The Justice Department announced that Genzyme Corporation, a subsidiary of French pharmaceutical company Sanofi, agreed to pay $32,587,439 to resolve criminal charges over the distribution of the surgical product Seprafilm.
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.
As part of the resolution, Genzyme admitted to and accepted responsibility for the facts underlying the charges and will pay a monetary penalty of $32,587,439, according to a Justice Department news release. 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. In a December 2013 civil agreement, Genzyme agreed to pay $22.28 million to resolve allegations under the False Claims Act related to Seprafilm.
Seprafilm is a clear piece of film that can be applied to internal tissues during open abdominal and pelvic surgeries to reduce the formation of adhesions—scar tissue that can form between tissues and organs after surgery, causing them to stick together. The Food and Drug Administration (FDA) approved Seprafilm for use in patients undergoing open abdominal or pelvic laparotomy, a traditional surgical technique that uses a relatively large incision. But laparotomy has become much less common because many surgical procedures can now be performed laparoscopically, through very small incisions. Where possible, surgeons favor minimally invasive techniques, which reduce blood loss and risk of infection, and offer smaller scars and quicker recovery times for many patients.
In response to the diminishing number of open surgeries, some Genzyme sales representatives showed surgeons and other medical staff how they could use Seprafilm in laparoscopic procedures by mixing the sheets into a liquid “slurry” that could be squirted through the narrow tubes used during laparoscopic surgery. But Seprafilm did not have FDA approval for such use.
During the course of the Justice Department investigation, 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 warned 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. One of the government’s charges is that Genzyme’s use of misleading promotional material rendered Seprafilm misbranded under the FDCA.
Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, called the deferred prosecution an 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.”