News | February 05, 2010

Ablation Company Pays $3.8 Million for Off-Label Use

February 5, 2010 – Cardiac surgical ablation system maker AtriCure agreed to pay $3.8 million plus interest for allegedly using illegal kickbacks and an off-label marketing campaign to induce physicians and hospitals to perform its costly inpatient cardiac surgical ablation procedures over less expensive outpatient catheter ablation procedures.

The settlement with the U.S. Department of Justice (DOJ) and the Office of the Inspector General for the Department of Health and Human Services is part of the government's emphasis on combating healthcare fraud. The suite was filed under the False Claims Act, which the Justice Department has used to recover approximately 2.2 billion since January 2009 in cases involving fraud against federal healthcare programs.

The qui tam, or whistle blower, provisions of the False Claims Act permit private citizens, called relators, to bring lawsuits on behalf of the United States and receive a portion of proceeds of any settlement or judgment. The relator who filed the case against AtriCure will receive a total of $625,000 as the statutory share of the current settlement.

Sanford Wittels & Heisler and Grant Morris represent the relator in the case against AtriCure, which was filed in the United States District Court for the Southern District of Texas. The complaint charges that AtriCure violated the Federal False Claims Act. As a result, the Medicare program has faced substantial increased costs from AtriCure's unnecessary and expensive procedures.

"The misuse of medical devices has the potential of exposing patients to dangerous procedures and taxpayers to payment for unwarranted claims against Medicare," said Tim Johnson, United States attorney for the Southern District of Texas. "This settlement demonstrates the government's commitment to maintaining safe and affordable health care for its citizens."

The complaint alleges that AtriCure enticed hospitals to purchase its products by promoting the spread between Medicare reimbursement for AtriCure's surgical ablation procedure and the relatively low cost to the hospital itself. AtriCure further provided physicians and hospitals with kickbacks, including free equipment; price discounts; free advertising, marketing, and referral services; and extensive training for surgeons performing AtriCure procedures.

"This settlement allows us to focus on the remaining two companies under active investigation, Boston Scientific and Medtronic," said Grant Morris, co-lead counsel in the AtriCure qui tam case.


Related Content

News

Oct. 10, 2025 β€” Johnson & Johnson MedTech, in collaboration with the Heart Rhythm Clinical and Research Solutions, LLC ...

Home October 13, 2025
Home
News

Sept. 2, 2025 β€” Johnson & Johnson MedTech has announced acute safety and effectiveness results from the Varipure ...

Home September 05, 2025
Home
News

Sept. 3, 2025 β€” Kardium Inc. recently announced it has received pre-market approval (PMA) for the Globe Pulsed Field ...

Home September 03, 2025
Home
News

July 14, 2025  –  Johnson & Johnson MedTech has announced U.S. Food and Drug Administration (FDA) approval of an update ...

Home July 14, 2025
Home
News

July 7, 2025 β€” Catheter ablation is a minimally invasive treatment for abnormal heart rhythms. It is often successful in ...

Home July 09, 2025
Home
News

June 4, 2025 β€” A new study published in The Annals of Thoracic Surgery, a journal from The Society of Thoracic Surgeons ...

Home June 04, 2025
Home
News

April 24, 2025 – The Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) have released a scientific ...

Home April 24, 2025
Home
News

April 9, 2025 β€” Merit Medical Systems has announced the U.S. commercial release of its Ventrax Delivery System. Ventrax ...

Home April 16, 2025
Home
News

March 27, 2025 β€” Abbott recently announced it has received CE Mark in Europe for the Volt PFA System to treat patients ...

Home March 27, 2025
Home
News

Oct. 24, 2024 β€” Medtronic plc has announced United States Food and Drug Administration (FDA) approval of the Affera ...

Home October 30, 2024
Home
Subscribe Now