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March 24, 2008

Drug Companies May Be Liable for Off-Label Use of Third Parties' Generics

In a case of first impression in Pennsylvania, a trial judge has refused to grant the defendant drug companies' motion for summary judgment, ruling that those companies may be liable for money paid by patients to other drug companies making the generic equivalent of the name-brand drug if the class plaintiffs can prove their allegations that the defendants marketed that drug for off-label use.  See Amaris Elliott-Englel's article for The Legal IntelligencerClark v. Pfizer, Inc., No. 1819, Philadelphia Co. Court of Common Pleas (June Term 2004) is a class action lawsuit in which the plaintiffs allege that Warner-Lambert Co. and its merger partner Pfizer fraudulently promoted Neurontin and its generic equivalent, gabapentin for uses not approved by the FDA.  Plaintiffs seek a refund of all money paid by those who purchased either the name-brand drug or the generic, including monies paid to third-party sellers of the generic drug.

The defendants argued that they never realized any profits from the sales by other manufacturers of the generics.  But the trial judge determined that it was foreseeable that the marketing of Neurontin for off-label use would increase the demand for the generic version of the drug.

JDP

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