Design Defect

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. 

Questions as Framed for the Court by the Parties

Written by

Edited by