Medical Products Liability Lawsuit Case

895 WordsNov 2, 20154 Pages
Medical Products Liability Claims in the Wake of Coleman v. Medtronic The California Court of Appeals’ decision in Coleman v. Medtronic has made it easier for plaintiffs to pursue medical products liability claims. In the landmark 2014 decision, the court held that the state law tort claims asserted by the plaintiff were not federally preempted. The decision is part of a growing body of medical products liability law regarding the circumstances under which a state law claim can impose "parallel" requirements to those under the Food, Drug & Cosmetics Act (FDCA) and, therefore, avoid federal preemption. The Facts of the Case John Coleman filed a product liability lawsuit against Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, Medtronic), alleging that he suffered painful complications after a spinal surgery in which Infuse, Medtronic 's federally-approved bone fusion medical device, was used in an “off-label” manner. The Federal Drug Administration (FDA) granted Infuse premarket approval for use in certain types of spinal fusion surgeries, including Anterior Lumbar Interbody Fusion (Anterior Fusion). The type of surgery Coleman underwent — Posterior Fusion — was promoted by Medtronic but not approved by the FDA. As detailed in court documents, studies funded by Medtronic found that the medical device could cause bone growth in the spinal canal, but the company did not report the adverse events to the FDA. Medtronic was also aware that adverse

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