Medtronic Inc’s Infuse bone graft, a bioengineered bone-growth product used in spinal surgery, has been linked to a greater cancer risk than previously thought in patients treated with high doses of Medtronic’s controversial protein. People who received Infuse, especially in off-label procedures, may be at higher risk for stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, and pancreatic cancers. Amplify, another Medtronic product that contained a higher dose of rhBMP-2, the bio-engineered bone growth protein found in Infuse, was rejected by U.S. regulators because of its association with cancer. However, it is known that off-label Infuse procedures often require doses of rhBMP-2 that are even higher than what was present in Amplify.
Parker Waichman LLP’s defective drug lawyers are actively investigating potential lawsuits on behalf of anyone who developed cancer after treatment with Medtronic Infuse. If you or someone you love was diagnosed with stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, or pancreatic cancer following surgery with Medtronic Infuse, you may be entitled to compensation through a lawsuit. Parker Waichman LLP offers free lawsuit evaluations to possible Medtronic Infuse cancer victims. We urge you to contact one of our experienced attorneys today to discuss your potential Medtronic Infuse cancer lawsuit by completing the form at right or calling us at 1-800-YOURLAWYER (1-800-968-7529) for a FREE Lawsuit evaluation.
Medtronic Infuse, Amplify Bone Growth Products and Cancer
In March 2011, the U.S. Food & Drug Administration (FDA) rejected Medtronic’s approval application for the Amplify bone graft product because of concerns it could increase cancer risks among patients who received it. The FDA Amplify decision came after Medtronic trial results showed a significantly higher number of cancers in the study group that received Amplify when compared to a control group that received a bone graft as part of a spinal fusion.
In November 2011, during a meeting of the North American Spine Society (NASS), Dr. Eugene J. Carragee of Stanford University revealed that not all the findings of that Medtronic-sponsored clinical trial had been made public. In an interview with The New York Times, Dr. Carragee said the Amplify study findings had potential implications for patients who received Infuse, as doctors often administered Infuse off-label at doses equal to or higher than Amplify.
According to Dr. Carragee, his research reflected a 2.5 times greater risk of developing cancer one year after rhBMP-2 was used and a five times greater risk after three years. He said Infuse was linked to a cancer diagnosis more often than when the product was not used at all. Amplify was tied to more cancer risk than Infuse.
Dr. Carragee was also the author of a June 2011 Spine Journal article that found that Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.
Medtronic Infuse Off-Label Use
Medtronic’s Infuse product is approved for use in a type of spine surgery called anterior approach lumbar fusion, and two types of dental procedures. However, Infuse is widely used off-label in other spine procedures, especially cervical (neck) spine surgery, as well as in lateral approach (through the side of the body) or posterior approach (through the back of the body) spinal procedures. In July 2008, the FDA warned that Infuse bone graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
While doctors are not prohibited from using an approved medical product in any way they see fit, manufacturers are not legally permitted to promote or market products based on off-label uses. Even before Dr. Carragee revealed his cancer findings, the U.S. Department of Justice was investigating whether Medtronic had promoted off-label use of Infuse. The investigation was launched in November 2008, when at least 280 reports of side effects involving Infuse had been made to the FDA when the investigation. At least three quarters of those reports involved off-label use of Infuse.
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