Toxic Tort Litigation Blog : Toxic Tort Lawyer & Attorney : Epstein Becker Green Law Firm : Product Liability, Contamination, Pollution

In the case of Wyeth v. Weeks, the Alabama Supreme Court consented to answer the following question from the Middle District of Alabama: “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by plaintiffs claiming physical injury from a generic drug manufactured and distributed by a different company?" In its brief filed on December 12, 2011—a combined effort with the Alabama Defense Lawyers Association—the Defense Research Institute (DRI)  argues that well-established state tort duty principles prohibit imposing liability on a brand-name manufacturer that did not manufacture the product ingested by plaintiffs. The contrary decision of the Middle District of Alabama is one of but three decisions in the entire country that have allowed failure-to-warn claims to proceed against a brand-name manufacturer where the plaintiff ingested a generic version of the brand-name drug.

The dispute in this case stems from plaintiffs who ingested generic metoclopramide and developed tardive dyskinesia. The plaintiffs claimed that the generic manufacturer failed to warn of the dangers of metoclopramide adequately, and sued the generic defendant on a failure to warn theory. However, the United States Supreme Court recently ruled in PLIVA, Inc. v. Mensing that, because federal regulations prohibit generic manufacturers from unilaterally altering their warning labels, state tort failure-to-warn claims against generic manufacturers are preempted by federal law. Accordingly, the plaintiffs brought suit against the brand-name manufacturers, and the Middle District of Alabama denied in part the brand-name manufacturers’ motion to dismiss. DRI argues against extending common tort principles out of their shape to impose a duty on a defendant who did not manufacture the product and has no control over it. DRI maintains that federal preemption of generic manufacturers does not change this result, even if application of proper tort principles leaves the plaintiff without a remedy.

It would be bad jurisprudence and bad precedent for the Alabama Supreme Court to uphold plaintiffs' position and impose liability on a drug manufacturer, whose  product did not cause the alleged harm.  If that was the result, it is conceivable that a manufacturer with only 10% market share could be held strictly liable for adverse drug reactions caused by generic competitors, who might collectively control 90% of the market.  It would be unfair and unequitable to shift the burden of liability to a manufacturer whose product did not cause the injury merely because the Supreme Court has ruled that preemptioin protects generic manufacturers against state tort failure-to-warn claims. 

Consumer Reports, among others, reported this week that the International Agency for Research on Cancer ("IARC"), which is part of the World Health Organization ("WHO"), has classified low-level radiation from cell phones as "possibly carcinogenic to humans" based on limited evidence linking cell phone use to glioma, a type of brain cancer.  Although Consumer Reports concluded in its article that IARC's action was based on "limited evidence" and doesn't "convincingly" link typical cell phone use with cancer, an American public that often skims only headlines of articles, may be susceptible to appeals of sympathy by plaintiff lawyers representing long-time cell phone users with brain cancers.  Throughout the 1980's the utility industry battled spurious claims, premised upon junk science, that electromagnetic field radiation was responsible for "cancer clusters" of child leukemias and other dreaded diseases.  Although virtually every major EMF toxic tort claim was successfully defended by industry over a period of years, tens of millions of dollars was spent defending these lawsuits, which were brought in courts all  across the country.  As in the case of low dose radiation from cell phone use, there were  millions of millions of potential plaintiffs in the EMF cases and all of the prospective utility industry defendants had deep pockets. Following issuance of the IARC release, a spokeswoman for the Federal Communications Commission ("FCC") stated that FCC currently requires that all cell phones meet safety standards based upon the advice of federal health and safety agencies.  Moreover, according to the National Cancer Institute's Surveillance Epidemiology and End Results Program ("SEER"), the incidence of brain cancer in the United States has actually declined over recent years as cell phone use has skyrocketed.  Despite these reassuring pronouncements, well-heeled plaintiff lawyers may bring some cases as trial balloons to test industry resolve based upon other equally ambiguous pronouncements, such as the contention that cell phone use can affect "brain function".  As in the cases brought against chemical manufacturers in the 1980's,  which alleged that chemicals cause generic  "immune system dysfunction", enterprising plaintiffs may attribute any number of injuries to purported "brain function" impacts.  Hopefully, courts will continue to exercise their gatekeeper roles to maintain some semblance of scientific rigor in the courtroom to exclude inconclusive science  if these cases are brought. 

The application of CPLR Article 16 can significantly limit a defendant’s exposure in NY litigation for non-economic loss to his or her equitable share of fault. The CPLR defines “non-economic loss” to include pain and suffering, mental anguish, loss of consortium or other similar categories of damages. Thus, Article 16 does not avail a defendant in a claim to recover lost earnings or unreimbursed medical expenses. However, for claims seeking recovery for pain and suffering, Section 1601 modifies the common law rule of joint and several liability by making a joint tortfeasor, whose share of fault is fifty percent or less, liable for plaintiff’s non-economic loss only to the extent of that tortfeasor’s equitable share. For a thoughtful analysis of whether to assert a contribution claim or to rely on the application of Article 16, I commend you to “Securing Full Protection of CPLR Article 16 for Defendants,” an article by John Lyddane and Ellen B. Fishman, partners at Martin Clearwater & Bell, which appeared in The New York Law Journal on September 14, 2010. Although the article focuses on the application of Article 16 in defending medical malpractice actions, the authors’ analysis is equally applicable to the defense of toxic tort litigation. In particular, Mr. Lyddane and Ms. Fishman provide a valuable discussion concerning how to keep Article 16 issues, (i.e., the non-defendants’ wrongs) before the finder of fact.

CPLR Article 16 contains many traps for the unwary practitioner. In particular, the exceptions to CPLR Article 16 must be considered in advising clients concerning the relief this section potentially affords them as defendants. For example, tortfeasor liability on property damage and wrongful death claims remains joint and several in respect to all categories of damages. There may be instances when a defendant should implead a co-tortfeasor as a third-party into the case rather than seek relief from Article 16. Another trap for the unwary litigant is in construction litigation. A tortfeasor shown to have violated what the law denominates a “non-delegable duty” gets no several-only status. Thus, in Labor Law Section 240 and 241 cases, a tortfeasor found liable under those sections may be found joint and severally liable for satisfying an adverse judgment if that liability is predicated upon a “non-delegable duty.”

Michael Hoenig’s Product Liability column in The New York Law Journal, “Complexities Abound In Product Design Claims” (January 11, 2010), provides an excellent primer  on the law of product liability in New York state and a good discussion of the leading cases. (NYLJ.com requires a subscription to access. If you cannot download the article, Mr. Hoenig  will post the article within a couple of weeks on his law firm's web site).   Mr. Hoenig devotes the body of his article to a recent Appellate Division, First Department decision, Chow v. Reckitt & Colman Inc., 2010 NY Slip Op 00013 (App. Div., 1st Dept., Jan. 5, 2010).  There, a split First Department upheld the trial court's grant of summary judgment to the defendant manufacturer of of a drain cleaner called "Lewis Red Devil Lye", which blinded the plaintiff during an attempt to unclog a floor drain in the kitchen of the restaurant where he worked.  Applying the Court of Appeals standard in Voss v. Black & Decker Manufacturing Co, the court examined the 'risk-utility balancing' calculus, which often lies at the heart of a defective design product liability inquiry. In addition to Mr. Hoenig’s “refresher” survey of the law of product design liability, he directs his readers to the commentary issued by the Committee on Pattern Jury Instructions of the Association of Justices of the Supreme Court of the State of New York, particularly PJI 2:120. For further reading, a thoughtful discussion of PJI 2:120 appears in a 2008 article "New  Design-Defect Jury Instructions: Catching 'Denny' " by Stephen R. Blacklocks, a partner in Hunton & Wiliams'  New York office.  As Mr. Hoenig states in the conclusion of NYLJ article, “Mastery of the legal principles – our survey merely scratches the surface – is indispensable in perfecting one’s advocacy.”  When your client next assigns you a new case for  you to defend, take a few minutes to review Mr. Hoenig's primer to remind yourself just how many hurdles plaintiff's counsel needs to overcome to make out a prima facie case of design defect. 

The Mass Tort Defense Blog reported recently that the North Carolina federal district court overseeing the MDL concerning panacryl sutures declined last week to certify a proposed national class action in In re Panacryl Sutures Products Liability Cases, 2009 WL 3874347 (E.D.N.C. 11/13/09).  The decision is a significant one for pharmaceutical and medical device MDL practitioners because the court's reasoning in denying class certification is broadly applicable to other medical device products. It is increasingly rare for plaintiffs to obtain class certification in medical device litigation and this case is no exception. Panacryl Sutures are synthetic, braided, absorbable surgical sutures, designed to remain in a patient's body for 24-36 months after surgery to provide wound support. Various plaintiffs alleged that Panacryl Sutures were defective in that they allegedly caused a high rate of foreign body reactions when used as directed. Plaintiffs further alleged that the defendants failed to provide adequate warning of the dangers associated with the devices. Plaintiffs eventually filed a motion to certify a National Class Action. The Panacryl sutures were the subject of a  2006 recall by FDA.

In his blog post, Dechert's Sean P Wajert, discusses the various rationale underlying the court's decision not to certify a national class. In evaluating the requirements under Rule 23(a) and Rule 23(b), the court considered the impact that the laws of the various states where plaintiffs reside would have on the proposed class.  Considering Rule 23(a)(3)'s "typicality" requirement, the court found that the plaintiffs had not considered the varying substantive laws governing every class member.  Considering to Rule 23(b), the court found that in class actions governed by the laws of several states, variations in state law often overwhelmed common issues.  The court held that the plaintiffs would have to demonstrate by "extensive analysis" that the laws of interested jurisdictions did not pose "insuperable obstacles" to class certification.  As Mr. Wajert points out, courts have generally found that common questions of fact do not predominate in medical device products cases. In the Panacryl Sutures litigation, the sutures were used in a variety of surgical procedures, which required different techniques and skill sets on the part of the surgeon and presented different risks of post-operative complications.  Thus, it is not likely that any class would have been certified due to a lack of predominance of common issues, let alone a national class. For a further discussion of the policy and legal considerations that warrant denial of class actions in pharmaceutical and medical device litigation, take a look at the enthusiastic discussion of the decision in the Drug and Device Law Blog authored by Jim Beck and Dechert and Mark Herrmann at Jones Day.

The plaintiff's bar continues to look for fresh targets in the asbestos litigation, utilizing increasingly creative theories of liability, as the original targets of plaintiffs' lawsuits have been largely forced into bankruptcy.  One of the new asbestos battlegrounds centers around the liability of parts manufacturers, such as pump and valve manufacturers, who never manufactured or sold asbestos-containing materials ("ACM").  Plaintiffs typically argue that these manufacturers may be liable for asbestos-containing products manufactured by different companies that they can reasonably anticipate will be used with their equipment.  However, in recent months, there have been a handful of appellate decisions suggesting that liability will not be extended to equipment manufacturers that neither sold nor included with their equipment ACM.  At the end of last year, the Supreme Court of Washington issued two decisions that rejected plaintiffs' claim that defendants should be held liable for failing to warn of the hazards of another manufacturer's product that is applied to or incorporated into the defendants' products.  The Supreme Court of Washington articulated a blanket rule that a duty to warn under common law negligence "is limited to those in the chain of distribution of the hazardous product."  The court also concluded that the defendants were not strictly liable for manufacturing a defective product because, not being product sellers or manufacturers, they could not translate their knowledge of the product's dangerous aspects into a cost of production against which liability insurance could be obtained.  Thus, the court held, it would be manifestly unfair to hold a defendant liable for another party's product. There is a good discussion of these cases, Simonetta v. Vlad Corp. and Braaten v. Saberhagen, in a Metropolitan Corporate Counsel article written by John E. Heintz and Justin F. Lavella at Kelly Drye & Warren LLP. A great deal was at stake on the appeal of these cases.  On February 25, 2009, The California Court of Appeal decided Taylor v. Elliot Turbomachinery Co. Inc  2009 WL 458543, and reached the same result as the Washington Court.  In rejecting plaintiffs' theory that the defendant should be liable for exposure to ACM in replacement parts sold and manufactured by other companies, the California court relied upon the California's "chain of distribution" line of cases that culminated in Cadio v. Owens-Illinois Inc. These cases recognize that "legal nightmares" would result if one company was held liable for the products of other companies.  There is a discussion of both the California and Washington decisions in a March 17, 2009 Law360 article  In an August 21, 2009 blog post by Michael J. Pietrykowski of Gordon & Rees, LLP, the DRI Blog reported that the California Supreme Court has declined to accept an appeal of Taylor v. Elliot Turbomachinery Co. Inc.  In the world of asbestos litigation, defense victories like these in Washington and California are hard fought and few and far between.

Kenneth Ross, one of the more discerning authors in the product liability defense bar, has authored a thoughtful piece titled, Is There Anything Optional About Safety? in the August '09 DRI Product Liability Committee Newsletter--"Strictly Speaking".  As manufacturers design new products and update the design of old products, many times they sell and offer for sale differing levels of safety and quality.  Ken's article explores the legal and practical risks in selling products with these differences and provides advice to manufacturers about minimizing risk.  As one law professor notes, the case law is "muddled and quite sparse".  There are cases on both sides--those that hold that safety devices can be optional and those that hold that not installing a safety device establishes a basis for liability.  Ken discusses several important considerations that should be weighed in performing this delicate balancing act.

According to Senator Herb Kohl, the intention of the "Sunshine in Litigation Act of 2009" (S. 537) is to require federal judges to perform a " simple balancing test" to ensure that in any proposed secrecy order, the defendant's interest in secrecy truly outweighs the public interest in information related to public health and safety.  Citing court-approved confidential settlement agreements in product liability cases entered into by drug and tire manufacturers, Senator Kohl argues that federal judges must be required to consider public health and safety when deciding whether to allow a secrecy order.   Although this proposal may have a populist appeal, the  American Bar Association believes that the proposed law would make discovery more burdensome, more expensive, and more time-consuming, and would threaten important privacy interests.  The Act would change Federal Rule of Civil Procedure 26(c) by limiting a court's ability to enter an order in a civil case: (1) restricting disclosure of information obtained through discovery; (2) approving a settlement agreement restricting the disclosure of such information; or (3) restricting access to court records in civil cases. Before entering a secrecy order, a court would first have to perform the balancing test discussed by Senator Kohl or reach a determination that the order would not restrict the disclosure of information relevant to the protection of public health or safety.  I concur with the ABA that the Sunshine Act is a bad idea; its adoption would not serve the public interest.

The Committee on Rules of Practice and Procedure of the Judicial Conference of the United States reported last year that empirical studies demonstrate that there is no evidence that protective orders create a significant problem of concealing information about public hazards.  The Judicial Conference Advisory Committee on Civil Rules strongly opposes the measure as unnecessary legislation that will burden the courts and have significant adverse consequences for civil litigation.  Moreover, the ABA already has adopted policy that encourages courts to permit disclosure of information relevant to potential hazards.  Typically, in cases involving a sealed settlement agreement, there is sufficient information available to the public providing details of a potential public health or safety hazard. As product liability litigators are well aware, protective orders serve to facilitate the timely production of documents. Requiring that a court hearing be conducted before such an order is entered into in every civil case would consume precious judicial resources and further delay litigants' day in court.

In his  recent article, "Made in China: Consumer Product Lawsuits Imported to the United States", Seattle defense lawyer and IADC member Gregory Shelton offers American importers several good suggestions for avoiding potential liability from imported products.  These include: (1) requiring the exporter to comply with all applicable U.S. product quality standards and product safety regulations; (2) obtaining legal counsel in the exporter's home jurisdiction; (3) requiring the exporter to obtain appropriate insurance coverage from an American or international insurer that will protect the importer in the event of a recall or lawsuit; and (4) retaining good legal counsel early.  I would add to Greg's checklist: (5) having an independent U.S. consultant available to test, if necessary, the components of imported products, particularly if an American consumer reports a complaint to the company or to the CPSC.  Early independent product evaluation can be critical for an importer in planning its next steps, such as whether to perform a recall or halt future shipments until an issue can be addressed.  There are many good consultant firms to chose from. One excellent consultant up-to-speed on the new CPSC requirements is Exponent.

However, we disagree with Mr. Shelton when he argues that Chinese imports are more likely to result in lawsuits or recalls than imports from other countries.  There is simply no empirical evidence to support this assertion.  To the contrary, China has made enormous progress, particularly over the last year, to police its domestic suppliers.  To blame China for the spate of recalls over the last couple of years is to ignore the past lack of adequate funding for the CPSC, the agency that provides regulatory oversight of consumer products.  Moreover, blaming China results in Americans turning a blind eye to problems in our domestic product supply chain. 

In a provocative thought piece appearing in the Wall Street Journal on March 9, 2009, L. Gordon Crovitz predicts that the United States Supreme Court decision in Wyeth v. Levine will usher in an era of increased prices for drug and create a disincentive for new product innovation. Mr. Crovitz compares the American legal culture behind the Court's decision to the Luddites that smashed mechanized looms in England at the beginning of the Industrial Age in 19th century England.  He also suggests that the decision's logic may lead product manufacturers to "carry 50 different warnings, one for each state, updated by local juries from time to time."  Despite his misgivings about the decision, it is not likely that any product manufacturers, drug makers or otherwise, are likely to start tailoring their warning on a state by state basis.  As a practical matter, products are sold nationally, often through distributors, and it would be virtually impossible to  ensure that product warnings for Texas purchasers ended up in Texas and that product warnings intended for California purchasers ended up in California.  Moreover, from a jury standpoint, nothing would please a plaintiff's lawyer more than to be able to argue that the manufacturer provided a less strict warning for the product in the jurisdiction where his client's accident occurred. 

How can a brand-name pharmaceutical manufacturer owe a duty to patients who take only a generic version of its product? In a case of first impression in California, a state appellate court held on November 7, 2008 that Wyeth, Inc. owed a duty to plaintiff Elizabeth Conte, who developed a serious and irreversible neurological condition as a result of taking metoclopramide, the generic version of Wyeth’s Reglan, which is used to treat gastroesophageal reflux disease. In so holding, the California appellate court declined to follow the holdings of a majority of courts that have grappled with this issue.

In Elizabeth Ann Conte v. Wyeth, Inc. et al., the Court of Appeal of the State of the California in the First Appellate District in San Francisco, held that a brand-name pharmaceutical manufacturer’s common law duty to use due care when providing product warnings extends not only to consumers of its own product, but also to those patients whose doctors foreseeably rely on the name-brand manufacturer’s product information in prescribing a medication, even if the prescription is filled with the generic version of the drug. In reversing summary judgment granted to Wyeth by the trial court, the appellate court accepted Conte’s argument that Wyeth should be liable for her injuries because a brand-name manufacturer that disseminates information about its product owes a duty of care to ensure the information’s accuracy to all physicians who prescribe the drug in reasonable reliance on that information, even if the patient ends up taking the product’s generic equivalent.

The court agreed with Wyeth that Conte could not pursue a strict products liability claim against Wyeth. Indeed, Conte did not allege that Wyeth was strictly liability due to inadequate warnings. Rather, she claimed that Wyeth failed to exercise due care in disseminating its product information to physicians.  The court rejected Wyeth’s contention that Conte’s case was merely a product liability suit masquerading as a negligence case. The court held that the plaintiff could pursue claims of intentional and/or negligent misrepresentation based upon Wyeth’s labeling information about the safety of metoclopramide, the risks of its long term use, and the likelihood of serious side effects. 

Was the court correct in determining that Wyeth owed the plaintiff a duty in a negligence context where no such duty could be found to exist in a strict liability case? As a matter of public policy, should a brand-name drug manufacturer be subjected to what Wyeth argued might be “permanent and uncontrolled liability” in perpetuity. Even as a brand-name manufacturer’s sales decrease over time, its potential product liability exposure may actually increase because of higher market share won by generic competitors. Ironically, the generic manufacturer takes precious market share from the brand-name manufacturer at the same time that the court shifts the generic’s product liability exposure back to the pioneer. 

We believe that the better reasoned analysis of this issue may be found in Foster v. American Home Products Corp. (4th Cir. 1994) 29 F.3d. 165 (2003), in which the Fourth Circuit held that a manufacturer of a name-brand drug could not be held liable under a theory of negligent representation for an injury arising from the ingestion of a generic version of the drug. Taken to its logical extreme, in the brave new world envisioned by the Conte court, it may not matter that a plaintiff cannot identify the manufacturer of a product that caused an alleged injury so long as the plaintiff can plausibly claim to have relied on some other manufacturer’s operator’s manual.

The Consumer Product Safety Improvement Act of 2008 ("CPSIA") provides that the Consumer Product Safety Commission ("CPSC") will establish and maintain an Internet database on the safety of consumer products.  The CPSIA Section 212 requires that the database be: (1) available to the public; (2)  searchable; and (3) accessible on the CPSC's website.  Reports of harm caused by consumer products may be reported by consumers; local, state or federal govenment agencies; health care professionals; child service providers; and public safety entities. Ideally, the database will encourage the sharing of information and direct communications among consumers, consumer advocacy groups and state attorneys general, who have been given an important new role under the CPSIA.  For the first time, consumers will have direct instant access on the Agency's website to potentially important product safety information. 

The CPSIA of 2008 is much needed legislation to upgrade the level of  protection provided to the American consumer by the federal government.  The law represents the Congress' response to a year of multiple, embarrassing consumer product scandal after another during what some commentators have termed the "Year of the Recall".  In the past, information vital to the public welfare concerning defective consumer products has not been promptly provided to the American people.  At times, this delay may have been responsible for what may have been preventable injuries or deaths --  hence, the legislative mandate for the database.   

In light of these public benefits, can there be any dark side to this new era of governmental transparency?  Are consumer product companies justified in fearing that the database has the potential to  spread disinformation and unfairly tarnish reputations? 

The statute requires that a report submitted for inclusion on the database: (1) describe the consumer product; (2) identify the manufacturer or private labeler; (3) describe the harm related to the use of the product; (4) provide contact information; and (5) contain a verification that the report is true and accurate. Based upon informal Commission staffer comments, the CPSC is not required to perform an independent investigation to determine the veracity of a report or whether the incident that is the subject of the report occurred in the manner claimed or occurred at all.  For this reason, there is a risk that the database may morph into a  consumer Wikipedia, but with the imprimatur of United States approval and the gloss that comes from being hosted on a federal regulatory agency website.  What opportunity will  manufacturers have to comment on a report that one of their products may have triggered a fire in a home or caused a child to suffocate before the report is posted?  Unfortunately, not a whole lot!  The statute requires that within five days of receiving a report the Commission shall "to the extent practicable" transmit the report to the manufacturer identified in the report prior to the report being posted on the database.   Because the person making the report need not be identified to the manufacturer unless he or she explicitly consents, there may not be much the manufacturer can do, within the 10 day window provided before the report is posted, to determine whether the report is accurate. Certainly, this narrow window does not permit a manufacturer to obtain the product from a consumer, assuming the consumer can be identified, and inspect it.  The manufacturer can request that proprietary or trade secret information not be posted on the database, but that request, if granted, will result only in the sensitive information being redacted, not in a delay in posting the report on the database.  The statute permits a manufacturer to request that its own comments also be included in the database, but in the absence of a realistic time frame to perform an investigation of the underlying report, what would be an appropriate comment to make?  Moreover, the manufacturer may be at a disadvantage if reporters call seeking comment after the consumer's report is posted by the Commission.