A Medtronic Infuse lawsuit was reanimated last week when a California appeals court decided to reverse a lower court’s decision that the claims were preempted by federal law. Preemption means that state law is superseded by federal law in the event that they ever differ. A high court caveat, however, includes claims that involve state laws that are exactly parallel to federal laws. According to Mass Device, the California Court of Appeal took that exception into account, and partially overturned a lower state court’s decision that the plaintiff’s claims were preempted.
The plaintiff in the lawsuit is John Coleman, who received Infuse in April 2009. The artificial bone graft device was implanted through a posterior fusion operation, meaning that it performed through the back of the body. The FDA has only approved Infuse for anterior fusion, performed through the front of the body. Coleman’s lawsuit alleges that he suffered from pain and numbness, allegedly due to Infuse. According to court documents, CT scans show that he suffered from bone growth that “encased the nerves in Coleman’s spine,”
The appeals court ruled that California’s liability laws about failure to warn are parallel to federal laws on how medical device companies must report adverse events, 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,” Through this reasoning, the court agreed with 2 of Coleman’s claims for negligence, which include failure to warn about adverse events and off-label promotion.
“Off-label” is when a drug or medical device is used in a manner not approved by the FDA. Doctors can use devices off-label at their own discretion, but it is illegal for companies to engage in off-label promotion.
Infuse has been on the market since 2002. In recent years, it has become extremely controversial due to safety concerns about hidden complications and off-label uses. In 2011, The Spine Journal dedicated an entire issue to the matter; a group of spine experts discussed complications associated with Infuse, including cancer, leg pain, infection and male sterility. None of these side effects was mentioned in the Medtronic-funded studies, the experts pointed out. Later on, a federal investigation found that the Medtronic studies were partially written by company employees, biasing the studies.