In 2008 a New Hampshire federal jury awarded Karen Bartlett $21 million for injuries she sustained after using a medication called sulindac. She was prescribed Clinoril for shoulder pain and received the generic version — sulindac. The drug was directly responsible for Bartlett developing Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), conditions that led to severe skin deterioration. Bartlett eventually suffered additional permanent injuries, including near-blindness, lung damage and burns in her esophagus.
The jury award relied on a New Hampshire products liability law allowing for damages based on defective design. The defendant in the case, Mutual Pharmaceutical Company, appealed to the U.S. Court of Appeals for the 1st Circuit arguing that the federal law regulating generic drugs preempts state design-defect laws. The 1st Circuit upheld the lower court decision and Mutual Pharmaceutical then appealed to the U.S. Supreme Court. The Supreme Court agreed to hear the case and oral arguments were held on March 19, 2013.
Mutual Pharmaceutical claims no liability since they are required, pursuant to the Food & Drug Cosmetic Act (FDCA) to use the same ingredients and warning labels as those used by the original manufacturer. In other words, they claim they are legally required to keep a generic drug identical to the brand name drug. Brand name manufactures maintain that they are not responsible for injuries caused by drugs that were not purchased from them.
Ultimately, this case well help clarify how federal law applies to generic pharmaceutical companies as well as determine the extent to which state product liability laws pertain to the generic drug industry.
For a thorough analysis of the legal issues involved in this case see Cornell’s Legal Information Institute.