Medtronic Infuse, a product that promised to help regrow spine, has led to controversy and safety concerns since it hit the market in 2002. Medtronic has been accused of promoting Infuse for off-label use, which accounts for 85% of Infuse procedures. The product came under greater scrutiny due to allegations that the company paid doctors to hide side effects. These reports led to government investigations, one of which found that Medtronic had hand in writing studies about Infuse.
Despite all the trouble surrounding Infuse, people who have been injured by Infuse have not been allowed to sue Medtronic because of federal pre-emption status. Federal pre-emption is when state law is nulled by federal law. In this case, the federal law rules that patients can’t sue for a medical device that was approved through premarket approval. Now, hundreds of Infuse patients are challenging this by alleging that Medtronic illegally promoted Infuse for unapproved or off-label uses.
Infuse was only approved for use in the lower spine when it was approved in 2002. Using Infuse, or any medical product, in any way other than approved by the FDA is considered off-label. A drug or medical device can be used off-label if it is advised by a physician, but it is illegal for companies to promote their products for this purpose. According to hundreds of claimants who claim they were injured by Infuse, this is exactly what Medtronic did. By alleging that Medtronic illegally marketed Infuse for unapproved procedures such as in the cervical spine (neck), Infuse patients may be able to circumvent the federal pre-emption status. If the court rules against Medtronic, it may have drastic effects on pharmaceutical companies as a whole.
In 2008, the FDA warned that using Infuse off-label in the cervical spine could lead to deadly side effects such as neck and throat swelling.
In June 2011, a group of spine experts publicly rebuked Medtronic over studies promoting Infuse. The scientists dedicated an entire issue of the Spine Journal to the issue, stating that Medtronic –funded studies failed to mention side effects such as cancer, male sterility, infections and leg and back pain. In response to these allegations, Medtronic asked Yale researchers to conduct independent reviews of the data. The review, led by Yale Professor Dr. Harlan Krumholz, only helped confirm suspicions put forth in the Spine Journal. The two groups who studied the data found that Infuse was associated with cancer, and is not more beneficial than a traditional bone graft.
In December 2012, the Senate Finance Committee criticized Medtronic over Infuse. The Senate report found that Medtronic employees helped write and edit studies about Infuse. The doctors who were listed as authors in those studies were paid a total of $210 million.