In a 5-4 decision dividing conservative and liberal justices, the Supreme Court held that state tort claims for inadequate warning labels on generic drugs are preempted by federal regulations requiring generic and brand-name drugs to have the same warning labels, even though generic manufacturers could have requested FDA’s assistance to strengthen both sets of warnings. PLIVA v. Mensing, No. 09-993, 2011 WL 2472790 (June 23, 2011). Justice Thomas wrote the opinion of the Court, except as to Part III-B-2 on the interpretation of the Supremacy Clause, which Justice Kennedy did not join. He joined the rest of the opinion, and Justices Roberts, Scalia, and Alito joined the opinion in full. Justice Sotomayor filed a dissent and was joined by justices Ginsburg, Breyer, and Kagan.
Gladys Mensing and Julie Demahy, the plaintiffs in a consolidated case, were prescribed Reglan in 2001 and 2002 respectively, the brand name version of metoclopramide, which is “designed to speed the movement of food through the digestive system.” They received generic metoclopramide from their pharmacists and developed tardive dyskinesia, a “severe neurological disorder” after using it for several years as prescribed. Since Reglan’s approval in 1980, the warning label for metoclopramide has been strengthened several times, most recently in 2009, as evidence accumulated indicating a large risk of the disease from extended usage (beyond twelve weeks).
Mensing and Demahy filed state tort claims against the manufacturers of the generics, alleging that, although the medical evidence indicated a greater risk than the label indicated, they did not adequately update their labels. The manufacturers responded that these claims were preempted because federal law determined that their labels should be the same as that of brand name version. The Eighth and Fifth Circuits, respectively, held that the claims were not preempted.
The Supreme Court reversed the circuit courts. Following FDA’s interpretations of its regulations, the opinion of the Court and the dissent agreed that generic and brand name drugs must carry the same warning labels, and that generic manufacturers could not unilaterally change their warning labels through the “changes-being effected” (CBE) process or with “Dear Doctor” letters that function like warning labels.
The majority then considered the respondents’ argument that, since the manufacturers were required to propose stronger warning labels to FDA if they considered them necessary. Without deciding whether this duty exists, the Court held that even if it does exist, the state-law claims are nonetheless preempted because even contacting FDA would not have allowed the manufacturers to simultaneously meet state and federal label requirements simultaneously. It noted that proposing label changes to FDA was not required by state law. Significantly, it rejected the argument against preemption that, by informing FDA of the need for stronger warnings, FDA might have directed a label change that would then have allowed the manufacturers to comply with both federal and state law.
Instead, the Court articulated a rule that impossibility preemption applies “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency.” Acknowledging that the preemption result turned on whether a brand name or generic drug was at issue, it distinguished Wyeth v. Levine, 555 U.S. 555, 572-73 (2009), noting that in that case, the brand name manufacturer could unilaterally strengthen its warning through the CBE process.
Part III-B-2, which Justice Kennedy did not join (and thus is not part of the Court’s opinion), asserted an interpretation of the Supremacy Clause that “courts should not strain to find ways to reconcile federal law with seemingly conflicting state law,” based on what it characterized as a non obstante provision: “any…Laws of any State to the Contrary notwithstanding.”
The dissent did not find that the manufacturers met the standard for impossibility preemption and asserted that the majority “invent[ed] a new preemption rule.” Instead, following Wyeth, its rule would “require the Manufacturers to show that the FDA would not have approved a proposed label change.” The dissent would have found preemption if FDA had rejected a proposal for a different label or if the agency had not yet responded to the proposal. Sotomayor saw no distinction between Wyeth and the present case, because the label change of a brand name drug manufacturer in Wyeth was since similarly subject to FDA review.
The dissent also concluded that preemption in this case did not reflect the purposes of Congress. It highlighted the presumption against preemption in traditional State matters like health and safety. Also, it pointed to “absurd consequences” that Congress could not have intended, including “silently immunizing generic manufacturers from all failure-to-warn claims,” eliminating all protections for drugs that no longer have a brand name version available, and contravening the “core principle of the Hatch-Waxman Amendments that generic and brand-name drugs are the ‘same’ in nearly all respects.”