Medical Products Liability Lawsuit Case - 895 Words

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 â€Å"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 adverseShow MoreRelatedProduct Warning Labels and Protection Against Liability Lawsuits1478 Words   |  6 PagesProduct Warning Labels and Protection Against Liability Lawsuits We have all purchased a new consumer product with several labels, stickers, and product inserts containing warnings, disclaimers and oversimplified directions. 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The reason behind this is his compass that was installed in his car by Zoom Car Company was faulty which lead him in the wrong direction where he got lost and ended up in a horrible situation. Daniel Boone is suing for his medicalRead MoreTort Reform1420 Words   |  6 Pagescentury that the distinction between intentional and unintentional acts was made (Columbia Electronic Encyclopedia). In recent years, tort law has become the center of scrutiny through the increase in tort costs, insurance liability costs, and the number of frivolous lawsuits made. This scrutiny has lead to the creation of tort reform. Tort reform is a movement to reshape the way consumers can access the courts by restricting their right to sue and limiting the award that could be received (Crane)Read MoreThe Violation Of The Duty Of Care1565 Words   |  7 PagesElement one is duty of care, meaning there is a legal obligation imposed in circumstances where harm could be reasonably foreseen to occur to others. This element can be found by applying the ‘neighbour principle’ established in the Donoghue v Stevenson case. The neighbour principle states that a person must take reasonable care to avoid omission which you can reasonably foresee would be likely to injure your neighbour. Element two is breach of the duty of care. The plaintiff has the burden of proof toRead MoreNegligence Is An Important Legal Principle1587 Words   |  7 Pagesduty of care, which means that there is a legal obligation imposed in circumstances where harm could be reasonably foreseen to occur to others. This element can be found by applying the ‘neighbour principle’ established in the Donoghue v Stevenson case. The neighbour principle states that a person must take reasonable care to avoid acts or omission which you can reasonably foresee would be likely to injure your neighbour. Element two is breach of the duty of care. The plaintiff has the burden of