Mutual Pharmaceutical Co. v. Bartlett

State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law.

Petitioner created a generic version of a brand name drug. Under the Hatch-Waxman Act, 98 Stat. 1585, a generic drug must be identical to the brand name drug in composition and labeling in order for it to be sold in the United States. Once approved to be sold in the United States, no changes are allowed to the composition or labeling.

After taking the generic drug, Respondent filed suit claiming defective design after the drug caused Respondent severe and disfiguring injuries. Respondent argued that New Hampshire law mandates strict liability for manufacturers to create items that are reasonably safe for its foreseeable uses, including a duty to warn about potential harm from usage. State law in this case creates a higher duty to warn than legally permissible under federal law. Petitioner removed the case to federal district court which found for Respondent. The Court of Appeals affirmed the judgment stating that the Petitioner could comply with both state and federal laws by choosing not to manufacture the generic drug.

The Court held that this case was similar to PLIVA, Inc. v. Mensing, 564 U. S. ___, in which the Court ruled that state failure-to-warn claims were pre-empted by the FDCA because the conflict between state and federal laws made it impossible to comply with both. In both this case and PLIVA, the Supreme Court held that the state laws were pre-empted and that the drug companies need only comply with the federal laws which stated that there can be no change to the labels. The Court holds that leaving the market in order to comply with both federal and state laws is not a option that the Court will indorse; if it were to do so, the Court would be invalidating a vast portion of cases in this area.