Preemption Upheld in Clomid Case
The 10th Circuit Court of Appeals has upheld a Utah federal court finding that a branded drug company cannot be held liable for failing to warn consumers about alleged birth defect risks when FDA previously rejected a petition seeking the same warnings. Four Morrison & Foerster attorneys write in an online blog post that a family alleged that Aventis’ fertility drug Clomid led to birth defects in a child due to the mother’s use of the drug before becoming pregnant. The family filed suit under Utah tort claims including failure to warn, breach of implied warranty, negligent misrepresentation, and fraud.
The district court granted Aventis’ motion for summary judgment, saying that since FDA would not have approved the drug warnings sought in the petition, it was impossible for Aventis to comply with both agency regulations and state law, and thus state law was preempted, the attorneys say.
On appeal, the plaintiffs relied on a 1987 proposed warning that the drug may cause fetal harm when administered to pregnant women. Although Aventis did not adopt the proposed warning, and although the plaintiff was not pregnant when she used the drug and thus was outside the scope of the proposal, the plaintiffs contended that the agency proposal showed it was willing to approve warnings for women taking Clomid before becoming pregnant and the female plaintiff would not have taken the drug before her pregnancy had the warning been in place.
The attorneys write that Aventis made the argument that it only needed to comply with the FDA regulations and not Utah state law because complying with both would be impossible. As evidence that FDA would not have approved the plaintiffs’ suggested warnings, Aventis cited the agency’s history of approving Clomid for use by women before becoming pregnant, and the agency’s rejection of a citizen petition.
“Although the court determined that Clomid’s regulatory history did not, in and of itself, constitute clear evidence [that FDA would not approve a warning],” the post says, “FDA’s rejection of a citizen petition did provide the requisite evidence.”
The attorneys say the plaintiffs argued that when FDA considers proposed label changes, it treats manufacturers more favorably than a citizen’s petition, leading the agency to accord greater deference to the changes proposed by manufacturers that those proposed in a itizen petition. But the court rejected this argument, saying that the FDA standard for revising a warning label “does not discriminate” between proposals submitted by manufacturers and proposals submitted by citizens.
“This ruling clarifies a defendant’s burden of proof in establishing a preemption defense,” the attorneys conclude. “It establishes that FDA’s denial of a sufficiently similar citizen’s petition satisfies the clear-evidence standard required to successfully preempt a failure-to-warn claim. Therefore, branded drug manufacturers have an additional evidentiary tool even when no other form of FDA decision-making exists to demonstrate that FDA would have rejected a label change. Ultimately, if other circuits follow the 10th Circuit’s lead, pharmaceutical companies may no longer need to demonstrate an attempt to provide the kind of warning allegedly required under state law. We anticipate that going forward parties will disagree on the issue of how similar a citizen’s petition needs to be in order to have this preemptive effect…. The 10th Circuit acknowledged that the citizen’s petition was ‘virtually identical’ to the warnings the plaintiffs advocated; however, we anticipate that courts may still find a preemptive effect when a citizen’s petition is substantially similar to proposed warnings. So long as the substance of the proposed warning is the same, as well as its effect on the consuming public, it is unlikely that a decision will turn on semantics.”