Am I My (Generic) Brother’s Keeper? In California, Yes.

November 11, 2008

By James R. Phelps

On November 7, 2008, the First Appellate District in the Court of Appeal of the State of California, which sits in San Francisco, issued a remarkable decision in Conte v. Wyeth, Inc.  The court said:  “We hold that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturer’s product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug.”

Lawyers should read the entire opinion.  However, for present purposes, the interesting part of the decision is this:  The plaintiff’s successful argument was that Wyeth should have warned doctors that its product (metoclopramide) and the generic forms of its product should be administered for no more than 12 weeks at a time.  Conte was given a generic by her physician, and she claimed the physician didn’t give her the warning and she took the drug for a longer period, causing her harm.  Conte relied upon the fact that the alleged misrepresentations she used as the basis for her claim appeared in the labeling of Wyeth’s product, Reglan, and in a monograph on Reglan it provided for the Physician’s Desk Reference (“PDR”).  The generics used the language of the monograph in the FDA-approved labeling for their products.  Conte’s physician said he did not rely on the monograph, but he also said he had “probably” read it; he also acknowledged generally using the PDR.  That, the court ruled, was enough to raise a factual issue requiring a trial, and it reversed the summary judgment that had been granted for Wyeth.

The implications of this finding are potentially vast.  Product liability defense lawyers have expressed surprise and deep concern that the net of liability should be spread to include those who did not make or market the drugs that are the subject of tort litigation.  The decision, if it stands or is followed, certainly will further complicate the relationship between generic and brand name manufacturers.

Hat tip to Drug and Device Law Blog.

Categories: Drug Development