What is Seprafilm?
Seprafilm is an adhesion barrier designed to reduce internal scarring after surgery by forming a thin film between abdominal tissue and organs. The device is a mesh made of chemically modified sugars, some of which occur naturally in the human body, so it does not need to be removed after being implanted. Seprafilm was developed by Genzyme Corp., and approved by the U.S. Food & Drug Administration (FDA) in 1996. Genzyme was purchased by Sanofi-Aventis SA in 2011.
Watchdog Group Urges Seprafilm Recall
On July 7, 2015, the consumer watchdog group Public Citizen petitioned the FDA to recall Seprafilm, according to Reuters. Public Citizen requested the action after Seprafilm was linked to complications including:
- Inflammatory reactions
- Bowels cemented to the abdominal wall / lymphocele
- Interfere with healing
FDA’s Manufacturer and User Facility Device Experience (MAUDE) database cites at least 9 patient deaths associated with Seprafilm over the past decade.
Seprafilm Approved Based on ‘Highly Questionable’ Studies
All 3 studies used to prove Seprafilm’s efficacy had serious problems, including protocol violations at a trial site, according to Public Citizen’s petition to the FDA. Re-analyses of data from a post-marketing study were ‘highly questionable,’ and Seprafilm has been criticized by medical experts, the watchdog group said.
Public Citizen also questioned 2 studies which Seprafilm’s original marketing application was based on. Instead of analyzing the adhesion barrier’s effectiveness at improving outcomes, Genzyme evaluated the incidence and severity of adhesions and concluded that such improvements would imply meaningful clinical benefit, according to the watchdog.
“Evidence of (Seprafilm’s) clinical efficacy has been sorely lacking despite widespread adoption,” said Dr. Neil Hyman, a professor of surgery at the University of Chicago.
Public Citizen said it was aware of at least 21 deaths linked to Seprafilm, and a search of an FDA database from Jan. 1, 1998 to May 27, 2015 found 524 reports of adverse events associated with the adhesion barrier.
Genzyme Fined $22M for Off-Label Marketing of Seprafilm Slurry
In Dec. 2013, Genzyme agreed to pay $22.28 million to resolve allegations that it marketed a “slurry” version of the Seprafilm adhesion barrier, according to the U.S. Justice Department.
“There will be consequences when medical device companies alter products to increase sales and profits without regard for risks to patient safety,” said Stuart F. Delery, Assistant Attorney General for the Civil Division of the Justice Department. “Federal health care participants should receive only devices that are medically reasonable and necessary.”
The government alleged that Genzyme sales representatives taught doctors how to cut Seprafilm into small pieces, add saline and allow it to dissolve into “slurry.” The reps traded recipes for slurry and trained each other in how to make it, according to the Justice Department.
Seprafilm slurry was used in minimally-invasive laparoscopic or “key hole” surgeries by inserting a catheter filled with the substance into the body and injecting it into the abdominal cavity. Seprafilm is approved for use in open abdominal surgery, but not for laparoscopic or key hole surgery.
As a result, Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to healthcare programs for indications that were not reimbursable.
“As with drugs, patients need assurance that medical devices are safe and effective,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “The government contends that Genzyme marketed an altered, untested device. Taxpayers and patients deserve better.”
The 2 lawsuits settled were: United States ex rel. Fuentes, Russo v. Genzyme Corp., No. 09-cv-1245 (M.D. Fla.) and United States ex rel. Kelley v. Genzyme Corp., No. 10-cv-549 (M.D. Fla.).
About Seprafilm Class Action Lawsuits
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at our law firm has decided against the filing of a Seprafilm Class Action Suit, and is currently filing individual claims on behalf of individuals and/or their family members that have been injured after being treated with Seprafilm.
A class action is a type of lawsuit filed with the court on behalf of large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Seprafilm Lawsuits on their behalf.
Do I Have a Seprafilm Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Seprafilm Lawsuits. We are handling individual litigation nationwide and currently accepting new Seprafilm injury and death cases in all 50 states.
Free Seprafilm Lawsuit Evaluation: Again, if you or a loved one was injured by Seprafilm, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.