After receiving a prescription for sulindac, the generic version of Clinoril, Karen Bartlett developed Stevens-Johnson Syndrome and toxic epidermal necrolysis, rare skin disorders that causes the sufferer’s skin to deteriorate by either being burned off or by turning into an open wound. Bartlett subsequently suffered painful, permanent injuries, including near-blindness, esophageal burns, and lung damage. A New Hampshire federal jury awarded Bartlett $21.06 million for her injuries based on a New Hampshire products liability claim for defective design. Mutual Pharmaceutical Company, a sulindac manufacturer, now challenges that decision by arguing that federal law regulating generic drugs preempts New Hampshire's design-defect law. The United States Court of Appeals for the First Circuit upheld the lower court design, finding no preemption, despite Supreme Court precedent finding preemption in similar contexts. Mutual Pharmaceutical argues that the Food, Drug, and Cosmetic Act preempts the state design-defect law because the Act requires generic drug manufacturers to produce generic medications that are bioequivalent to the corresponding name brand version of the drug. Bartlett responds that the state law does not conflict with federal law because the state law imposes no duty for sellers to change their product from the name brand version.
Whether the First Circuit erred when it created a circuit split and held-in clear conflict with this Court's decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)-that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.
Does federal law governing claims against generic pharmaceutical products preempt state law design-defect claims against the makers of those products?
- Terry Baynes & Jonathan Stempel, Supreme Court to review lawsuits over flaws in generic drugs, Thompson Reuters News & Insight (Nov. 30, 2012).
- Greg Stohr, Generic-Drug Makers Get Top Court Review on Patient Suits, Bloomberg (Nov. 30, 2012).