Medtronic Continues to Make Large Payments to Doctors for InFuse

Medical device maker Medtronic continues to pay millions of dollars to doctors whose research on the InFuse spinal fusion device has been called into question.

Data released last month under the federal Open Payments program reveals that Medtronic’s spine division, Medtronic Sofamor Danek, paid $60.7 million in royalties to 79 doctors and their affiliates in 2014. Some of the money went to the authors of disputed studies of InFuse. The device is the subject of thousands of patient injury lawsuits, the Minneapolis Star Tribune reports.

Among those who received large payments are Dr. Ken Burkus, a Georgia surgeon and lead author on six studies that omitted adverse events related to InFuse, who received $374,000 last year, and Dr. Regis Haid, an Atlanta neurosurgeon who led one of the studies and received $2.3 million. Medtronic paid $90 million in royalties last year, the most of any device company, according to the Star Tribune.

The Open Payments’ data show that device makers paid $800 million last year in royalties for patented and licensed innovations. Dr. Michael Carome, director of health research for the advocacy group Public Citizen, says, “The goal of these kinds of fees is to influence prescribing behavior.” Carome says such payments are “not in the best interest of the patients.” But Medtronic argues that payments to physicians spur innovations that benefit patients, according to the Star Tribune. In an email, Medtronic spokeswoman Cindy Resman, said, “When a new technology is used to improve care and outcomes for a large number of patients, it makes sense for a physician to benefit from their inventive contributions.”

The InFuse device, which incorporates synthetic human bone protein, is used in surgery to treat serious back pain. InFuse received Food and Drug Administration approval for lower-back spinal fusion procedures, but it has been widely used “off-label” for upper (cervical) spine fusions. Medtronic funded doctors’ research on InFuse but then, according to information uncovered by the Senate Finance Committee in 2012, the company edited the resulting journal articles to make InFuse seem safer and less painful than other spinal-fusion techniques. In response to widespread concerns about the research, Spine Journal devoted an entire issue to examining InFuse research, and concluded that the Medtronic-funded research failed to report serious complications, including unwanted bone growth, male sterility, infections, increased cancer risk, bone dissolution, and worsened back and leg pain, according to Reuters.

The North American Spine Society reported in December 2014 that many patients undergoing spinal fusion do not need bone-growth protein. Healthy people who are only getting two lower vertebrae fused, most pediatric patients, and patients getting routine fusions of neck bones do not need the protein, according to the Star Tribune.

Information contained in securities filings indicate that more than 6,000 InFuse-related injury claims have been filed in court or are awaiting filing. Medtronic has paid an average $23,000 per case to settle 950 cases, and the device maker has set aside another $140 million for future legal costs, the Star Tribune reports.

 

 

 

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