Tuesday, March 25, 2008
As the Philadelphia Legal Intelligencer (via law.com) reports, Philadelphia Common Pleas Judge Mark I. Bernstein has held that Pfizer can be held liable for off-label marketing of the generic version of its epilepsy drug, Neurontin:
The plaintiffs in the class action allege that the drug company defendants conducted a campaign to promote the prescription of its Neurontin drug and its generic equivalent, gabapentin, for a number of medical uses not approved by the FDA, according to court papers.
Philadelphia Common Pleas Judge Mark I. Bernstein let stand the claims of negligent misrepresentation, negligence and intentional misrepresentation in Clark v. Pfizer Inc. regarding the generic gabapentin made by third-party drug manufacturers.
Bernstein said that the legal question presented in Pfizer's and Warner-Lambert's motion for partial summary judgment was whether a drug company, which "negligently or intentionally perpetrates a fraud upon the medical community" by the off-label marketing of its name-brand drug, can be held responsible for money paid to other drug companies that make the generic equivalent of the name-brand drug. Assuming that the plaintiffs can prove their allegations at trial, "under Pennsylvania law, a defendant may be liable for misrepresentation to foreseeable plaintiffs even without any direct relations between the parties," Bernstein said in his March 14 opinion. It was foreseeable that the marketing of Neurontin for off-label use would increase the demand for the generic version of the drug, Bernstein said.
Under the judge's order, the class action against Pfizer will proceed with purchasers of both the brand-name Neurontin as well as purchasers of the generic gabapentin.