List of off-label promotion pharmaceutical settlements

The following are settlements reached against pharmaceutical companies to resolve allegations of off-label promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may be subject to civil liability under the False Claims Act as well as criminal penalties.

Descriptions of the lawsuits are listed in chronological order.

In 1996, whistleblower David Franklin left his position as a medical liaison with Parke-Davis, a pharmaceutical division of Warner-Lambert Company, after learning of the company's marketing strategy to promote the epilepsy drug Neurontin for uses not approved by the FDA. Franklin and his attorney, Thomas M. Greene, filed a lawsuit, Franklin v. Parke-Davis, under the False Claims Act in federal district court in Boston. In the first off-label promotion case ever litigated in a whistleblower suit under the False Claims Act, the settlement was announced after eight years of litigation in May 2004. Warner-Lambert agreed to pay $430 million to resolve all civil and criminal liability, with $24.64 million going to Franklin for his participation in the lawsuit. To date, it is one of the largest recoveries against a pharmaceutical company in U.S. history.

Serono, a Swiss biotechnology company, obtained approval from the FDA for the drug Serostim in 1996 to treat AIDS wasting, a condition in which AIDS patients experience rapid weight loss. However, around the same time, the advent of more robust protease inhibitors that could interact in AIDS cocktails to markedly slow the advancement of the syndrome led to a decline in symptoms of AIDS wasting and, consequently, demand for Serostim. As a result, according to prosecutors, Serono devised a marketing scheme by which the definition of AIDS wasting would be changed to measure a loss in "body cell mass." The company then created a computerized medical test designed to detect loss of body cell mass and thereby diagnose AIDS wasting even in patients who had not experienced any weight loss. Serono ultimately agreed to pay $704 million to resolve all civil and criminal liability. Five whistleblowers, all former employees of Serono, initiated complaints under the False Claims Act, ultimately leading to the government's investigation. The whistleblowers shared in a $51 million reward from the settlement.

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