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According to Florida law, to succeed on a claim of strict liability based on a design defect, the plaintiff must prove that the product is defective or unreasonably dangerous:

To succeed on either state law theory of liability—strict liability or negligence in manufacture, design, and warnings—Brown must prove that RP Knee, which was approved through the premarket approval process and is subject to ongoing reporting requirements, is defective or unreasonably dangerous, whether by design defect, a manufacturing defect, or by a failure to warn. See Cooper v. Old Williamsburg Candle Corp., 653 F.Supp.2d 1220, 1223–24 (M.D.Fla.2009) (“To sustain a claim of defective product, whether alleging strict products liability … or negligence, a plaintiff must demonstrate that … a defect existed in the product….”); Marzullo v. Crosman Corp., 289 F.Supp.2d 1337, 1342 (M.D.Fla.2003) (“In the context of products liability, the basic elements of a negligence cause of action apply…. The plaintiff also must establish that the product was defective or unreasonably dangerous.”) (internal citations omitted). Because the state law claims require a determination that the product is defective or unreasonably dangerous, it is also possible that “a fact finder could find liability under [the] Florida … laws even if the manufacturer had completely complied with the FDA regulations.” Stokes, 2013 WL 1715427, at *6. The preemption provision of the MDA exists *1273 to dissuade the possibility of such a conflicting result.
The district court in Wolicki–Gables found that Florida laws “corresponding to strict liability for design defect and failure to warn, as well as for negligent design, manufacture, and assembly, imposed requirements that were ‘different from, or in addition to’ the federal requirements established for the premarket approval of the device at issue in that case. Accordingly, the District Court dismissed these claims as preempted by the federal scheme.” Stokes, 2013 WL 1715427, at *6 (citing Wolicki–Gables, 641 F.Supp.2d at 1285–88). Following the same reasoning, this Court finds that the state law claims alleged by Brown are preempted.

See: Brown v. DePuy Orthopaedics, Inc., 978 F. Supp. 2d 1266



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