Genzyme Corp. pays over $22 million to settle claims it marketed its device off-label

by Ben Vernia | January 1st, 2014

On December 20, the Department of Justice announced that Genzyme Corp., the manufacturer of an adhesive barrier, had agreed to pay $22.28 million to resolve allegations that it marketed its device for an off-label use, as a “slurry” in minimally-invasive surgeries. According to DOJ’s press release:

Genzyme Corp. has agreed to pay $22.28 million to resolve allegations that it marketed, and caused false claims to be submitted to federal and state health care programs for use of, a “slurry” version of its Seprafilm adhesion barrier, the Justice Department announced today. Seprafilm is a thin film intended to reduce adhesions after surgery by forming a bio-resorbable barrier between abdominal tissue and organs. Genzyme is a biotechnology corporation based in Cambridge, Mass., and was acquired by Sanofi-Aventis SA in April 2011.

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The government alleges that 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. Allegedly, as a result of this conduct, Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to federal health care programs for uses of Seprafilm that were not reimbursable.

The case was originally filed by whistleblowers in two cases, the government announced, adding that the relators’ share had not yet been determined.

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