The Supreme Court heard oral argument Wednesday in PLIVA v. Mensing, the consolidated cases testing whether federal drug labeling law preempts state tort claims against generic drug manufacturers for failure to warn of drug hazards.
If the issue sounds familiar, that’s because it is: The Court ruled in 2009 in Wyeth v. Levine that federal law did not preempt state tort claims against brand-name manufacturers for failure to warn. The difference in the cases is only the difference between generic manufacturers (in Mensing) and brand-name manufacturers (in Levine). Or, more particularly: Do generic manufacturers have the same kinds of opportunities and requirements to effect labeling changes through the FDA as brand-name manufacturers? If so—as the Fifth and Eighth Circuits ruled in these consolidated cases—generic manufacturers could comply with both federal drug labeling requirements and state tort standards of care. There would be no conflict between the two. This means that federal law would not preempt state failure-to-warn claims, and the plaintiffs’ state cases could move forward.
The Court at oral argument yesterday was thus keenly concerned about generic manufacturers’ abilities and requirements to effect changes to their own drug labels. This question turns on FDA regulations of generic manufacturers’ labels, and much of the Court’s questioning centered on those regulations.
PLIVA conceded that under the regulations generic manufacturers “have a myriad of disclosure obligations†to the FDA when they learn about problems with their drugs. But it argued that those obligations run between the manufacturers and the FDA—and that they are not enforceable by third parties in state court. To support this claim, PLIVA relied heavily on Buckman Co. v. Plaintiffs’ Legal Committee, a 2001 case holding that third parties’ state fraud-on-the-FDA claims are preempted.
PLIVA’s Buckman theory—its principal argument yesterday—resonated with at least one key Justice. Justice Kennedy commented at two different points in the argument that the device manufacturer in Buckman was subject to a formal FDA process, unlike the generic manufacturers here, making this case “a fortiori.â€Â Justice Kennedy’s point was that if a device manufacturer that is subject to firm federal regulatory requirements cannot be sued in state court for failure to comply with those requirements, then surely a generic drug manufacturer with far less formal federal requirements cannot be sued in state court for failure to comply. Buckman was a clear problem for Justice Kennedy; Justices Scalia and Breyer also pressed the parties about the case’s application here.
But PLIVA’s Buckman theory did not seem to resonate more broadly. Chief Justice Roberts seemed to distinguish it, for example, and others moved beyond it. The problem with PLIVA’s Buckman theory is that, unlike Buckman, this case does not hinge on PLIVA’s failure to comply with FDA regulations. Instead, the plaintiffs argue that PLIVA could comply with both state failure-to-warn standards and its regulatory options and requirements under the FDA. Thus, a good deal of the argument focused on the federal regulatory scheme.
Justices Breyer, Sotomayor, and Kagan were perhaps most hostile to PLIVA’s claim that it could not comply with both FDA regulations and state failure-to-warn standards. All three at different points asked why PLIVA couldn’t simultaneously satisfy its federal obligation to notify the FDA when it learned of drug hazards (on the one hand), and any failure-to-warn standard imposed by state courts (on the other). PLIVA’s principal answer wasn’t always entirely satisfying: it often simply fell back on its Buckman theory.
Others, most notably Justices Scalia and Alito, were openly sympathetic to PLIVA’s claim that there was a conflict between federal requirements and state tort suits. Justice Scalia, for example, was quite clear in his position, stating at one point, “I mean, I don’t see how you can hold [generic manufacturers] liable, so long as they continued to give the warnings that they had to give.â€Â He also challenged the legitimacy of the regulatory authority for generic manufacturers to notify the FDA when they learn of drug hazards and seek a label change, arguing that this authority was based only on a regulatory prologue that was never submitted for notice and comment rulemaking. Justice Alito had a different point: he argued that the plaintiffs’ position meant that a generic manufacturer could be sued in state court anytime it merely failed to lobby the FDA for a label change—a position that would undermine federal regulatory goals.
The Court also expressed concern for the policy implications of the case. On one side, Justices Ginsburg, Breyer, and Sotomayor each worried in different ways that preemption would mean that generic drug manufacturers have no enforceable duty to notify the FDA (or anyone else), even when they knew about drug hazards. And given generics’ predominant role in the drug market, this result could seriously undermine drug safety. On the other side, Chief Justice Roberts and Justices Scalia and Alito worried that allowing state failure-to-warn suits would cause generic manufacturers to cover themselves by issuing merely pro forma notices to the FDA of potential drug hazards. Allowing state suits against generics could also open up state suits against others, for example physicians, on a similar failure-to-notify theory. And finally state suits could undermine the very purpose of the federal regulatory scheme for generic manufacturers: to provide affordable generic drugs.
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