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. 

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.