Sep 24, 2018
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Heck No, FDCA Violations Can’t Be Inferred Merely From Product Malfunctions

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We recently commented on Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), for several reasons – all bad – but one stands out, the ruling that used what’s essentially res ipsa loquitur to wave plaintiff through PMA preemption with a manufacturing defect.  According to Sumpter:

Plaintiffs allege that, due to manufacturing defect, the products . . . [user plaintiff] received were not the products approved by the FDA.  Even though “the precise contours of their theory of recovery have not yet been defined,” the Court holds Plaintiffs’ allegations sufficiently allege that Defendants did not adhere to FDA manufacturing requirements.

Id. at *2.  For this remarkable inference, Sumpter cites only Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which had nothing to do with manufacturing defects as a form of parallel claim.

What Sumpter held is not the law.  Not even close.  While we recognize that manufacturing defect claims in some circumstances can thread the “narrow gap” between express and implied preemption, such allegations cannot do so by mere inference.  “Plaintiffs cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (citation and quotation marks omitted).

This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury. Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.

Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011).

To infer an FDCA violation, and therefore an unpreempted manufacturing defect, from the mere fact of a device malfunction demands an “actual guarantee” of safety.  But “the FDA recognizes the device will not always function in accordance with specifications,” so such “additional requirement[s]” are “precluded.”  Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012).  The “FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work.”  Banner v. Cyberonics, 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010).  Therefore, “if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a device thereby produced that nevertheless does not function as intended does not give rise to liability.”  Id.

For similar reasons, numerous courts have rejected res ipsa loquitur as a basis for inferring FDCA violations in PMA preemption cases.

[Plaintiff] relies, instead, on the doctrine of res ipsa loquitur for the proposition that full compliance would have resulted in a problem-free device.  Res ipsa loquitur does not suffice.  Res ipsa loquitur permits an inference of negligence when there can be no other explanation. . . . If negligence were the only cause of a Class III device’s failure, there would be no need for the MDA’s ongoing reporting requirements. See 21 C.F.R. § 814.84(b)(2). Plaintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe.

Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1094 (D. Minn. 2008).  “Because of the general nature of the doctrine of res ipsa loquitur, a fact finder could rule in favor of [plaintiff] without finding that [defendant] violated any federal regulation.  Such a finding would impose requirements ‘different from, or in addition to,’ those in the [device’s] PMA and would thus be expressly preempted.”  Williams v. Bayer Corp., 541 S.W.3d 594, 612-13 (Mo. App. 2017).  Accord McAfee v. Medtronic, Inc., 2015 WL 3617755, at *6 (N.D. Ind. June 4, 2015) (“[t]o the extent [plaintiff] alleges that [defendant] is liable under a theory of res ipsa loquitur . . ., his claims are preempted”); Kallal v. Ciba Vision Corp., 2013 WL 328985, at *3 (N.D. Ill. Jan. 28, 2013) (preempting “argument hints at reliance on the doctrine of res ipsa loquitur”), aff’d, 779 F.3d 443 (7th Cir. 2015); Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393, at *7 (C.D. Cal. Sept. 24, 2013) (“the res ipsa loquitur doctrine is barred by [preemption] because the PMA process does not demand that a product be risk free, but only that its benefits, if manufactured according to specifications, outweighs its risks”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 483 (W.D. Pa. 2012) (“references to federal regulations in his negligence and res ipsa loquitur claims are too vague and general”); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197, 202 (W.D.N.Y. 2011) (res ipsa claims “are based squarely on Defendants’ purported breach of state tort duties of care,” which “are precisely the type of claims Riegel held are preempted”); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011) (“one may not infer a manufacturing defect without creating a duty that adds to, rather than parallels, federal requirements”); Funk v. Stryker Corp., 673 F. Supp.2d 522, 531 (S.D. Tex. 2009), (because “the PMA process does not demand that an innovation be risk free . . . [i]t would follow that one may not infer a defect in the product simply because a patient encountered negative side effects in using it”), aff’d, 631 F.3d 777 (5th Cir. 2011); LeMay v. Eli Lily [sic] & Co., 960 F.Supp. 183, 186 (E.D. Wis. 1997) (parallel claims “proceed only for violations of the FDA regulations” but “res ipsa loquitur could allow recovery for negligence that Congress has preempted,” so plaintiffs “may not rely on the doctrine”).

Therefore, “[t]he fact that the [defendant’s device] allegedly failed does not itself establish a deviation from the FDA-approved standards.”  Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *4 (D. Md. Mar. 13, 2013).  In Burgos v. Satiety, Inc., 2013 WL 801729 (E.D.N.Y. March 5, 2013), no inference that an investigational device violated FDA regulations could be inferred from its malfunction, even though plaintiff had been offered a settlement and there were allegations of spoliation (neither of which were present in Sumpter).

Plaintiff has failed to provide any circumstantial evidence, other than the fact that Plaintiff was injured and that she was offered some money, to argue that the . . . device was actually manufactured in a way that violated the IDE.  Plaintiff has not presented any evidence that the . . . device was adulterated, or that it was unreasonably dangerous and unfit for [its] intended purpose to show that the IDE was violated.  Failure to provide any evidence in support of Plaintiff’s claim is fatal and it must be dismissed.

Id. at *7 (citations and quotation marks omitted).  See also Herrnandez v. Stryker Corp., 2015 WL 11714363, at *3 (W.D. Wash. March 13, 2015) (plaintiff could not escape preemption on “conclusory allegations” that explanted device violated FDA regulations); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *11 (E.D. Va. Aug. 23, 2012) (facts that support causation from a malfunction “are not sufficient to link the [malfunction] or [plaintiff’s] injuries to any federal violation . . . in the manufacture of the device”); Anthony v. Stryker Corp., 2010 WL 1387790, at *4 (N.D. Ohio Mar. 31, 2010) (an “attempt to recast generalized deviations from ‘manufacturing performance standards’ as specific violations of federal regulations is insufficient to state a claim”); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010) (“that the [device] allegedly failed during normal use does not override the clear language of §360(a) or the Supreme Court’s ruling in Riegel that the plaintiffs’ claims are preempted by federal law”); Cenac v. Hubbell, 2009 WL 10678961, at *4 (E.D. La. July 31, 2009) (“mere fact that a device malfunctions or produces an adverse result does not plead a violation of federal law”); Delfino v Medtronic, Inc., 2018 WL 2688420, at *8 (Minn. Dist. May 18, 2018) (“the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement”).

Sumpter cited nothing to support its letting the plaintiff slide under TwIqbal on the theory that a device malfunction, without more, is enough to establish not only a product defect, but an FDCA violation.  That’s two bridges too far.  One can only hope that defense counsel will be able to show the trial court the error of its ways soon, without the need for an appellate court to do it for them.



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Article Categories:
Manufacturing Defect · Pleading · Preemption

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