Seprafilm is a surgical barrier made by Genzyme that was marketed for unapproved surgeries. Recently, it has been linked to hundreds of adverse events, including infections, adhesions, abscesses, and nearly two dozen deaths.
UPDATE: Genzyme Pays $33 Million Criminal Fine for Seprafilm Marketing
September 3, 2015 — Genzyme Corp. has agreed to pay a $32.6 million to resolve criminal charges that Seprafilm was unlawfully marketed for unapproved uses from 2005-2010, according to a statement from the Justice Department. Click here to read more.
Consumer Group Petitions FDA to Recall Seprafilm
In July 2015, the D.C.-based watchdog group Public Citizen filed a petition (PDF) demanding that the U.S. Food and Drug Administration (FDA) issued a mandatory recall for Seprafilm. The group warned about serious safety problems, “highly questionable” clinical trials, and a large number of adverse events.
Seprafilm Linked to Serious Side Effects
Since 1998, the FDA has received reports of about 525 adverse events and 21 deaths associated with Seprafilm. One report described in the Journal of the Royal Society of Medicine involved a 71 year-old woman who died from complications three weeks after Seprafilm was implanted in her body.
According to the report, 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 Schmidt Firm, PLLC is nationally recognized as a class action law firm. However, our attorneys are not currently filing a Seprafilm class action lawsuit against Genzyme. Instead, we are investigating potential lawsuits on behalf of individuals who were injured or family members of people who died from side effects of Seprafilm.
Seprafilm Safety Risks
Side effects linked to Seprafilm in FDA adverse event reports:
- Acute inflammatory reaction
- Intestinal blockage
- Bacterial abscess
- Poor healing after surgery
About Class Actions
There can be disadvantages to class actions for people with very serious injuries. The outcome of most class actions depends on a representative — not the individual. Even if compensation is awarded, everyone in the class action must divide it equally. In many cases, attorneys accept a “low-ball” settlement and take a large cut of the payout.