Now in Legal Rebels:
Posted Aug 31, 2007 11:32 am CDT
Eight putative class action suits consolidated before a federal judge in Newark, N.J., will be among the first cases to test whether pharmaceutical companies may face civil liability for promoting off-label use of their products.
The suits were filed against Schering-Plough Corp. after the company agreed to a $435 million settlement of civil and criminal charges last year, the New Jersey Law Journal reports. The government had claimed the company paid kickbacks to physicians and promoted drugs for uses not approved by the Food and Drug Administration.
The civil suits claim Schering promoted off-label uses of certain hepatitis and cancer drugs, in some cases for longer periods or higher doses than needed. One of the company’s alleged schemes involved paying physicians up to $1,500 to participate in clinical trials for cancer drugs that were never submitted to the FDA for approval.
The suits allege fraud, civil conspiracy, unjust enrichment and negligent misrepresentation.
Schering’s lawyer, Joan McPhee of Ropes & Gray in Boston, told the New Jersey Law Journal that the suits are on untested ground.
“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,” said McPhee. “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 said the company had a free-speech right to discuss off-label uses with doctors, who are permitted to prescribe drugs this way. “Science moves much more quickly than the FDA does,” she said, and any effort to interfere with treatment of illnesses involves serious policy issues.