Senate investigation finds that Medtronic manipulated studies to make its products appear safer

by Eric Pearson

The medical device giant Medtronic is probably best known for its pacemakers and implantable defibrillators and other devices used for cardiac and cardiovascular problems. However, Medtronic develops and manufacture devices and therapies to treat more than 30 chronic diseases, including heart failure, Parkinson’s disease, urinary incontinence, obesity, chronic pain, spinal disorders, and diabetes.

In 2002, the FDA approved Medtronic’s InFuse for use in stimulating spinal bone growth in patients with a degenerative disease affecting the lower spine. InFuse uses a bioengineered protein to fuse spinal vertebrae as a way of reducing back pain.

In recent years, critics of InFuse have charged that Medtronic overplayed its benefits in studies in medical journals that also played down its risks. For example, last year in a special issue of the The Spine Journal, a group of spine specialists publicly repudiated the studies performed by the Medtronic-financed researchers, saying they had understated serious adverse effects connected with Infuse, including male sterility.

Prompted by reports alleging that physician authors who had financial ties to Medtronic failed to report dangerous side effects associated with InFuse, the U.S. Senate Finance Committee decided to investigate. The results of that 16-month investigation covering 5,000 documents relating to 13 studies of InFuse have recently been announced.

The Senate Committee’s findings include the following:

  • Medtronic was heavily 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.
  • 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 miscellaneous arrangements.
  • An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
  • Documents indicate that Medtronic prepared Dr. Hal Mathew’s remarks to the U.S. Food and Drug Administration (FDA) advisory panel meeting prior to InFuse being approved. At the time, Dr. Mathews was a private physician but was hired as a vice president at Medtronic in 2007.

“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,” said Senate Finance Committee Chairman Max Baucus. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

If you or a loved has been injured as a result of a defective medical product or device, contact the lawyers at Heygood, Orr & Pearson for your free case evaluation and to learn more about your legal right to compensation. You can reach us by calling toll-free at 1-877-446-9001, or by filling out a free legal consultation form.