Manipulating Infuse Bone Graft Studies

defective medical device, medtronic infuse bone graftThe medtronic infuse bone graft has garnered attention from the FDA, research organizations, courts, patients and even the U.S. Senate.  Apparently, Medtronic was involved in manipulating infuse bone graft studies.

The Senate Finance committee released the results of their 16-month investigation into Medtronic and its involvement in manipulating infuse bone graft studies which revealed questionable ties between the medical technology company and the physician consultants tasked with testing and reviewing Medtronic products.

It appears – as based on the report – that Medtronic was manipulating infuse bone graft studies:

  • without public disclosure of their roles, Medtronic employees collaborated with physician authors to edit – and in some cases, write – segments of published studies on its bone-growth product InFuse
  • in which the studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments
  • in which Medtronic, which describes itself as “the world’s largest independent medical technology company,” also maintained significant, previously-undisclosed financial ties with physicians who authored studies about InFuse, making $210 million in payments to physicians over a 15-year period

Senator Baucus stated the following:

“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,” Senator Baucus said.  “Patients everywhere will be better served by a more open, honest system without this kind of collusion. ”

In 2002, The Food and Drug Administration (FDA) approved InFuse for use stimulating spinal bone growth in patients with a degenerative disease affecting the lower spine.  According to Medtronic, InFuse has been used to treat more than 500,000 patients.

The full report on the investigation is available on the Finance Committee’s website above.  Major findings of the investigation include:

  • Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.  The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles.  Medical journals should ensure any industry role in drafting articles or  contributions to authors be fully disclosed.
  • Medtronic paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty and other arrangements.
  • An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events, or side effects, possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
  • Medtronic officials inserted language into studies that promoted InFuse as a better technique than an alternative by emphasizing the pain associated with the alternative.
  • Documents indicate that Medtronic prepared one expert’s remarks to the FDA advisory panel meeting prior to InFuse being approved.  At the time, the expert was a private physician but was later hired to be a vice president at Medtronic in 2007.

Medtronic manufactures and sells Infuse, a medical device used in surgery to strengthen the spines of individuals with degenerated vertebral discs.

Infuse consists of an absorbable collagen sponge, rhBMP-2 (a manufactured version of a protein found in small quantities in the human body), and a titanium threaded fusion cage. During surgery, the doctor infuses the collagen sponge with liquid rhBMP-2 and inserts the sponge into the cage to both stabilize the spine and maintain spacing between the vertebrae during the fusion process.

Unfortunately, some potential problems may be connected to the use of the medtronic infuse bone graft during spinal surgery. Some the potential problems may include:

  • Difficulty Breathing
  • Difficulty Swallowing
  • Difficulty Speaking
  • Compression of the Airway
  • Respiratory Depression
  • Paralysis
  • Nerve Damage
  • Death

For more information on Medtronic’s Infuse Bone Graft, click here.

If you or your loved one has are suffering a side effect/injury from use of the infuse bone graft – off label – in neck cervical spine surgery, please seek and consult with your healthcare provider as soon as possible. And, if you have been injured and want to talk to a infuse bone graft lawyer and/or file a low medtronic infuse bone graft lawsuit, contact us.

FREE CASE REVIEWContact Us At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases. We are here to help with your medtronic infuse bone graft lawsuit. If you are suffering a side effect or injury from the off-label use of the medtronic infuse bone graft in neck or cervical spine surgery and would like your case evaluated, contact our office at 1.844.329.5955.