Over the past several years, the Food and Drug Administration (FDA) has begun asserting that its authority over device and drug labeling cannot be reconciled with state laws that impose stronger or different requirements on industry. In February 2008, the US Supreme Court ruled that FDA’s premarket device approval process preempts some state common law product liability claims (Riegel v. Medtronic, Inc., 128 S. Ct. 999). That landmark ruling has already prompted an attempt in Congress (so far unsuccessful) to reverse the Supreme Court’s ruling.  Meanwhile, trial and appellate courts remain split on whether FDA’s review and approval of drug label warnings preempt state common law product liability claims. On Monday, November 3, 2008, the Supreme Court will hear oral argument in a case that turns on this contentious issue.

Will the Supreme Court Rule that FDA’s Control Over Drug Labeling Preempts State Suits Seeking Compensation for Drug-Related Injuries?

In January 2006, buried within a lengthy preamble to a final regulation amending FDA’s drug labeling requirements, the agency noticeably shifted its position to favor conflict preemption of all state product liability claims (see Arent Fox Alert of 1/20/2006). The FDA had previously asserted the contrary position in proposing the rule change in the December 22, 2000 Federal Register. At that time, FDA specifically stated that the new rules would not introduce policies “that have federalism implications or that preempt State law.”  FDA’s changing positions have given rise to a split among the courts, some of which have found the 2006 preemption statement to be entitled to significant deference, while others have ruled against conflict preemption. The Supreme Court will consider this in its November 3 hearing in Wyeth v. Levine (Docket No. 06-1249). 

Unlike the express preemption provision interpreted last term in Riegel, the defendant’s position in Levine hinges on implied conflict preemption. In Levine, the Vermont Supreme Court ruled (over the dissent of its chief judge) that Ms. Levine’s failure-to-warn claims were not preempted by FDA’s approval of the drug label. Ms. Levine had alleged that she had developed gangrene after taking Wyeth’s prescription anti-nausea medication Phenergen, which had been inadvertently injected into her artery. Ms. Levine – a professional guitarist – lost her arm to amputation. She prevailed at the trial level and was awarded $6.7 million. 

Wyeth appealed, arguing the trial court should have dismissed the complaint because FDA had approved the drug’s label warnings, thereby preempting any state common law claims. The Vermont Supreme Court ruled that “federal labeling requirements create a floor, not a ceiling, for state regulation.” 944 A.2d 179, 184 (Oct. 27, 2006). In the appeal currently before the US Supreme Court, the question presented is “whether the prescription drug labeling judgments imposed on manufacturers by the FDA . . . preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.” 

The US Solicitor General has submitted an amicus brief that stresses FDA’s “expert weighing of the risks and benefits of requiring additional or different warnings.” Citing the 2006 Federal Register preamble, the Solicitor General argues that the Vermont Supreme Court incorrectly interpreted FDA regulations to permit manufacturers unilaterally to strengthen drug warnings, when in fact such changes are only permitted to be based on “newly available information” and not on information that FDA had when it reviewed the drug for approval.   

In an amicus brief arguing against preemption, two former FDA commissioners (David Kessler and Donald Kennedy) argue FDA’s drug approval process should not displace the post-approval duty of manufacturers to warn physicians and patients about emerging safety risks. “The simple fact is that drug companies have far superior information-gathering tools about the safety profile of the drugs they sell, while FDA’s tools to keep track of safety hazards post approval are imperfect at best.”

The Supreme Court Decision in Levine Should Resolve the Persistent Split Among Lower Courts

Lower courts deciding prescription drug product liability cases either have given deference to FDA’s expertise and its 2006 preamble statement or have disregarded the statement altogether. Some courts have even begun postponing their decisions pending the Supreme Court’s decision in Levine. Significantly, however, the US Court of Appeals for the Third Circuit recently issued a consolidated opinion on the appeal of two district court decisions that came to opposite conclusions regarding federal preemption based on prescription drug warnings.   

In Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006), the trial court gave considerable deference to FDA’s position on the drug labeling question. It held that drug manufacturers were precluded from placing stronger warnings advising physicians and patients of the association between antidepressant drugs and suicidality because FDA had determined there was insufficient scientific evidence to support such an association. 

However, in the other case appealed to the Third Circuit, McNellis v. Pfizer Inc., 2006 WL 2819046 (D.N.J. Sept. 26, 2006), the trial court refused to defer to FDA’s 2006 preamble statement, referring to it as an “advisory opinion” and highlighting the agency’s inconsistent position on preemption. In McNellis, the plaintiff had asserted failure-to-warn claims that were similar to those in Colacicco.

The Third Circuit issued its consolidated opinion on April 8, 2008 (521 F.3d 253). The court concluded there was a direct conflict between a state-based legal obligation to include a warning about suicidality and antidepressant use and FDA’s repeated approval of those drug labels without a stronger warning statement. For that reason, the Third Circuit held that both plaintiffs’ failure-to-warn claims were preempted by the specific actions taken by FDA. One circuit judge dissented, arguing that the presumption against preemption should prevail where Congress has not clearly expressed its desire to preempt state tort law.

Conclusion

The Supreme Court’s upcoming review of the preemptive effect of FDA’s approval of prescription drug labeling and product warnings will be closely watched by the nation’s pharmaceutical companies, patients, and physicians. Predictions on the outcome made by professional Court-watchers are by no means consistent and, indeed, there are several methods by which the Court could resolve the case without ruling on the merits of the implied preemption issue. Nonetheless, Wyeth v. Levine should prove to be a historic ruling regardless of the approach taken by the Court.

For further information on federal preemption by the FDA, please feel free to contact Wayne Matelski, Brian Waldman, or Joanne Hawana.