ReedGuest Commentary

By Matthew A. Reed, Sedgwick LLP

“Impossibility preemption,” the US Supreme Court has warned, “is a demanding defense” to a state tort claim for failure to warn about the risks of a prescription drug.  Wyeth v. Levine, 555 U.S. 555, 573 (2009).  It is not, however, impossible to prove.  Indeed, the Utah federal district court on March 16, 2016 acknowledged in Cerveny v. Aventis, Inc. two ways by which a prescription drug manufacturer may prove the impossibility of complying with conflicting state law and federal regulations.

Cerveny involved a child born with birth defects after his mother took the infertility drug Clomid in the two months prior to her pregnancy in 1992.  The child and his parents sued Aventis, the drug’s current manufacturer, claiming it had a duty to warn the mother’s physician that Clomid can cause birth defects when taken prior to pregnancy.

Clomid’s FDA-approved label had, since 1967, warned that it should not be taken during pregnancy due to a risk of fetal abnormalities, but FDA has never required a warning that Clomid can cause birth defects if taken prior to pregnancy—despite approving label changes in 1980, 1991, 1994, and 2012.  In fact, the label was changed in 1994 to indicate there was insufficient scientific evidence that taking Clomid before pregnancy increased the general rate of birth defects.

In addition, a 2007 citizen petition—replete with purportedly supportive scientific literature—specifically asked FDA to require Clomid’s label to include a warning that it could cause birth defects if ingested prior to pregnancy.  FDA independently evaluated the scientific research and denied the petition in 2009, finding insufficient scientific support for the alleged danger.

Citing these facts, Aventis moved for summary judgment in Cerveny on impossibility preemption grounds, arguing it could not comply both with plaintiffs’ warning demands and FDA’s labeling regulations.  Wyeth held that a failure-to-warn claim is subject to impossibility preemption when there is clear evidence that FDA would not have approved the labeling change the plaintiff claims state tort law required.  It did not, however, define “clear evidence” or identify the level of proof required.  Aventis argued that two facts regarding Clomid together constitute “clear evidence”: (1) FDA’s rejection of the citizen petition, and (2) FDA’s approval of labeling language contrary to plaintiffs’ claims, despite knowledge of the risks they alleged.

On the first point, the court cited several lower court cases holding that, “where a citizen petition post-dates the alleged injury and addresses the failure-to-warn claim proffered by a plaintiff, a citizen petition denial can be evidence to support a manufacturer’s preemption defense.”  The court then found that the citizen petition regarding Clomid, which was filed over fifteen years after the mother’s use of the drug, presented plaintiffs’ causation theory to FDA.  FDA’s rejection of that theory was clear evidence that it would have rejected the labeling change plaintiffs sought, and thus mandated preemption.

On the second point, the court noted that FDA inaction, despite full awareness of a purported risk, is “highly persuasive” evidence of impossibility preemption.  FDA, the court observed, never required the warning the plaintiffs sought on Clomid, even after it had reviewed and rejected the citizen petition.  Moreover, FDA had approved labeling specifically stating insufficient scientific evidence existed to establish that taking Clomid prior to pregnancy caused birth defects.  These facts were “highly persuasive evidence” that FDA would have rejected plaintiffs’ suggested warning, and thus provided a separate “dispositive” ground for impossibility preemption.

Prevailing under Wyeth’s “demanding” brand of preemption in the face of the Supreme Court’s requirement of “clear evidence” can be daunting.  The Cerveny opinion, however, properly identifies and applies the core of the inquiry: If FDA has considered and expressly or impliedly rejected a risk associated with a prescription drug, a state tort failure-to-warn claim predicated on that alleged risk is properly subject to impossibility preemption.  Other courts would do well to emulate the Cerveny judge’s rigorous analysis and straightforward conclusion in factually similar cases.