Defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions, as our PMA Preemption Score Card (now with well over 500 decisions) demonstrates. Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020), is one of these, but some aspects of Conley make it more interesting than most PMA preemption decisions – presumably why West chose it for publication in F. Supp.
The principal plaintiff in Conley was an amputee implanted with a pain-fighting stimulator. He had lost the limb to cancer, and thus needed frequent MRIs to look for possible recurrence. The device was designed with an “MRI mode” to accommodate that situation. However, that MRI mode allegedly malfunctioned, and he had the device explanted. Id. at *1. In an attempt to avoid preemption, plaintiffs also tried to involve the defendant’s representative, alleging that the rep “regularly tested” the device, and when the problem arose, “informed . . . that the stimulator ‘was not reading properly’ when it was last tested.” Id.
Only one of plaintiffs’ attempts to avoid preemption was successful, and even that claim failed as a matter of Pennsylvania law.
Plaintiffs’ negligence claim “related to the conduct of Defendant’s employee” failed because, “to state a valid parallel claim for negligence, the ‘duty’ element must arise from federal requirements applicable to a medical device.” Id. at *5 (citation and quotation marks omitted). As to the manufacturer’s representative, “Plaintiffs here have failed to identify any duty arising from the federal requirements applicable to the [device].” Id.
Aside from the sales representative, the only claimed negligence duty concerned purported violations of FDA GMPs (also called “CGMPs”). Significantly, since the Third Circuit has not decided the issue, Conley came down on the “specific” side of the split over how GMP violations must be pleaded. “[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.” Id. (citations and footnote omitted). Conley cites a useful selection of favorable Third Circuit district court opinions on this issue, and distinguishes the major adverse decision. Id.
The same reasoning applied to plaintiffs’ strict liability claim for manufacturing defect. Vague claims of “recalls” and that the device was “adulterated could not avoid preemption:
Once again, the Court notes that Plaintiffs have failed to allege any specific violations of federal law that might establish a parallel state duty. The amended complaint neither identifies a specific manufacturing defect, nor specifically alleges how Defendant’s practices ran afoul of FDA requirements. Insofar as Plaintiffs argue this claim can survive preemption due to their reliance on the GMPs, once again, the Court notes that the GMPs are too vague to satisfy the requirements of a parallel claim.
2020 WL 5087889, at *7 (citations omitted).
Plaintiffs’ warning claim in Conley was also preempted. Since “Pennsylvania’s duty to warn for medical devices runs to the physician,” there was no analogous state-law duty to report adverse events to the FDA. 2020 WL 5087889, at *6 & n.6. Thus, the plaintiffs’ failure-to-report claim predicated on such a non-existent duty was both expressly and impliedly preempted. Id. at *7 & n.7. Nor did plaintiffs in Conley plead that “actual” unreported incidents or how any failure to report caused the alleged injuries. Id. at *7.
Only express warranty escaped preemption, based on what we consider to be the archaic and simplistic rationale that such claims “do not involve a state requirement.” Id. at *6. This reasoning dates to the pre-Riegel decision, Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995), and most other courts, including several in the Third Circuit, hold at least some express warranty claims – those arising from FDA-approved language – to be preempted. See Hart v. Medtronic, Inc., 2017 WL 5951698, at *6 & n.6 (D.N.J. Nov. 30, 2017) (only express warranty claims “beyond those appearing in the FDA-approved instructions and warnings” escape preemption); Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586, 602 (D.N.J. 2015) (“an express warranty claim is not necessarily preempted under the MDA”; no preemption “if the plaintiff can show that the defendant-manufacturer made voluntary statements that were not approved by the FDA or mandated by the FDA”) (citation and quotation marks omitted); Becker v. Smith & Nephew, Inc., 2015 WL 4647982, at *4 (D.N.J. Aug. 5, 2015) (“If a claim is based on the information contained in FDA approved product labels and packaging inserts, it is barred.”) (citation and quotation marks omitted); Morton v. Allergan, Inc., 2015 WL 12839493, at *4 (D.N.J. April 2, 2015) (plaintiff “does not factually allege that [defendant] made any voluntary statement . . . that was not approved by the FDA”; express warranty “is therefore preempted”); see also Bexis’ book, at §5.01[c][iv], at n.226.
Nonetheless, the express warranty claim in Conley was dismissed because plaintiffs’ claim failed to plead reliance, as required by the statute’s “basis of the bargain” element:
[Plaintiffs] appear to acknowledge that they were unaware that any warranty may have existed at all until after [the] explant surgery, a year after the device was originally implanted.
2020 WL 5087889, at *6. An unknown “warranty” simply cannot be part of the “basis of the bargain” on which a product was sold.
Leave to amend was also denied. Id. at *8. Conley applied (as it should have) the rule from Albrecht that “[p]reemption is a matter of law.” 2020 WL 5087889, at *8 (citing Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1680 (U.S. 2019)). Conley is the first medical device decision in the Third Circuit explicitly applying Albrecht to medical device preemption, but it surely won’t be the last. Plaintiffs’ request for discovery on this legal question amounted to a “fishing expedition”:
In medical device cases, courts have regularly rejected the argument that plaintiffs are entitled to discovery prior to dismissal on preemption grounds. As the Court is disinclined to allow Plaintiffs to undertake a discovery fishing expedition . . ., the Court finds that allowing further amendment in this case would be futile.
Id. at *8 (citation omitted).