Seprafilm Lawsuits

On July 7, 2015 the public watchdog group Public Citizen petitioned the FDA to issue an immediate recall of a medical device called Seprafilm, citing evidence of at least 524 adverse events and 21 deaths linked to Seprafilm since its approval in 1996. In light of mounting evidence supporting claims that Seprafilm poses an unreasonably high risk of injury or death, we are currently investigating Seprafilm lawsuits on behalf of patients or family members who have suffered as a result of this potentially dangerous medical device.

Seprafilm Overview

Seprafilm was approved by the FDA in 1996. This medical device, made by Sanofi-Aventis subsidiary Genzyme, is a thin film which is implanted during abdominal or pelvic surgery to prevent scarring. After abdominal or pelvic surgery, organs may knit themselves together during the healing process, and this can have dire consequences including intestinal blockages. Seprafilm may be inserted between organs to prevent this from happening.

Unfortunately, Seprafilm has been associated with a high rate of very serious issues, including:

• Inflammation
• Infection
• Peritonitis
• Abscesses
• Fistula
• Bowel obstruction
• Lack of healing
• Patient death

Consumer Group calls for Seprafilm Recall

Public Citizen, a consumer advocacy group, filed a petition with the FDA on July 7, 2015 demanding a recall of Seprafilm. In this petition, the group notes that at least 524 adverse events have been reported to the FDA since Seprafilm was approved in 1996, and at least 21 patient deaths linked to Seprafilm have been documented.

In addition to claiming that Seprafilm is likely to cause more injuries and deaths, Public Citizen also called into question the validity of all 3 studies conducted to gain FDA approval of this device. According to Public Citizen, these studies were riddled with errors and protocol violations. The group states that these studies "failed to show clinically meaningful benefits and raised serious safety concerns" about Seprafilm. They also say that the device never should have gained FDA approval in the first place.

In a press release, Dr. Michael Carome, director of Public Citizen's Health Research Group, states, "Seprafilm never should have been approved. There is no evidence that this device achieves any important clinical benefit for patients – but ample evidence showing serious adverse health consequences. The FDA needs to immediately withdraw the approval of Seprafilm and initiate a mandatory recall of the device."

U.S. Government sues Genzyme for Illegal Marketing of Seprafilm

This petition from Public Citizen is not the first time Seprafilm has come under fire. In December 2013, the U.S. Department of Justice announced that two whisteblowers had alerted the government that Genzyme had illegally marketed Seprafilm. According to evidence uncovered by a DOJ investigation, Genzyme sales reps had showed doctors how to create a "Seprafilm slurry" by mixing small pieces of the surgical film with saline. This "slurry" could then be inserted into the surgical field during laparoscopic abdominal surgery. This is a use of Seprafilm which was never approved by the FDA, and so it is against federal laws for Genzyme to market or promote this "off-label" application of Seprafilm.

Genzyme agreed to settle this issue with the DOJ by paying $22.28 million in penalties. Stuart F. Delery of the DOJ stated at the time, "There will be consequences when medical device companies alter products to increase sales and profits without regard for risks to patient safety."

Contact a Medical Device Lawyer

If you or your loved one underwent abdominal or pelvic surgery where Seprafilm was used and suffered serious complications, or if you lost a loved one after surgery with Seprafilm, you could be entitled to substantial compensation for your suffering and damages. For a free Seprafilm lawsuit consultation, please contact a medical device attorney today.