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SAN FRANCISCOThe California Supreme Court on Wednesday denied petitions to review an appellate court decision that held name-brand prescription drug manufacturers liable for injuries caused by the generic version of the drug made by another manufacturer.
The Nov. 7, 2008, ruling by the 1st District Court of Appeal in San Francisco in Elizabeth Ann Conte vs. Wyeth Inc. allowed a lawsuit against Madison, N.J.-based Wyeth Inc. to go to trial.
Observers said at the time that the decision was contrary to numerous other decisions and could create liability concerns for brand-name drug manufacturers if upheld.
The basis of the appellate court decision was that Ms. Conte's physician allegedly relied on Wyeth's product warnings about Reglan, the brand name of metoclopramide, a drug used to treat gastroesophageal reflux disease.
Ms. Conte developed tardive dyskinesia, a debilitating and incurable neurological disorder that causes involuntary muscle movements, after taking a generic version of the drug for nearly four years, although it is approved for only 12 weeks of use.
Ms. Conte, who never took Reglan, claimed Reglan's product warnings substantially understated the risks of serious side effects from extended use.
She sued Wyeth for fraud, fraud by concealment and negligent misrepresentation. The appellate court, which overturned a lower court's dismissal of the case, said a name-brand manufacturer owes a duty of care to ensure any information it disseminates about its product to physicians is accurate, even if the patient ends up taking a generic equivalent.