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1.6.2.1.2 Supreme Court decisions; parallel claims

Questions of federal preemption commonly arise in cases involving defects in medical devices that are subject to the system of review described in § 1.6.2.1.1, supra. The statute provides that no state or political subdivision of a state “may establish or continue in effect with respect to a device intended for human use any requirement—(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.”216

The United States Supreme Court interpreted this preemption language in 1996 in Medtronic, Inc. v. Lohr.217 The Court held that negligence claims (failure to use reasonable care in design, assembly, manufacture, and sale) and strict liability claims against a pacemaker manufacturer were not preempted. The pacemaker had not undergone the FDA’s most rigorous review, but was grandfathered in under section 510(k) of the Act because it was substantially equivalent to a pre-amendment device. Only a plurality of the Court joined in some critical portions of the 1996 opinion, however, leaving many issues unclear.218

In 2008 the Court, in Riegel v. Medtronic, Inc.,219 answered a number of the questions that Lohr left unanswered. Unlike Lohr, Riegel involved a medical device that had received pre-market approval from the FDA. This type of review is the FDA’s most rigorous and is quite rare.220 The Court held that this process, which involved approval of the medical device’s label, preempted state tort claims except those based on a violation of the FDA regulations.

The Court held that the preemption analysis should address two questions: first, whether the FDA has established requirements applicable to the specific device; and, second, whether the state law at issue creates a requirement that is directly related to the device’s safety or effectiveness and is different from, or in addition to, the federal requirement.221 A common law duty imposed by state tort law can be a state “requirement” that is preempted.222 However, the Court stressed that the statute “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations,” as “the state duties in such a case ‘parallel,’ rather than add to, federal requirements.”223

If a medical device has gone through the FDA’s full pre-market review process, claims regarding safety and effectiveness are likely preempted in light of Riegel.224 Conversely, many courts interpret Riegel to make the statute’s express preemption provision inapplicable to a device that has gone through less than full pre-market review.225 Moreover, even a full pre-market review will not preempt a parallel claim—a state law claim that is based on the manufacturer’s violation of the requirements imposed by the FDA.226 In addition, although they do not all agree on the exact analysis, many courts hold that a full pre-market review does not protect a manufacturer that promotes a device for an off-label use that the FDA did not review.227

Footnotes

  • 216 {216} 21 U.S.C. § 360k(a). See also 21 C.F.R. § 808.1(d) (narrowly interpreting preemption provision).

  • 217 {217} 518 U.S. 470, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996).

  • 218 {218} See Webster v. Pacesetter, Inc., 171 F. Supp. 2d 1 (D.D.C. 2001) (detailed analysis of questions on which the various opinions agreed and disagreed).

  • 219 {219} 552 U.S. 312, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008).

  • 220 {220} Id., 552 U.S. at 317 (noting that 3148 devices were grandfathered in in 2005, while pre-market approval was granted to just thirty-two devices).

  • 221 {221} Id., 552 U.S. at 322.

  • 222 {222} Id., 552 U.S. at 323–325.

  • 223 {223} Id., 552 U.S. at 330.

  • 224 {224} See, e.g., Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012) (MDA preempts claim that Class III device did not meet performance standard that was the intended result of compliance with FDA’s approved design and manufacturing process); Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (claims that purport to impose liability on manufacturer despite its compliance with FDA standards are preempted, but not failure to warn claims premised on failure to report injuries and malfunctions to FDA); In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (federal law preempts design defect claim and claim that manufacturer should have provided more warnings than federal standards require).

  • 225 {225} Riegel v. Medtronic, Inc., 552 U.S. 312, 322–324, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008) (describing Lohr as concluding that the section 510(k) grandfathering process does not impose “requirements” as defined in the preemption provision); Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020) (MDA does not preempt design defect claim regarding Class II device that had not gone through premarket approval); Shuker v. Smith & Nephew, P.L.C., 885 F.3d 760 (3d Cir. 2018) (negligence, strict liability, and implied warranty claims preempted when the component in question had received premarket approval); Hovey v. Cook Inc., 97 F. Supp. 3d 836 (S.D. W. Va. 2015); Redd v. DePuy Orthopaedics, Inc., 48 F. Supp. 3d 1261 (E.D. Mo. 2014) (express preemption inapplicable to device that was grandfathered in under § 510(k); FDA’s general regulations applicable to this device are too general to constitute “requirements” that trigger preemption); Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748 (S.D. W. Va. 2014) (no preemption of device that was grandfathered in under § 410(k), even though one of its components had gone through full pre-market review for a different use); Smith v. Phoenix Seating Sys., L.L.C., 894 F. Supp. 2d 1088 (S.D. Ill. 2012) (preemption inapplicable to wheelchair components, which are Class I devices); Funk v. Stryker Corp., 673 F. Supp. 2d 522, 530 (S.D. Tex. 2009) (“If the device received approval under § 510(k), then Riegel does not apply and Funk’s claims are not preempted.”), aff’d, 631 F.3d 777 (5th Cir. 2011). Cf. Bertini v. Smith & Nephew, 8 F. Supp. 3d 246, 252 (E.D.N.Y. 2014) (§ 510(k) grandfathering process does not create “requirements,” so no express preemption, but claims are preempted when they focus on components that had undergone pre-market review even though other components were grandfathered in). But cf. Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010) (claim is preempted when product as a whole went through full pre-market review, even though component had been approved through grandfathering process).

  • 226 {226} See, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001); Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc) (no preemption of claim based on manufacturer’s violation of continuing duty under Arizona law to warn of dangers and report them to third parties such as FDA, as this claim parallels FDA requirements; concurrence notes difficulties of proving causation); Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (claim that hip prosthesis had manufacturing defects resulting from violations of federal requirements is not preempted; no need to show that FDA made a formal finding of a violation or brought an enforcement action); Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011); Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (both common law and statutory claims are preserved, and claim can be based on violation of either device-specific requirements or general manufacturing requirements); 21 C.F.R. § 808.1(d)(2) (FDA rule stating that MDA does not preempt state or local requirements that are equal to or substantially identical to federal requirements). See also Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (recognizing that parallel claims are not preempted, but insufficiently alleged here). Cf. Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019) (parallel claim not preempted, but mere existence of a defect or malfunction does not show violation of FDA’s manufacturing standards); Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012) (parallel claims based on violation of federal requirements are not preempted, but a performance standard is a federal requirement only if the FDA promulgates it through formal notice and comment procedure; inclusion of a performance standard in manufacturer’s application for approval is insufficient).

  • 227 {227} See, e.g., Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844 (W.D. Tenn. 2015) (claims based on misrepresentations during marketing for off-label use); Hawkins v. Medtronic, Inc., 62 F. Supp. 3d 1144 (E.D. Cal. 2014) (finding no preemption of claims based on deceptive promotion of off-label use); Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868 (N.D. Cal. 2013) (claims based on fraudulent misrepresentations in promotion of device for off-label use are not preempted, nor is a claim that manufacturer violated a state law duty to warn of dangers and report them to third parties such as the FDA); Zaccarello v. Medtronic, Inc., 38 F. Supp. 3d 1061 (W.D. Mo. 2014) (claims based on affirmative misrepresentations regarding off-label use survive preemption, but others do not); Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026 (D. Ariz. 2014) (if device has gone through pre-market approval process, preemption analysis applies even when it is promoted for off-label use, but claims based on misleading promotion are not preempted); Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692 (S.D. Tex. 2014) (no preemption of claims based on false representations made as part of promotion of off-label use); Blankenship v. Medtronic, Inc., 6 F. Supp. 2d 979 (E.D. Mo. 2014) (all claims are preempted except those based on false representations regarding off-label use); Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868 (N.D. Cal. 2013) (claims based on fraudulent misrepresentations in promotion of device for off-label use are not preempted, nor is a claim that manufacturer violated a state law duty to warn of dangers and report them to third parties such as the FDA); Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013). But see Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) (preemption applies to off-label use; claims preempted when plaintiff did not identify any parallel duty on which her claim could be based); Arvizu v. Medtronic, Inc., 41 F. Supp. 3d 783 (D. Ariz. 2014); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1178 (C.D. Cal. 2013) (claim based on manufacturer’s promotion of product for off-label use is equivalent to “fraud on the FDA” and is preempted).