context: We agree with several other circuits which have considered the issue that, with respect to a Class III device that has undergone the PMA process, such claims are preempted because they undoubtedly would add requirements "different from, or in addition to," those set forth in the MDA. "FDA approval of a premarket application shows the FDA has reviewed a device's testing, design specifications, intended use, manufacturing method, performance standard, and labelling, ... and decided the device is safe and effective."
citation_a.signal: cf.
citation_a.identifier: 961 F.2d 1332, 1332-33
citation_a.parenthetical: indicating that claims for inadequate testing, defective design, and failure to warn were preempted in case involving device not subject to PMA process
citation_a.sentence: Martello v. Ciba Vision Corp., 42 F.3d 1167, 1169 (8th Cir.1994), cert. denied, — U.S. -, 115 S.Ct. 2614, 132 L.Ed.2d 857 (1995) (citing 21 U.S.C. §§ 360c(a)(2), 360e(c)(1)); see also Ministry of Health, Province of Ontario, Can. v. Shiley, Inc., 858 F.Supp. 1426, 1438-39 (C.D.Cal.1994) (stating that “a finding of negligence would mean implicitly finding that the FDA approval was not good enough,” and that a successful strict liability claim would require a court to hold that the product was unsafe and dangerous “in opposition to the contrary determination made by the FDA”); cf. Slater, 961 F.2d at 1332-33 (indicating that claims for inadequate testing, defective design, and failure to warn were preempted in case involving device not subject to PMA process).
citation_b.signal: see also
citation_b.identifier: 858 F.Supp. 1426, 1438-39
citation_b.parenthetical: stating that "a finding of negligence would mean implicitly finding that the FDA approval was not good enough," and that a successful strict liability claim would require a court to hold that the product was unsafe and dangerous "in opposition to the contrary determination made by the FDA"
citation_b.sentence: Martello v. Ciba Vision Corp., 42 F.3d 1167, 1169 (8th Cir.1994), cert. denied, — U.S. -, 115 S.Ct. 2614, 132 L.Ed.2d 857 (1995) (citing 21 U.S.C. §§ 360c(a)(2), 360e(c)(1)); see also Ministry of Health, Province of Ontario, Can. v. Shiley, Inc., 858 F.Supp. 1426, 1438-39 (C.D.Cal.1994) (stating that “a finding of negligence would mean implicitly finding that the FDA approval was not good enough,” and that a successful strict liability claim would require a court to hold that the product was unsafe and dangerous “in opposition to the contrary determination made by the FDA”); cf. Slater, 961 F.2d at 1332-33 (indicating that claims for inadequate testing, defective design, and failure to warn were preempted in case involving device not subject to PMA process).