In an effort to avert lawsuits filed over injuries attributed to its InFuse bone growth device, device maker, Medtronic Inc., has tried to convince courts that the federal preemption clause of the federal Food, Drug and Cosmetic Act preempts the lawsuits.
Recently, a split 10th Circuit Court of Appeals rejected the plaintiff’s arguments that her injury claims were not preempted. The dissenting judge on the three-judge panel noted that the majority opinion discarded state claims protecting citizens against adulterated medical devices in the marketplace under the Food, Drug and Cosmetic Act, which was actually supposed to “promote the safety of medical devices through honest labeling and promotion.” Judge Carlos F. Lucero found that the majority was wrong in finding that Medtronic’s misrepresentations to the plaintiff, her doctor and others, were irrelevant. Judge Lucero said 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. The other two judges held that Medtronic’s actions were preempted by federal law, but Judge Lucero found that federal law offered no protection to a manufacturer who promoted its product outside of that law. Those types of acts were always in violation of state law and were parallel with existing Oklahoma law, which is where the original action had been brought. In another Medtronic case, Medtronic v. Lohr, 518 U.S. 470 (1996), the United States Supreme Court held that parallel claims such as these are not preempted under federal law.
Gary Falkowitz, managing attorney at Parker Waichman LLP, said, “Although there were significant issues with this complaint, the majority’s interpretation provides clearer direction in how to proceed and overcome preemption issues in future cases.” Parker Waichman is investigating what Medtronic may have done wrong with InFuse labeling, especially with respect to serious adverse reactions. Serious complications, including male sterility, infections, increased cancer risk, bone dissolution, and worsened back and leg pain have been reported after InFuse surgery. The firm is also investigating whether the manufacturer may have been aware of the risks before InFuse was released. The firm has multiple cases filed against Medtronic relating to injuries allegedly caused by the InFuse device.
In previous decisions, the high court has interpreted federal law involving medical device approval as limiting the types of lawsuits individuals may bring. A 2008 ruling found that device makers may not be subject to “additional requirements under state product liability law,” which means that individuals may sue under state rules that are deemed “parallel” to the federal requirements. According to the 9th Circuit Court of Appeals in San Francisco, California, claims that meet those requirements may proceed.