Healthy Skepticism Library item: 11401

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Toutant C.
Schering-Plough Defends Suits Over Marketing of 'Off-Label' Drug Uses
New Jersey Law Journal 2007 Aug 31
http://www.law.com/jsp/article.jsp?id=1188464549972

Full text:

Suits follow 2006 agreement under which company agreed to pay $435 million to settle charges over drug-marketing practices

Schering-Plough Corp. faces a spate of federal court litigation over promotion of its drugs for uses not approved by the Food and Drug Administration.

Eight putative class action suits are pending with U.S. District Judge Stanley Chesler in Newark, N.J., consolidated by the U.S. Judicial Panel on Multidistrict Litigation on Aug. 16.

The suits come in the wake of an August 2006 agreement by which the Kenilworth drug maker agreed to pay $435 million to settle criminal and civil charges over its drug-marketing practices. The government had alleged kickbacks to physicians and aggressive promotion of drugs for unapproved uses.

The pending suits concern the drugs Intron, approved by the FDA for chronic hepatitis, AIDS-related Kaposi’s Scarcoma, melanoma and lymphoma; Temodar, for certain brain tumors; Eulexin, for prostate cancer; PEG-Intron, for chronic hepatitis; Rebeton, for hepatitis C; Integrilin, for heart conditions; and Fareston, for breast cancer.

None of the suits suggest users suffered ill effects from the drugs. Rather, they claim that Schering’s sales force devised and implemented a variety of schemes to promote “off-label” uses, which they contend are prohibited by the federal Food, Drug and Cosmetic Act.

As one scheme, the suits allege, Schering set up clinical trials in which doctors — paid $1,000 to $1,500 to participate — prescribed cancer drugs for uses for which the company made no effort to win government approval.

The suits also claim the company promoted use for durations or doses greater than is safe or effective and that its marketing efforts prevented doctors from prescribing less-expensive drugs.

One suit, in behalf of the estate of John Hutson of Findlay, Ohio, who was prescribed Eulexin for prostate cancer, claims Schering paid doctors to treat patients with Eulexin instead of less-expensive medications or alternative treatments, such as surgery.

The suits allege fraud under the New Jersey Consumer Fraud Act, unjust enrichment, civil conspiracy, common-law fraud and negligent misrepresentation. They seek compensatory and punitive damages, proceeds of unjust enrichment, statutory damages and costs of suit. The plaintiffs are private drug users and third-party payers, such as unions and health insurance companies.

Schering, in a motion to dismiss, says the lack of any identifiable injury arising from the alleged misconduct means the plaintiffs lack standing to sue and have failed to state causes of action.

Schering argues there is no private right of action for violations of the Food, Drug and Cosmetic Act and that the plaintiffs are seeking “to piggyback on the government investigation, and also to turn an alleged regulatory violation under the [FDCA] — off-label promotion — into a private cause of action on behalf of a putative class of insurance companies and other third-party payers.”

“There is no allegation of a false or misleading statement by the company with regard to these drugs — all that is at issue is speech-related activities by company personnel,” says Schering’s lawyer, Joan McPhee of Ropes & Gray in Boston. “This will be one of the first cases to test the question of whether you can have a cognizable civil claim about off-label prescriptions.”

McPhee says Schering will defend what it considers a free-speech right to discuss off-label uses with doctors, who are not restricted from prescribing drugs for purposes not approved by the FDA. Schering claims that 95 percent of oncology drugs are prescribed off-label and that off-label usage is also common for pediatric and psychological drugs.

“When you’re talking about having a number of drugs being used for treatment of serious illnesses, there are serious policy issues … where you have an effort to squelch out a certain segment of those potential therapies,” McPhee says. “The reality is, science moves much more quickly than the FDA does.”

Chesler has appointed two plaintiffs lawyers as lead counsel for the case: John Keefe Jr., of Keefe Bartels in Shrewsbury, and Jay Eisenhofer, of Grant & Eisenhofer in Wilmington, Del. They did not return a reporter’s calls about the case.

Schering co-counsel Gavin Rooney, of Lowenstein Sandler in Roseland, says that at a Sept. 7 status conference with U.S. Magistrate Judge Claire Cecchi, the defense will ask that the plaintiffs prepare a single, superseding pleading.

The case is In Re: Schering-Plough Corp. Intron/Temodar Consumer Class Action, 06-5774.