Calif. Court of Appeals overturns decision in Conte v. Wyeth; branded drug makers may be liable for generic side effects, injuries

NEW YORK If a generic drug causes adverse side effects or injuries, the manufacturer of the branded drug can be held liable, a California appeals court ruled in November 2008 in the case of Conte v. Wyeth.

The First District Court of Appeals of California overturned a lower court's decision in favor of Wyeth, while upholding its ruling in favor of three generics companies that made versions of Wyeth's gastro-esophageal reflux disease drug Reglan (metoclopramide). It upheld the argument by plaintiff Elizabeth Conte that because the generics companies relied on product safety information that Wyeth originally formulated, Wyeth was responsible for ensuring the information's reliability, whether in branded Reglan or its generic equivalents.

Wyeth disputed the court's decision and submitted a petition for review with the California Supreme Court on Dec. 17, 2008.

"Wyeth disagrees with the reasoning of the California Court, which rejected a long line of cases in which courts have uniformly found that a drug manufacturer of a brand drug cannot be held liable for injuries caused by a generic version of the brand drug that is sold by another manufacturer," Wyeth spokesman Doug Petkus said. "Wyeth intends to appeal this California Court decision."

Plaintiff Elizabeth Conte said she used generic versions of Reglan made by Teva Pharmaceutical Industries and others for four years to treat her GERD, and eventually developed the neurological disorder tardive dyskinesia, allegedly due to the prolonged use of the drug. Tardive dyskinesia, often associated with long-term use of certain psychiatric drugs, causes involuntary movements throughout the body, but has no cure.

The Food and Drug Administration approves metoclopramide for 12 weeks of use, though physicians often prescribe it for 12 months or longer, allegedly because the drug's labeling understates possible serious side effects from extended use. Conte said the drug companies should have known this, and she accused Wyeth of fraud, fraud by concealment and negligent misrepresentation; she also accused the generics companies of negligence, strict products liability, negligence per se and breach of express and implied warranties. She further accused her doctor, Robert Elsen, of medical negligence.

In a Jan. 5 friend-of-the-court brief, the Pharmaceutical Research and Manufacturers of America said the court's decision "effectively makes pioneer drug companies the indemnitors of competing generic drug companies for injuries caused by competing generic drugs."

Teva declined to comment, and a spokesman for the Generic Pharmaceutical Association only reiterated that the labeling of a generic product must be the same as that of the branded product.

To see the full text of the court's decision, visit <a title="http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF" href="http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF" />http://www.courtinfo.ca.gov/opinions/documents/A116707.PDF