Mutual Pharmaceutical Co. v. Bartlett
- Case Date: 1/22/2013
- Project Name: Health Care Project
On June 24, 2013, the U.S. Supreme Court held today that federal law impliedly preempts state-law product liability suits alleging that a generic prescription drug is defectively designed, where the drug has been determined to be safe and effective by FDA. The Court explained that such suits make it impossible for generic manufacturers to comply with both federal and state law because federal law does not permit them to alter either the composition of their drug or its labeling, yet such alterations are the only way that they can avoid liability under state tort law. The 5-4 decision was a victory for WLF, which filed a brief urging the Court to find in favor of federal preemption. WLF argued that state law judgments against a pharmaceutical manufacturer that are based on a determination that the drug is defectively designed undermine the new-drug approval process by calling into question FDA’s decision that a drug’s benefits outweigh its risks.
More Information and Downloads:
1/22/2013: Download the Brief
Litigation Update: Court Upholds Preemption Of Design Defect Suits Involving Drugs