Firm wins summary judgment for defendant pharmaceutical company in Stephens-Johnson Syndrome case in federal court

Glenn S. Kerner and Joseph P.H. Babington

Glenn S. Kerner, chair of the Mass Tort and Class Action SLG of DRI’s Product Liability Committee and partner of Goodwin Procter LLP in New York City, teamed with Joseph P.H. Babington, partner of Helmsing, Leach, Herlong, Newman & Rouse, P.C., in Mobile, Alabama, recently to obtain summary judgment in favor of Teva Pharmaceuticals USA, Inc. (Teva) in a product liability action involving the prescription drug cephalexin in the United States District Court for the Southern District of Alabama. Barnhill v. Teva Pharmaceuticals USA, Inc., et al., case no. 06-cv-00282 (S.D. Ala. May 10, 2011). Plaintiff’s negligent failure to warn claims were dismissed on the basis of the learned intermediary doctrine. In dismissing the plaintiff’s claim for negligent failure to conduct post-marketing surveillance, the court declined to extend Teva’s post-marketing surveillance duty beyond the requirements of FDA regulations. The court also dismissed the plaintiff’s breach of implied warranty of merchantability claim.

The plaintiff alleged that, at age 12, she developed Stevens-Johnson Syndrome, a rare and severe hypersensitivity reaction, as a result of ingesting Teva’s antibiotic cephalexin. Plaintiff’s complaint asserted various claims under Alabama law, including strict liability, misrepresentation, negligence, breach of express warranty and breach of implied warranty of merchantability. Early in the litigation, Teva prevailed on a motion to dismiss the plaintiff’s strict liability and misrepresentation claims. All remaining claims were dismissed on summary judgment, including negligent failure to warn, negligent failure to conduct post-marketing surveillance and breach of implied warranty of merchantability.

The court held that summary judgment for Teva was warranted on the failure to warn claim because the plaintiff could not establish proximate cause under Alabama’s learned intermediary doctrine. The plaintiff’s prescribing physician had testified at deposition that she still prescribes cephalexin today, despite being aware of the potential risks. Given that testimony, the court held there was no evidence to support the plaintiff’s allegation that a more forceful warning would have changed the physician’s decision to prescribe cephalexin for the plaintiff. In so holding, the court rejected the plaintiff’s argument that a heeding presumption should apply in this case.

The court rejected the plaintiff’s claim that Teva had a legal duty to conduct post-marketing surveillance beyond the requirements of FDA regulations. Teva demonstrated that it complied with all FDA regulations relating to reporting adverse events. However, the plaintiff argued that Teva was obligated to monitor and report adverse events from other manufacturers’ cephalexin products, as well as its own. The court found that the plaintiff provided no support for her argument that such a duty existed.

The court also rejected the plaintiff’s breach of implied warranty of merchantability claim, holding that the plaintiff presented no evidence to rebut the presumption under Alabama law that cephalexin, as an inherently dangerous product, is fit for its intended use.