U.S. Court of Appeals Affirms Dismissal of Failure-to-Warn Claim for Generic Drug

This case was based on the distinction between brand name drugs and generics as decided by the U.S. Supreme Court in Wyeth v. Levine, 555 U.S. 555 (2009) and PLIVA v. Mensing, 564 U.S. 604 (2011). The federal district court judge in Chicago, the Northern District of Illinois, dismissed failure-to-warn claims made against Pfizer, the manufacturer of Depo-T, a testosterone therapy that the Food and Drug Administration (FDA) classified as a generic drug.

In the Wyeth case, it was ruled that federal law does not pre-empt state law claims based on allegations that the manufacturer of a brand name drug failed to provide an adequate warning label. When a drug manufacturing company that produces a brand name drug realizes its warning label is inadequate, it can invoke a changes-being-effected regulation to immediately provide beefed-up warnings without prior FDA approval.

But because federal law requires the manufacturer of generic drugs to use the warning label approved for the brand-named version, Mensing ruled that conflict-pre-emption bars claims that the manufacturer of the generic version failed to provide adequate warnings.

On appeal in this case, the plaintiffs argued that Depo-T should not be considered a generic under Mensing because of what they consider a crucial factual distinction:

The FDA classified Depo-T as the “referenced listed drug” – the compound that new generics are compared to for bioequivalence – for its class of testosterone treatments.

The 7^th Circuit Court of Appeals affirmed the dismissal of the claims by interpreting Mensing as barring any use of the changes-being-effected regulation by the manufacturers of generic drugs – even if a generic is a “referenced listed drug.”

The court explained in its decision that “the federal statutes and regulations are applied to brand-named drug manufacturers are meaningfully different than those that apply to generic drug manufacturers.”

In sum, the statutes, regulations and FDA that govern the labeling requirements for drug approved pursuant the abbreviated new drug application (ANDA) control the outcome of this case. Those authorities, and the reading given to them by the Supreme Court in Mensing, indicate that there is no meaningful difference for pre-emption purposes between ANDA holders for a reference listed drugs and those for non-reference listed drugs (RLD).

There is also no clear reason why the specific circumstances of the approval history of this particular drug, Depo-T, should make the result any different than in the Mensing decision. Since unilateral changes to Depo-T’s label were not possible, state law claims alleging the failure to take that action are pre-empted.

Guilbeau v. Pfizer, 2018 U.S. App. LEXIS 1285 (Jan. 19, 2018).

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