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.
“There will be consequences when medical device companies alter products to increase sales and profits without regard for risks to patient safety,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Federal health care participants should receive only devices that are medically reasonable and necessary.”
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.
“Beneficiaries of federal health care plans, including Medicare recipients and military families, should not be treated with devices that have been improperly altered,” said Acting U.S. Attorney for the Middle District of Florida A. Lee Bentley III. “When companies promote such practices, resulting in the submission of health care claims that cannot legally be reimbursed, they will be made to pay by this office and the Department of Justice.”
“As with drugs, patients need assurance that medical devices are safe and effective,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “The government contends that Genzyme marketed an altered, untested device. Taxpayers and patients deserve better.”
The allegations resolved by today’s settlement were originally raised in two lawsuits filed against Genzyme under the qui tam, or whistleblower, provisions of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The whistleblowers, or relators’, share of the settlement has not been determined.
Assistant Attorney General Delery thanked the Office of Chief Counsel for the Food and Drug Administration, the U.S. Attorney’s Office for the Middle District of Florida, the Justice Department’s Commercial Litigation Branch, the Defense Health Agency, the Office of Personnel Management, the Department of Veterans Affairs and the Department of Health and Human Services Office of Inspector General for the collaboration that resulted in the settlement.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.
The claims settled by this agreement are allegations only, and there has been no determination of liability. The two lawsuits are captioned United States ex rel. Fuentes, Russo v. Genzyme Corp., No. 09-cv-1245 (M.D. Fla.) and United States ex rel. Kelley v. Genzyme Corp., No. 10-cv-549 (M.D. Fla.).