Will Congress Overturn Mensing?

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Will Congress Overturn Mensing?

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The Mensing decision (Pliva, Inc. v. Mensing, No. 09-993 (U.S. Sup. Ct. Jun. 23, 2011)) was a landmark victory for generic pharmaceutical manufacturers. The issue of federal pre-emption meant the generic drug manufacturers would be treated differently from the brand name manufacturers. The brand name pre-emption decision in the pharmaceutical arena is Wyeth v. Levine, 555 U.S. 555 (2009). In Wyeth, the Court held that plaintiffs’ state law failure to warn claims against brand-name pharmaceutical manufacturers did not conflict with federal law. But, just two years later in Mensing, the Supreme Court, by a 5-4 decision, held that state law failure to warn claims against generic pharmaceutical manufacturers are pre-empted by federal law. The Court reasoned that, because it was impossible for a generic manufacturer to unilaterally add or strengthen warnings without violating FDA regulations, all state law failure to warn claims are pre-empted.

It’s an important distinction if you were injured by a prescription drug. Say for example, that two potential plaintiffs took the same drug and have the same grievous injury caused by that drug. But one of them took the generic and the other the brand name. Mensing says that the generic plaintiff’s case is pre-empted by federal law. The brand name plaintiff’s case is not pre-empted. In fact, since the Supreme Court issued Mensing, many lower courts have dismissed litigation against generic drug manufacturers.

In an effort to resolve the inconsistency described above, Senator Patrick Leahy (D-VT) plans to legislatively reverse Mensing. Senator Leahy’s bill would be titled the “Patient Safety and Generic Labeling Improvement Act.” The bill would change the FDC Act to add new section 505(w):

(w) Notwithstanding any other provision of this chapter, the holder of an application approved under subsection (j) may change the “Warnings” section of the labeling of a drug so approved in the same manner as the holder of an approved new drug application under subsection (b), unless the Secretary prescribes by rule another manner.

Hopefully the Congress can figure out a way to allow consumers who take generic drugs to have the same rights as those who take the brand name drug.

Source: Leahy Bill Would Legislatively Undo the U.S. Supreme Court’s Mensing Decision; March 29, 2012, Kurt R. Karst.

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