United States: FDA Approval of Pharmaceutical Labeling Preempts Warning Claims

In a Chadbourne & Parke LLP Client Alert issued earlier this year,we reported that the FDA had issued revised regulations governing prescription drug labeling requirements generally preempting state laws.¹ Since then, the issue has come to decision in at least two cases favoring pharmaceutical interests -- Abramowitz and Colacicco.

Abramowitz appears to have been one of the first reported decisions addressing the preemptive effect of these regulations. It involved allegations that Cephalon -- the maker of a pain medication called Actiq -- had failed to warn plaintiff that use of the drug, which contains sugars used to mask the unpleasant taste of the Fentanyl it contains,was associated with tooth decay.

On summary judgment, Abramowitz found that Cephalon had discharged its duty to warn under the "learned intermediary doctrine" by informing plaintiff’s treating physician of the risk of tooth decay in "FDA approved package insert[s] and . . . information." Id. at *2. In reaching this conclusion, the court held that "the New Jersey courts have limited the availability of [failure-to-warn claims] when the warnings have been FDA approved" by presumption, on the basis that "compliance with FDA regulations serves as compelling evidence that a manufacturer satisfied its duty to warn." Id. at *3. On proof that Cephalon had provided plaintiff’s physician with information regarding the presence of sugar in Actiq, and the associated risk of tooth decay, along with the fact that it had forwarded "Med Watch" notices of tooth decay to the FDA’s attention, the court concluded a "reasonable juror could not find that the defendant did not provide an adequate warning." Id.

Past the failure of proof,and of wider significance, the court ruled that plaintiff’s failure-to-warn claim was preempted by FDA labeling regulations released on January 18, 2006. Citing New Jersey Supreme Court precedent that"state law can be preempted by a federal regulation when the federal agency intends to preempt state law,"the court found the requisite preemptive intent in a preamble statement by the FDA in releasing revised regulations pertaining to package inserts or professional labeling under its statutory authority. Id. at *4. There, the FDA stated that "under existing preemption principles,FDA approval of labeling . . . whether it be in the old or new format,preempts conflicting or contrary state law." Id. at *3 (citing 71 Fed. Reg. 3922-3997).

A similar conclusion regarding the preemptive effect of these regulations was issued some three months later in Colacicco, involving the anti-depressant Paxil. Significantly, in this case the FDA submitted an amicus brief at the court’s request, stating the position that its regulations impliedly preempted state law failure-to-warn claims. With the benefit of this submission, and thus able to dig deeper than was the case in Abramowitz, the Colacicco court noted the FDA’s position that a manufacturer is not free to alter its labeling for pharmaceutical products absent prior FDA approval, id. at *9, *10 and *17, grounding its decision in the end on the observation that "[f]undamentally, a series of Supreme Court decisions point this Court in the direction of deference" to the FDA, id. at *7-*15.

A more detailed analysis of the Colacicco decision can be found in our Client Alert,"Recent Federal Court Decision Dismissing as Preempted Pharmaceutical Failure-to-Warn Claims" (June 7, 2006).²

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