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Medtronic is Paying the Authors of Controversial InFuse Research Millions of Dollars in Royalties Even as it Faces Thousands of Lawsuits

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Medtronic is Paying Millions to the InFuse Research Authors

Medtronic is Paying Millions to the InFuse Research Authors


Medtronic continues to pay millions of dollars to doctors who authored questionable research articles concerning the safety and effectiveness of the company’s InFuse spine growth product.

In 2014, Medtronic Sofamor Danek – Medtronic’s spine division – paid $60.7 million in royalties to 79 doctors and their affiliates, including to the authors of controversial studies of InFuse. Dr. Ken Burkus, a Georgia surgeon and the lead author on six InFuse studies that omitted adverse events, received $374,000 from Medtronic. Dr. Regis Haid, an Atlanta, Georgia, neurosurgeon and the lead author of one study, was paid $2.3 million in royalties. Both doctors received their payments from third-party companies. StarTribune.com reports the company paid $90 million in royalties last year.

“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.”

The vast majority of royalty payments are paid for patented and licensed innovations. Last year, medical device companies paid a total of $800 million in royalties, according to data released last month under the federal Open Payments program that was viewed by StarTribune.com. Seven of the 10 companies or divisions paying royalties in 2014 sell medical devices for skeletal problems.

InFuse is a controversial spine fusion product that contains a synthetic human protein. Thousands of patients have been injured by the product, many of whom have filed lawsuits against Medtronic. InFuse is known to cause unexpected bone growth, sexual dysfunction in men and other serious adverse events. The credibility of early InFuse research has been called into question because at least 11 studies that omitted key safety data were written by doctors who received millions of dollars in royalties from Medtronic, according to StarTribune.com.

The insurer Humana has sued Medtronic, accusing the company of paying “disguised royalties” to study authors who wrote peer-reviewed journal articles concerning uses of InFuse that are not approved by the U.S. Food and Drug Administration (FDA). Many of the authors named in the suit were first identified during a 2012 Senate Finance Committee report that criticized what it referred to as biased InFuse research. Those doctors collected more than $11 million in royalties from Medtronic in 2014. E-mails released by the Senate Finance Committee in 2012 that were viewed by StarTribune.com show Medtronic edited their journal articles to make InFuse seem safer and less painful than other spinal fusion techniques.

More than 6,000 patient-injury lawsuits have either been filed against Medtronic in court or are awaiting filing, security filings viewed by StarTribune.com show, and the company has set aside about $140 million for future legal costs.

breakinglawsuitnews.com disclaimer: This article: Medtronic is Paying the Authors of Controversial InFuse Research Millions of Dollars in Royalties Even as it Faces Thousands of Lawsuits was posted on Tuesday, July 14th, 2015 at 2:43 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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