In McClelland v. Medtronic, the U.S. District Court for the Middle District of Florida explains some of the legal hurdles facing a person looking to sue a medical device maker for negligence.
The case surrounded the tragic death of B. McClelland in August 2011 as a result of heart failure. McClelland had complained of recurrent heart palpitations prior to this time and was driving to the hospital when she passed away. Later tests showed that an EnPulse pacemaker Model E1DR21 implanted in her had failed due to certain deficiencies. Product manufacturer Medtronic issued a recall of the pacemakers more than one year later and released a software update to reprogram the defective devices that were recalled.
McClelland’s mother, as representative of her estate, sued Medtronic for negligence. She alleged that the company had a duty to notify McClelland and the Food and Drug Administration about defects in the E1DR21 that could lead to serious injury or death and that it failed to do so. According to the suit, the product would have been recalled earlier – before McClelland’s death – had the company reported the defects in a timely manner.
Dismissing the complaint, the Middle District held that the negligence claim was pre-empted under the federal Medical Device Act (MDA). The MDA, according to the court, amended the Food, Drug, and Cosmetic Act’s regulation of medical devices entering the market and “imposed a regime of detailed federal oversight.” The law specifically pre-empts any state regulations that are different from or in addition to the federal regulations that apply to a certain device. Nevertheless, the U.S. Supreme Court clarified in Riegel v. Medtronic in 2008 that state law claims based on the alleged violations of regulations that “parallel,” but do not add to the relevant federal requirements are not pre-empted.
Here, the court said the claim that Medtronic breached a duty owed to McClelland by failing to adequately warn her about dangers associated with the product, if allowed to go forward, “would impose requirements different or in addition to those in place under the MDA. “The MDA and its implementing regulations set forth a comprehensive scheme under which a device manufacturer must submit reports to the FDA regarding incidents where the device may have contributed to a death or serious injury,” the court explained. That scheme does not, however, require the manufacturer to inform patients about such incidents.
The court further ruled that the claim was impliedly pre-empted by the FDCA. That law states that all actions for violations of it are to be brought “by and in the name of the United States.” This, according to the court, bars private litigants from bringing suit alleging violations of the FDCA regulations of medical devices.
As this case makes clear, medical device products liability claims can be complicated and persons who are injured by a defective device may face an uphill climb in Florida courts. It is important to note, however, that the court here pointed out that pre-emption does not bar all potential claims in this area. If you or a loved one has been injured due to a defective medical device or other product, contact the South Florida personal injury lawyers at Anidjar & Levine. We are dedicated to aggressively representing clients throughout the region, including in Hialeah, Boca Raton and Pompano Beach.
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