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Biotechnology firm Genzyme Corp. will pay $32.5 million to resolve criminal charges with regard to the allegedly unlawful distribution of a surgical device it markets and promotes, the U.S. Department of Justice said.
The latest settlement with the Cambridge, Massachusetts-based firm, which is a wholly owned subsidiary of Paris-based pharmaceutical company Sanofi S.A., is in addition to the $22.28 million civil agreement the U.S. government had reached with Genzyme in December 2013 to resolve allegations under the False Claims Act related to Seprafilm, the Justice Department said Thursday in a statement.
The conduct at issue occurred between 2005 and 2010, which was prior to Sanofi's 2011 acquisition of Genzyme, the department said.
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, which are bands of scar tissue that can form between traumatized tissues and organs after surgery, causing them to stick together, the department said.
It said Seprafilm was approved by the U.S. Food and Drug Administration for use in patients undergoing open abdominal or pelvic laparotomy, which is a traditional surgical technique that utilizes a relatively large incision. Over time, however, laparotomy became a less common surgical technique as laparoscopic surgery, which is perceived to have several advantages for the patient, came into favor.
The Justice Department charged that Genzyme sales representatives then taught surgeons and other medical staff how to use Seprafilm in laparoscopic procedures, for which it was not approved and which resulted in it becoming adulterated, according to the criminal charges.
“Today's action demonstrates that the Department of Justice will evaluate the facts of each case and choose the most appropriate tool of the several available to it to best address criminal misconduct,” Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's civil division, said in the statement.
A Genzyme spokesman could not immediately be reached for comment.
(Reuters) — A Seattle hospital has joined a lawsuit against the manufacturer of endoscopy medical scopes linked to a “superbug” outbreak at the medical center, claiming the company, Olympus America Inc., put patients’ lives at risk by failing to disclose design flaws.