Genzyme Corporation, a subsidiary of French pharmaceutical company Sanofi, agreed today to resolve criminal charges that it violated the Federal Food, Drug and Cosmetic Act (FDCA) with the unlawful distribution of the surgical device Seprafilm, the Justice Department announced last week.
As part of the resolution, Genzyme agreed to admit to and accept responsibility for the facts underlying the charges and pay a monetary penalty of $32,587,439, according to a Justice Department news release.
The Justice Department filed a two-count criminal information (a formal criminal charge) in the U.S. District Court for the Middle District of Florida charging that between 2005 and 2010 Genzyme caused a medical device to become adulterated and misbranded. Genzyme entered into a deferred prosecution agreement with the government for a term of at least two years. If Genzyme fulfills its obligations under the agreement, the government will dismiss the charges it filed today at the end of the agreement’s term.
Court documents describe Seprafilm as a clear piece of film that can be applied to internal tissues during pelvic and abdominal surgeries to reduce the formation of adhesions—scar tissue that can form between tissues and organs after surgery, causing them to stick together. Seprafilm was approved by the Food and Drug Administration (FDA) for use in patients undergoing open abdominal or pelvic laparotomy, a traditional surgical technique that uses a relatively large incision. Laparotomy has become a less common technique because many surgeries are now performed laparoscopically, through very small incisions. Laparoscopic techniques reduce blood loss and risk of infection, and offer smaller scars and quicker recovery times for many patients.
To respond to the diminishing number of open surgeries, some Genzyme sales representatives taught surgeons and other medical staff how to mix Seprafilm sheets into a liquid “slurry” that could be squirted through the narrow tubes used during laparoscopic surgery. But Seprafilm was never approved for use in laparoscopic procedures.
During the course of the government’s investigation of the Seprafilm slurry, Genzyme disclosed that it had distributed promotional material for Seprafilm that implied that Seprafilm had been proven safe and effective for use in gynecologic cancer surgeries, although the FDA-approved label cautioned that Seprafilm had not been clinically evaluated in the presence of malignancies. Genzyme based its claim on a study that involved only fourteen patients, which was far too few to support such an assertion, according to the Justice Department. A separate count in the government’s information charges that Genzyme’s use of this misleading promotional material rendered Seprafilm misbranded under the FDCA.
In a December 2013 civil agreement, Genzyme agreed to pay $22.28 million to resolve allegations under the False Claims Act related to Seprafilm. Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, said, “The deferred prosecution agreement with Genzyme is yet another example of the department’s continuing efforts to ensure that pharmaceutical and medical device manufacturers adhere to laws and regulations that . . . protect the health and safety of the American public.”