Litigation

Damned if you, damned if you don't: pharma held potentially liable for overwarning

By Ted Frank

Via Beck, a New Jersey appellate court has released Kendall v. Hoffman-La Roche, Inc., slip op. (N.J. Super. A.D. August 5, 2010), a case about Accutane. The plaintiff argued that the statute of limitations should be tolled because there were so many "conspicuous" warnings for his Accutane about birth defects and suicide risks that he was unaware that the package also warned about the abdominal or bowel problems that he wished to sue upon. Of course, making the birth-defect or suicide warnings less "conspicuous" would open up Hoffman-La Roche to liability for those injuries. It's a demonstration of the moral bankruptcy of failure-to-warn law that a defendant is effectively supposed to guess which side effect a particular patient might have and tailor a personalized warning to them.

The good news/bad news for pharma is that Kendall throws out the verdict on other grounds (the trial judge permitted the plaintiffs to introduce evidence that there were a number of complaints about side effects but not the defendants to introduce evidence about the much-larger denominator and make the statistical "so what?" argument). So Hoffman-La Roche will not be able to raise this appalling legal holding before a higher court unless the plaintiff appeals.

Full post as published by Point of Law on August 09, 2010 (boomark / email).