Preemption Decision Reversed in Medtronic Infuse Case

A California appeals court has reverse a lower court’s preemption argument with regards to a lawsuit over Medtronic Infuse Bone Graft. The plaintiff in the case, John Coleman, alleges that the artificial bone graft causes numbness and pain after it was implanted in 2009. Coleman’s lawsuit alleged that Medtronic failed to warn about complications and engaged in off-label promotion. Previously, a lower court ruled that these claims were preempted, or trumped, by federal law.

There is, however, an exception to the preemption doctrine; cases are allowed if they are citing state laws that exactly parallel federal law. In this case, the California Court of Appeals found that state laws about failure to warn are parallel to federal laws on how medical device companies must report adverse events. The court partially overturned the lower court’s decision, stating “California law imposes a parallel requirement under the common law strict liability tort of failure to warn. The device manufacturer can be found liable if it ‘did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution,” Therefore, the court ruled, 2 of Coleman’s claims about failure to warn and off-label promotion are not preempted.

Infuse has been a subject of controversy due to allegations of off-label side effects and hidden complications. Off-label means that a device or drug is used in a manner not approved by the FDA. Even though doctors can do this at their own discretion, it is illegal for companies to promote off-label use. Coleman’s operation was off-label, according to court documents; he had Infuse implanted through posterior fusion as opposed to anterior fusion, which is the method approved by the FDA. According to Mass Device, the lawsuit alleges that Infuse caused excess bone growth that “encased the nerves in Coleman’s spine,”

Infuse hit the market in 2002. In its short time on the market, it has drawn a substantial amount of negative attention due to safety issues. Concerns truly began in 2011, when The Spine Journal dedicated an entire issue to the matter. In a bold and unusual move, a group of spine experts called out Medtronic researchers for failing to including cancer, leg pain, infection, male sterility and other complications that were associated with Infuse. Later on, a federal investigation found that the Medtronic studies were partially written by company employees, biasing the studies.