News & Updates

Supreme Court Finds State Laws for Generic Drug Labeling Are Pre-Empted by Federal Regulations August 16, 2011

In a 5-4 decision, the U.S. Supreme Court recently granted a victory to generic drug manufacturers in Pliva v. Mensing, 131 S.Ct. 2567 (June 23, 2011). The court found that state laws requiring safer labeling were pre-empted by federal law requirements as interpreted by the Food and Drug Administration (FDA). Respondent patients had claimed that their long-term prescribed use of the digestive drug metoclopramide, the generic form of Reglan, had led to tardive dyskinesia (TD), a serious neurological disorder. They asserted that despite mounting evidence of the risk of developing the disorder with long-term use of the drug, the generic drug manufacturers did not adequately warn of such risk.

The Minnesota and Louisiana state laws at issue require a manufacturer to warn consumers of any dangers of which it has actual or constructive notice. However, under federal law, a generic drug manufacturer must show that its proposed labeling is the same as that approved for the identical brand-name drug. Further, the generic drug must maintain the same label as the brand-name drug.  The brand-name drug manufacturer is responsible for both the accuracy and adequacy of the label. The respondents argued that the manufacturers could have changed their labels through the FDA’s CBE (changes-being-effected) process, which allows a manufacturer to add or strengthen a warning to increase the safe use of a drug with a simultaneous supplemental application to the FDA rather than pre-approval. However, the court deferred to the FDA’s interpretation of the CBE regulation, noting that changes to generic drug labels could only be allowed to match the brand-name label or if following the FDA’s instructions. The FDA argued that any unilateral changes made by a generic drug manufacturer to the label would violate its ongoing duty to match the brand-name label. A “Dear Doctor” letter would also be considered labeling by the FDA.

The court held that it would have been impossible for the generic drug manufacturers in Pliva to have followed both state and federal law. That is, they could not have changed the labeling to provide stronger warnings about TD without violating the federal requirement of “sameness” as the brand-name label. Therefore, the respondents’ tort claims based on state law were pre-empted by federal law.

The court did note that the decision in Pliva was not contrary to that of Wyeth v. Levine, 555 U.S. 555, 583 (2009), where the court found that plaintiff’s lawsuit against Wyeth, a brand-name drug manufacturer, was not pre-empted. In that case, as a brand-name manufacturer, Wyeth could have unilaterally changed its warning label through the use of the CBE process, at the same time satisfying its state tort duty.

If you have questions about how this may impact your business, please contact a member of the Goldberg Segalla Product Liability Practice Group.