New federal data show medical device maker Medtronic is still paying millions of dollars to doctors who provided sketchy research on the company’s controversial Infuse spinal product.
StarTribune.com reports that Medtronic’s spine division, Medtronic Sofamor Danek, paid $60.7 million in royalties to 79 doctors and their affiliates in 2014. Some of that money went to the authors of dubious studies of Infuse, a product that has become the subject of hundreds of patient injury lawsuits. Medtronic paid $374,000 in royalties last year to Georgia surgeon Dr. Ken Burkus. Burkus was the lead author on six studies that omitted adverse events related to Infuse. Atlanta, Georgia, neurosurgeon and lead author of one of the studies, Dr. Regis Haid, received $2.3 million. Payments for both were sent to third-party companies. Medtronic paid a total of $90 million in royalties in 2014.
“The goal of these kinds of fees is to influence prescribing behavior,” Dr. Michael Carome, health research director at the consumer advocacy group Public Citizen, told StarTribune.com. The payments are “in the financial interests of the company and the physicians,” he added, “not in the best interest of the patients.”
Royalties paid for patented and licensed innovations comprise the largest chunk of payments to doctors. Data released last month under the federal Open Payments program that was obtained by StarTribune.com showed companies paid a total of $800 million in royalties last year. Seven of the 10 companies or divisions paying royalties in 2014 sell medical devices for skeletal problems.
Infuse is one of the most controversial medical devices on the market. The product contains a synthetic human protein that has left thousands of patients with serious injuries including unexpected bone growth and sexual dysfunction in men. At least 11 key studies carried out during the early stages of research that excluded adverse events were authored by doctors who were paid millions in royalties by Medtronic, according to StarTribune.com.
Medtronic is currently locked in a legal battle with the insurer Humana. Humana alleges the company paid “disguised royalties” to study authors who wrote peer-reviewed journal articles about off-label uses of Infuse. Medtronic denies the accusation. Many of the authors named in Humana’s lawsuit were first called out during a 2012 Senate Finance Committee report that criticized Infuse’s “biased” research. Last year, those doctors collected more than $11 million in royalties from Medtronic. E-mails released by the Senate Finance Committee in 2012 showed Medtronic edited their journal articles to make Infuse seem safer and less painful than other spinal fusion techniques, StarTribune.com reports.
Medtronic is currently facing more than 6,000 patient-injury lawsuits that have been filed in court or are awaiting filing, according to security filings viewed by StarTribune.com. The firm has paid an average of $23,000 per case to settle 950 cases, and has set aside an additional $140 million for future legal costs.