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...
