September 3, 2015 — The U.S. Department of Justice has announced a $32.6 million criminal fine against Genzyme Corp. for unlawfully marketing the surgical barrier Seprafilm for “off-label” surgeries between 2005 and 2010.
Genzyme has now paid nearly $55 million to end government investigations into Seprafilm, after paying $22.28 million in December 2013 for false claims allegations.
Seprafilm is a thin, bio-absorbable barrier that is placed between organs and tissues after surgery. It helps prevent adhesions, which are bands of fibrous scar tissue that can cause organs and tissues to stick together during the healing process.
The FDA has only approved Seprafilm for use in open abdominal surgery (laparotomy), in which a surgeon makes large incisions to view organs. As the popularity of laparotomy declined in favor of minimally-invasive “keyhole” surgery (laparoscopy), Genzyme sales representatives began marketing Seprafilm for unapproved uses.
Representatives taught surgeons how to cut tiny pieces of Seprafilm and mix them into a liquid “slurry” that could be squirted into a patient’s abdomen through tubes during minimally-invasive surgery. This use was not approved by the FDA or evaluated for safety in clinical trials.
Genzyme also admitted marketing Seprafilm for gynecological cancer surgeries, despite only studying this use in 14 patients — far too few to support claims of safety and effectiveness. Furthermore, the FDA-approved label warned that Seprafilm had never been evaluated in the presence of malignancies.
Public Citizen, a consumer advocacy group, asked the FDA to recall Seprafilm in July 2015. They cited numerous case reports linking Seprafilm to deaths and post-operative complications, including bacterial abscess, sepsis, inflammatory reactions, peritonitis, and more. Public Citizen documented serious flaws in three clinical trials of Seprafilm, calling them “highly questionable” and warning about a lack of evidence to establish the product’s effectiveness.