Generic Drug Manufacturers To Face Failure-To-Warn Claims In California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20, 2015). This leaves intact the California Court of Appeal's ruling and provides plaintiffs claiming injury from generic drugs with a trifecta of liability theories—failure to update, failure to communicate, and innovator liability.

PROCEDURAL HISTORY

The Teva case arose out of plaintiffs' use of the drug alendronate, the generic form of the branded drug Fosamax, a drug indicated for treating osteoporosis. Multiple plaintiffs alleged that they suffered femur fractures from prolonged use of the drug and filed suit against the manufacturers of the brand and generic drugs. After coordination of the cases in Orange County Superior Court, the parties agreed to a test case (brought by Olga Pikerie) to resolve whether claims against the generic manufacturers were preempted by federal law.

The trial court held that plaintiffs had adequately stated causes of action for failing to make timely label changes and failing to communicate safety information to healthcare providers via Dear Doctor letters. The generic defendants filed a petition for a writ of mandate and/or prohibition, which was denied by the California Court of Appeal. Teva Pharms. USA, Inc. v. Super. Ct., 217 Cal. App. 4th 96 (2013), review denied (Sept. 25, 2013) ("Pikerie").

The California Supreme Court declined to hear the defendants' appeal, and they petitioned the Supreme Court for a writ of certiorari. The Court requested the views of the Solicitor General, who recommended in December 2014 that the Court deny defendants' petition.

THE COURT OF APPEAL'S OPINION

The California Court of Appeal's opinion held that plaintiffs properly pleaded claims against the generic defendants for (1) failure to update and (2) failure to communicate, and that neither of these claims were preempted under the reasoning set forth by the Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

1. Failure to Update

   Since the Supreme Court decided Mensing, plaintiffs have sought new avenues of liability for injuries cause by generic drugs. In large part, generic manufacturers are immune from failure-to-warn claims because federal law prohibits them from unilaterally updating their labels, triggering impossibility preemption. 21 U.S.C. § 355(j)(2)(A)(v) (generic labels must be "the...