Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed "parallel" violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a "Current Good Manufacturing Practice" or "CGMP") and show that the claimed violation is plausibly linked to the injury the plaintiff claims. The leading case for the anything goes position is Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (bashed here), which held:
Defendants' proposed distinction between concrete, product-specific requirements and more general requirements would also leave injured patients without any remedy for a wide range of harmful violations of federal law. The FDA regulations contain many requirements that are not concrete or product-specific, yet which are obviously vital to producing safe and effective medical devices.
Id. at 555. See also Howard v. Sulzer Orthopedics, Inc., 382 F. Appx. 436, 441 (6th Cir. 2010).
More courts, thankfully, go the other way, with probably the leading case being Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011):
[W]e must first consider whether [plaintiffs] have demonstrated that they have alleged a parallel claim. Plaintiffs cannot simply incant the magic words "[defendants] violated FDA regulations" in order to avoid preemption. Parallel claims must be specifically stated in the initial pleadings. A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue. To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated.
Id. at 1301 (citations and quotation marks omitted). See also Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011); In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1211-12 (8th Cir. 2010); cf. Weber v. Allergan, Inc., 940 F.3d 1106, 1114 (9th Cir. 2019) (expressly avoiding this issue).
For a long time, the Third Circuit had not touched on that issue. In the absence of definitive guidance, district courts in Third Circuit states had generally required specific pleading of parallel claims in accordance with how courts generally apply Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009) (collectively, "TwIqbal"). "[I]nsofar as Plaintiffs attempt to use the GMPs as the basis for a parallel claim, courts have regularly found that general citations to the GMPs or federal regulations are not specific enough to sustain a parallel claim." Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889, at *5 (M.D. Pa. Aug. 28, 2020). Conley cited: Walls v. Medtronic, Inc., 2019 WL 6839942, at *4 (E.D. Pa. Dec. 16, 2019) ("Plaintiffs have pled their claims in general terms, and they have not identified any violation of specific FDA regulations."); Starks v. Coloplast Corp., 2014 WL 617130, at *5 (E.D. Pa. Feb. 18, 2014) ("broad references to federal regulations are insufficient" to state a parallel claim); and especially Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), which held:
Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court's reasoning in Riegel [v. Medtronic, Inc., 552 U.S. 312 (2008)], as well as the pleading requirements articulated in [TwIqbal]. This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.
Id. at 495-96 (citations omitted). See also Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *7 (W.D. Pa. Sept. 19, 2013) ("CGMPs do not provide such a fine level of detail concerning the manufacture [of a medical device], the manufacturer must establish its own specific quality control system for the medical devices it produces to ensure that they are safe and effective.") (citations and quotation marks omitted).
About the same time Walls was decided, a footnote decision in Irizarry v. Abbott Laboratories, 2019 WL 5061127 (E.D. Pa. Oct. 8, 2019), likewise held that vague violation allegations failed to plead a viable "parallel" violation claim.
Here, the plaintiffs are unable to establish that the . . . device was manufactured in a manner that violated the PMA requirements. Essentially, their allegations do not fit through the "narrow gap" necessary to avoid preemption. The original complaint lacked any specific allegations of the way in which the device was manufactured that failed to comply with the PMA requirements.
Id. at *1 n.1. Those plaintiffs appealed and not long ago the Third Circuit agreed with the district court:
In anticipation of [defendant's] preemption defenses, [plaintiffs] attempted to plead only non-preempted claims, commonly referred to as "parallel" claims. . . . [H]ere, in their complaint, [plaintiffs] do not set forth the premarket approval requirements for the . . . Device. Without doing so, they do not provide any non-conclusory, non-speculative allegations to support a parallel claim. Absent reference to actual premarket approval requirements, [plaintiffs] do not plausibly allege that [defendant] abridged a state-law duty that neither adds to nor differs from the federal premarket approval requirements.
Irizarry v. Abbott Laboratories, ___ F. Appx. ___, 2020 WL 6441117, at *1 (3d Cir. Nov. 3, 2020) (citations omitted). Nor could that lack of specificity in plaintiffs' pleadings be cured with an expert report, since an expert report is not a "written instrument" and thus "cannot be incorporated into the complaint for purposes of the plausibility analysis" under TwIqbal. Id. at *2.
New Jersey courts have reached the same conclusion. Desai v. Sorin CRM USA, Inc., quoted and followed Gross:
Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court's reasoning in Riegel, as well as the pleading requirements [under Rule 8]. This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.
2013 WL 163298, at *7 (D.N.J. Jan. 15, 2013). "[A] plaintiff must successfully plead a claim before obtaining discovery, not the other way around." Becker v. Smith & Nephew, Inc., 2015 WL 4647982, at *3 (D.N.J. Aug. 5, 2015) (citations omitted). See also Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, at *12 (D.N.J. March 18, 2013) ("none of Plaintiff's claims are parallel to federal requirements because none of the claims are adequately pled with the specificity required for parallel claims"), aff'd, 552 F. Appx. 192 (3d Cir. 2014) (dismissal without discovery not abuse of discretion); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859, at *7 (D.N.J. Dec. 15, 2009) (complaint was "fatally conclusory and . . . does not connect the device implanted in the plaintiff with any of the allegations about noncompliance with FDA requirements").
While anything could still happen - such as an outlier pro-plaintiff panel like In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), vacated, 139 S. Ct. 1668 (2019) ? for the time being it appears that specificity is a firmly established requirement in the Third Circuit in "parallel claim" preemption cases.
This article is presented for informational purposes only and is not intended to constitute legal advice.