Sanofi's Genzyme pays $32.59M penalty for misbranding, unlawful usage of Seprafilm surgical implants

Genzyme Corporation admitted the offense over the Seprafilm surgical implant and agreed to sign a DPA (deferred prosecution agreement) to pay $32.59M, solving the criminal cases on the Department of Justice, Thursday.

To address the fluctuating number of laparotomy surgery in the U.S., "Genzyme sales representatives taught surgeons and other medical staff how to mix the Seprafilm sheets into a liquid "slurry" that could be squirted through the narrow tubes used during laparoscopic surgery, even though Seprafilm was never indicated or FDA-approved," the Boston Globe reported.

Seprafilm is permissibly applied in internal tissues to avoid scratches after a pelvic or abdominal surgery. It was approved by the Food and Drug Administration for patients under a laparotomy surgery; a traditional medical procedure that requires a large incision. The method has been replaced over time by laparoscopic surgery, which uses a long and thin tube that doesn't require broad cuts.

Genzyme Corporation, under the pharmaceutical company, Sanofi, admits the unlawful practice and agrees to solve the criminal offense. The corporation violated the FDCA when it illegally distributed the Seprafilm.

Two criminal counts have been filed in the U.S. District Court in Florida indicting from 2005 to 2010. Genzyme entered into a DPA with the government to pay a penalty of $32,587,439 to be exact under a two-year term, the Department of Justice publicized.

Genzyme confessed it hands out promo brochures claiming the Seprafilm is safe and effective to use in gynecologic cancer surgery procedures, specified on the Morning Star.

Even so, the authorities ordered a consent motion requesting to dismiss the case if Genzyme adheres to the agreement. In line with that, Seprafilm promotions would only be limited to label indications approved by the FDA.

The government's appeal is due to the early actions implemented by Genzyme cooperating in the investigation firing employees involved and moderating sales quota, trimming down its incentives that urge illicit endorsement acts before recognizing the cases filed.

Before the agreement, Genzyme paid around $22.28M to solve the civil case under the False Claims Act with the government in December 2013.