C.A. Rules Drug Product Liability Claim Not Preempted

Monday, September 29, 2008

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C.A. Rules Drug Product Liability Claim Not Preempted

By SHERRI M. OKAMOTO, Staff Writer

A woman’s suit alleging that a generic drug manufacturer downplayed the risks associated with its product in the drug’s labeling is not preempted by federal law, the Fifth District Court of Appeal has ruled.

Ruling that a federal requirement that a generic drug have the same labeling as a reference listed drug does not necessarily result in preemption of a state tort action against the manufacturer for failure to adequately warn of dangers, the court on Thursday reversed a decision by Stanislaus Superior Court Judge William A. Mayhew sustaining Purepac Pharmaceutical Company’s demurrer to Carlyne McKenney’s product liability claim.

The Food and Drug Administration promulgates regulations overseeing the labeling of drugs, and its regulations require that the agency approve the labeling of any new drugs, and that any generic equivalent of any previously approved drug must use the same labeling as the original, or “reference” drug.

Purepac distributed a generic form of the drug metoclopramide, which is the active ingredient in a prescription heartburn medication called Reglan, and McKenney alleged that Purepac’s label for the generic drug “substantially understated and downplayed the risks of tardive dyskinesia,” a condition which she contracted as a result of her treatment with metoclopramide.

Because generic drug manufactures are not free to deviate from the FDA-approved labeling for reference drugs, Purepac argued that it could not be held liable for failing to use whatever labeling McKenney contended should have been used to warn of metoclopramide’s dangers because any finding of liability would conflict with the FDA’s authority over drug labeling.

However, on appeal, Presiding Justice James A. Ardaiz reasoned that the FDA’s approval of a particular warning is not determinative of liability because a generic drug manufacturer may compel a revision to the FDA-approved label by presenting the FDA with evidence that new safety information should be added.

Although the California Supreme Court held in Carlin v. Superior Court (1996) 13 Cal.4th 1104 that a manufacturer will not be held liable in tort for failing to give a warning which the FDA had already determined to be inappropriate, Ardaiz noted that nothing in McKenney’s complaint alleged that Purepac should have given any warnings about the use of metoclopramide that the FDA had expressly precluded Purepac from giving.

Noting that the FDA has expressly recognized that its regulation of drug labeling will not preempt all state law actions, Ardaiz concluded federal preemption principles did not exempt generic drug manufacturers from strict products liability simply because they must obtain approval from the FDA before issuing any label which deviates from the labeling previously approved by the FDA.

Justices Bert Levy and Bettly L. Dawson joined Ardaiz in his opinion.

The case is McKenney v. Purepac Pharmaceutical Company, 08 S.O.S. 5537.