Massachusetts-based Genzyme Corp., a subsidiary of Sanofi (NYSE:SNY), agreed to pay $22.3 million to settle a whistleblower lawsuit accusing the company of off-label marketing of its Seprafilm surgical product.
Seprafilm protects organs and muscles following surgery, forming a barrier that prevents them from attaching to one another during healing.
The product has had FDA approval since 1996 for use during open surgeries, but whistleblowers claimed that Genzyme marketed the product for use during laparoscopic surgery. Genzyme sales reps allegedly encouraged doctors to mix the product into liquid form and to inject it into the body.
The company told reporters that it has taken measures to cooperate with federal investigations and to put a stop to all off-label marketing, according to the Tampa Bay Times.
The settlement comes amid tough times for Genzyme, which at the end of 2013 revealed that the FDA had struck down the company’s bid to win approval for its Lemtrada multiple sclerosis therapy, citing concerns about the product’s safety and the clinical trials used to support approval. Genzyme has said it plans to appeal the FDA’s ruling.