C.A. Revives Claim Against Generic Drug Maker

Friday, September 26, 2008

Page 3

C.A. Revives Claim Against Generic Drug Maker

By a MetNews Staff Writer

The federal requirement that a generic drug have the same labeling as a reference listed drug does not necessarily result in federal preemption of a state tort action against the generic manufacturer for failure to adequately warn of the dangers of the drug, the Fifth District Court of Appeal ruled yesterday.

The justices reinstated a suit by Carlyne McKenney, who claims that Purepac Pharmaceutical Company and other defendants failed to warn her of the dangerous propensities of metoclopramide, the active ingredient in the brand name drug Reglan. She alleges that that she contracted a muscular condition called tardive dyskenisia, and that the advertising and labeling of the drug “substantially understated and downplayed the risks” associated with the drug.

Stanislaus Superior Court Judge William A. Mayhew sustained Purepac’s demurrer, concluding that as a generic manufacturer of the drug, Purepac was required to obtain FDA approval for any labeling that deviated from the previous labeling of the drug, and that preemption applied.

But Presiding Justice James Ardaiz agreed with the plaintiff, saying there was “no reason to distinguish between original or ‘listed’ drugs and their generic equivalents for federal preemption purposes.” The FDA, he added, does not appear to have taken the position that its labeling requirements for generics exempt manufacturers of generics from tort liability.

The presiding justice cited Carlin v. Superior Court (1996) 13 Cal.4th 1104, holding that drug makers are strictly liable for failure to warn of known or reasonably scientifically knowable risks from prescription drugs. Strict liability, the court said, does not conflict with federal regulatory policy.

Ardaiz wrote:

“In the case presently before us, Purepac has not called our attention to anything in the allegations of McKenney’s fourth amended complaint that would demonstrate the necessary applicability of a preemption defense to those allegations. To state this a bit differently, 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 case is McKenney v. Purepac Pharmaceutical Company, F052606.