On June 24, 2013, the United States Supreme Court issued a decision that further forecloses remedies for people injured by generic pharmaceutical drugs. In a five-to-four decision in a case titled Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466 (U.S. 2013) (“Bartlett“), the Supreme Court ruled that “state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law” under the earlier Supreme Court decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (“Mensing“).
Generic pharmaceutical drugs are typically drugs that are no longer subject to a valid patent. Such drugs are manufactured by companies other than the holder of the original patent and brand-name. These companies are known as generic drug manufacturers.
In 2011, the Supreme Court ruled in Mensing that generic drug manufacturers cannot be held liable under state law for failure to change a drug label to give an adequate warning. The Supreme Court explained that federal law prohibits generic drug manufacturers from making changes to a label without approval from the U.S. Food and Drug Administration. The Court reasoned that it is impossible to comply with both the state law, which requires a better warning, and federal law, which prohibits label changes. The Supreme Court then held that the federal drug labeling laws trump the state causes of action for failure to warn.
Based on technical interpretation of federal preemption and drug labeling laws, the Supreme Court, through its ruling in Mensing, arbitrarily denied state remedies to severely injured plaintiffs who happened to take a generic drug instead of the brand name equivalent. As Justice Sotomayor commented in her dissenting opinion in Mensing:
As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: This outcome “makes little sense.”
In Bartlett, the Supreme Court extended its rationale in Mensing to state design-defect causes of action. The Supreme Court overturned a 21 million dollar jury verdict in favor of a plaintiff who was severely and permanently disfigured by a generic version of the drug Clinoril. In arriving at this ruling, the Supreme Court first determined that the New Hampshire design-defect law imposes on a generic drug manufacturer a duty to change a drug label to provide an adequate warning. Having concluded that a design-defect cause of action in New Hampshire is, in effect, same as a failure to warn claim, the Supreme Court applied its ruling in Mensing and overturned the award.
While the result in Bartlett leaves no hope for the plaintiff in that case, the Supreme Court expressly suggested that its rationale does not automatically apply to design-defect causes of action under other states’ laws. Thus, applicability of Bartlett is open to litigation on a state-by-state basis.
Sources: PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011); Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466 (U.S. 2013).