October 25, 2012 — The U.S. Senate Finance Committee has published a scathing report after more than a year-long investigation of Medtronic, Inc., the company that manufactures the Infuse Bone Graft and other bone-growth products.
The investigators found evidence that Medtronic was “ghostwriting” medical journal articles, paying tens of millions of dollars in “consulting fees” to doctors who co-authored the articles, and failing to disclose the financial ties when the articles were published.
The Committee found that a group of 13 physicians were paid about $210 million in royalties, consulting fees, and other fees. Over the course of 15 years, these physicians co-wrote articles with heavy editing from Medtronic. According to the Committee, Medtronic “was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by the physician consultants.” At least 11 medical journal articles were manipulated by Medtronic.
When the articles were published, the financial ties between Medtronic and the physicians was never disclosed. Investigators wrote,
“The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fully disclosed.”
The highest-paid researcher was Dr. Thomas Zdeblick. Medtronic paid him $34 million from 1996 until 2010 in royalties and consulting fees, mostly due to his 22 patents in the bone-growth technology. As editor of the Journal of Spinal Disorders & Techniques, Dr. Zdeblick published two studies that were edited by Medtronic. An investigation revealed that the financial ties between were not fully disclosed when the articles were published.
The investigation also found that Medtronic sought weaker safety rules that would have allowed them to continue clinical studies of the Infuse in cervical neck surgery patients, even if the patients had swelling in their neck. The FDA has never approved bone-growth for use in the neck because of the risk of angioedema, or life-threatening swelling in the neck. In 2008, the FDA published a warning about this hazard, after receiving dozens of reports.
Serious side effects of the Medtronic Infuse Bone Graft include:
- Excessive bone growth
- Nerve damage
- Swelling in the neck (angioedema)
- Inflammation, which can be life-threatening
- Male sterility
- And more
Do I have an Infuse Bone Graft Lawsuit?
The Schmidt Firm, PLLC is currently accepting Infuse Bone Graft induced injury cases in all 50 states. If you or somebody you know has been injured by the Infuse Bone Graft, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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