As we’ve pointed out elsewhere, particularly in our duty to test cheat sheet, most states do not recognize any sort of separate negligence or strict liability claim for “duty to test” or “failure to test” separate and apart from the more usual sort of product liability claims involving the design and warnings of products. So defendants looking to file motions to dismiss against testing-based counts of their opponents’ complaints could do worse than to check out our cheat sheet.
Manufacturers of FDA pre-market approved medical devices, however, have a second option. They can also go after testing-based claims on preemption, because claims that manufacturers of such devices should have done more or different testing than the FDA considers necessary for approval are either “different from or in addition to” the FDA’s PMA criteria. Indeed, the seminal express preemption case, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), recognized that express preemption under 21 U.S.C. §360k(a) extends to “tort law, applied by juries under a negligence or strict-liability standard,” such as state tort claims alleging “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of [a PMA device],” id. at 320, although the dismissed testing claims were not separately discussed by the Supreme Court in Riegel.
Lawrence v. Medtronic, 791 F. Appx. 679 (9th Cir. Jan. 28, 2020), affirmed preemption-based dismissal of allegations that the defendant failed to conduct “further analysis” on allegedly defective PMA medical devices. Id. at 679-80. The Lawrence plaintiff:
Identifie[d] no federal authority that requires medical-device manufacturers to send removed medical devices anywhere for evaluation. Indeed, there is no federal regulation mandating any analysis of removed medical devices, and thus a tort claim premised on such a course of conduct would impose a requirement that is “different from” and “in addition to” what is required under federal law.
Id. at 680. Lawrence is the only appellate case involving preemption of testing based claims that we know of.
The same fate has befallen plaintiffs who allege more general duties to conduct more tests on PMA devices than the FDA has required:
Negligence in researching, manufacturing, selling, labeling, testing, distributing, and analyzing [the device] are claims preempted by federal law because they all address the safety of the device in ways that the FDA considers as part of the PMA process. The FDA found that Defendants were not negligent in carrying out those functions when it approved the PMA application and finding otherwise in this case would undermine the FDA’s finding and its risk-benefit analysis. The Court will not do so and finds that those claims are preempted.
Scovil v. Medtronic, Inc., 995 F. Supp.2d 1082, 1096 (D. Ariz. 2014). Thus, “claims that Defendant negligently tested, inspected, stored, distributed, repaired, maintained, prepared, and packaged the [PMA] device are also expressly preempted.” Skinner v. Small Bone Innovations Inc., 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023) (following Scovil). Accord Poozhikala v. Medtronic Inc., 2022 WL 1076173, at *6 (C.D. Cal. April 7, 2022) (plaintiffs’ claimed injury, “even taken together with the recall notices . . ., is insufficient to plausibly establish that Defendant inadequately tested components” [of the device]”); Hafer v. Medtronic, Inc., 99 F. Supp.3d 844, 862 (W.D. Tenn. 2015) (also following Scovil).
Decisions holding duty-to-test claims preempted go beyond Medtronic cases that Bexis helped defend. Another spate of testing-related claims were brought against a manufacturer of cochlear implants. Plaintiffs had some initial success, because the FDA did mandate some arguably specific tests. But as is so often the case, what the plaintiffs alleged went well beyond what the FDA in fact required. Thus, in Stout v. Advanced Bionics, LLC, 2013 WL 12133966 (W.D. Pa. Sept. 19, 2013), the out-over-his-skis plaintiff suffered summary judgment against because his testing-based claim was preempted. Yes, the FDA required testing – but not the testing that plaintiffs were demanding:
The PMA supplement regarding . . . was submitted to and approved by the FDA, and included the specific tests to be performed for design validation. The testing included a [two specific testa]. The FDA-approved design validation testing . . . included none of the testing Plaintiffs claim should have been done. Accordingly, such requirements are in addition those required by the FDA and are expressly preempted. Moreover, Plaintiff fails to direct this Court to a specific rule or regulation of the MDA or FDA that require any of the above tests except the test “under actual or simulated use conditions.” Pursuant to 21 C.F.R. §820.30(g), a manufacturer is required to validate the device design, which “shall include testing of production units under actual or simulated use conditions.”
Section 820.30(g) is a current good manufacturing process (“CGMP”) regulation that is part of the umbrella Quality System Regulations applicable to all medical devices. . . . Though the Purchase Court found the design validation requirement was sufficient to support a parallel claim, this Court disagrees. The CGMP at issue does not mandate a particular test or a particular result, it only mandates that such testing be conducted “under actual or simulated use conditions.” The CGMP, therefore, is too generic to provide a requirement that could support a parallel claim.
2013 WL 12133966, at *6 (footnote omitted) (emphasis added).
As Stout indicates, other courts in the same litigation considered the same regulation’s “actual or simulated user conditions” language sufficiently specific to support a parallel claim, even though it did not reference any particular test – unlike the device’s PMA supplement. See Eggerling v. Advanced Bionics, L.L.C., 958 F. Supp.2d 1029, 1039 (N.D. Iowa 2013); Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 688 (W.D. Ky. 2013); Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694, 697-98 (W.D. Tenn. 2011). To us, this divergence demonstrates the absurdity of “parallel” claims as a concept, since courts cannot even agree on what is “parallel.” But these cases are basically a fight over the language of one of many FDA CGMPs.
Aside from their disarray over that one regulation, these cases agree with the general proposition that testing claims that deviate from FDA testing requirements are preempted. In Eggerling:
[T]he plaintiffs here have not cited any federal regulations that require “life-cycle testing,” so that imposing such a requirement would constitute imposing an additional duty pursuant to state law, which is expressly preempted. . . . [Plaintiffs] have leaped from FDA requests to see the results of “accelerated life-cycle testing” to some regulatory requirement for such testing, without citing any regulatory authority for the FDA’s request or any requirement under the MDA for such testing. To the extent [plaintiffs] rely on language in 21 C.F.R. §820.30(g) stating, “Design validation shall ensure that devices conform to defined user needs and intended uses,” as requiring “life-cycle testing,” that language is too general to support the specific requirement of “life-cycle testing,” and nowhere does that regulation define “conform[ing] to defined user needs” . . . as specifically including “life-cycle testing.”
958 F. Supp.2d at 1039.
In Sadler:
Plaintiffs’ negligence claim based on [defendant’s] failure to conduct life cycle testing is preempted, because Plaintiffs do not cite any federal regulations that require life cycle testing. To impose an obligation to perform life cycle testing would require an additional duty under state law, which is expressly preempted under § 360k.
929 F. Supp.2d at 690. We further note that Sadler applies Kentucky law, and that state precludes use of federal law to impose negligence liability on independent state-law grounds not mentioned in the Sadler opinion.
Finally, in Purchase:
The CGMP regulations cited by Plaintiffs govern a manufacturer’s general practices; in this regard, they are vague and open-ended, imposing administrative standards and/or generalized (and flexible) guidelines. They cannot support a negligence per se claim and, likewise, a parallel claim.
896 F. Supp.2d at 699.
And there’s more. The testing allegations in Lowery, v. Sanofi-Aventis LLC, 535 F. Supp.3d 1157 (N.D. Ala. 2021), were not based on any actual FDA requirements – only a non-binding guidance document. Id. at 1183 (“nothing in the [summary judgment] record . . . cites a single specific GMP that the allegedly deficient endotoxin testing violated”), 1184 (“deviation from a guidance document by itself is not a violation . . ., and Plaintiff has not connected any such purported deviation to any specific binding requirement”). But violation of a specific, binding FDA requirement “is precisely what the Eleventh Circuit requires to state a claim” that can survive preemption.” Id. (citations omitted). That the defendant ran tests that an FDA inspector found objectionable was “of no moment” where the plaintiff “failed to establish that Defendant was compelled by any federal regulations to perform [different] testing.” Id. at 1184.
Thus, this [testing] theory would add to or modify the federal requirement placed upon Defendant in its handling and distribution of this Class III device. Plaintiff cannot rely on this theory to support his negligence claim because nothing in the Rule 56 record establishes that this duty parallels a federal requirement.
Id. Nor could that old plaintiff stand-by – defendants could always do more – survive preemption.
[O]ther than Plaintiff’s conclusory assertion that Defendant was compelled to perform this testing, nothing . . . supports a reasonable inference that retesting was “necessary” in the circumstances based on any PMA or FDA requirement. . . . Plaintiff argues that Defendant was not prohibited from conducting additional testing . . . [b]ut, this is of no moment because “where a federal requirement permits a course of conduct and a state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.
Id. at 1185-86. (citation and quotation marks omitted).
Nagel v. Smith & Nephew, Inc., 2016 WL 4098715 (D. Conn. July 28, 2016), held a similar testing-based negligence claim preempted because it was likewise factually unsupported:
[P]laintiff has pled no facts that would show that defendant did not do the necessary testing or did not follow the FDA specifications . . . and therefore was in violation of FDA requirements. Allowing a plaintiff to claim that a particular testing or manufacturing regime was negligently inadequate, despite being required or allowed by the FDA, would establish an additional requirement beyond federal law and is subject to express preemption under §360k.
Id. at *8.
The plaintiff in Funke v. Sorin Group USA, Inc., 147 F. Supp.3d 1017 (C.D. Cal. 2015), alleged that the defendant “fail[ed] to test the device under reasonably foreseeable worst case conditions.” Id. at 1027. That was “a straightforward attack on the product’s design,” and was preempted absent any allegation of “deviat[ion] from” what “the FDA had approved in its PMA.” Id. A similar result enforced preemption in McQuiston v. Boston Scientific Corp., 2009 WL 4016120, at *5 (W.D. La. Nov. 19, 2009)
[Plaintiff] asserts that the [device] was defective “due to inadequate testing.” This claim essentially challenges the safety testing that formed the basis upon which the FDA approved the [device’s] PMA. A finding under state law that the [device] was inadequately tested would impose a requirement that differs from the testing that was approved by the FDA. Because this state requirement would be “different from, or in addition to” the requirements imposed by federal law, this claim is also expressly preempted.
Id. at *5 (citation omitted).
The testing-based claim in Farrand v. Stryker Corp., 2014 WL 11514684 (S.D. Iowa Nov. 12, 2014), was likewise preempted because it “call[ed] into question the adequacy of the rigorous PMA process which resulted in express FDA approval for commercial distribution of the implant.” Id. at *5. Once again, in a case where the plaintiff made “no contention [that the defendant] failed to perform FDA mandated testing,” “[a]ny claim that other or additional testing should have been done is preempted.” Id. The same result occurred in Hart v. Medtronic, Inc., 2017 WL 5951698 (D.N.J. Nov. 30, 2017). Because the plaintiff was “bringing into question the testing . . . , that the FDA approved and requires for this Class III medical device,” his claims “would impose requirements different from, or in addition to, the FDA requirements for this very device,” which was “precisely what §360k(a) preempts.” Id. at *5. See Gallego v. Tandem Diabetes Care, Inc., 776 F. Supp.3d 119, 141 (E.D.N.Y. 2025) (claim that challenge[d] the sufficiency of the failure mode testing that the FDA found to be adequate to approve the [device] . . . is expressly preempted”); Keim-Bacon v. Stryker Corp., 2024 WL 4886051, at *6 (N.D. Okla. Nov. 25, 2024) (“Plaintiff seeks to add a claim that Defendant failed to test the [] device under realistic or simulated conditions”; “this claim is unsupported by specific facts and assumes that the defect ‘speaks for itself,’ which is insufficient to establish a plausible, non-preempted claim”); Tice v. Boston Scientific Corp., 2023 WL 360983, at *5 n.10 (N.D. Ohio Jan. 23, 2023) (plaintiff’s “state-law claims are preempted to the extent [she] is alleging [defendant] was required to conduct more clinical trials”); Titko v. St. Jude Medical, LLC, 2019 WL 13197982, at *4 (D. Ariz. Dec. 13, 2019) (inadequate testing claim “preempted by the MDA because [it] address[es] the safety of the device in ways that the FDA considers during the premarket approval process); White v. Medtronic, Inc., 2019 WL 1339613, at *7 (Mag. E.D. Mich. Feb. 20, 2019) (“premarket approval by the FDA “constitutes approval of the product’s . . . testing”), adopted, 2019 WL 1330923 (E.D. Mich. March 25, 2019), aff’d, 808 F. Appx. 290 (6th Cir. 2020); Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122, at *2 (C.D. Cal. Dec. 27, 2018) (absent any proof that a test performed by the defendant was “FDA required,” testing allegation was “insufficient to survive a motion to dismiss”); Babayev v. Medtronic, Inc., 228 F. Supp.3d 192, 215-16 (E.D.N.Y. 2017) (“to the extent that [plaintiff] alleges that the FDA-approved . . . testing . . . was defective, those claims are preempted”) (citation omitted); Felger v. Smith & Nephew, Inc., 222 F. Supp.3d 746, 755 (D. Alaska 2016) (“Negligence in researching, . . . testing, . . . and analyzing a medical device are claims preempted by federal law because they all address the safety of the device in ways that the FDA considers as part of the PMA process.”) (citation and quotation marks omitted); Morgan v. Medtronic, Inc., 172 F. Supp.3d 959, 967 (S.D. Tex. 2016) (claim that defendant “failed to properly and adequately test” its device held “expressly preempted” because plaintiff “does not allege the design of the [device] deviates from the design approved by the FDA”); De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085, 1096 n.4 (N.D. Cal. 2016) (plaintiff “alleges that [defendant] acted negligently by failing to adequately test and analyze data relating to [the device], which requirements are part of the premarket approval procedure. [Plaintiff] has made no attempt to rescue that aspect of claim three from preemption. Nor could she, inasmuch as the FDA approved [the device] notwithstanding the alleged negligence.”); Blair v. Medtronic, Inc., 2016 WL 9149503, at *1 (N.D. Cal. Sept. 12, 2016) (“negligence claims challenging the . . . testing . . . of a premarket approved device impose upon the device manufacturer requirements that are ‘different from, or in addition to’ the MDA’s requirements − and consequently are preempted”) (citation omitted); Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 4546369, at *9 (D. Idaho Aug. 30, 2016) (testing claims preempted because they challenge “affirmative actions taken by [defendant] and disclosed to the FDA for their review”); Marion v. Smith & Nephew, Inc., 2016 WL 4098608, at *6 (D. Utah July 28, 2016) (“to the extent [plaintiffs] contend that the device as approved by the FDA was negligently . . . tested . . . such an allegation would be preempted”); Stanfield v. Boston Scientific Corp., 166 F. Supp.3d 873, 881 (S.D. Tex. 2015) (“Because [defendant’s products’ were Class III devices approved as safe and effective by the FDA during the PMA process, which imposes device-specific federal requirements, [plaintiff’s] claims for . . . negligent . . . testing . . . of these devices are preempted”); Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *11 (E.D. Pa. March 31, 2015) (“insofar as [testing] claims are directed to the PMA-approved [device], they are expressly preempted”), aff’d, 885 F.3d 760 (3d Cir. 2018); Cline v. Advanced Neuromodulation Systems, Inc., 17 F. Supp.3d 1275, 1283 (N.D. Ga. 2014) (testing-related allegations preempted where plaintiffs “fail[ed] to plausibly allege” any violation and only sought “to challenge the FDA’s reliance on this data in its approval”); McConologue v. Smith & Nephew, Inc., 8 F. Supp.3d 93, 110-11 (D. Conn. 2014) (“Defendant’s motion to dismiss the Plaintiff’s failure to test . . . and failure to perform a proper study or test claims is GRANTED”); Carlson v. Medtronic Inc., 2014 WL 11514911, at *4 (S.D. Miss. Aug. 28, 2014) (“all of [plaintiff’s] claims, whether sounding in strict liability or negligence, that are predicated on alleged defects in the manner in which the [device] was . . . tested . . . will be dismissed as preempted”); Kubicki v. Medtronic, 2013 WL 1739580, at *6 (D.D.C. March 21, 2013) (claims that posed “a direct challenge to the FDA’s assessment and approval of the . . . testing . . . of the [device]” “would be preempted”); Kallal v. Ciba Vision Corp., 2013 WL 328985, at *3 (N.D. Ill. Jan 28, 2013), aff’d, 779 F.3d 443 (7th Cir. 2015) (previously permitted testing-based claim preempted once it was established that the test at issue “was not a specification for the [device]”); Walker v. Medtronic, Inc., 2010 WL 4822135, at *6 (S.D.W. Va. Nov. 24, 2010) (“to contend that the device should have been . . . tested, [or] inspected . . . in a manner different than that approved by the FDA imposes requirements ‘different from, or in addition to,’ the FDA’s premarket approval. Therefore, such a claim is preempted.”), aff’d, 670 F.3d 569 (4th Cir. 2012); Franklin v. Medtronic, Inc., 2010 WL 2543579, at *5, 7 (Mag. D. Colo. May 12, 2010) (testing-based claims preempted, whether brought as negligence, or negligence per se), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010); Riley v. Cordis Corp., 625 F. Supp.2d 769, 789 (D. Minn. 2009) (claim that the defendant “did not conduct adequate premarket testing” was “obviously preempted” due to “conflict with the conditions imposed by the FDA”); In re Sulzer Hip Prosthesis & Knee Prosthesis Liability Litigation, 2009 WL 10664164, at *13 (N.D. Ohio Feb. 25, 2009) (“a determination that [defendant] was negligent for failure to perform additional testing . . ., beyond any testing required by the FDA, would clearly be a ‘different’ or ‘additional’ requirement imposed by state law that is preempted”) (footnote omitted); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1158 (D. Minn. 2009) (“inadequate testing” claim preempted as it “necessarily” would “impose requirements that differ from” the device’s PMA), aff’d, 623 F.3d 1200 (8th Cir. 2010). There may be similar results prior to the Riegel decision, but we see no need to make the rubble bounce by tracking those down.
What state-court precedent there is also recognizes preemption of failure-to-test claims in the absence of any factually supported allegation that specific FDA testing requirements were violated. California leads the way here. McGuan v. Endovascular Technologies, Inc., 106 Cal. Rptr.3d 277 (Cal. App. 2010), affirmed that testing-related claims against PMA medical devices are expressly preempted:
Here, though plaintiffs’ complaints are based, in part, on alleged defects in the . . . testing . . . of the [] Device . . ., they do not allege that defendants violated FDA regulations. Since the FDA reapproved the [] Device prior to plaintiffs’ surgeries, the FDA gave its approval of the device’s . . . testing. . . . Thus, to the extent that plaintiffs’ complaints allege that the [] Device was unsafe . . ., they are seeking to impose requirements that are “different from, or in addition to” the [Medical Device Amendments]. Consequently, the state law claims for strict product liability, negligence, breach of express warranty, breach of implied warranty, and violations of the Consumer Legal Remedies Act are preempted.
Id. at 285-86.
A California trial court, in Gall v. Stryker Orthopaedics, 2016 WL 7011530 (Cal. Super. Jan. 19, 2016), similarly held that the plaintiff’s claim that “[a] reasonable manufacturer would have conducted wider testing” were preempted.
[T]he “wider testing” component of Plaintiff’s response is pre-empted. Plaintiff’s argument is premised on the contention that, in order to avoid state tort liability, a manufacturer must conduct testing beyond those benchmarks set by the FDA. This imposes an additional state law requirement over and above those imposed under federal law. It is thus not parallel to federal law, but over and above federal law.
Id. at *7. See also Gall v. Stryker Orthopaedics, 2015 WL 12803805, at *6 (Cal. Super. Sept. 17, 2015) (prior iteration of testing-based claim in same litigation either preempted or inadequately pleaded).
Another state appellate court recognized that “any cause of action based on testing . . . is preempted by the FDA standards for premarket approval” in Weston v. Kim’s Dollar Store, 684 S.E.2d 769, 778 (S.C. App. 2009), aff’d on other grounds, 731 S.E.2d 864 (S.C. 2012). Mitaro v. Medtronic, Inc., 886 N.Y.S 71 (N.Y. Sup. 2009), aff’d, 900 N.Y.S.2d 899 (N.Y. App. Div. 2010), held that a negligent testing claim was preempted because it “necessarily imposes requirements that are different from, or in addition to, federal regulations.” Id. at *3. A Colorado trial court likewise dismissed an inadequate testing claim “under both Riegel and Buckman” where “Plaintiffs have not pled that [defendant] tested the device in a way that deviated from the requirements under the device’s PMA.” Blanar v. Prager, 2024 WL 6467030, at *8 (Colo. Dist. June 25, 2024).
Failure to test is one of these annoying quasi-claims that, for the reasons we discussed in our cheat sheet, logically should not exist at all because testing, itself, doesn’t cause any injury – and only impacts product design or warnings. Both of those claims are broadly preempted under Riegel in product liability litigation involving PMA devices. Thus, testing claims should be preempted to the same extent. That’s what we sought to establish in this post.