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US Senate Report Blasts Medtronic Over Manipulated InFuse Bone Graft Studies

- Ennis & Ennis News

10/27/2012 - A United States Senate Finance Committee report sharply criticized Medtronic for deliberately scheming to suppress evidence and manipulate studies pertaining to its InFuse bone graft system. The report follows a 16-month investigation and concludes that Medtronic employees wrote and edited peer-reviewed studies regarding Infuse without disclosure, deliberately manipulated studies, downplayed adverse events and actively promoted off label use. The report further noted that Medtronic, “also maintained significant, previously-undisclosed financial ties with the physicians who authored studies about InFuse, making $210 million in payments to physicians over 15-year period.”

Senate Finance Committee Chairman, Max Baucus (D-Mont.) stated, “Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.” Chuck Grassley (R-Iowa) added, “these findings emphasize the value of the Grassley-Kohl Physician Payments Sunshine Act, which will result in public disclosure of industry payments to physicians starting next year.”

The full report on the investigation is available on the Senate Finance committee’s website. Other inappropriate conduct noted in the report include that Medtronic officials inserted language into studies that promoted Infuse as a better technique than an alternative by emphasizing the pain associated with the alternative; a Medtronic employee recommended against publishing a complete list of adverse events or side effects, including serious adverse event data that were already a concern of the FDA; and that Medtronic may have prepared Dr. Hal Mathew’s remarks to the FDA advisory panel meeting prior to InFuse being approved. Dr. Mathew was later hired to be a vice president at Medtronic.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies, as well as medical device makers.

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