Mutual Pharmaceutical Co. v. Bartlett

Case Updates

The Court held that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA.

The U.S. Chamber urged the Supreme Court to reverse the decision of the First Circuit, which held that a company could simultaneously comply with a federal license to make and sell an FDA approved drug and a state law duty not to make that same drug by choosing to “stop selling” the drug at issue. In this case, a lay jury in a state law design-defect case determined, based on its own risk-benefit analysis, that an FDA approved drug the defendant company manufactured had a design-defect. The First Circuit upheld the jury's determination based upon a radical new theory that a manufacturer can simply stop manufacturing a drug, and thus avoid any conflict between the federal laws approving the sale of the drug, and the state's determination that the drug, as designed, is unlawful in the state.

The Chamber's amicus brief argued that under the Supremacy Clause, the FDA's expert determination that a drug at issue was safe and effective and should be available as a matter of federal law to prescribing physicians and their patients preempts any determinations of a lay jury acting under state law. Additionally, the First Circuit's “stop selling” theory would result in a balkanized market, where federally approved drugs are available in some states, but not others. Such balkanization is incompatible with the Commerce Clause, which was designed by the Framers to foster the free flow of commerce in a single, national market.