Contrary to other court rulings in similar cases, the 10th Circuit Court of Appeals recently ruled that a plaintiff’s injury claims involving Medtronic InFuse bone graft are preempted. There have been numerous safety concerns surrounding InFuse, which is approved to stimulate bone growth in the spine and certain dental procedures. Medtronic has largely been able to avoid litigation by arguing that the federal preemption clause of the Federal Food, Drug and Cosmetic Act frees them of liability. While the 10th Circuit agreed, courts elsewhere have rejected this argument in certain cases.
The case was reviewed by a three-judge panel, and the decision was split. Two of the judges opined that the Food, Drug and Cosmetic Act superseded state claims protecting citizens from against adulterated medical devices. The dissenting judge, Judge Carlos F. Lucero, noted that the act is actually meant “promote the safety of medical devices through honest labeling and promotion. The majority opinion found that Medtronic’s misrepresentations to the plaintiff or her doctor were irrelevant, but Judge Lucero disagreed. The plaintiff “incorporated allegations, supported by facts, that Medtronic misbranded Infuse in violation of federal law because it sold Infuse for an intended use not approved by the FDA. This would render its labeling no longer necessarily ‘adequate’ under federal law.” he stated.
The majority found that federal law preempted Medtronic’s actions, but Judge Lucero asserted that preemption does not apply when a manufacturer markets its medical devices illegally. The plaintiff in this case alleged that Medtronic has marketed Infuse off-label, or in ways not approved by the U.S. Food and Drug Administration (FDA). These actions have always been in violation of state law and were parallel with existing Oklahoma law where the original action was filed. The Supreme Court has held in a previous ruling that parallel claims such as these are not preempted under federal law.
In 2008, a court ruling found that individuals may file lawsuits against medical device makers under state rules that are deemed “parallel” to federal requirements. The 9th Circuit Court of Appeals in San Francisco, California ruled that a Medtronic lawsuit may proceed, having met these requirements.