Supreme Court to Consider Preemption of Design Defect Claims

Plaintiff Karen Bartlett was prescribed the generic drug, sulindac, to treat shoulder pain. In 2005, Ms. Bartlett developed a sever skin reaction knows as Stevens Johnson Syndrome or Toxic Expidermal Necrolysis. She filed suit in New Hampshire against Mutual Pharmaceutical Co. (the generic drug manufacturer) alleging that sulindac was unreasonably dangerous because its risks outweighed its benefits. The jury awarded her a $21 million verdict in 2010.

The United States Supreme Court issued its decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), holding that failure-to-warn claims against generic manufacturers were preempted by the Food, Drug, & Cosmetic Act and FDA regulations because generic manufacturers could not change product labeling and therefore could not comply with the duties imposed by state law failure to warn claims. Mutual then appealed the jury verdict in the Bartlett matter.

Mutual Pharmaceutical argued that Ms. Bartlett’s theory of recovery was preempted because the Supreme Court’s Mensing decision imposed on generic manufacturers a “duty of sameness” that applied to product design as well as labeling. Ms. Bartlett responded with the popular theory among plaintiffs that Mutual could have satisfied its state law obligations and federal obligations by merely opting not to market the product. The First Circuit held that the Mensing decision was limited to labeling and did not preempt Ms. Bartlett’s design defect claim. Yet, the First Circuit acknowledged that it could not justify its distinction between these theories of recovery and encouraged the Supreme Court to review the issue.

Mutual then petitioned the United States Supreme Court for a writ of certiorari in the matter, noting the First Circuit’s concerns and claiming that a circuit split existed between the First and the Fifth, Sixth, and Eighth circuits on the issue. On November 30, 2012, the United States Supreme Court granted review. Given how heavily litigated this issue, more guidance from the Supreme Court regarding the scope of its preemption holding will be welcome. Parties interested in the proceedings can monitor the Supreme Court docket .