The First Circuit Court of Appeals has upheld a jury verdict of $21.06 million in compensatory damages awarded to a women allegedly injured by a generic drug she took for shoulder pain, finding, among other matters, that her state law-based design-defect claims were not preempted by federal law. Bartlett v. Mut. Pharm. Co., Inc., No. 10-2277 (1st Cir., decided May 2, 2012).
The claims arose from the plaintiff’s use of generic sulindac, a known cause of toxic epidermal necrolysis. The plaintiff lost 60 to 65 percent of her body surface and spent nearly two months in a hospital burn unit and months in a medically induced coma. She was tube fed for one year and experienced two major septic shock episodes. Despite 12 eye surgeries, she is almost blind and is not only seriously disfigured, but cannot eat normally because of esophageal burns nor engage in aerobic activity due to lung injuries. The core theory tried during the 14-day trial was that the generic drug’s “risks outweighed its benefits making it unreasonably dangerous to consumers, despite the federal Food and Drug Administration (‘FDA’) having never withdrawn its statutory ‘safe and effective’ designation that the original manufacturer had secured and on which [the defendant] was entitled to piggyback.”
Providing an overview of U.S. Supreme Court preemption rulings as to failure-to-warn claims involving branded (not preempted) and generic (preempted) prescription drugs and noting that the Court has ruled out implied preemption under the Federal Food, Drug, and Cosmetic Act, the court decided that it would be up to the high Court to decide whether design-defect claims asserted in generic drug cases are preempted under federal law, thus refusing the defendant’s request that it do so here.
According to the court, while a generic drug maker cannot unilaterally change its labels, “and thus cannot comply with both federal labeling standards and state law requirements deviating from those standards,” a generic drug maker “can choose not to make the drug at all.” In other words, “while the generic maker has no choice as to label—the decision to make the drug and market it in New Hampshire is wholly its own. Thus, [the plaintiff] having lost her warning claim by the mere chance of her drug store’s selection of a generic, the Supreme Court might be less ready to deprive [the plaintiff] of her remaining avenue of relief.”