Expanded Liability for Generic, Brand Manufacturers Ahead? - Pharmaceutical Executive


Expanded Liability for Generic, Brand Manufacturers Ahead?

Pharmaceutical Executive

The Case: Mensing v. Pliva

On March 30, the Supreme Court heard oral arguments in Mensing v. Pliva and a companion case. The cases—two in a growing inventory of thousands of cases pending around the country—involve Wyeth's Reglan (metoclopramide) and its generic counterparts, indicated for gastrointestinal disorders such as reflux. Extended use of metoclopramide has been associated with tardive dyskinesia (TD), a movement disorder. Reglan labeling has warned of the TD risk for some time, but in 2009 FDA added a boxed warning and risk evaluation and mitigation strategy (REMS). Plaintiffs claim that all labeling predating the boxed warning was inadequate.

In state and lower federal courts, the generics manufacturers argued that they were not free to modify the FDA-approved labeling for Reglan. FDA regulations require that the labeling for a generic must be the same as that of the brand-name drug. The generics companies also asserted that they were not permitted to request a label change by way of prior approval supplement, or to make labeling changes on their own pursuant to the "changes being effected (CBE)" regulation. Since federal law precluded the generics companies from changing the Reglan labeling, the claims against them should be preempted by operation of federal law.

Two federal appellate courts disagreed with the generics companies' position, and ruled that the generics companies could have requested a labeling change, or, at the very least, suggested to FDA that additional steps be taken to advise doctors of the TD risk.

At the request of the Supreme Court, the federal government participated in the appeal. The government noted that—contrary to the rulings of the appellate courts—the generics companies were not free to submit a prior approval supplement or make unilateral labeling changes under a CBE, but they were able to suggest to FDA that new safety information be communicated to physicians. While disagreeing with the reasoning of the Courts of Appeal, the government endorsed their results: Preemption should not apply, and the personal injury suits against the generics companies should move forward.

It is impossible to predict the outcome of Supreme Court cases on the basis of oral arguments. But the Court seemed divided, and the justices posed difficult questions to both sides and the government. Justices Kagan, Sotomayor, and Ginsburg seemed inclined to accept that the generics companies could have urged a labeling change in some informal manner not recognized by federal regulations (this became known as the "take steps" approach).

Chief Justice Roberts and Justices Scalia and Alito seemed skeptical of that approach. Apart from the fact that the "take steps" approach is not set forth in any regulation, Roberts and Scalia suggested that the government's approach meant that generics manufacturers could avoid liability simply by attaching a boilerplate letter suggesting a label change every time they submitted an adverse event report. Most observers expect a decision before the Court leaves for its summer recess.


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