risks.

The Year of the China Recall

The year 2007 has been dubbed the year of China recalls because of the significant recalls of toys with lead, as well as tainted pet food, and toothpaste with chemical contamination. In fact, toy recalls had been stable (at about 30 per year) until 2007, which saw a huge spike in toy recalls to more than 80, involving 25 million units. [There have been about 50 already in 2008.]

Overall product recalls have been on the rise for several years. China’s share of total product recalls in the U.S. rose significantly (to about 67% overall), and China accounted for about 98% of all toy recalls in 2007. As recently as 1999, China accounted for less than half of U.S. toy recalls. Overall U.S. imports from China have increased steadily, and China supplies most of our imported toys, but recently the recalls of China-made toys has outpaced the increases in imports of toys.

And the presence of lead was the leading cause of products made in China being recalled. Overall, lead-focused recalls increased 10x in the last 4 years.

The number of products removed from the European Union market in 2007 increased by 53 percent, with more than half of the items coming from China. The EU notes that toys were the products most often removed from markets in the 27 EU member states. About 80 percent of all toys sold in Europe come from a Chinese manufacturing facility. (The EU has a rapid alert system known as RAPEX. The RAPEX report on goods pulled from the market in 2007 can be found  here.


IMPACT OF RECALLS

Recalls have direct and indirect costs to product sellers. The costs of notice, labor costs, disposal costs, lost inventory value, refunds and repair costs, and legal fees are some of the direct costs. Indirect costs include bad publicity, damage to goodwill and reputation, loss of sales, increased production costs and testing costs in the future, diversion of management and employees from normal duties, potential legal liability (personal injury, medical monitoring, punitive damages), and increased insurance premiums. The recall may spawn shareholder derivative lawsuits if the stock price is affected by the recall. An interesting report from Lucy Allen at NERA looks at the market cap impact of recalls. Government fines are possible. The CPSC recently issued a $1 million civil penalty against athletic-shoe maker Reebok International Ltd. related to company-issued charm bracelets with toxic levels of lead. It is not unusual for recalls to cost companies tens of millions of dollars.

REGULATION
Congress has already taken steps in response to the spate of recalls. The House passed the Consumer Product Safety Modernization Act, H.R. 4040, in December, and the Senate passed its own CPSC Reform Act, S.2663 in March. The two bills will be reconciled, and the CPSC budget, staff, and enforcement powers will be increased. Both bills mandate reduction of the amount of lead in toys; third-party testing of certain children's products; raise allowable penalties for violations; and give state attorneys general enforcement authority. Empowering state attorneys general is likely to generate more enforcement claims against companies, as state AGs have been willing to take an aggressive stand on other recent issues, beginning with tobacco. This provision might also undermine uniformity of enforcement of the CPS Act. State attorney generals may simply create a confused patchwork of standards.

The Senate provision would require the CPSC to post on Internet-searchable database the reports it receives about product-related injuries. This seems of limited use to the average consumer, but may encourage additional litigation; just like plaintiffs’ attempt with ADE reports in pharmaceutical litigation, this could be misused in product liability litigation.


WHAT CAN BE DONE
In some quarters, there is a notion that the market will force China to make improvements in quality control to avoid a repeat of the year of recalls. That is, if the products cannot be trusted, then importers will stop buying them. But the fact remains that regulation of product safety in China is not as advanced as it is in Europe and the United States. In essence the growth of their economy may have outpaced their ability to regulate product quality control.

Is there an ability to hold the Chinese companies accountable for the QC issues? Frequently, mass litigation arising from a large product recall will involve numerous parties within the chain of distribution, if not originally, then through indemnification and contribution claims. The original manufacturer of the allegedly defective product rarely is not involved. But plaintiff attorneys/consumers rarely try to pursue Chinese companies, forcing the U.S. importer/seller to try to pursue them.  But U.S. companies invariably may have difficulty pursuing the chain to a Chinese company that doesn't have assets or an office in the United States. Most Chinese companies have no assets in the United States, and will ignore U.S. complaints.

In the case of Menu Foods, the pet food manufacturer whose China-sourced ingredients allegedly contaminated dozens of brands of American pet food, several putative class-action suits were filed. See In re Pet Food Products Liability Litig., MDL No. 1850. But the Chinese defendants reportedly have not responded.

  • There can be issues of personal jurisdiction. Asahi Metal Indus.. Co. v. Superior Court of Calif., 480 U.S. 102 (1987)(plurality suggesting that placement of product in stream of commerce, without more, may not be the substantial connection between defendant and forum state necessary for finding of minimum contacts). 
  • Second, especially if the manufacturer is state owned, Chinese defendants may also assert defenses based on principals of sovereign immunity and international comity. Service of a Chinese company must be conducted in accordance with the Hague Convention, which can be cumbersome. Authorities in China frequently cannot locate the accused companies because the firms are often dissolved and the factories are under new ownership.
  • Discovery is extremely limited in China. Even if a damage award is entered against a Chinese company, enforcement of the judgment may be impossible if the Chinese company does not have significant assets in the U.S.. There is no treaty between China and the United States that requires reciprocal enforcement of judgments. (Although a U.S. judgment may not be enforced in China, there may be assets of the Chinese company in other countries that enforce U.S. judgments...worth thinking about)

 

How about suits in China? Its nearly infeasible to file a lawsuit against a Chinese company in China. It can be impossible to get an expert to testify. There is limited discovery, if any. There is tolerance or lenient views of perjury.  Precedent can be irrelevant. The damages obtainable are often insufficient, with lost profits seemingly a lost concept. There are a variety of practical realities that favor the “home team.”  Foreign lawyers typically cannot be utilized.

More of what can be done in the next posting.

Rehearing Rejected in Colacicco

Although coming as no big surprise, it is good to note that the 3d Circuit refused to revisit its recent decision that federal law preempts claims against antidepressant manufacturers for failing to warn of suicide-related risks (Colacicco v. Apotex Inc., 3d Cir., No. 06-3107, 5/5/08).


Readers of MassTortDefense know that plaintiff Colacicco filed suit after his wife allegedly committed suicide while under treatment with a generic equivalent to Paxil. The EDPA found preemption. However, the DNJ reached the opposite conclusion in a claim by plaintiff McNellis, whose father allegedly committed suicide while taking Zoloft. Both decisions were appealed, and the appeals were consolidated. The Third Circuit's decision was the first by a federal appeals court to address the preemptive effect of prescription drug law and regulation since the FDA’s clarified guidance on the issue.


Plaintiffs sought a rehearing. Only two judges on the panel, including Judge Thomas L. Ambro, who dissented from the panel’s preemption decision, would have granted the petition for rehearing en banc. (Judge Fisher also would have granted the petition for rehearing en banc.)

Many eyes turn now to Wyeth v. Levine, in the US Supreme Court, on the crucial issue of preemption. 

2d Circuit Rejects Novel Mass Tort

Here at MassTortDefense, the focus is often on developments in ongoing mass torts and significant product liability litigation. How interesting to be able to report on the Second Circuit’s decision to reject plaintiffs’ attempt to create “in essence a mass tort for making inaccurate statements.” In Benzman v. Whitman, No. 06-1166, 2008 WL 1788401 (2d Cir. 4/22/08), the court ordered the dismissal of a putative class action seeking to hold the former EPA administrator liable for her erroneous reassuring statements about the health risks of the World Trade Center dust in the aftermath of the Sept. 11, 2001, attack.

Background
The class action lawsuit was brought on behalf people who lived, attended school, or worked in lower Manhattan or Brooklyn following the attack. The class alleged under a variety of theories that Christine Todd Whitman and EPA officials acting at her direction made statements regarding air quality  that failed to report health risks associated with WTC dust or misrepresented the nature of those risks, thereby violating the Plaintiffs' Fifth Amendment substantive due process right to be free from government-created health risks. The district court denied Whitman's motion to dismiss the claim against her as an individual for misleading the public about the air quality.

2d Circuit Reverses
The Second Circuit rejected any individual liability claim, pointing out that no court has ever held a government official liable for denying substantive due process by issuing press releases or making public statements. Such a suit against a federal official for decisions made as part of federal disaster response and cleanup efforts implicate the special judgment and policy factors that counsel against creation of a litigation remedy. Plaintiffs' allegations fell far short of showing either the type of special relationship between governmental actor and victim or a state-created danger arising from the relationship between the state and the private assailant.

The 2d Circuit noted the evidence “that the agency's performance in discharging its responsibilities in the aftermath of the 9/11 attacks, which involved an attack on America's largest city unprecedented in our history, was flawed. But legal remedies are not always available for every instance of arguably deficient governmental performance.” Id. at *11.

The nuances of a Bivens Fifth Amendment claim, and intricacies of the APA, are perhaps not frequent aspects of mass torts. But the 2d Circuit clearly recognized the potential impact of recognizing the claim alleged. Plaintiffs alleged a state-created danger, sufficient to impose liability, based on a senior official's public statements that offered assurances of environmental safety that turned out to be substantially exaggerated. The Court called this an attempt to create “in essence a mass tort for making inaccurate statements.” Id. at *5. The 2d Circuit would have no part of creating such a novel mass tort.

That type of policy hesitation ought to at least be part of the analysis of new causes of action (like medical monitoring), attempts to expand existing causes of action (CFA claims), and application of important legal defenses (preemption).

BPA Litigation Begins- But Why?

Bisphenol A (BPA) is in the news. This is a chemical produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins. Polycarbonate plastics in turn have many important applications, including use in certain food and drink packaging, e.g., water and infant bottles, compact discs, impact-resistant safety equipment, and medical devices. Polycarbonate plastic can also be blended with other materials to create molded parts for use in mobile phone housings, household items, and automobiles. Epoxy resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants or composites contain bisphenol A-derived materials. U.S. manufacturers produce some 7 billion pounds of BPA annually, and business worldwide has been growing about 4 percent a year, driven by rising demand in Asia.


Recently, BPA has been in the news, with regulatory and legislative attention being applied, scientific data being generated, and litigation being brought. MassTortDefense questions those in the media suggesting this should be the “next mass tort.”

FDA Role

BPA has been in use for decades, and has been long regarded as safe by FDA. (Aside: Attacks on the FDA, and the alleged politicization of science is a favorite line of plaintiffs, and we will see it here. But, the agency relied in part on research backed by the American Plastics Council only because FDA had input on its design, monitored its progress, and reviewed the raw data. The fact is, it is industry's responsibility to demonstrate the safety of the products they sell; that industry generated data is used in looking at product safety is neither unusual or inappropriate. )

NTP Report
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 CECHR was established by the National Institute of Environmental Health Sciences (NIEHS) as part of the National Toxicology Program in 1998. CERHR convenes a scientific expert panel that meets in a public forum to review, discuss, and evaluate the scientific literature on a selected chemical. CERHR selects chemicals for evaluation based upon several factors including production volume, extent of human exposure, public concern, and the extent of published information from reproductive and developmental toxicity studies.

The CERHR/NTP draft report, issued April 15 for public comment, expressed "some concern" based on animal studies that the chemical might affect the neurological systems and behavior of fetuses, infants, and children.


Legislative Reaction

The legislative [knee jerk] reaction? Sen. Charles Schumer (D-N.Y.) and Sen. Dianne Feinstein (D-Calif.) announced recently that they have introduced legislation that would prohibit the use of bisphenol-A in all children's products. Canada recently proposed to ban bisphenol-A from polycarbonate baby bottles. Several states also are considering legislative bans or restrictions on the chemical. California legislators, for example, are considering a bill that would ban BPA in children's products.

Litigation?

And the litigation wasn’t far behind. A California woman has initiated a class action accusing Nalge Nunc International Corp. of suppressing key information about the potential health risks of its hard-plastic sports bottles containing bisphenol A. See Felix-Lozano v. Nalge Nunc International Corp., E.D. Cal., No. 08-cv-854, filed 4/22/08). Of course, the suit comes despite the fact the manufacturer already announced it was phasing out the production of bottles using the chemical within a few months. Plaintiff does not claim use of the bottles has harmed her or her children's health. As is typical with product claims in which the plaintiff was not injured by the product, the suit alleges fraud, and violations of consumer fraud laws, specifically the Unfair Competition Law, False Advertising Law, etc. Based on all available scientific evidence, the defendant in this case continues to believe that products containing BPA (bisphenol-A) are safe for their intended use.

However, plaintiffs will try to treat the product-line change/subsequent remedial measure as an admission of liability rather than a simple reflection of the fact that customers indicated they preferred BPA-free alternatives and the company acted in response to those concerns. U.S. retailers Wal-Mart and Toys 'R Us have already removed baby bottles containing BPA from store shelves. Playtex said it would offer free non-BPA bottles to parents and will stop using BPA in all products by the end of the year.

And a purported class action has been filed over the use of bisphenol A in plastic baby bottles and toddler training cups. The suit, Maria Sullivan et al. v. Avent America Inc. et al., 4:08-cv-00309 (W.D.  April 30, 2008), alleges that five baby bottle makers failed to disclose that BPA poses risks to an infant’s brain and sexual development. Plaintiffs allege that defendants continue to represent that their BPA-laced products are safe despite mounting evidence to the contrary. The suit is seeking to recover the amount plaintiffs spent to purchase the defendants’ products and the amount plaintiffs spent and will spend to replace the products.

Does the NTP draft report warrant all this?

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 report found that there was negligible danger in exposure to BPA for adults and pregnant women, and only minimal concern for adults exposed even to high levels of the chemical in an occupational setting. The CERHR Panel also noted the apparent scientific implausibility of any mechanism that would produce endocrine effects at low doses that are not also observed in well conducted studies at higher doses. Again, the need for more research. And the panel report documents that much of the sampling to date on possible migration of BPA into food has been done utilizing an approach subject to interference from substances naturally present in food products.

The American Chemistry Council has noted that the weight of scientific evidence, as assessed by Health Canada and other agencies around the world, provides reassurance that consumers can continue to safely use products made from bisphenol A. Consumer products made from polycarbonate plastic and epoxy resins, including products for infants and children, are accepted as safe for use, and used, around the world. But an FDA re-review of the safety of the chemical for additional reassurance to the public on the safety of consumer products makes perfect sense to industry.

Cure Worse Than Problem

Any wide-spread ban of the product – or litigation accomplishing the same result -- may risk the public safety more than enhance it. Epoxy resins derived from bisphenol A are used to manufacture protective polymer coatings for the inner surface of metal food and beverage containers. This critical technology protects the contents of these containers from aggressive food products, thereby assuring a safe, wholesome, and nutritious food supply. Compared to other coating technologies, coatings derived from epoxy resins provide superior adhesion to the metal surface, greater durability, and higher resistance to the wide range of chemistries found in foods and beverages. These attributes are essential to protect the packed food from microbiological contamination, which is a significant food safety issue.

Canning might be the single most important innovation in the preservation of food in history. More than 1500 food items are regularly packed in cans, making out of season foods globally accessible year-round. More than 90% of food and beverage cans use epoxy-based coatings because of their strength, adhesion, formability and resistance to chemical reactions in the food and drinks -- without affecting the taste or smell of the product. They protect the food from the container and from bacterial contamination. They give canned foods their long shelf-life.

State court jury rooms are a bad place to make policy decisions that can have far-reaching impact on public health.

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.

Texas Appeals Court Affirms Dismissal of Property Damage Claims

At MassTortDefense we are not adverse to spotlighting the occasional interesting, helpful (or even scary) intermediate appellate court decision. Hence, our focus today on Adamcek v. Reynolds Metals Co., Tex. Ct. App. 13th Dist., No. 13-06-240-CV, 2008 WL 1822772 (April 24, 2008), in which the Texas court of appeals ruled that expert testimony for plaintiffs living in an area affected by a hazardous waste plume was insufficient in a toxic tort case.

Those readers confronting toxic tort litigation know the importance of causation: including whether the substance is capable of causing the injury alleged (general) and whether the substance did cause the injury (specific). And a component of the latter is that the plaintiff actually suffered an exposure, and an exposure above background, and an exposure sufficient to have caused the damage alleged. In the property damage context, causation is equally important, and should not be taken for granted by defendants. This opinion is interesting in part because it shows the importance of putting plaintiffs to their proof on every element of a claim in the property damage context, and because it also involves a nuisance claim – which plaintiffs have been trying to expand and distort beyond its historical foundation and policy roots.


Background
The lawsuit involved 1200 consolidated plaintiffs, who filed suit after the discovery of groundwater contamination by a chemical called Trichloroethylene (TCE). Plaintiffs alleged that the TCE originated at an aluminum extrusion facility owned and operated by various defendants at various times. They alleged personal injuries, punitive damages, and this part of the case involved their claims of property damage under the theories of nuisance, negligence, and gross negligence.
Defendants filed a “no evidence” motion, basically a summary judgment motion asserting that there is no evidence of one or more essential elements of a claim on which an plaintiffs have the burden of proof. In order to avoid the no-evidence summary judgment, plaintiffs must produce more than a scintilla of probative evidence that raises an issue of material fact on each element challenged. That is, they need evidence that rises to a level that would enable reasonable and fair-minded people to differ in their conclusions. The trial court granted the motion, and 97 plaintiffs appealed.

Need for Causal Link to Injury 

The court defined a nuisance as a condition that substantially interferes with the use and enjoyment of land by causing unreasonable discomfort or annoyance to persons of ordinary sensibilities attempting to use and enjoy it. Under Texas law, in order to recover on a nuisance claim, the defendant must have generally engaged in one of three kinds of activity: (1) intentional invasion of another's interests; (2) negligent invasion of another's interest; or (3) other conduct, culpable because abnormal and out of place in its surroundings, that invades another's interests. The invasion must cause an injury, an interference. Just as in a claim for negligence which requires that damages were proximately caused by the breach.

Plaintiffs’ “Proof” Insufficient

Plaintiff relied on an affidavit from an expert to meet their burden on causation. The expert identified an “additional plume, which had its genesis in a leak from a sewer line.” In his affidavit, he referred to a map that he alleged showed where the plaintiffs live. However, carefully analyzed, it was clear that the expert did not show that any of the appellants owned an interest in the property within the additional plume he demonstrated. Moreover, he did not designate which properties or whose interests were in fact affected by the TCE under his theory, and how. Thus, the affidavit did not provide any evidence that any particular appellant had an interest that was affected by the TCE contamination. The Texas Court of Appeals upheld dismissal of the nuisance claim, finding the residents failed to assert sufficient evidence of causation of injury.

Think about putting plaintiffs to their proof on each and every element of the toxic tort claim.