Navigation Links
Whistleblower Alerts Americans to Dangers of Risky Unapproved Treatment for Atrial Fibrillation

WASHINGTON, March 11 /PRNewswire/ -- 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.

For more information on this case and other any qui tam matters please contact David Sanford of Sanford Wittels & Heisler at 202-742-7780 or Grant Morris (202) 486-0678.


Sanford Wittels & Heisler is a law firm with offices in Washington, D.C., New York, and San Francisco that specializes in employment discrimination, wage and hour, consumer and complex corporate class action litigation and has represented thousands of individuals in some of the major class action cases in the United States. The firm also represents individual clients in employment, employment discrimination, sexual harassment, whistleblower, public accommodations, commercial, medical malpractice, and personal injury matters.

SOURCE Sanford Wittels & Heisler, LLP

Back to top
SOURCE Sanford Wittels & Heisler, LLP
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Prominent New York City Real Estate Investor, Attorney and Atlanta Nursing Home Chains Pay $14 Million to Settle Whistleblower Kickback Case
2. U.S. Department of Justice Alleges Johnson & Johnson Paid Kickbacks to Steer Nursing Home Prescriptions: Joins Chicago Pharmacist's Whistleblower Case
3. Pierre S. Freeman Adds Book AMORC Unmasked! To his Arsenal of Whistleblower Weapons Aimed at Rosicrucian Order
4. Whistleblower Lawsuit Nets Record $27.5 Million
5. Omnicare Pays Nearly $100 Million to Resolve Medicaid Fraud Charges: Second Omnicare Settlement With Chicago Whistleblower Pharmacist
6. Former Corporate Whistleblower Says The Informant Movie is Only Part of the Story
7. Bextra Whistleblower Case Started Investigation of Pfizer
8. Sheller, P.C. Law Firm Instrumental in Pfizers $2.3 Billion Settlement Today in Largest Pharmaceutical Whistleblower Case in History
9. Health Insurance Whistleblower Urges Obama Health Chiefs to Join Him at Free Urban Health Care Expedition in L.A. Stadium
10. CIGNA Whistleblower Calls for More Heath Insurance Accountability in Heath Care Reform
11. Smithsonian Worker Exposed to Asbestos Files Whistleblower Retaliation Complaint
Post Your Comments:
(Date:11/30/2015)... , ... November 30, 2015 , ... The world of ... harvesting and follicular unit extraction. These techniques and procedures have been in use for ... from hair loss. While Dr. Parsa Mohebi, M.D. has utilized many of these methods ...
(Date:11/30/2015)... Battle Creek, Michigan (PRWEB) , ... November 30, 2015 , ... ... Creek, MI, the American Cancer Society held an annual fundraising event, a 5K walk ... Recovery, a holistic treatment center for substance abuse which is also located in Battle ...
(Date:11/30/2015)... ... November 30, 2015 , ... The presidential race normally deals with political issues ... it a national news story when Donald Trump makes disparaging remarks about Hillary Clinton’s ... more than anyone wants to admit when it comes to how people are viewed ...
(Date:11/30/2015)... Angeles, CA (PRWEB) , ... November 30, 2015 , ... ... star Jessie James Decker made a brave but slightly unusual choice to show her ... returning to her pre-pregnancy form may have been pre-mature. Saying that she didn’t “want ...
(Date:11/30/2015)... ... ... According to Los Angeles bariatric surgeon Michael Feiz, M.D., F.A.C.S., many of ... hunger, but instead by a hormone called ghrelin which (often prematurely) signals to ... aware that weight loss surgery can help patients lose weight by restricting the capacity ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... --  Royal Philips  (NYSE: PHG ; AEX: ... a fully integrated, consultative approach to enhance radiology ... management approaches that combine imaging systems, services, informatics ... delivery and reduce costs. Making its debut at ... Annual Meeting (RSNA) in Chicago ...
(Date:11/30/2015)... CHICAGO , Nov. 30, 2015 Nautilus ... next-generation Radiology Image Management platform ( ). The ... was announced from RSNA 2015 (Radiology Society North America) ... Radiology conference in the U.S. --> ... radiology platform that enables access to radiology studies worldwide ...
(Date:11/30/2015)... (HK$,000)For the Six Months Ended 30 September 2015 2014RestatedChange%Turnover 545,575 , 518,852 ... , 384,242 , 9.8 Hospital ... , (18.3) Medical Insurance Administration Service Income , ... Medical Devices and Accessories Sales , 89,645 , ... , 2,822 , 2,917 , ...
Breaking Medicine Technology: