|TRENTON – Acting Attorney General John J. Hoffman announced today that New Jersey has joined a global settlement resolving civil allegations that Genzyme Corp. caused false claims to be submitted to federal and state health care programs by unlawfully marketing a “slurry” version of its adhesion barrier product known as Seprafilm.
Genzyme is a biotechnology corporation based in Cambridge, Mass. Its product Seprafilm is a thin film designed to reduce adhesions after open abdominal surgery by forming a barrier between abdominal tissue and the body’s organs.
The settlement announced today resolves allegations that Genzyme sales representatives taught doctors and other staff how to create a non-approved “slurry” version of Seprafilm by cutting Seprafilm sheets into small pieces, adding saline and allowing the pieces to dissolve until a desired consistency was reached. This slurry mixture was used in laparoscopic surgeries by inserting a catheter filled with the mixture into a patient’s body and applying it into the abdominal cavity. Genzyme sales representatives allegedly traded recipes for Seprafilm slurry, and trained each other in how to create it.
Seprafilm is approved by the federal Food and Drug Administration for use in open abdominal surgery, but not for minimally invasive surgeries such as laparoscopic surgery. In addition, because Seprafilm’s original chemistry, composition and overall consistency are changed through the process of turning it into a slurry, it is alleged that the slurry is not the same product, and that FDA approval of Seprafilm does not cover the slurry.
Through its conduct, Genzyme is alleged to have 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.
“Whether we are talking about drugs, topical medications or, as in this case, an anti-adhesion barrier for surgical patients, the marketing of treatments for unapproved uses is wholly inappropriate, and the resultant false billing to government health care programs costs us all,” said Acting Attorney General Hoffman. “Our commitment is to identify this kind of conduct and, working both on our own and in collaboration with our state and federal partners, to hold those involved accountable.”
As part of the overall Genzyme settlement, New Jersey will receive $102,000 in restitution and other recoveries.