In an apparent case of first impression, a Philadelphia judge has ruled that two pharmaceutical companies may have a legal duty to class members for money spent on the generic version of the companies' name-brand drug allegedly marketed by the companies for uses not approved by federal regulators.
The generic drug in the case was produced by a third-party manufacturer.
Three class action claims alleging that Warner-Lambert Co. and its merger partner, Pfizer Inc., marketed a drug for off-label use to treat medical conditions not approved by the federal Food and Drug Administration have survived partial summary judgment following the judge's ruling earlier this month.
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.
More at law.com
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