With numerous lawsuits filed against it over injuries attributed to its InFuse bone growth device, device maker, Medtronic Inc., has been trying to convince various courts nationwide that the federal preemption clause of the federal Food, Drug and Cosmetic Act frees the company from liability for the injuries. In a recent case, a split 10th Circuit Court of Appeals rejected the plaintiff’s arguments that her injury claims were not preempted.
The three-judge panel was split, with the dissenting judge noting 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 majority 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. Parallel claims such as these, the United States Supreme Court has already held in another Medtronic case, Medtronic v. Lohr, 518 U.S. 470 (1996), are not preempted under federal law.
“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,” said Gary Falkowitz, managing attorney at Parker Waichman LLP. The firm is investigating whether Medtronic may have done something wrong with InFuse labeling information, especially with respect to certain life-altering adverse reactions. Serious complications, including male sterility, infections, increased cancer risk, bone dissolution, and worsened back and leg pain have been reported with InFuse. The firm is also investigating whether the manufacturer may have been aware of these risks prior to the product’s release. Parker Waichman currently has multiple cases filed against Medtronic relating to injuries allegedly caused by InFuse.
Prior high court decisions have interpreted the federal law involving medical device approval as limiting the types of lawsuits individuals may bring. But a 2008 ruling found that device makers may not be subject to “additional requirements under state product liability law.” This means that individuals may sue under state rules that are deemed “parallel” to the federal requirements. In fact, according to the 9th Circuit Court of Appeals in San Francisco, California, claims that meet those requirements may proceed.