As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, "different from or in addition to," precludes plaintiffs from demanding more or different warnings. Since warning claims are the bread and butter of prescription medical product liability, plaintiffs will try just about anything to get around that simple fact.
One common plaintiff-side tactic is to relabel failure to warn as "fraud." Plaintiffs then argue that "fraud" claims shouldn't be preempted, either because they are predicated "on a more general obligation[,] the duty not to deceive," Cipollone v. Liggett Group, Inc., 505 U.S. 504, 528-29 (1992), or because they are a "parallel" claim associated both with that "general" state-law duty and FDA regulations prohibiting "false or misleading" statements.
While sometimes plaintiffs gain some traction with "fraud" claims asserting affirmatively false statements, most failure to warn claims involve omissions. Thus, plaintiffs are also wont to argue that "fraudulent concealment" or "fraud by omission" claims should also be unpreempted. Here plaintiffs lose. Such concealment/omission claims are always at least "in addition to" a PMA device's FDA-approved labeling.
The key case, Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013), held that not only is a "fraud by omission claim [] expressly preempted" – but "obvious[ly]" so. Id. at 1118.
The teachings from the Supreme Court cases plus our application of MDA preemption . . . lead to an obvious result: [plaintiff's] fraud by omission claim is expressly preempted by § 360k(a). [T]he [omission] claim here depends on a requirement that is "in addition to" those federal requirements. [Plaintiff] effectively seeks to write in a new provision to the FDCA: that physicians and medical device companies must affirmatively tell patients when medical devices have not been approved for a certain use. . . . Just as significant, the alleged missing disclosure . . . "relates to the safety or effectiveness" of the [PMA device].
Id. at 1118-19 (emphasis added). See Martin v. Medtronic, Inc., 2017 WL 825410, at *7 (E.D. Cal. Feb. 24, 2017) (following Perez; fraudulent concealment claim expressly preempted); Frere v. Medtronic, Inc., 2016 WL 1533524, at *10 (C.D. Cal. April, 6, 2016) (same); Jones v. Medtronic, 89 F. Supp.3d 1035, 1050 (D. Ariz. 2015) (same); Hawkins v. Medtronic, Inc., 2014 WL 346622, at *6 (E.D. Cal. Jan. 30, 2014) (same).
This rationale means that, the "distinction between claims premised on false misrepresentations and those premised on omissions" has been described as "the key dividing line" for preemption purposes. Schouest v. Medtronic, Inc., 13 F. Supp.3d 692, 701 (S.D. Tex. 2014).
The affirmative misrepresentation/omission distinction is representative of the two types of claims [plaintiff] is asserting: on the one hand, that [defendant] did not do enough, and on the other, that [defendant] did too much.
Id.
In another claim, like Perez and Schouest, alleging failure to warn of risks of off-label use of a PMA device as "fraudulent concealment," the court held such claims expressly preempted to "to the extent it is based on any alleged omissions or concealments." Byrnes v. Small, 142 F. Supp.3d 1262, 1269 (M.D. Fla. 2015).
Plaintiffs have not identified any federal requirement to inform the public or to update warning labels regarding the dangers of the off-label use of medical devices. Therefore, to the extent this claim is premised on [defendant's] alleged concealment of information . . ., it is expressly preempted, because requiring [defendant] to warn [prescribers] of the dangers of the off-label use of [the device] would clearly be different from, or in addition to, the federal requirements.
Id. (citation, footnote, and quotation marks omitted).
In Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670 (W.D. Ky. 2013), state "law for fraudulent omissions . . . requires that the defendant have a duty to disclose information." Id. at 683 (citation omitted).
Plaintiffs cite no federal duty to disclose to the public or to patients the omitted information. Therefore, to the extent Plaintiffs assert that [defendant] was under some state law duty to disclose, this amounts to an additional requirement, which §360k expressly preempts.
Id. at 683-84 (citation and footnote omitted)
In Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 9, 2011), the plaintiffs claimed that their concealment allegations were "actually a fraud claim" when faced with a preemption motion. That dodge went nowhere:
This claim is preempted because it would require [defendant] to give different, additional warnings about the [device's] safety and effectiveness, which is strictly prohibited without FDA approval. . . . Plaintiffs' fraud claim thus necessarily imposes state requirements that are "different from, or in addition to" the federal ones.
Id. at *11 (citation omitted).
Likewise, in Littlebear v. Advanced Bionics, LLC, 896 F. Supp. 2d 1085, 1091 (N.D. Okla. 2012), the plaintiff "d[id] not claim [defendant] made any affirmative misrepresentations" but only that it did not disclose its use of a purportedly non-FDA-approved part. Id. at 1091. Since no FDA regulation mandated such a disclosure, the "fraud by nondisclosure [wa]s expressly preempted." Similarly, in Purcel v. Advanced Bionics Corp., 2010 WL 2679988 (N.D. Tex. June 30, 2010), plaintiff's "claims of fraud by nondisclosure . . . impose a requirement in addition to those approved by the FDA — the duty to warn consumers if devices are adulterated − and are therefore preempted." Id. at *6. See Burrell v. Bayer Corp., ___ F. Supp.3d ___, 2017 WL 1955333, at *8 (W.D.N.C. May 10, 2017) (fraudulent concealment claims "alleg[ing] misrepresentations [that] are indistinguishable from FDA-approved labeling statements" held preempted); Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 4546369, at *9 (D. Idaho Aug. 30, 2016) ("fraud by concealment claim addresses essentially the same conduct as the failure to warn claim" and is expressly preempted because state "law cannot require stronger duties than the FDA actively requires under the MDA"); Humana Inc. v. Medtronic Sofamor Danek USA, Inc., 133 F. Supp.3d 1068, 1076 n.12 (W.D. Tenn. 2015) ("fraud by omission is expressly preempted under the FDCA") (quoting Perez, supra); Day v. Howmedica Osteonics Corp., 2015 WL 13469348, at *8 (D. Colo. Dec. 24, 2015) ("because Plaintiffs' concealment and misrepresentation claims take issue with the labeling and representations made regarding the [device] and the clinical trial of the device, these claims are preempted"); Cline v. Advanced Neuromodulation Systems, Inc., 17 F. Supp.3d 1275, 1288 (N.D. Ga. 2014) ("[t]o the extent Plaintiff's fraud claim is based on Defendant's omissions of information regarding known device failures, it is preempted"); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *17 (E.D. Va. Aug. 23, 2012) ("The cause of action for fraud by nondisclosure is also preempted by the MDA because it would impose requirements under [state] law that add to federal requirements on statements [defendant] can make concerning [the device]."); Latimer v. Medtronic, Inc., 2015 WL 5222644, at *8 (Ga. Super. Sept. 4, 2015) ("a fraud by omission claim is expressly preempted . . . because the underlying state-law disclosure requirement would necessarily be different from, or in addition to the requirements applicable" under federal law) (quoting Perez, supra).
The converse is also true. In McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. 2016), the basis for the plaintiffs' fraudulent concealment claim against the maker of a PMA device was an alleged "duty to disclose" under the FDCA. Id. at 825. Because "[t]he Complaint in this case alleges only that federal law and the PMA imposed a duty to speak by requiring [defendant] to disclose certain information," it was impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 172 F. Supp.3d at 825 (emphasis original). Since plaintiffs "do[] not allege that [state] law imposed any duty on [defendant] to disclose the allegedly undisclosed information . . ., the "fraudulent concealment claim, as pled, exists 'solely by virtue of FDCA requirements,'" and was thus preempted under Buckman. Id. Accord Perez, 711 F.3d at 1119-20 (fraud by omission claim impliedly preempted because premised on defendant's non-disclosure concerning scope of FDA's premarket approval); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1178 (C.D. Cal. 2013) (fraudulent concealment claim impliedly preempted); Bush v. Thoratec Corp., 837 F. Supp.2d 603, 608-09 (E.D. La. 2011) (same).
Since fraudulent concealment/omission claims in PMA device litigation are merely failure to warn claims with a scienter requirement – and scienter is irrelevant to express preemption under §360k – it is only fitting that these claims are preempted for the same fundamental reasons as warning claims.
This article is presented for informational purposes only and is not intended to constitute legal advice.
