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Tag: off-label

Class Action Suit To Test Whether Drug Companies Have Legal Duty to Class Members for Money Spent on Off-Label Uses of Generic

Written by on Wednesday, March 26th, 2008

Following up on our blog posting last week about the indictment of the former Intermune CEO on fraud charges related to allegedly marketing off-label uses of a drug, an unrelated class action suit has been filed in the state of Pennyslvania against Pfizer and Warner-Lambert alleging neglience and negligent and intentional misrepresentation for allegedly conducting a marketing campaign to promote off-label uses of its Neurontin drug and its generic equivalent, gabapentin, reported Amaris Elliott-Engel for Law.com.  These claims have survived a partial summary judgment ruling by Philadelphia Common Pleas Judge Mark I. Bernstein.

This case is reported to be the first case to hold that a brand name manufacturer can be held liable for money spent to promote a drug manufactured by a third party.

Elliot-Engel reported on the case as follows:

During the class certification hearing, the plaintiffs produced evidence that the defendants unlawfully promoted Neurontin to physicians for off-label use, despite the lack of scientific proof that the drug was effective in treating those conditions. . . . A $40 million promotional budget was devoted to those efforts, including the insertion of anecdotal articles in medical journals, paying physicians considered to be opinion leaders and sponsoring continuing medical education conferences that actually were paid promotional events, Bernstein said. At least 200,000 prescriptions for Neurontin were written in Pennsylvania, and the defendants earned between $53 million and $64 million on the drug per quarter in the state, Bernstein said. . . .

Neurontin was approved to treat epilepsy in 1993 and neuralgia in 2002. . . .Bernstein granted class certification last June. The class involves all people who purchased Neurontin and gabapentin between 1995 and the present for medical conditions other than adjunctive therapy for epilepsy and management of pain associated with herpes zoster rash outbreaks.

Each class member has damages worth less than $75,000; the class action members seek a refund for the amount they spent on Neurontin/gabapentin prescriptions given to treat off-label medical conditions not approved by the FDA, according to court papers.

This case and the recent indictment of Dr. W. Scott Harkonen raise some interesting public policy questions about off-label uses of medications and the promotion of such uses.  Have drug companies and the medical community been too quick to embrace off-label uses of drugs that are approved for other medical conditions?   Should there be greater regulation of off-label uses of drugs than what currently exists?   Do patients really understand when they take an approved drug for an off-label medical condition the full ramifications of what "off-label" really means? 

I am interested in hearing what the blog community thinks about this issue, so I welcome any comments on the topic.  We will continue to follow these two cases here at the California Biotech Law Blog as they unfold.

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