State Attorneys General and the CPSAct

One potential products liability development to watch in 2009 is the impact of the Consumer Product Safety Improvement Act of 2008. As MassTortDefense alerted readers before the legislation was even passed, one of the potentially most significant aspects of the legislation is the provision giving state Attorney Generals expanded jurisdiction to seek to enforce the Act against manufacturers and sellers of consumer products.

Under the Act, state AGs are authorized to bring federal court actions to enforce any regulation or standard of the CPSC which affects their state's residents. Previously, many such standards and rules were enforced only by the CPSCommission. (An AG must give the CPSC 30 days notice before filing, unless the product poses a "substantial product hazard," in which case no notice is required.)  The legislation has given a potentially sweeping and relatively undefined authority for state Attorneys General to act on perceived product safety concerns, largely independent of the CPSC.

While this move has potentially increased the resources available for enforcement actions, it has also created the likelihood of different interpretations and applications of product safety rules, as different state officials apply different approaches to enforcement. The Act does not require that an Attorney General pursue the CPSC's viewpoint or position in regard to a consumer product issue. The provision could thus undermine both the uniformity of product safety standards as applied across the country, and the CPSC's role in providing centralized regulation and guidance to industry and consumers alike.

The media reports that the National Association of Attorneys General has amassed a war chest of $140 million dollars, available to help individual state Attorneys General investigate alleged wrongdoing and to pay for expert consultants. State AGs have already been very active in product liability contexts, even before the Act, with tobacco, baby products, toys and mattresses being involved in recent memory.
 

Nano-technology Conference Set for March, 2009

Those interested in nano-technology issues may want to check out a conference next Spring, entitled NanoImpactNet: For a Healthy Environment in a Future with Nanotechnology.

NanoImpactNet is the European network on the health and environmental impact of  nanomaterials. It is a platform for exchange about research ideas and to bring together scientists, industry, policy makers and consumers to ensure the safe and responsible development of nanomaterials. NanoImpactNet is part of the European Commission’s commitment to define a robust European strategy on nanotechnology which includes health, safety and environmental issues.

Launched in April 2008, this multidisciplinary network’s objective is to create a scientific basis to support the definition of regulatory measures and the implementation of legislation across the EU.  The 24 institutes behind NanoImpactNet members are leading European research groups active in the fields of nanosafety, nanorisk assessment and nanotoxicology. Through numerous workshops over a period of four years, NanoImpactNet will bring together some of the top researchers to discuss future strategies, to exchange their ideas with the different stakeholder groups and to further the responsible development of nanotechnology.
 

The conference is set for Laussanne, Switzerland, March 23-27, 2009.
 

New Article: Platitudes From Plaintiffs About Product Stewardship

A recent academic paper may be worth a look. Noah, Lars, “Platitudes about 'Product Stewardship' in Torts: Continuing Drug Research and Education,” 15 Michigan Telecommunications and Technology Law Review 2009.

This paper focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, might portend a dramatic (and potentially counterproductive, in the author’s view) expansion in the prescription drug industry's exposure to liability. A growing number of liberal commentators would seek to impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of "product stewardship"). This paper explains some of  the serious flaws in such proposals.

The article is thus part of the overall debate about what role tort law may have to play in drug research and development. Does the threat of liability create important safety incentives (and make up for perceived, alleged failings in regulatory oversight), or, instead, does it unduly interfere with innovation and patient access to life-saving therapies? These and related questions have
inspired an active debate among commentators, the author notes;  courts and legislators have also made occasional forays into the area by constricting the scope of potential tort liability in particular circumstances. The Restatement (Third) of Torts: Products Liability, which ALI published a decade ago, included special provisions governing prescription drug cases, and the pitched battle over using implied preemption as a defense, which the United States Supreme Court may address in 2009, represents only the latest manifestation of these sharp disagreements.

Worth a read.
 

Supreme Court Agrees To Hear Manville-Related Asbestos Insurance Issues

The U.S. Supreme Court has agreed to review a federal appeals court decision rejecting the resolution of asbestos claims against an insurer, and to decide whether thousands of personal injury plaintiffs may directly sue the insurer. Travelers Indem. Co. v. Bailey, 2008 WL 4106796 (U.S., December 12, 2008).

The case arises from the now-decades old Manville bankruptcy. From the 1920s until the 1970s, Johns-Manville was the largest manufacturer of asbestos-containing products and the largest supplier of raw asbestos in the United States. As a result, in the 1960s and 1970s, Johns-Manville became the target of product liability suits. Johns-Manville filed for Chapter 11 protection under the federal bankruptcy law on Aug. 26, 1982. On that date, Johns-Manville was a defendant in more than 12,500 asbestos-related suits. To fund its reorganization plan, the bankruptcy court allowed Johns-Manville to settle its insurance claims for about $850 million.

Travelers, Johns-Manville's primary insurer from 1947 to 1976, paid about $100 million into the bankruptcy estate in exchange for a full and final release of Manville-related claims. In 1986, Bankruptcy Judge Lifland entered a confirmation order, inter alia barring any person from commencing any actions based upon, arising out of or related to insurance policies that Travelers issued to Manville. In 2004, Judge Lifland found that his injunction was being violated by a new species of asbestos-related lawsuits (referred to by some as “direct action” claims) against insurers. These new asbestos claims were part of a global strategy developed by the plaintiffs' bar to put insurers in Manville's shoes and thereby hold them liable on account of their insurance relationship with Manville.

The Second Circuit, rather than enforce the confirmation order as it was originally written, entered and affirmed on a prior appeal, ruled that Judge Lifland had exceeded the “subject matter jurisdiction” granted by the Judicial Code. In re: Johns-Manville Corp., 517 F.3d 52 (2d Cir. 2008). The Second Circuit concluded that the bankruptcy court in 1986 was without power to enjoin all claims that literally arise out of the insurance policies that Manville purchased from Travelers. Thus, the bankruptcy court had exceeded its authority in approving a multi–million dollar settlement of asbestos–related claims filed against Travelers. The court said the bedrock issue in this case requires a determination as to whether the bankruptcy court had jurisdiction over the disputed statutory and common law claims. While the bankruptcy court repeatedly used the terms “arising out of” and “related to,” global finality for Travelers is only as global as the bankruptcy court's jurisdiction.

Travelers filed a petition for writ of certiorari, as did a group of plaintiff attorneys. Travelers argued that “decades of bankruptcy practice in the lower federal courts” are at risk, and that the Second Circuit opinion is inconsistent with “the carefully crafted legislative scheme Congress constructed.” The plaintiffs petitioner group asserted that the Second Circuit obscured the distinction between jurisdiction and statutory authority and that as a result of the Second Circuit decision, the finality of certain Chapter 11 reorganization plans in federal bankruptcy would be rendered uncertain.

One may wonder whether mass tort reorganization plans might be in jeopardy, under the Second Circuit opinion. Some tens of billions of dollars have been committed to asbestos trusts in cases that relied at least in part on the finality of the Johns-Manville bankruptcy. And the Second Circuit noted that Travelers had alleged that all underlying asbestos settlements were dependent upon the continued validity of the settlement scheme utilized over the past 20 years.

 

Happy Holidays!

No post today, except to wish all the readers of MassTortDefense a Happy Kwanzaa, a Happy Hanukkah, and a Merry Christmas.  Here's hoping that this time of year finds you with friends and family celebrating the important things in your lives.
 

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Study Released Of Low Level Melamine Effects In Children

Low doses of melamine did not cause severe kidney problems in children exposed to the industrial chemical during the recent tainted milk scandal arising from China, according to researchers reporting last week. In Lam, et al., Renal screening in children after exposure to low dose melamine in Hong Kong: a cross sectional study, 337 BMJ 2991 (2008), no severe adverse renal outcomes, such as acute renal failure or urinary tract obstruction, were detected in children after exposure to low doses of melamine. The results were similar to initial findings by other scientists in Hong Kong. The prevalence of suspected melamine related abnormalities on ultrasonography was only 0.2%.

The researchers looked at more than 3,000 children aged 12 or younger. All of them had consumed melamine-tainted products for a month or more. Every child was given a urine test, and an ultrasound was performed on their kidneys. Only one child had a kidney stone, and seven had possible melamine-related deposits in their kidneys. An additional 208 tested positive for blood in their urine, a possible sign of kidney troubles.

The study is one of the first to measure the health impact of exposure to low doses of melamine, which was apparently added to infant formula and other foods in mainland China to boost their protein content and help them pass muster on protein tests. Some contaminated products were sold in Hong Kong, but the researchers noted that those products contained much lower concentrations of melamine than the tainted products sold in mainland China.

Since early September, melamine-contaminated baby formula has sickened more than 54,000 children in China and is being blamed for at least four deaths. Melamine has been detected outside China in candies, chocolates, and coffee drinks.  This latest finding may suggest that outside of China, the chances are more remote of a similar level of injury. MassTortDefense has posted on the issues here and here.
 

Severance Ordered In Digitek MDL

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

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

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

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

9th Circuit Affirms Summary Judgment In Failure To Warn Case

The Ninth Circuit has affirmed that the trial court did not err in granting summary judgment for defendant Merck under California's learned intermediary doctrine in a failure to warn case. Latiolais v. Merck & Company, Inc., 2008 WL 5157705 (9th Cir. 2008).

Latiolais appealed the district court's grant of summary judgment on her claim that Merck failed to adequately warn, as a result of inadequate testing, of claimed suicide risks associated with the cholesterol-lowering medication Zocor.

Under California's learned intermediary doctrine, a prescription drug manufacturer's duty to warn runs to the physician. A product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the prescribing physician's conduct. See Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir.2004).

Here, there was no genuine issue of material fact as to causation made out by the prescriber’s deposition testimony. It indicated that the drug inserts accompanying Zocor did not play a role in his decision to prescribe that medication. Furthermore, Dr. Oppenheim was not equivocal regarding whether he would have prescribed Zocor in light of a supposed warning of suicide risk associated with Zocor. Such a warning was deemed “hypothetical” by the court, and, in any event, could come into play only after one makes several assumptions on issues that include whether Merck was obligated to issue a suicide risk warning for Zocor, whether Dr. Oppenheim would have read or heeded such a warning, and what information Mr. Davis would have disclosed to Dr. Oppenheim with respect to his mental state. Such speculation did not create an issue of fact.

 

Opposition To Cert Petition In Colaccico: That Other Preemption Case

While much preemption focus has been on Levine v. Wyeth, including by posts here at MassTortDefense, other preemption decisions are winding there way through the federal appellate courts. Defendants Pfizer Inc., GlaxoSmithKline, and Apotex Inc. last week asked the U.S. Supreme Court to uphold a ruling by the U.S. Court of Appeals for the Third Circuit that failure to warn claims are impliedly preempted by federal law based on the regulatory history of the antidepressants at issue. Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008), Petition for Certiorari Filed, 77 USLW 3229 (Oct 02, 2008). 

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 district court for the E.D. of Pennsylvania found preemption. The appeal was consolidated with a contrasting preemption decision in the McNellis case out of the district court in New Jersey, involving Zoloft. 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 had expanded on its guidance on the issue.

Plaintiffs sought certiorari, asking the Court to review the Third Circuit's decision; alternatively, they asked the court to hold the petition pending resolution of Levine, argued last month. But the Court should do neither, the manufacturers argued, and cert should just be denied.

Pfizer Brief

According to Pfizer's brief, the Third Circuit properly determined that plaintiff below McNellis sought a warning about suicidal behavior that conflicted with the federal warning requirements for Zoloft. For more than 15 years, the FDA had considered whether SSRIs were associated with an increased risk of suicidality in adult patients. The agency repeatedly determined that the scientific evidence did not support such a warning.

Pfizer notes there is no disagreement among appellate courts (a well-established basis for Supreme Court review) on preemption in SSRI litigation.  No other federal appeals court has ruled in a contrary way on the preemptive effect of the type of conflict at issue here. The 3d Circuit found preemption based on “the direct, real conflict” between plaintiff’s claim that New Jersey law required a warning about adult suicidality and the FDA's requirement—based on its repeated finding of no reasonable evidence of such an association—that only the FDA's approved warning be given. McNellis relied on the Court's decision in Sprietsma v. Mercury Marine, 537 U.S. 51 (2002) to argue that the FDA merely failed to act with respect to suicidality warnings, and that a federal agency's failure to act does not create a federal requirement triggering preemption. But the FDA “regulated with great specificity and care” in repeatedly finding no reasonable association between SSRIs and suicidality, and by requiring the manufacturer to provide the specified warnings.

As to the claim that the manufacturers failed to disclose information to the FDA, defendants assert that the lower court correctly found that this claim should be presented to the FDA first. In addition, Buckman preemption likewise prevents plaintiffs from evading a definitive FDA regulatory record by arguing that the FDA was somehow defrauded; the appellate court found that the preemption doctrine of Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), bars claims that the manufacturer withheld information from the FDA.

Direct Conflict

Arguing against even staying the petition until Levine is decided, Pfizer said the issues in the cases are distinct, asserting that the 3d Circuit's decision in this case is correct regardless of whether Levine is affirmed or reversed. Respondents point out what they see as distinct regulatory facts in that case, involving contraindication claims.

Brief for Apotex, GlaxoSmithKline

Apotex, a maker of generic Paxil, and GlaxoSmithKline, the maker of brand-name Paxil, also argued against review. Like Pfizer, they contended the 3d Circuit properly concluded that the FDA's repeated rejection of suicidality warnings preempts plaintiff Colacicco's claims.

The brief also argued that state law failure to warn claims challenging FDA-approved labeling should be preempted. To allow this sort of tort action to continue would place state-law juries in the position of second-guessing FDA decisions regarding the proper warnings for drugs. Lay juries should not be able to undermine the agency's expertise by second-guessing the agency's warning decisions. At its base, Colacicco's argument against preemption is the theory that a court, applying state law, has authority to decide whether GSK could have under federal law, and should have under state law, unilaterally added a suicidality warning to the Paxil labeling, despite FDA regulation.

Courts do not share concurrent jurisdiction with the FDA over drug labeling; there should be no preemption test that would require a court to delve deeply into internal FDA decision making. Specifically, the lower courts do not share jurisdiction with the FDA over the CBE regulation, which is the basis for the “could have, should have” argument, Apotex and GSK both wrote. FDA has made clear that CBE supplements fall squarely within its regulatory jurisdiction. Under Colacicco's theory, the lower court would be authorized to decide, without reference to the FDA, that a CBE supplement adding the putative warning could have been submitted, that the added warning would have been consistent with the FDCAct, and that FDA would have approved it. Thus, the lower courts would become “shadow” FDAs. That is not the scheme adopted by Congress for drug regulation.

 


 

New Report From National Research Council On Nanotechnology

A new report from the National Research Council questions the government's current plan for research on the possible health and environmental risks posed by nanomaterials, which are increasingly being used in consumer products and other industry. The report emphasizes the need for an effective national plan for identifying and managing potential risks, a step seen as essential to the successful development and public acceptance of nanotechnology-enabled products.

Nanoscale engineering manipulates materials at the molecular and atomic level to create structures with unique and useful properties – materials that are both very strong and very light, for example. More than 600 products involving nanomaterials are already on the market, the majority of them health and fitness products, such as skin care and cosmetics. And over the next decade, nanomaterials will be used increasingly in products ranging from medical therapies to food additives to electronics. MassTortDefense has posted about nano-issues before.

Growing use of nanomaterials means that more workers and consumers may be exposed to them, and uncertainties remain in the minds of some about their health and environmental effects; while nanomaterials can yield tremendous, special utility, they may also have possibly toxic risk properties.

The National Nanotechnology Initiative, which coordinates federal agency investments in nanoscale R&D, developed a research plan to investigate these risks, and the office that oversees NNI asked the National Research Council to review the plan.  (The NRC report was sponsored by the National Nanotechnology Coordination Office. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter.)  The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering.

The committee report did not focus on current uses of nanomaterials and any potential risks to the public. Rather, the report focused on what would constitute an effective national research strategy for ensuring that current and future uses of nanomaterials are without significant impacts on human health or the environment.

The current plan, involving nano-risk research across several federal agencies, lacks an overarching research strategy needed to gain public acceptance and realize the promise of nanotechnology, according to the report.  NNI's plan identifies broad research categories for assessing health and environmental risks, and many of the research needs listed within these categories will aid risk assessment, the report says. But the plan fails to identify some important other areas that should be investigated; for example, "Nanomaterials and Human Health" should include a more comprehensive evaluation of how nanomaterials are absorbed and metabolized by the body and how toxic they are at realistic exposure levels. Furthermore, the current research plan, according to the report, does not provide a clear picture of the current understanding of these risks or where it should be in 10 years. And though the research needs listed in the plan are valuable, the NRC committee thinks they are incomplete, in some cases missing elements crucial for progress in understanding nanomaterials' health and safety impacts.

In its assessment of gaps in existing research, the current NNI plan overstates the degree to which already funded studies are meeting the need for research on health and environmental risks, the report says. For example, more than half of the currently funded projects on nanotechnology and human health are aimed at developing therapies for diseases. While this research is important, it will not shed light on health risks that may be posed by nanomaterials. Moreover, the plan does not note the current lack of studies on how to manage consumer and environmental risks, such as how to manage accidents and spills or mitigate exposure through consumer products.

A truly robust national strategic plan would involve a broader group of stakeholders, and would consider the untapped knowledge of nongovernment researchers and academics, the committee said. The current structure of NNI would make developing a new strategy difficult, says the report. NNI should continue to foster successful interagency coordination, with the aim of ensuring that the federal research strategy on the health and safety impacts of nanotechnology is an integral part of the broader national strategic plan.
 

FDA Studies A Revised Advisory On Mercury In Fish

The issue of mercury levels in fish has spawned litigation, including some controversial decisions about the preemptive effect of FDA policies on the regulation of labels of tuna. Now, the FDA is urging amendment of the 2004 advisory that women and children should limit how much fish they eat, saying that the benefits of seafood outweigh the health risks. Bottom line, people should eat more fish, even if it contains mercury.


Currently, the government suggests that women of childbearing years, pregnant women, nursing mothers, infants and children, can be harmed by the mercury in fish and should limit their consumption. In a draft report, FDA proposes to update the existing health advisory. The report argues that nutrients in fish, including omega-3 fatty acids, selenium and other minerals could boost a child's IQ. The greatest benefits, the FDA report said, would come from eating more than 12 ounces of fish a week, which is the current limit advised for pregnant women, women of childbearing age, nursing mothers and young children.


The FDA and the EPA both play a role in protecting the public from mercury contamination. The EPA investigates and regulates mercury and other contaminants in recreationally caught fish, while the FDA regulates mercury in seafood sold in markets and restaurants. States rely on the federal agencies in issuing their own advisories.


Not surprisingly, the Environmental Working Group attacked the draft report. But the National Fisheries Institute applauded the FDA's science-based approach, pointing out the amount of research since the advisory was last updated in 2004 suggesting the real risk to women and children is not eating enough seafood. A Harvard University study released in September of 2008 highlighted the benefits of a seafood rich diet. New research published in the Lancet in 2007 found that mothers who ate the most seafood during pregnancy had children with the highest developmental outcomes. A 2006 Institute Of Medicine report encouraged women to include seafood in their diets. The Harvard Center for Risk Analysis in 2005 wrote that curtailing fish consumption could lead to an increase risk of adverse health outcomes. 


 

Federal Court Denies Class Certification In Teflon Litigation

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

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

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


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

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

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

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

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

 

 

FDA To Hold Workshop On "Sentinel" Initiative

The Food and Drug Administration is holding a public workshop entitled Sentinel Initiative: Structure, Function, and Scope. The workshop is co-sponsored by the FDA and the eHealth Initiative Foundation, and convened by the Engelberg Center for Health Care Reform at the Brookings Institution. The workshop is intended to bring together academia, government, patient, consumer, and provider groups, health care data owners, the pharma industry; and other interested organizations for an update on the current status of the Sentinel Initiative, and to allow for comment from all interested stakeholders.

In May, 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 is being designed to 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 may never get reported.

Date and Time: The public workshop will be held on December 16, 2008, from 9 a.m. to 3:30 p.m. Location: The public workshop will be held at the Omni Shoreham Hotel, 2500 Calvert Street NW., Washington, DC 20008.
 

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 included 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.” 
 

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 potential issues, the Pharmaceutical Research and Manufacturers of America supported the FDA initiative, 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.
 

Medical Monitoring Webinar

Your faithful blogger is in NY today speaking at the ACI Drug and Medical Device CLE Seminar.

On this topic of CLE seminars, however, a note that I will be co-presenter at the upcoming webinar, Defending Medical Monitoring Claims— Recent Developments and Best Practices. The webinar is presented by DRI’s Product Liability Committee and its Mass Torts & Class Actions Subcommittee. Co-presenter Jeff Holmstrand, Esquire.

This webinar is designed to help attorneys representing companies in the pharmaceutical, medical device, chemical, and consumer product industries understand what to expect when facing a claim for medical monitoring. In addition to a discussion of important developments and trends in medical monitoring law—including recent cases and an update on the ALI Restatement section related to monitoring—this course will explore some critical actions that clients and their counsel can take to maximize their chances of defeating class certification and prevailing on the merits of medical monitoring claims at trial.

DATE AND TIME

Tuesday, December 16, 2008
3:00 p.m. – 4:30 p.m. Eastern

Register.

Recent Paper: Does Tort Law Deter Innovation?

At MassTortDefense, we from time to time point out an interesting academic take on the issues we deal with in the litigation trenches. Readers may want to check out "Torts and Innovation," a thought provoking article by Gideon Parchomovsky, University of Pennsylvania Law School, and Alex Stein, Cardozo Law School.


The paper exposes and analyzes a perhaps sometimes overlooked cost of the current workings of U.S. tort law: its potential adverse effect on innovation. Academic discussions of innovation are typically confined to the domains of patent and trade secret law. But tort liability for negligence, defective products, and medical malpractice is determined in part by reference to custom (industry standards, reasonable prudent manufacturer, state of the art, etc.). The article explores the courts’ reliance on custom and conventional technologies as the benchmark of liability, and whether this chills innovation and distorts its path. Specifically, the recourse to custom may tax innovators and subsidizes replicators of conventional technologies.

The authors explore the causes and consequences of this phenomenon and propose two possible ways to modify tort law in order to make it possibly more welcoming to innovation. Specifically, policymakers can accomplish this result, argues the paper, either by eliminating courts’ reliance on custom in making liability determinations or by instructing courts to give innovations whose safety was verified by independent industry experts the same deference they give custom.  An interesting read.

Medical Monitoring: Evidence Of More Harm Than Good

MassTortDefense has posted about medical monitoring claims. One of the advantages plaintiffs may have with juries in such claims is the pre-loaded notion that early detection is "always" better; therefore, screening tests must be helpful, right? Jurors are inundated with messages from public health authorities, government agencies, insurers and others about getting this or that screening test. The latest we saw: get your husband a colo-rectal screening for Christmas.


Undoubtedly, preventive care is crucial, and early detection by some tests of some disease has been shown to save lives. But not every test regime conjured up by plaintiffs' attorneys or their experts for a class of litigants falls into the same category as tests recommended for specific populations by, for example, the US Preventive Services Task Force.

Defendants need to explore the argument that a proposed monitoring test may do more harm than good. Proposed tests have potential side effects, risks. For example, researchers are looking at the risks posed by CT scans.

Researchers from Brigham and Women's Hospital in Boston told a meeting of the Radiological Society of North America in Chicago last week that as many as 7 percent of patients from a large U.S. hospital system had enough radiation exposure from CT scans during their lifetime to noticeably raise their risk of cancer. CT scans help diagnosis of a variety of illness and injuries, and are routinely used to track the advance of cancer. But a number of recent studies have raised alarms about the potential cancer risks from the radiation. The BWH group studied all patients who had a CT scan in 2007 at Brigham and Women's Hospital, or at the Dana-Farber Cancer Institute, in Boston. Then they checked on prior CT scans from a database that includes 20+ years of patient history and calculated overall radiation exposure based on the type and location of the scan. This allowed them to determine a lifetime risk. They found about 7 percent of the patients did have a cancer risk that increased by at least 1 percent over the baseline cancer rate.


And that's for symptomatic patients using the scans. For them, the radiation exposure from CT scans may be worth the risk. But for non-symptomatic, healthy plaintiffs who claim some often unverified level of exposure to a toxic substance, getting repeated CT scans under a medical monitoring regime could raise their risk of a tumor. And certain groups are more likely to be harmed by radiation, including younger people whose growing tissues may be more vulnerable according to some studies.

A typical CT scan can deliver 50 to 100 times more radiation than a conventional X-ray, depending on the site being examined and the type of the machine. Some 62 million CT scans are done in the U.S. annually.

 

FDA Issues Guidance For Industry On Retaining Data From Clinical Trials

Limiting mass tort/class action exposure is a key part of the role of in-house litigators. In the drug and device areas, limiting plaintiffs' ability to take unfair advantage of clinical trials research is becoming a real focus. Issues include limiting liability due to alleged inadequate monitoring during trials, and preventing off-label and product liability claims associated with alleged under-reporting and over-reporting of data. Litigators need to offer their input on the company's determination of the extent to which data from ongoing clinical trials will be distributed, helping the company to assess the liability risks of disclosing and failing to disclose clinical trial data related to off-label uses. A thorny legal issue is the degree to which the First Amendment is a viable defense, and in a complex regulatory world the company needs to understand and comply with state as well as federal disclosure obligations.


Ideally, the company will be developing a framework for deciphering where scientific exchange ends and drug promotion begins, as a guide to avoiding language in describing clinical trials that could be construed as promotional while still providing fair and balanced information on clinical trials involving their products. The most prudent may be developing a strategic, long-term plan to protect clinical trial information from turning into grist for the plaintiff ’s case (and outside counsel can help with that too). That program may include training employees to recognize the litigation potential arising from clinical trials; maintaining protocols as to the language and terms that will be used in clinical trial reports; and minimizing common liability risks arising from posting of data by establishing thorough review processes.


Into this complex situation the FDA has issued new guidance for drug, biologic, and medical device companies about retaining data from clinical trial participants who no longer are participating in the trial, according to a notice just published in the Federal Register (73 Fed. Reg. 72807). The guidance document on Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials states that data must be retained for participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, or who were discontinued from participation by the clinical investigator.
FDA's reasoning is that data resulting from these clinical investigations are used to support research applications and new product approvals;  thus it is critical that it has a complete and accurate data set available. While it may be appropriate to remove data from various reported figures, based on the study protocols, FDA worries that if data were to be removed from the study database altogether, the FDA may miss something that may be relevant to their decision-making.
 

The agency said it issued this guidance for immediate implementation to prevent the potential loss of important clinical trial data. If comments are received on the guidance, FDA said it will review the comments and revise the guidance as appropriate.
 

Defense Jury Verdict In Welding Rod Trial

Defendants last week secured another jury verdict in the federal welding rod MDL trials. Byers v. Lincoln Electric Co.,et al., N.D. Ohio, No. 04-17033. A jury delivered a verdict in favor of three rod manufacturers, finding they offered adequate warnings to an Alabama welder about potential negative health effects associated with working with their products.

The federal cases in the welding rod litigation are part of an MDL. In re Welding Fume Products Liability Litigation, MDL-1535 (N.D. Ohio). Although plaintiffs secured a significant verdict last December in the Tamraz case (currently on appeal), it was the first plaintiff victory in several years, and juries have found for defendants now, by our count, in 21 of the last 24 plaintiffs’ cases tried in this litigation, including consolidated cases that are heavily weighted toward plaintiffs and cases in jurisdictions that are considered plaintiff-friendly. Indeed, plaintiffs have moved to voluntarily dismiss more than 4,000 cases in the MDL. The total number of cases pending against the welding defendants has dropped by over two-thirds.

In the latest trial, Eddie Byers and spouse alleged his long-term exposure to manganese fumes released during the welding process caused him to suffer neurological problems in the form of a Parkinson's type disease. Plaintiffs claimed that the welding rod manufacturers should be held liable for allegedly failing to warn welders about the harms posed by manganese releases. Defendants, however, presented evidence showing that numerous warnings about the dangers of working around welding rods were given in Material Safety Data Sheets and other documents over the three decades that Eddie Byers worked as a welder.

Some see the jury's decision as an affirmation of what the industry has been saying all along—there is no scientifically proven link between welding rod exposure and neurological problems. But the fact that the jury found that the defendants did not distribute a product with a marketing defect seems as significant to MassTortDefense. In toxic tort litigation, juries can be helped to understand the potentially hazardous nature of chemicals or products which help provide important societal and economic benefits. If the information shared about the products addresses the potential risks, the defense is a long way towards home.
 

Senator Raises Issue Of Dental Implants With Lead

Dental implants are traceable to early Egyptians and to ancient Central and South American cultures. But the modern versions from China are in the products liability news again. A few months back, there were media reports about a dental patient in Ohio who claimed to have lead contamination in her dental restoration. The affected patient, a senior citizen, received a three-unit dental bridge from a dentist in Ohio. Reportedly, the prescription was sent to an offshore dental laboratory and made in China. A lab analysis apparently showed levels of lead in the porcelain on the restoration.

When the story broke in February, the American Dental Association notified the CDC and the FDA, and asked the agencies to address any safety concerns. (The not-for-profit ADA is the nation's largest dental association, representing more than 156,000 dentist members.)  The FDA regulates the materials used to make dental crowns and bridges, and the CDC has extensive information and expertise in the area of lead exposure.

According to the CDC’s response, many consumer products contain lead in trace amounts; federal regulations limit the amount of lead in consumer products based on the way the body absorbs lead, the potential hazard, and the lead level product manufacturers can achieve using good manufacturing practices. According to the CDC, trace amounts of lead at a level of 200 ppm, such as the amount the Ohio dentist reportedly found in dental crowns, are extremely unlikely to cause adverse health effects. The CDC also states that given the current information at hand, they do not recommend that individuals defer needed dental treatment or have existing dental crowns, bridges or other prostheses removed.

However, U.S. Senator Sherrod Brown (D-OH) has now called on the Food and Drug Administration to revisit the issue. In a letter to FDA, Brown cites reports of tainted implants with higher levels of lead than that ceiling. He is requesting that FDA delineate the actions it is taking to assess the prevalence, source, and impact of lead-containing dental implants in the United States. And address:

• What standards exist for domestic and international dental products and the dental labs that produce them?
• What is the estimated volume of China-produced dental implants in the country today, and what is the annual volume of such products?
• What tracking mechanisms are in place to prepare for potential contamination by tainted dental implants?
• What inspection mechanisms are in place to ensure the safety of dental implants?
• What are the risks posed by dental implants with lead levels above those that the CDC has determined are safe?
 

Meanwhile, the ADA is testing both foreign- and domestic-made dental crowns to determine:
• The degree to which lead may be present;
• Where the lead may be located (i.e., in the metal alloy, the porcelain, etc.); and
• How much, if any, lead may be released from dental crowns.
 

White Paper On Combination Products

Dr. Steven Richter has issued a white paper, “Combination Products: Navigating Two FDA Quality Systems.” Dr. Richter founded the consulting firm Microtest after working at the U.S. Food & Drug Administration. Combination products involve medical devices embedded with pharmaceutical or biologics components, like a drug-coated stent.

While none currently exist, the white paper predicts that FDA will issue guidelines specific to combination products, and the result will be increased GMP regulatory action that affects both laboratory and manufacturing.

The combination products market is moving forward with a new direction and emphasis regarding product safety and FDA requirements. The paper quotes an estimate that the market for such products will reach approximately $9.5 billion in 2009. The FDA received 275 combination product submissions in 2005, and that number has been growing. According to one survey, an estimated 30% of new products under development are “combo products.”

Such combination products can raise thorny legal issues if products liability litigation arises.  E.g., In re St. Jude Medical, Inc. Silzone Heart Valves Products Liability, 2004 WL 45503
(D. Minn., January 05, 2004)(discussing which preemption doctrine may apply to such). 
 

Upcoming Medical Monitoring Webinar Worth A Listen

Your faithful blogger will be co-presenter at the upcoming webinar, Defending Medical Monitoring Claims— Recent Developments and Best Practices. The webinar is presented by DRI’s Product Liability Committee and its Mass Torts & Class Actions Subcommittee. Co-presenter Jeff Holmstrand, Esquire.

This webinar is designed to help attorneys representing companies in the pharmaceutical, medical device, chemical, and consumer product industries understand what to expect when facing a claim for medical monitoring. In addition to a discussion of important developments and trends in medical monitoring law—including recent cases and an update on the ALI Restatement section related to monitoring—this course will explore some critical actions that clients and their counsel can take to maximize their chances of defeating class certification and prevailing on the merits of medical monitoring claims at trial.

DATE AND TIME

Tuesday, December 16, 2008
3:00 p.m. – 4:30 p.m. Eastern
2:00 p.m. – 3:30 p.m. Central
1:00 p.m. – 2:30 p.m. Mountain
12:00 p.m. – 1:30 p.m. Pacific

Register here
 

Federal Court Denies Certification Of Mouthwash Consumer Fraud Class

MassTortDefense has posted about the growing trend of plaintiffs to use consumer fraud act claims in place of traditional product theories. Plaintiffs continue to believe that claims based on unfair and deceptive trade practices acts are somehow easier to certify as class actions because of differing notions of reliance and causation. Score one for the defense in the effort to beat back this tide, with the lesson that if plaintiffs live by such statute they have to live by all the statute. Silverstein v. The Procter & Gamble Manufacturing Company,  2008 WL 4889677 (S.D.Ga. Nov. 12, 2008).

This action arose out of Procter & Gamble's manufacture and sale of Crest Pro-Health mouthwash, which allegedly stains its users'  teeth and impairs their sense of taste. Plaintiffs purchased Crest Pro-Health mouthwash as consumers. After using the mouthwash, each allegedly noticed that his teeth had acquired a brown stain and that his sense of taste allegedly was impaired. Since then, both plaintiffs stopped using Crest Pro-Health mouthwash. Plaintiffs alleged a violation of Georgia's Uniform Deceptive Trade Practices Act (“UDTPA”) and moved to certify a plaintiff class. Defendant opposed this motion and moved for summary judgment.

The court noted that an analysis of class certification must begin with the issue of standing. Specifically, the court must determine whether the named plaintiffs, as individuals, have standing to pursue the claims they intend to pursue on behalf of the class. There are multiple types of standing. Constitutional standing ensures that courts do not assume jurisdiction over disputes that are not cases or controversies within the meaning of Article III. Prudential standing encompasses a host of doctrines of judicial self-restraint, such as the rule that courts will not address political questions more appropriately resolved by the representative branches of government. Statutory standing asks whether a statute creating a cause of action permits the plaintiff before the court to prosecute that cause of action. Here, the court addressed constitutional and statutory standing.


Plaintiffs in this case sought injunctive relief, as injunctive relief is the only remedy permitted to consumers by Georgia's UDTPA. The function of an injunction is to afford preventative relief, not to redress alleged wrongs which have been committed already. Because injunctions can rectify ongoing or future harm but cannot redress past harm, a plaintiff who cannot show continuing, present adverse effects or a real and immediate threat of future harm lacks Article III standing to pursue an injunction. Plaintiffs alleged past harm --browned teeth and a loss of taste. An injunction could not right these wrongs. They stopped using the product, and they now obviously know of the alleged defects. In determining whether to certify the class that plaintiffs proposed, the court determined it must not focus on the standing of unnamed class members, some of whom might, in theory, have standing to seek an injunction because they do not yet know about Crest Pro-Health's alleged defects. Whether the unnamed class members have standing is irrelevant, found the court. The result of the rule, in most applications, acknowledged the court, is that once a plaintiff learns about a product's defect, he has lost his standing to enjoin the manufacturer from producing it. “Such is the state of the law.”

When a plaintiff asserts statutory authorization to sue, he must fall within the class of plaintiffs to whom the statute grants the authority to maintain suit. It has been said that statutory standing comprises the zone-of-interests test, which seeks to determine whether the plaintiff is within the class of persons sought to be benefited by the provision at issue. A plaintiff who demonstrates past harm, but does not allege ongoing or future harm, has not shown that he is “likely to be damaged” within the meaning of the statute. Instead, Plaintiffs' alleged harm is entirely past. Because plaintiffs cannot “raise a factual question about the likelihood of some future wrong,”  they lack statutory standing to maintain an action under the UDTPA.

While plaintiffs described this result as a “catch twenty-two of statutory construction,” the court found no Joseph Heller-like dilemma: this result is actually a vindication of the UDTPA drafters' intent. Although its text does not foreclose lawsuits by consumers, the UDTPA was drafted primarily to allow businesses to enjoin their competitors' unfair or deceptive trade practices.

Because it determined that plaintiffs lacked constitutional and statutory standing to maintain their UDTPA claim, the court granted defendant's motion for summary judgment as to plaintiffs' UDTPA claim.