New Life for Generic Liability?

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Contributing Author: Eric Lyttle

We have written about efforts by federal courts across the country to deal with Conte v. Wyeth, the California state appellate decision which held that manufacturers of brand name drugs could be liable for injuries caused by generic versions.  To date, those efforts had all been one sided, with court after court rejecting Conte.  Indeed, most recently, the U.S. District Court for the Middle District of Louisiana held that Wyeth had no liability to a man that used only the generic equivalent of its heartburn drug, Reglan.  (Cooper v. Wyeth Inc., No.09-929 (M.D. La. Oct. 26, 2010).

But just before Cooper was decided, the U.S. District Court for the District of Vermont became the first federal court to agree with the Conte decision.  In Kellogg v. Wyeth, No. 2:07-cv-82, (D. Vt. Oct 20, 2010), the court permitted negligent misrepresentation and fraud claims to proceed against Wyeth based on the labeling of its drug, Reglan.  The plaintiff alleged that Wyeth’s inaccurate and misleading information on the label caused her doctor to overprescribe the drug metoclopramide, the generic version of Reglan.  The court examined Conte and the decisions rejecting it, but decided that the allegations here required nothing more than a straightforward application of Vermont’s common law negligence and fraud doctrines.  Applying those doctrines, it held that it was “reasonably foreseeable” that a doctor, relying on the information distributed by a brand name manufacturer, will write a prescription that will be filled by the generic version of the same drug.  Thus, there was “no reason, under Vermont law, to limit Wyeth’s duty of care to physicians by the pharmacist’s choice of a generic bioequivalent drug to fill the physician’s prescription.”  Critical to the court’s decision was its determination that the plaintiffs’ negligence and fraud claims were not subsumed into product liability claims, which require that the manufacturer have sold the product that caused the injury (indeed, this was the basis upon which the Cooper decision mentioned above went the other way).

The door on Conte had been closing, if not become completely closed.  Whether Kellog breathes new life into Conte – or whether it remains a rogue decision against the clear tide in the other direction – remains to be seen.  However, even if Conte (and now Kellogg) were to gain wider acceptance, the practical effects on litigation against brand name drug manufacturers are not entirely clear.  As we explained in the earlier post, the generic drug makers themselves could become a more viable plaintiffs’ target if the the effects of the U.S. Supreme Court’s 2009 preemption decision in Wyeth v. Levine continue to trickle down.  This is very much an area of the law in flux and we will continue to monitor the developments.