Over the past two years, the U.S. Department of Justice has investigated hundreds of operations involving implantable defibrillators, devices that regulate irregular heart rhythms, to determine whether they were medically appropriate. The results are troubling.

Defibrilator devices aren’t cheap – an average of $40,000 per unit – and because Medicare has covered them and the cost to surgically implant them since 2003, DOJ lawyers are seeking monetary damages for unnecessary operations under the Federal False Claims Act. To enlist help for its ongoing investigation, letters have been sent to hospitals across the country asking that they review patient files. In Southeast Michigan, officials for Beaumont Health System and Detroit Medical Center have acknowledged receiving the DOJ inquiries, according to Crain’s Detroit Business.

The stakes can be high for the wrongdoers. In January 2011, Minnesota-based St. Jude Medical Inc. agreed to pay $16 million “to resolve allegations that the company used post-market studies and a registry to pay kickbacks to induce physicians to implant the company’s pacemakers and defibrillators.” Nine months later, Boston Scientific subsidiary Guidant agreed to pay $9.25 million to settle similar allegations.

While the government argues that the costs of many defibrillator implant surgeries aren’t warranted, physician groups and hospital associations argue that the Department’s guidelines impose an unfair recording and reporting burden on doctors and impede the provision of critical patient care. In the meantime, the larger question remains – who’s looking out for the patient?

If you or someone you care about has had a heart defibrillator implant and worry about the the treatment you’ve received and significant medical expenses you may be facing, please give us a call – we’re here to help.

Robert B. Sickels

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Robert B. Sickels

For more than 30 years, Robert Sickels has successfully represented plaintiffs involved in complex personal injury, medical negligence, and products liability matters.

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