Minimally invasive surgical ablation for AFib: Unapproved, warns whistleblower

As reported in today's Wall Street Journal, the more than 2 million Americans with atrial fibrillation are now on notice that the over-zealous marketing tactics and incentives by manufacturers of expensive medical devices which are not approved by the U.S. Food and Drug Administration (FDA) for the treatment of atrial fibrillation are likely to be influencing doctors' and hospitals' decisions about treatment for their patients' heart conditions.

That's the message former Boston Scientific medical device sales representative Elaine George is trying to make public before there are more deaths and injuries caused by the escalating use of this unapproved treatment for atrial fibrillation (AFib). The suspect procedure in question, called minimally invasive surgical ablation, is being promoted and used as a treatment for AFib, one of the most commonly occurring heart conditions, despite the fact that this specific use has never received FDA approval. Ms. George hired Sanford Wittels & Heisler LLP to bring whistleblower (qui tam) suits against the major medical device companies engaging in these dangerous practices in the billion-dollar a year AFib industry

Ms. George Files Suit Against Five Companies; Two Have Settled

In 2007, Ms. George filed qui tam suits under the federal False Claims Act in the U.S. District Court for the Southern District of Texas, blowing the whistle on the five major manufacturers of these devices AtriCure, Estech, St. Jude Medical, Boston Scientific and Medtronic for illegally marketing and rewarding doctors' and hospitals' for the off-label use of minimally invasive surgical ablation devices as a treatment for atrial fibrillation. The cases against Boston Scientific, St. Jude Medical and Medtronic are still pending. A $3.8 million settlement with AtriCure, Inc. was reached with the U.S. Department of Justice in February and a $1.4 million settlement with Estech was reached by the U.S. DOJ in late 2009.  The latter two companies no longer market their minimally invasive surgical ablation devices for use as treatment of AFib; St Jude and Medtronic continue to market and sell their devices; Boston Scientific has sold off its division.

Sanford Wittels & Heisler and Attorney Grant Morris Comment

Ms. George is represented in the matter by David Sanford of Sanford Wittels & Heisler LLP, a class action and whistleblower/qui tam law firm with offices in Washington, D.C., New York and San Francisco, Co-Counsel Grant Morris, also of Washington, D.C. and Mitch Kreindler of Kreindler & Associates, of Houston, Texas.

With the rapid aging of the U.S. population, the prevalence of atrial fibrillation is increasing nationwide.  

"The minimally invasive surgical ablation device makers saw the situation as a golden opportunity to feather their nests with Medicare and Medicaid reimbursements for an expensive procedure, even though their devices aren't approved and can't be legally promoted for the treatment of atrial fibrillation," said Mr. Sanford.  "As a result of our lawsuits, two manufacturers have already agreed to stop marketing these ablation devices for individuals with atrial fibrillation.  We have the other three manufacturers in our sights, and won't stop until all of them shut down their illegal promotional activities, and stop endangering critically ill cardiac patients' lives and wasting scarce health care dollars."

"The only use for these manufacturers' minimally invasive surgical ablation devices is the off-label, unapproved treatment of atrial fibrillation," said Mr. Morris.  "The manufacturers convinced doctors and hospitals to give preference to the use of such devices over safer treatments by deploying aggressive marketing techniques and illegal inducements. Elaine George knew a dangerous sales scheme when she saw one, and she's done everything in her power to protect vulnerable patients and stop the fraudulent Medicare and Medicaid billing that's also victimizing U.S. taxpayers."

Overview of Atrial Fibrillation

Atrial fibrillation (AFib) refers to uncoordinated contractions of the upper heart chambers. It is one of the most common arrhythmias – or abnormal heart rhythms, affecting about 2.3 million adults in the United States alone.  Men and Caucasians are more likely to have AF than women and African Americans, and its prevalence increases with age. Almost ten percent of Americans 80 years of age or older experience AF.

Several treatments for AFib are FDA-approved and work effectively, including medication and outpatient catheter ablation. According to Ms. George, the minimally invasive surgical ablation devices being used have not been proven safe or efficacious, and have not received FDA approval for the treatment of atrial fibrillation.

Ms. George was trained to market Boston Scientific's ablation device for AFib, and she witnessed first-hand the illegal marketing campaigns waged by many companies making minimally invasive surgical ablation products. She also has first hand knowledge of how manufacturers of these devices provide kickbacks, free equipment, seminars, travel opportunities and other incentives to doctors and hospitals to encourage them to perform expensive, inpatient cardiac surgeries using their device.  According to Elaine, these companies continue to aggressively promote surgical ablation as a treatment for atrial fibrillation even though this specific use has never been approved by the FDA.  These companies also train providers to code these procedures to get more money from Medicare than they'd get from FDA-approved AFib treatments which is not just illegal, but medically irresponsible and dangerous.

SOURCE Sanford Wittels & Heisler, LLP