by: Jonathan Knoll, Attorney
Recently, in a divided 5-4 opinion, the United States Supreme Court dealt a crushing blow to victims of dangerous and defective drugs. In Mutual Pharmaceutical Co., Inc. v. Bartlett, the Supreme Court found that state-law design defect claims against generic drug manufacturers that turn on the adequacy of a drug’s warnings are pre-empted by federal law. In doing so, the Court extended its 2011 decision in PLIVA, Inc. v. Mensing, which found that state-law failure to warn claims against generic manufacturers are pre-empted under federal law.
In 2004, Karen Bartlett suffered horrific injuries as a result of taking a generic form of the nonsteroidal anti-inflammatory drug (NSAID) sulindac. The generic form was manufactured by Mutual Pharmaceutical. After taking this drug, Karen developed an acute case of toxic epidermal necrolysis. The results were tragic. About 65% of her skin was deteriorated, she spent months in a medically induced coma, underwent 12 eye surgeries and had to be fed by a feeding tube for a year. Karen is now severely disfigured, has severe physical disabilities and is nearly blind.
When Karen took Mutual’s drug, the drug’s label did not specifically warn about the dangers of toxic epidermal necrolysis. In 2005, the FDA recommended changing all NSAID labels to include a clearer toxic epidermal necrolysis warning. Karen sued Mutual on a claim for design-defect under New Hampshire law. New Hampshire law imposes a duty on manufacturers to ensure that the drugs they design, manufacture and sell are not unreasonably dangerous. Following trial, a jury awarded Karen over $21 million in damages, finding that Mutual’s drug was unreasonably dangerous. The evidence at trial showed that the drug posed a higher than normal risk of causing the injuries that Karen sustained and other risks without any offsetting benefits. The jury’s verdict was affirmed by the First Circuit Court of Appeals.
The Supreme Court reversed, wiping out Karen’s verdict award. The Supreme Court found that under New Hampshire law, Mutual was required to change its drugs’ design or strengthen the drugs’ warnings by changing the label. However, the Court found that it was impossible for Mutual to comply with both state and federal law because federal law prohibits generic drugs manufacturers from changing a generic drug’s design or label.
In a dissenting opinion, Justice Sotomayor pointed out that it was not impossible for Mutual to comply with both state and federal law, even if the manufacturer cannot change the drug’s design or label. If a drug is unreasonably dangerous, a manufacturer can simply continue to sell the product knowing that it may have to compensate consumers injured by the product or stop selling its product all together. While manufacturers may not like that choice, as Justice Sotomayor notes, it is a choice a State “may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumers receive compensation.” The Majority of the Court was not moved by this argument.
The sad reality for consumers of generic drugs is that, as Justice Sotomayor noted in her dissent, “the Court has left seriously injured consumer[s] without any remedy despite Congress’ explicit efforts to preserve state common-law liability.”