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Eleventh Circuit Court of Appeals rules that Florida product liability case involving Class III medical device not preempted by federal law

On June 26, 2017, in Mink v. Smith & Nephew, Inc., No. 16-11646, the Eleventh Circuit Court of Appeals reversed a federal district court’s dismissal of the plaintiff’s negligence and product liability claims in a case involving the defendant’s metal-on-hip replacement system. The district court had dismissed the plaintiff’s claims after determining that the product, a Class III medical device requiring premarket approval from the FDA before it could be made commercially available, was subject to federal preemption of the plaintiff’s claims. On appeal, the Eleventh Circuit Court of Appeals clarified that federal express preemption for Class III medical devices that have undergone the FDA’s premarket approval process will only bar state law claims that impose on the medical device a requirement different from or in addition to federal requirements. Implied preemption only prohibits state law claims that seek to privately enforce duties owed to the FDA. This creates a “narrow gap” for pleadings. To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption). Quoting the Seventh Circuit Court of Appeals in Bausch v. Stryker Corp., 630 F.3d 546, 558, (7th Cir. 2010), the Court opined that a plaintiff may proceed on her claim so long as she claims the “breach of a well-recognized duty owed to her under state law” and so “long as she can show that she was harmed by a violation of applicable federal law.” In other words, where the plaintiff can prove she was hurt by a manufacturer’s breach of a common-law duty owed to her and that duty is parallel to the requirements of federal law, there is no preemption.

On that basis, the Eleventh Circuit ruled that the negligence and strict liability counts of the plaintiff’s complaint alleging liability based on manufacturing defects could proceed, but the count alleging negligent failure to report adverse events to the FDA was federally preempted and the count alleging improper training by the defendant of the doctor was barred by Florida’s learned-intermediary doctrine. See Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989) (“[T]he prescribing physician, acting as a ‘learned intermediary’ between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend [something] to meet the patient’s needs.”); see also Rounds v. Genzyme Corp., 440 F. App’x 753, 755–56 (11th Cir. 2011) (per curiam) (unpublished) (holding the learned intermediary doctrine barred a failure-to-train claim under Florida law). The Court specifically noted that the manufacturing liability claims alleged violations of state common law duties that are parallel to the federal requirement that the product System be manufactured according to the approved specifications for the medical device.

The Eleventh Circuit also allowed the plaintiff to proceed on his claim that the defendant misrepresented its product to him in representations relayed through his doctor about the past success of the product, its appropriateness for his needs, and the monitoring, testing and examinations he would receive for free if the product was implanted. The Court determined that the claim could proceed under Florida law as a fraudulent misrepresentation claim and that it was not preempted by federal law because the claim was not imposing any FDA requirement on the defendant or any requirements imposed by the State of Florida.

The Eleventh Circuit also noted that the recent decision of the Florida Second DCA in Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., ___ So. 3d ___, 2017 WL 603316 (Fla. 2d DCA Feb. 15, 2017), mistakenly stated that that as a general matter, “[c]ommon law damage claims are inadequate to escape federal preemption.”