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Recent Federal Court Decisions Impact Preemption Argument by Medical Device Manufacturers

other-litigation-areasSince 2008, medical device manufacturers have avoided state law personal injury claims by relying on a 2008 United States Supreme Court decision, Riegel v. Medtronic, 552 U.S. 312 (2008). In Riegel, the Supreme Court held that federal law barred most state-law personal injury claims involving a medical device approved through the FDA’s safety review and premarket approval process, pursuant to the preemption clause of the Medical Device Amendment. However, recent rulings by federal district courts in Iowa and Kentucky indicate that the Supreme Court’s decision left open a window for plaintiffs to file personal injury lawsuits involving allegations of violations involving state-law requirements that are equivalent, or parallel, to federal requirements.

In Eggerling, et al. v. Advanced Bionics, LLC (Case No. 5:11-cv-04104), the parents of a minor child sued the manufacturer of their child’s cochlear implant after the child was forced to have open head surgery to remove the faulty implant. The manufacturer, Advanced Bionics, argued that the suit could not go forward because the claims were preempted and relied on the 2008 decision by the United States Supreme Court in Riegel . On July 24th, the Honorable Judge Mark Bennett of the United States District Court for the Northern District of Iowa entered an order against the manufacturer, ruling that the plaintiffs’ inadequate testing claim could proceed on grounds that the company failed to adequately test the device under “actual or simulated used conditions” (i.e., conditions that simulate the human body).

Another court has similarly concluded that if the inadequate testing claim involves medical devices not tested under conditions that mimic the human body, state-based personal injury claims may be allowed to proceed. In March, the United States District Court for the Western District of Kentucky in Sadler v. Advanced Bionics, Inc. (Case No. 3:11-cv-00450) also decided that claims against Advanced Bionics were not preempted because Advanced Bionics did not conduct testing under actual or simulated conditions and because the state law cause of action presented parallel federal requirements.

These recent decisions by United States District Courts in Iowa and Kentucky have paved the way for plaintiffs injured by dangerous medical devices to bring state common-law claims against medical device manufacturers that received premarket approval from the Food and Drug Administration (FDA).


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