Potential Cover Up of Side Effects Regarding Medtronic Infuse

A number of U.S. Senators continue to debate over whether or not researchers, associated with Medtronic Infuse bone-graft products, neglected to divulge potential side effects of the device. Reports indicate that Medtronic, the developer of Infuse bone-graft products, paid researchers a substantial amount of money, reportedly in the millions, in an attempt to cover up dangerous side effects that could harm the future marketing of the device.

Medtronic Infuse is what is known as a bioengineered bone morphogenetic protein (BMP). As a BMP, Medtronic Infuse encourages bone growth, therefore enabling it to replace spinal disks in the vertebrae. The U.S. Food and Drug Administration (FDA) garnished Medtronic with their approval of the device in 2002. However, recent reports indicate that Medtronic may have intentionally hidden dangerous side effects in order to boost sales.

Leading the investigation against Medtronic’s alleged cover up, Senators Max Baucus and Charles Grassley wrote a letter to the manufacturer on June 21. At the heart of the letter was a request, in which the Senators demanded the release of documents detailing communications with researchers over the development and testing of Infuse bone growth products. More specifically, the Senators demanded that Medtronic relinquish all communications with medical journals, clinical investigators, the FDA and its advisory boards, and physician consultants that pertain to Infuse complications. Accordingly, the letter also indicates that the Senators are looking for detailed accounts of payments to researchers involved with infuse clinical trials.

The Senators efforts to obtain these documents came after reports surfaced that the researchers, each of whom are allegedly financially tied to Medtronic, appeared to have had hidden agendas. It is believed that the researchers in question purposefully neglected to divulge potential Infuse side effects, including an increased risk of fatal swelling of the neck, harmful bone growth and sterility.

Public concern over the potential cover up climaxed when a Medtronic Infuse study, published in the May edition of The Spine Journal, blatantly contradicted the claims of sponsored Medtronic researchers. As a result, the healthcare community began to suspect that those involved with the study were being paid by Medtronic to cover up many of the devices potentially dangerous side effects.

Upon initial review of these allegations, Senator Baucus announced that ” Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”

Do I Have A Medtronic Infuse Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Medtronic Infuse lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by a Medtronic Infuse device, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.