Genzyme Corp. Pays $32.5 Million To Resolve Criminal Charges Related to Med Device Promotion

Last week, Genzyme Corporation, a wholly-owned subsidiary of the French company Sanofi, agreed to pay $32.5 million to resolve criminal charges that it violated the federal Food, Drug and Cosmetic Act (FDCA) with regard to the unlawful distribution of Seprafilm, a surgical device it markets and promotes. The DOJ targeted two aspects Seprafilm promotion in particular–that the company (1) encouraged surgeons to use its Seprafilm surgical product in unapproved ways, and (2) suggested without enough proof that it was safe for certain cancer surgeries.This follows a separate $22.28 million civil agreement the government reached with Genzyme in December 2013 to resolve allegations under the False Claims Act related to Seprafilm. 

Seraphim is a clear film used to reduce abnormal internal scarring following pelvic and abdominal surgery by separating the internal tissues and organs while they heal. The anti-adhesion barrier device was approved by the Food and Drug Administration in 1996. According to the DOJ’s press release, the product was approved for use in patients undergoing open abdominal or pelvic laparotomy, which is a traditional surgical technique that utilizes a relatively large incision to permit the surgeon to open and view the patient’s abdominopelvic contents. 

“Over time, laparotomy became a less common surgical technique in favor of laparoscopic surgery, which is perceived to have several advantages for the patient,” the government indicated. “To respond to the diminishing number of laparotomies performed, some Genzyme sales representatives taught surgeons and other medical staff how to mix the Seprafilm sheets into a liquid “slurry” that could be squirted through the narrow tubes used during laparoscopic surgery, even though Seprafilm was never indicated or FDA-approved for use in laparoscopic procedures.” DOJ states that the sales reps’ participation in the preparation of slurry in the operating room caused Seprafilm to become adulterated, according to the criminal charges.

DOJ’s 2013 Press Release resolving civil claims sheds additional light onto this conduct:

Genzyme sales representatives taught doctors and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached.  This mixture was referred to as “slurry.”  Genzyme sales representatives traded recipes for slurry, and trained each other in how to create it.  The slurry was used in laparoscopic or “key hole” surgeries by inserting a catheter filled with the mixture into the body and squirting it into the abdominal cavity.  Seprafilm is FDA-approved for use in open abdominal surgery but not for minimally invasive surgeries, such as laparoscopic or key hole surgery. 

DOJ also honed in on promotional material that “implied that Seprafilm had been proven safe and effective for use in gynecologic cancer surgeries, even though Seprafilm’s FDA-approved label cautioned that the device had not been clinically evaluated in the presence of malignancies.” The company based its claim on a study that involved only fourteen patients, “which was far too few to support such an assertion,” DOJ stated. 

Genzyme’s Deferred Prosecution Agreement

Click here for the terms of Genzyme’s Enhanced Compliance measures. The document contains measures related to sales compensation and incentives of Seprafilm and off-label promotion. Further, the document puts the onus on business leaders to review compliance. The document states that the “President shall conduct a review of the effectiveness” of the compliance program and that the Board of Directors shall conduct a similar review.