Genzyme has paid over $22 million to settle a lawsuit involving “off-label” marketing of Seprafilm, and now a consumer group is calling on the FDA to recall it due to the risk of severe, life-threatening side effects.
UPDATE: Genzyme Settles Seprafilm Criminal Case for $33 Million
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. Click here to read more.
Seprafilm Recall Petition Filed with FDA
In July 2015, the consumer watchdog group Public Citizen filed a petition with the U.S. Food and Drug Administration (FDA) requesting a mandatory recall for Seprafilm. Public Citizen called three clinical trials “highly questionable” and warned that since 1998, at least 21 deaths and over 500 adverse events had been linked to the surgical implant.
Serious Side Effects Linked to Seprafilm
One event published in the Journal of the Royal Society of Medicine reported that a 71 year-old woman died from post-surgical complications linked to Seprafilm. Three weeks after Seprafilm was implanted in her body, doctors found “a dense, thick, glue-like mass involving 95% of the small bowel and part of the transverse colon, anchoring the abdominal contents to the anterior abdominal wall.”
What is the problem?
The Clark Firm, LLP is nationally recognized as a class action law firm in Texas. However, at this time our lawyers are not filing a Seprafilm class action. Instead, we are only accepting cases involving very serious injuries or wrongful deaths, and we are filing individual lawsuits against Genzyme.
Side effects linked to Seprafilm:
- Acute inflammatory reaction
- Intestinal blockage
- Bacterial abscess
- Poor healing after surgery