Concerns regarding Medtronic’s device royalty scheme, Part 2

We noted in our earlier blog post of this week that Medtronic, which describes itself online as “the world’s premier medical technology and services company,” is front and center in a recent media expose that denotes it as “a flash point in a national debate about the role of money in medicine.”

In a nutshell, here’s why: Reportedly, Medtronic paid out approximately $90 million in royalties to doctor researchers last year for work they did on studies regarding Medtronic medical devices.

Is that at all worrisome?

It might be, given evidence showing that a high percentage of the royalties Medtronic paid in 2014 went to researchers involved with journal articles that extolled Medtronic’s bone-growth system Infuse.

That could be problematic for several reasons, including these:

• Many thousands of patients say they suffer because of Infuse, and more than 6,000 personal injury lawsuits have been filed or are pending
• Many past Infuse-related studies written by doctors receiving royalties failed to include adverse information known about Infuse
• A U.S. Senate committee report cited royalty-receiving physicians who contributed to biased Infuse research
• Much recent research reportedly endorses a broader use for Infuse than what has been narrowly recommended by the FDA; one insurer has sued Medtronic for so-called “disguised royalties” paid to doctors who promote unapproved uses of Infuse

Infuse already has a troublesome product liability history, as evidenced by the massive amount of litigation it has sparked.

Notwithstanding that reality, the company continues to endorse its payments scheme, with one Medtronic official recently noting that royalties paid to doctors spur “their inventive contributions.”

Critics across a wide spectrum disagree. A director of the advocacy group Public Citizen counters that, while royalties obviously benefit both Medtronic and the doctors it pays, they are “not in the best interests of the patients.”

We will be sure to keep our readers in Southern California and elsewhere timely apprised of any material details that emerge regarding Infuse, including product liability-related news and litigation developments surrounding the bone-growth system.

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