Surgical Ablation Devices Draws Deparment of Justice Inquiry

Surgical ablation devices have been approved by the FDA to cauterize tissue in order to stop bleeding in wounds. However, a front-page Wall St. Journal article notes that 25,000 patients last year were treated with the ablation device in order to treat atrial fibrillation. The medical device used in these procedures has not been approved by the FDA. Doctors have been treating “A-fib” with these ablation devices in order to re-route the electrical impulses of the heart. While doctors may use medical devices and pharmaceutical drugs for off-label treatments, medical device and pharmaceutical companies may not market their products for off-label uses.
This is where the issue becomes complicated. The Journal cites doctors and industry executives to note that the surgical ablation devices are almost exclusively being used to treat atrial fibrillation and the market is a lucrative one for medical device companies-$100 million a year.
A former medical device sales executive, Elaine George, has filed lawsuits in which she contends that medical device companies are indeed marketing the ablation devices for purposes not approved by the FDA. She’s won two lawsuits against medical device makers AtriCure and Estech. The settlement with AtriCure cost the company $3.8 million while the lawsuit against Estech was resolved for $1.5 million. As a whistle blower, Ms. George has received $688,000 and $226,000. By law, she is entitled to 15% to 30% of any recovery as a whistle blower. George has three other lawsuits pending against Boston Scientific, Medtronic, and St. Jude Medical. All the lawsuits allege that these medical device companies marketed their products to doctors for uses which aren’t approved by the FDA.
FDA approval for medical devices is a costly process that requires medical trials and lengthy submissions to the FDA. Medical device companies argue that they want to get their devices to market to provide the maximum benefit to the patient.
The surgical ablation devices were approved by the FDA under a provision that allows their approval if they are similar to devices already approved by the federal agency. However, surgical ablation devices have not been approved to treat atrial fibrillation and there is no study available to determine is such use is safe or more beneficial than approved forms of treatment for “A-fib”.
“The misuse of medical devices has the potential of exposing patients to dangerous procedures,” said Tim Johnson, U.S. Attorney for the Southern District of Texas, after settling with AtriCure Inc. in January. As a result of the lawsuits, the FDA is considering revising the provision that allows similar medical devices to be approved for use.
The Journal article notes that 80% of atrial fibrillation patients are treated effectively with drugs. However, the medical device industry sees the growth of surgical ablation devices as a profitable new opportunity. The article provides excerpts of industry executive comments at two trade conferences last year, “Medtronic, at an investor conference last year, called it a “fast growing, underpenetrated market.” St. Jude, also at a 2009 investor conference, said atrial fibrillation “may be the best growth market in the medical device space for the next 5-7 years.”
Elaine George was an industry insider and participated in these conferences as well as medical device marketing seminars for 17 years before being fired by her last employer Boston Scientific after calling into question the marketing presentations she witnessed. During one training session, a presenter showed participants how to sell the surgical ablation devices to doctors for use in atrial fibrillation cases. Later during the conference, regulatory officials cautioned salespeople to be cautious not to market devices for unapproved uses. Understandably, she was confused by the contradictory messages. So she asked the trainer if there were legal uses for which she could promote the product. The response, according to the Wall St. Journal was, “Don’t worry about that. This is how you sell it.”
Soon after the training seminar, she received a letter from her supervisor critical of her job performance. Two months later she was fired by Boston Scientific. That’s when she decided to sue the company for wrongful termination and retaliation. The lawsuits sparked interest in the Department of Justice which is now investigating the medical device companies for illegally marketing medical devices to doctors for uses which haven’t been approved by the FDA.
The DOJ investigation is ongoing and will be interesting in terms of what they discover. It will be more interesting to see how the medical device companies respond to these allegations. This is a $100 million a year market. Will $3 million dollar settlements deter companies who stand to make $100 million?