A Medtronic Infuse lawsuit in Minnesota was pushed closer to trial this week, Star Tribune reports. Hennepin County judge Laurie Miller has allowed the lawsuit of Stephen and Barbara Lawrence to proceed against the company over alleged off-label marketing. The Infuse case is the second to progress recently.
Last week, a lawsuit was reanimated when a California appeals court reversed an earlier preemption decision. The decision was based on a caveat that allows cases based on state laws that were exactly parallel to federal laws. The plaintiff in that case, John Coleman, alleged that Infuse caused numbness, pain and excess bone growth when Infuse was implanted off-label through the back of his body.
According to Star Tribune, the Lawrence’s lawsuit was initially barred because of a Supreme Court ruling that prevented people from suing companies over injuries sustained from federally-approved devices. After analyzing more detailed allegations filed after this initial decision, Miller allowed the case to proceed. This brings the case more towards a trial, where a jury could decide whether or not Medtronic engaged in illegal off-label marketing.
Because of Miller’s decision, doctors paid by Medtronic can now be questioned under oath by plaintiffs’ parties. Litigation all over the country might also be influenced, including the 32 cases filed in Minnesota.
“Off-label” is when a drug or a medical device is used in a way that is not approved by the U.S. Food and Drug Administration (FDA). Companies cannot promote their products for off-label marketing, but doctors can choose to do so at their own discretion. Side effects related to off-label use has been one of the main safety issues with Infuse since it hit the market in 2002.
Infuse was supposed to be a product that helps regrow bone in the spine, but has become a subject of safety concerns and scandal. The product drew a substantial amount of attention in June 2011, when a group of spine experts examined Medtronic-funded trials and found that the studies failed to mention side effects like cancer, male sterility and excess bone growth. In October 2012, a condemning US Senate Finance Committee report showed that Medtronic paid $210 million to doctors researching Infuse. The Senate report also found that Medtronic employees helped edit studies on Infuse, downplaying its side effects and overstating its safety.