Medtronic Infuse Bone Graft Studies May Have Been Manipulated, According to U.S. Senate Report

A U.S. Senate Finance Committee report charges that Medtronic Inc. deliberately downplayed Medtronic Infuse Bone Graft side effects and promoted off-label uses, Bernstein Liebhard LLP Reports.

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Bernstein Liebhard LLP | Consumer Injury Lawyers
Medtronic’s action as described by the Senate Committee constitute a violation of the trust patients put in the company when they underwent procedures involving Infuse.

New York, NY (PRWEB) October 26, 2012

A U.S. Senate Finance Committee report is raising disturbing questions about the research used to back Medtronic Inc.’s Infuse Bone Graft product, according to Bernstein Liebhard LLP.    The report, which is based on some 5,000 documents furnished by Medtronic to the Senate Committee, charges that Medtronic deliberately manipulated the studies to downplay Medtronic Infuse Bone Graft side effects and promote off-label use of the bone graft protein. The report also found that Medtronic paid out $210 million in royalties, consulting fees, and other payments to the doctors who co-authored the Medtronic-sponsored Infuse studies.*

“The results of the Committee’s 16-month investigation of Medtronic Infuse Bone Graft are disturbing. Medtronic’s action as described by the Senate Committee constitute a violation of the trust patients put in the company when they underwent procedures involving Infuse,” says Bernstein Liebhard LLP, a nationwide law firm currently evaluating lawsuits on behalf of individuals who may have suffered Medtronic Infuse Bone Graft injuries.

Medtronic Infuse Bone Graft
Medtronic Infuse Bone Graft was approved by the U.S. Food & Drug Administration (FDA) in 2002 for stimulating spinal bone growth in patients with a degenerative disease affecting the lower spine. According to the Senate Finance Committee, Medtronic estimates that Infuse has been used in some 500,000 patients. In 2008, the FDA warned that Infuse Bone Graft had been associated with serious complications when used off-label in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage. **

In 2011, The Spine Journal dedicated an entire issue to studying the risks of the recombinant bone morphogenetic protein-2, or BMP-2, used in Medtronic Infuse Bone Graft.*** The journal’s investigation found that 13 Medtronic-funded studies downplayed or entirely omitted evidence of safety issues with Infuse. According to the report, the doctors who conducted the studies – some of whom were paid tens of millions by Medtronic - failed to accurately report serious Medtronic Infuse complications, including:

  • Cancer
  • Sterility in men
  • Infections
  • Bone dissolution
  • Worsened back and leg pain

Bernstein Liebhard LLP is offering free lawsuit consultations to anyone allegedly injured by Medtronic Infuse Bone Graft. Victims of serious Medtronic Infuse complications may be entitled to compensation for their medical care, pain and suffering, and other damages. A wealth of information regarding the potential dangers associated Medtronic Infuse Bone Graft is available on Bernstein Liebhard LLP’s website, http://www.consumerinjurylawyers.com/. For more information about Medtronic Infuse lawsuits, please contact one of our attorneys by calling 877-779-1414.

*finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86
**fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm
*** thespinejournalonline.com/article/S1529-9430%2811%2900299-3/abstract

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.

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