The Product Liability and Mass Tort Monitor is a monthly newsletter delivering critical updates, data insights and actionable strategies for navigating the complexities of product liability and mass tort litigation. This month’s issue explores the U.S. Supreme Court’s recent decision in Monsanto v. Durnell, which builds on a growing body of law concerning preemption of state law claims by federal labeling requirements.
Key Takeaways
- The U.S. Supreme Court held that state law failure-to-warn claims were barred by the Federal Insecticide, Fungicide, and Rodenticide Act’s (FIFRA’s) uniformity clause and EPA labeling requirements.
- Courts around the country have similarly held state law fraud, consumer protection and warranty claims are preempted under the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) uniformity clause.
- This decision strengthens a growing body of law preempting state law claims, which would require manufacturers to exceed the requirements of federal labeling regulations.
In Monsanto v. Durnell, the U.S. Supreme Court held that FIFRA expressly preempts state law failure-to-warn claims that would require Monsanto to add a cancer warning to the label of its glyphosate-based herbicide Roundup. Writing for a 7-2 majority, Justice Brett Kavanaugh explained that FIFRA’s uniformity clause bars states from imposing labeling requirements “in addition to or different from” those required under the act. Because federal law obligates Monsanto to use the EPA-approved label unless and until the agency approves or requires a change — and John Durnell’s state law tort claim would impose an additional, different labeling requirement — the Court held that FIFRA preempted his failure-to-warn claim. The Court’s opinion cited extensively to its 2008 opinion in Riegel v. Medtronic, Inc., which reached the same conclusion based on nearly identical language in the Medical Device Amendments of 1976 to the FDCA.
The Monsanto decision builds on a growing body of law holding that federal labeling requirements that are backed by preemption or uniformity clauses bar all state law claims that would require manufacturers to include labels beyond those required by federal regulations. As recognized in Monsanto, FIFRA’s uniformity requirement is nearly identical to those contained in the FDCA. While the FDCA exempts product liability actions from its uniformity clause for cosmetic and nonprescription drugs, courts around the country have held in recent years that the FDCA’s labeling requirements preempt other types of state law claims. For example, the U.S. Court of Appeals for the Second Circuit held the FDCA’s labeling requirements for cosmetics barred class action claims under numerous states’ unfair trade practices and consumer protection acts, common law unjust enrichment and the implied warranty of merchantability. Federal district courts in Illinois and Pennsylvania also barred fraud-based and warranty claims that would require manufacturers to include additional warnings beyond those required by the FDCA.
Moving forward, preemption is likely to play a major role in emerging areas of product liability litigation, including the rise of ultra-processed food (UPF) litigation. While the Eastern District of Pennsylvania recently dismissed a major UPF case on causation grounds, should plaintiffs’ claims survive elsewhere, the FDCA’s uniformity clause could provide a powerful shield for defendants, particularly as there is no product liability exception for food labeling. As courts continue to weigh whether the FDCA labeling requirement preempts claims in major ongoing nationwide drug, food and cosmetic litigation, manufacturers should monitor closely as this area of law develops.
For more information on these issues, contact the authors or their colleagues in McGuireWoods’ Product Liability & Mass Tort Practice Group.