This week’s Department of Justice “Catch of the Week” goes to Genzyme Corporation, a wholly-owned biotechnology subsidiary of French pharmaceutical company Sanofi. Yesterday, the company agreed to resolve criminal charges it violated the Food, Drug and Cosmetic Act (FDCA) with regard to the unlawful distribution of the surgical device Seprafilm. As part of the agreement, Genzyme agreed to admit to the facts underlying the charges and pay a monetary penalty of $32,587,439. It also agreed to undertake several groundbreaking measures to enhance its internal compliance program. The conduct at issue occurred prior to Sanofi’s acquisition of Genzyme in 2011. See DOJ Press Release.
Seprafilm is a clear piece of film that can be applied to internal tissues during pelvic and abdominal surgeries to reduce the formation of adhesions after surgery. It was approved by the FDA for use in patients undergoing open abdominal or pelvic laparotomy, a surgical technique that uses a 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.
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. They did so even though the product was never indicated or FDA-approved for use in laparoscopic procedures. According to the government, Genzyme sales representatives’ participation in the preparation of slurry in the operating room caused Seprafilm to become adulterated.
In addition, Genzyme distributed promotional material for Seprafilm that implied it 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. Genzyme based its claim on a study that involved only fourteen patients, which was far too few to support such an assertion. The government charged that Genzyme’s use of this misleading promotional material caused Seprafilm to become a misbranded product.
In announcing the settlement, the government stressed the importance of medical device companies complying with the law. Benjamin C. Mizer, head of the Justice Department’s Civil Division, said the 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 have been put in place to protect the health and safety of the American public.” US Attorney A. Lee Bentley III of the Middle District of Florida echoed this sentiment: “When manufacturers make misleading statements about using their products in ways that have not been approved by the FDA, patient care, confidence, and safety are put at risk.”
The government’s criminal agreement with Genzyme is in addition to a separate $22 million civil agreement the government reached with Genzyme in December 2013 to resolve allegations brought by whistleblowers under the qui tam provisions of the False Claims Act. This puts Genzyme’s total payout on its Seprafilm-related misconduct to almost $55 million.
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