Is a state law failure-to-warn claim preempted when the FDA rejects a drug manufacturer’s proposed warning, or should the jury consider whether the FDA would have approved a differently worded warning?
The Supreme Court will determine whether the Food and Drug Administration’s (“FDA”) prior rejection of a drug manufacturer’s proposed warning preempts a state law failure-to-warn claim against the same manufacturer. Merck Sharp & Dohme Corp. (“Merck”), a corporation that manufactures the drug Fosamax, argues that under the Supremacy Clause, a state law claim for failing to warn about a link between a drug and abnormal femoral fractures is precluded by the FDA’s rejection of a proposed warning about the fractures. Doris Albrecht, a consumer who took Fosamax and suffered atypical femoral fractures as a result, counters that the FDA’s rejection of the warning is not dispositive and that evidence showing that the FDA would have approved an alternative warning should be considered by a jury. The Third Circuit ruled that whether the FDA would have approved an alternative warning is a question of fact that should go to the jury. Merck is now appealing that decision in a case that will have implications for drug warnings, FDA reporting, and public health.
Questions as Framed for the Court by the Parties
Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer's proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning.
Before a drug manufacturer can permanently add warnings to a drug label, the Food and Drug Administration (“FDA”) must approve the addition. In Re Fosamax Alendronate Sodium Prods. Liab. Litig.. There are two different ways to implement this change. The first changes the label immediately and allows the FDA to review the change later. Id. at 273–74. The second requires seeking approval from the FDA before making the change.
- Julie A. Steinberg, Merck Wants SCOTUS to Review Decision in Fosamax Suits, Bloomberg BNA (Aug. 23, 2017).
- Lisa Soronen, Supreme Court to Decide Whether State Law Claim Against Drug Manufacturer is Preempted, National Conference of State Legislatures Blog (Sept. 10, 2018).
- Ilana Hope Eisenstein et al., Supreme Court Agrees to Hear Fosamax, DLA Piper (June 29, 2018).