Atricure Inc., a medical device manufacturer, has agreed to pay the United States $3.76 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices, the Justice Department announced today. Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.
The settlement resolves allegations that the West Chester, Ohio-based company marketed its medical devices to treat atrial fibrillation (the most common cardiac arrhythmia or abnormal heart rhythm), a use that is not approved by the U.S. Food and Drug Administration (FDA). Atricure also allegedly promoted expensive heart surgery using the company’s devices when less invasive alternatives were appropriate, advised hospitals to up-code surgical procedures using the company’s devices to inflate Medicare reimbursement, and paid kickbacks to health care providers to use its devices. The United States asserted that by engaging in this conduct, Atricure knowingly violated the Food, Drug, and Cosmetic Act and caused the submission of false and fraudulent claims in violation of the False Claims Act.
This settlement relates to topics we discussed back in the early days of Health Care Renewal, the convoluted financial ties beween the renowned Cleveland Clinic, its current CEO, and Atricure. In 2005, investigative reporting published in the Wall Street Journal revealed the complicated relationships among the Clinic, its current CEO Dr Toby Cosgrove, the Clinic's venture capital fund, Foundation Medical Partners, and a small medical device company called Atricure. This coincided with the Clinic's firing of Dr Eric Topol from his leadership positions there. (See posts here and here.) The Cleveland Plain Dealer uncovered more conflicts, involving Dr Cosgrove, the Clinic's board of trustees, Dr Bernadine Healy, and Invacare (see post here.) In response, in 2006, the Clinic promised to revise its conflicts of interest policy, and held a big conference on the topic of conflicts of interest, although some were skeptical of these efforts (see post here.)
As the Cleveland Plain Dealer just noted,
Cleveland Clinic Chief Executive Dr. Toby Cosgrove helped create the 'AtriClip Gillinov- Cosgrove LAA Exclusion System,' which is being sold by the company and won approval in October for use in the European market. While Cosgrove is eligible to receive royalties from the company, he has not recieved any, Clinic spokeswoman Eileen Sheil said.
This settlement is just the latest in a now long parade of settlements that serve as reminders of poor behavior by myriad health care organizations. As we have repeatedly noted, these settlements seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue.
The wrinkle in this case comes from the numerous past ties between the company involved and a prestigious US health care system and its top leadership. But I doubt that Cleveland Clinic CEO Dr Toby Cosgrove will have any public comment about it. But why should I expect that a former company director will admit any accountability for that company's poor behaivor?
Hat tip to the White Collar Crime Prof Blog.