A California appeals court ruled that drugmakers can be sued for failing to warn of potential dangers, even if product labeling was okayed by the FDA. As a result, the court reinstated a lawsuit against Purepac Pharmaceutical over its generic version of theReglan heartburn drug, The San Francisco Chronicle informs us.
Carlyne McKenney claimed she develoed tardive dyskinesia, which causes involuntary muscle movements, after taking metoclopramide, which was made by Purepac Pharmaceutical from November 2001 to December 2002. In her lawsuit, she alleged Purepac failed to warn of the risk by downplaying info on the labeling. A lower judge dismissed the case, noting the label contained all warnings required by the FDA.
However, the appeals court ruled 3-0 that an FDA-approved label isn't necessarily the last word on the risks and dismissed Purepac's preemption defense. Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The US Supreme Court will review a preemption case on November 3 (back story).
"Nothing in the McKenney’s fourth amended complaint alleges that Purepac should have given warnings about the use of metoclopramide that the FDA expressly precluded Purepac from giving. The superior court therefore erred in sustaining the demurrer," the appeals court wrote. "Nor has Purepac cited to us any appellate court decision holding that a generic manufacturer of a prescription drug can never be held strictly liable in tort for failure to warn when the generic manufacturer utilizes FDA-approved labeling." Here is the ruling.
A lawyer for Purepac tells the paper that the generic drugmaker will seek a rehearing and, if unsuccessful, would appeal to the state Supreme Court. He adds that a broad Supreme Court ruling in favor of drugmakers would require dismissal of the Purepac suit, but in any event, Purepac has a strong case because federal law requires generic makers to use only FDA-approved labels.
"Our hands are tied," says Purepac lawyer Richard Dean. "They (the plaintiffs) want to put us in jeopardy for adhering to clear federal regulations."
The appeals court said, however, that a generic drugmaker has the same ability as a brand-name manufacturer to ask the FDA to require further labeling info. McKenney's lawyer, Laurence Masson, praised the ruling and disputed the claim that Purepac's hands were tied. "They're the ones who are most knowledgeable about side effects," he tells the paper. "It's in patients' interest to have the most accurate information."