Supreme Court to Hear Defect In Design Appeal by Generic Drug Manufacturer

The Supreme Court will decide whether to overturn a First Circuit ruling finding a generic pharmaceutical maker liable for a defect in a drug design that caused tortuous burns to a consumer, despite federal laws that require generic drugs to be identical to brand-name drugs. The high court granted the petition for certiorari filed by Mutual Pharmaceutical Company, Inc. (Mutual), the manufacturer of the generic non-steroidal anti-inflammatory drug, sulindac (brand name Clinoril®). In Bartlett v Mutual Pharmaceutical Company, Inc., the First Circuit Court of Appeals previously ordered Mutual to pay $21.6 million to Karen Bartlett, a consumer injured by sulindac.

Bartlett took the drug to relieve shoulder pain. Her use of sulindac ultimately resulted in deterioration of more than 60 percent of the surface skin of her body, months in a medically induced coma, a year of tube feeding, and 12 eye surgeries, among other problems. Bartlett sued Mutual under New Hampshire law, alleging that the risks of sulindac’s design outweighed the benefits. The First Circuit ultimately accepted the argument, upholding a jury’s finding of liability. The court rejected Mutual’s argument that the case was preempted by federal law, as described in the Supreme Court’s holding in PLIVA, Inc. v Mensing, that generic products cannot deviate from the brand-name products on which they are based. The First Circuit specifically stated that “[I]t is up to the Supreme Court to decide whether [Mensing] is to be enlarged to include design defect claims.”

In 1984, Congress added the Hatch Waxman amendments to the Food, Drug and Cosmetic Act (FDCA). The amendments eased the way for generic drugs to enter the market by providing a process by which generic drug-makers could have prospective drugs approved for sale by demonstrating that they were bioequivalent to previously-approved brand name drugs. According to Mutual, the high court determined in Mensing that the amendments precluded consumers from arguing that generic drug manufacturers had a duty to warn consumers and health care providers of risks associated with the manufacturers’ products that were not included in brand name labeling and packaging. It rejected the argument that generic drug manufacturers could comply with state law by simply deciding not to sell the risky drugs. However, Bartlett argued that the ruling only applied to failure to warn cases, and not design defect cases. Mutual viewed the First Circuit ruling as a “frontal assault on Hatch-Waxman’s core objectives.” Two amicus curiae (friend of the court) briefs have been filed by pharmaceutical associations in support of Mutual’s appeal. The case does not yet appear on the Supreme Court’s upcoming docket.