Rule of Law

Preemption Back Before the Supreme Court: Oral Argument in PLIVA, Inc. v. Mensing

Counsel for a handful of generic drug manufacturers tried his best yesterday morning to convince the Supreme Court that PLIVA, Inc. v. Mensing was not simply the other shoe to drop after the Court’s 2009 decision in Wyeth v. Levine, in which the Court held that state failure-to-warn claims against brand-name drug manufacturers are not preempted by the Federal Food, Drug and Cosmetic Act (FDCA). But after yesterday’s argument, it seems that Pliva may turn out to be the sequel to Wyeth not only in substance but also in how closely the issue will divide the Justices.

Wyeth was decided 5-4, and from the Justices’ questions yesterday, the Court seems equally split on the claims made by Gladys Mensing and Julie Demahy that the generic drug manufacturers of metoclopramide, which the women took to treat heartburn and acid reflux, failed to adequately warn them of the serious adverse effects of the drug. After four years of taking the drugs, both Mensing and Demahy developed tardive dyskinesia, a severe, long-term neurological disorder that causes involuntary muscle movements. The generic drug manufacturers have argued that the women’s state failure-to-warn claims are preempted by the FDCA because federal law requires the manufacturers to use the same label as the relevant brand-name drug, and thus they cannot be held liable for the contents of the label.

As CAC argued in the brief we filed in PLIVA, federal law gives no indication that generic drug manufacturers should not be subject to state consumer-protection laws just as the Court held that brand-name drug manufacturers could be in Wyeth. There is nothing in the statutory text of the Hatch-Waxman Amendments to the FDCA, which encouraged the development of low-cost generic drugs, to suggest that the Amendments were intended to override the FDCA’s general preservation of state tort remedies as a complementary form of consumer protection. As the Supreme Court noted in Wyeth, if Congress wanted to preempt state tort claims based on allegations of inadequate labeling, it could have done so. It did not.

Moreover, as Justice Sotomayor pointed out during the argument yesterday morning, it would make no sense for Congress to have established a system in which state failure-to-warn claims could only be brought against brand-name drug manufacturers. “Do you think Congress really intended to create a market in which consumers can only sue brand-name products?” asked Justice Sotomayor. “Because if that’s the case, why would anybody ever take a generic? And why in the world would Congress — or even the FDA — create a different obligation on brand-name products than generic products?” Good questions.

Justice Alito brought up the possibility that cost could have been a factor, wondering if there had ever been an analysis of what the economic consequences would be if generic drug manufacturers were subject to state law liability if they did not disclose risks to the FDA and seek to have the label warnings improved. After all, generic drugs are supposed to be cheap, both Alito and Chief Justice Roberts noted.

But as Justice Ginsburg made clear, even cheap generic drugs must be safe. Noting that Congress and the FDA have viewed state failure-to-warn suits as complementary to the federal regulatory regime “because they give the manufacturers an incentive to come forward” with current safety information, Ginsburg stated emphatically that “everyone is interested in making sure that only safe drugs are marketed.”

The question now is whether the five-Justice majority from Wyeth will hold (with Justice Kagan substituting for the now-retired Justice Stevens). Justice Thomas, as is his custom, did not ask any questions at argument yesterday, but given his repeated insistence that federal preemption only be used to displace state law when there is a direct conflict — genuine impossibility — we hope that he will vote as he did in Wyeth, against implied preemption. The views of the four dissenting Justices from Wyeth were more transparent yesterday morning: based on their questions, it seems they are even less inclined to allow state consumer-safety laws to apply to drug manufacturers in the generic context than they were in the name-brand prescription drug context of Wyeth.

While the constitutional issues surrounding the use of federal preemption under the Supremacy Clause are of great consequence for our system of federalism, it is also important to note the significance of the PLIVA case in the lives of everyday Americans. More than 70% of prescriptions filled in the United States are filled with generic drugs, and about a third of generic drugs have no brand-name competitors. With state and federal laws encouraging the use of generic drugs as a cost-saving measure, the prevalence of generic drugs on the market is likely only to increase. As Louis Bograd, counsel for Mensing and Demahy, pointed out during the argument, “if [the manufacturers of] generics are not responsible, in many of these cases no one is responsible.”

It is thus important that state laws be allowed to continue their role in providing an incentive for drug manufacturers to work with the FDA to ensure that all drugs on the market — including generic drugs — are as safe and effective as possible. Stay tuned to Text & History for coverage of developments in PLIVA v. Mensing.