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Another Recent Federal Court Decision Impacts Preemption Arguments Made by Medical Device Manufacturers

We previously reported on medical device manufacturers’ attempts to avoid 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 bars most state law personal injury lawsuits involving a medical device that has gone through the FDA’s safety review and premarket approval process. However, a growing number of rulings by federal district courts indicate that the Supreme Court’s decision left open a window for plaintiffs to file personal injury lawsuits alleging violations of state law requirements that are equivalent, or parallel, to federal law.

While these rulings focused on inadequate clinical testing, a recent ruling by a federal judge in the District of Arizona held that preemption does not apply in cases involving promotion of off-label uses. According to Reuters Legal, U.S. District Court Judge Murray Snow in Ramirez v. Medtronic (Case No. 13-cv-00512) ruled that state law claims against Medtronic Inc. were not preempted because the company had allegedly promoted its Infuse® Bone Graft device for uses not approved by the U.S. Food and Drug Administration.

Cristina Ramirez was a patient who allegedly suffered injuries after her doctor, a paid Medtronic consultant, used the Infuse® Bone Graft in an “off-label” way. The doctor implanted the bone graft without a recommended cage and did so through her back instead of through her abdomen. She later developed uncontrolled bone growth and nerve compression, and filed a suit against the manufacturers of the Infuse® Bone Graft for her injuries. Ramirez argued that Medtronic promoted the Infuse® Bone Graft for off-label uses through its sales representatives, in journal articles, and by paying surgeons to urge off-label uses to fellow surgeons. Medtronic moved to dismiss the lawsuit on grounds of preemption. Ramirez argued that Medtronic’s off-label promotion constituted a “parallel claim,” meaning that the lawsuit was not barred by federal law, per recent rulings in other federal district courts.

Judge Snow sided with Ramirez, but not for the reasons she advocated. Instead, Judge Snow concluded that her claims fit through the narrow window of a parallel claim and that preemption does not apply in cases alleging off-label promotion. Despite some contrary rulings in other district courts, Judge Snow reasoned that preemption does not apply when a medical device manufacturer promotes off-label uses, because off-label use is “essentially unregulated.” Thus, the policy interests underlying the preemption doctrine (i.e., to avoid conflicts between state court decisions and FDA regulations) do not come into play. Therefore, Judge Snow’s ruling in Ramirez enlarges the window for plaintiffs bringing personal injury claims against medical device manufacturers who would otherwise argue preemption as a defense.

 

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