The judge’s order affirms that Medtronic’s off-label promotions misbranded the Infuse, which ultimately damaged the plaintiff. The FDA blatantly forbids off-label marketing, and so Medtronic is not protected by the FDCA amendments. The judge agreed, noting that all of Ramirez’s claims stem from her surgeon’s use of the Infuse device based on Medtronic’s promotions and advertisements. She claims Medtronic did this despite knowing the potentially severe side effects of such off-label use. Ramirez accused the company of encouraging doctors to use the Infuse in off-label procedures, such as lumbar fusion surgery, through various marketing platforms, including medical journal articles. The amendments would only apply if Medtronic recommended the device only for its intended purpose. The judge granted Ramirez’s suit based primarily on her claim that the company marketed the Infuse to physicians for uses not listed on its label, and therefore not approved by the FDA. The plaintiff sued Medtronic claiming failure to warn, defective design, fraud, negligence, breach of express warranty, and misrepresentation. The Arizona federal judge, however, stated that most of Ramirez’s claims were not preempted by these laws. These amendments give the FDA a substantial amount of control over how a medical device is manufactured and marketed. Medtronic moved to have the lawsuit dismissed based on the Medical Device Amendments to the Food, Drug and Cosmetic Act (FDCA). The chronic pain Ramirez now suffers is caused by an uncontrollable growth near the Infuse implant site.
Ramirez was unaware that her surgeon was using the Infuse even though it was not approved for such a procedure. The plaintiff, Cristina Ramirez, has suffered from severe back pain ever since she underwent a lumbar fusion procedure, during which she was implanted with Medtronic’s Infuse. The company attempted to argue that two federal laws preempted the injury lawsuit. Medtronic Infuse lawyers at Pintas & Mullins Law Firm report that a federal judge recently threw out Medtronic’s motion to dismiss an injury lawsuit concerning its popular bone graft substitute, the Infuse.
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