On June 24, 2013, the United States Supreme Court issued its decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, deciding the question of whether federal law governing FDA approval of generic drugs preempts state law claims against generic drug manufacturers based on state law design defect. The Supreme Court held that conflict preemption principles prevent a state law design defect claim against manufacturers of generic drugs approved by the FDA, where the design defect claim turns on the adequacy of a drug’s warning.
In December 2004, Karen Bartlett began treating shoulder pain with a generic anti-inflammatory medication known as Sulindac. Soon after beginning treatment, Bartlett began to suffer from toxic epidermal necrolysis, which ultimately deteriorated over 60% of her skin and caused permanent injuries, including near-blindness. At the time of the prescription, Sulindac’s label did not explicitly refer to toxic epidermal necrolysis, but by 2005, the FDA had recommended changing the label to do so.
Bartlett filed suit against the manufacturer of Sulindac, Mutual Pharmaceutical Company (“Mutual”), alleging, in part, a New Hampshire state law claim for design defect. In New Hampshire, a design defect cause of action imposes an affirmative duty on a manufacturer to design its products reasonably safely for foreseeable uses. New Hampshire courts look to three factors to determine whether a product’s design is unreasonably dangerous: (1) the product’s usefulness; (2) whether the risk of danger could have been reduced; and (3) the adequacy of the product’s warnings.
The Supreme Court explained that, for Mutual to increase Sulindac’s usefulness or reduce its risk of danger, Mutual would have had to redesign the drug. The FDCA requires a generic drug to be essentially identical to its brand-name counterpart. Redesign was therefore impossible without violating the FDCA. Therefore, the only way for Mutual to ensure the drug was reasonably safe for users was to change its labeling/warnings.
Mutual defended on the basis of federal preemption, claiming that the FDCA and FDA preempted state law design defect claims dependent on the adequacy of a drug’s warnings. Bartlett responded that, despite federal law, a manufacturer of a generic drug should still be liable under a state law design defect claim, where the manufacturer could have simply “stopped selling” the drug alleged to be dangerous.
The Supreme Court disagreed. Explicitly rejecting the “stop selling” argument, the Court clarified that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting, or stop selling, altogether to avoid liability. Grounding its opinion in its 2011 PLIVA, Inc. v. Mensing decision, the Supreme Court held that Bartlett’s claims were preempted under the doctrine of “conflict” or “impossibility” preemption.
In Mensing, the Supreme Court held that any claims that a generic drug manufacturer should have included stronger warning labels than those approved for use on the equivalent brand-name drug are preempted by federal law. In Mensing, the Court thereafter made clear that federal law prevents generic drug manufacturers from changing their labels.
Under New Hampshire law, a drug manufacturer was obligated to change its drug’s design or labeling to ensure that the drug is not unreasonably dangerous. Federal law, however, prohibits a generic drug manufacturer from changing the drug’s label and/or design. Thus, because it was impossible to comply with both federal and state law, the theory of impossibility preemption applied, precluding state law claims such as Bartlett’s.
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