Wednesday, March 4, 2009
The Supreme Court ruled (6-3) today in Wyeth v. Levine that FDA regulations did not preempt a Vermont jury's tort verdict for the plaintiff based on an inadequate label warning. I previously posted on the case here, and on related issues here and here.
Justice Steven's majority opinion rejected both of Wyeth's preemption claims. As to conflict preemption, the Court ruled that the state tort verdict setting a standard for drug labelling higher than FDA's requirement for Wyeth did not conflict with federal law and FDA regulations, because FDA regulations include a provision--the "changes being effected" provision--that permits a drug manufacture to add to or strengthen its label without waiting for FDA approval. Here, Wyeth could have changed its label under the CBE based on information of the drug's effects that it compiled since the drug came on the market. (This included 20 incidents in which injections of the drug resulted in gangrene and amputation, the same harm suffered by the plaintiff in this case.) Thus Wyeth could have complied with both the federal regulations and the standard of care set by the state jury.
As to Wyeth's claim that the state tort verdict undermined the purposes and objectives of the FDA labelling regulation, the Court simply found no evidence of contrary purposes and objectives. In fact, just the opposite:
Wyeth contends that the FDCA establishes both a floor and a ceiling for drug regulation: Once the FDA has approved a drug's label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue. The most glaring problem with this argument is that all evidence of Congress' purposes is to the contrary.
The Court gave little weight to the agency's bald (and late) assertion that state tort verdicts would undermine its purposes and objectives and the agency's under-the-radar assertion that its regs preempt. (Recall that the FDA slipped a preemption provision into its regulatory preamble without notice and comment opportunities and after it previously proposed the rule stating that it would "not contain policies that have federalism implications or that preempt State law." The majority wrote that the FDA's "views on state law are inherently suspect in light of this procedural failure.")
Justice Alito's dissent (joined by Chief Justice Roberts and Justice Scalia) argued that this case was no different than Geier v. American Honda Motor Co. in which the Court held that DOT regs providing automakers with a choice of a range of passive restraint devices preempted a state jury verdict. The defendant opted for seatbelts (one option), but the state jury ruled that the defendant had a duty to install airbags (another option). If DOT regs preempted the state jury verdict in that case, FDA regs should preempt here. (The majority distinguished Geier: That case was based on a "specific agency regulation bearing the force of law"; Wyeth was not.)
The majority opinion tightens preemption standards in several ways--four, according to Justice Alito. Thus the majority ruled that anything less than complete conflict--here, Vermont mandating a particular label--does not give rise to a conflict with the regs, even though the Court had previously held that any state intrusion upon federal law creates a conflict for preemption purposes. The majority ruled that the regs did not conflict in part because the FDA articulated its preemptive effect without notice and comment rule-making; but this is contrary to the plain holding in Geier. The majority also applied the presumption against preemption to a conflict preemption claim, even though the Court had rejected this position in Geier. Finally, the majority declined to give any weight to the FDA's explanation. (Justice Alito also faulted the majority for declining to treat the regulatory preamble as authoritative law for preemption purposes.)
The opinion will mean that regulatory agencies must do more to show that federal regulations preempt standards set in state tort claims. It's not enough for an agency merely to say that regulations preempt, especially when the saying so goes under the regulatory radar, and when it cuts against the agency's prior positions and Congressional purposes. Moreover, regs like the CBE provision--which permit but do not require more protective action on the part of those regulated--will provide strong fodder for state tort plaintiffs that the federal regulatory scheme does not preempt state standards.