As we write this, our firm’s “return to office” date is less than two weeks away.  We will be delighted to see, hug, and collaborate in person with colleagues we’ve missed for two long years (computer visages notwithstanding), though we confess to panic at the prospect of “real clothes.” And shoes.  It’s all a bit of a mixed bag, as is today’s case.

In Feeser v. Medtronic, Inc., 2022 WL 378143 (D.S.C. Feb. 8, 2022), the plaintiff was implanted with the defendant’s pacemaker.  The pacemaker allegedly stopped working at some point, and the plaintiff underwent a second surgery to remove the pacemaker and implant a different one.  The plaintiff asserted claims for negligence/gross negligence, strict liability, and breach of warranty.  The defendant moved to dismiss, arguing that all of the claims were preempted and that, in the alternative, none of the claims satisfied Twiqbal’s pleading standards.

Preemption

The pacemaker was a Class III medical device, subject to the FDA’s full premarket approval (“PMA”) process.  Under SCOTUS’s 2008 Riegel decision, as many of you know, the MDA preempts common-law tort claims against a manufacturer of a Class III device if the claims seek to impose requirements that are “different from or in addition to” federal requirements and that “relate to the safety or effectiveness of the device or to any other matter included in a requirement of the device.”  Feeser, 2022 WL 378143 at *2 (citation to Riegel omitted).  The only common-law claims not preempted under the MDA are claims asserting state duties that “parallel, rather than add to, federal requirements” id. at *3 (internal punctuation and citation omitted).   As the Feeser court explained, “this situation occurs when claims are premised on a violation of FDA regulations.”  Id. (citation omitted).

In Feeser, the plaintiff alleged that his pacemaker lacked a protective coating that was an essential element of the device the FDA tested and approved, and that the lack of coating caused the pacemaker to stop working.   The court held that, “through this allegation, [the plaintiff] sufficiently identifie[d] the federal requirement that [the defendant] allegedly violated” – that, “viewing the complaint in the light most favorable to [the plaintiff], [the plaintiff] . . . plausibly alleged that [the defendant] failed to comply with” [the device’s] specific PMA requirements.”  Id. 

The court emphasized that allegations related to the lack of protective coating were “the only specific allegations that [the defendant] deviated from the PMA approved design . . . .” id. (emphasis in original), and were, therefore, the only grounds on which the plaintiff would be permitted to proceed.  The court concluded:

At this stage, it remains to be seen whether [the plaintiff] can prove that the pacemaker’s PMA documents require a protective coating, that the pacemaker he received did not have a protective coating, or that the alleged lack of coating was, in fact, the cause of [the] problems that necessitated removal and replacement [of the plaintiff’s pacemaker].   However, [the plaintiff has pleaded enough facts to support a plausible inference that [the defendant] violated the PMA and federal law by manufacturing the pacemaker without a protective coating.  Therefore, to the extent [that the plaintiff’s] claims are based on the lack of a protective coating, those claims do not differ from or add to federal requirements and are sufficiently parallel to fall outside the scope of MDA preemption.

Id.  At least this holding effectively nails the plaintiff’s theories of recovery, and thus the scope of discovery, down to a specific set of purported facts at an early stage.

 Failure to State a Claim

The defendant argued that, even if the plaintiff’s claims were not preempted, the complaint failed to state a claim for three reasons.  First, the defendant alleged that the plaintiff did not adequately identify the pacemaker at issue.  Although the plaintiff identified a model number and serial number and alleged that the pacemaker was recalled because it lacked the protective coating, the defendant asserted that the pacemaker the plaintiff identified did not include the protective coating and was not recalled for coating issues.   The court rejected the defendant’s argument, holding that the “product identification” pleading was adequate on its face and that the challenge raised factual issues inappropriate for a Rule 12 motion.  (We note that, if discovery proves that the plaintiff deliberately distorted the relevant facts, Feeser would present a situation where the defendant would be justified in filing a Rule 11 motion to recover the costs of needless and baseless discovery.)

Second, the court rejected the defendant’s argument that the plaintiff had not alleged sufficient facts to satisfy the elements of his claims, holding that the plaintiff had adequately alleged that the lack of protective coating rendered the pacemaker “unreasonably dangerous, not merchantable, and not fit for its intended purpose.”  Id. at *4.

Finally, the defendant argued that the plaintiff had failed to support his design defect claims by identifying a reasonable alternative design for the pacemaker.  Because it had dismissed, as preempted by MDA, “any claims based on the pacemaker’s PMA-approved design,” id. at *5, the court denied this argument as moot.

Inexplicably, in light of this holding, the court went on to state that the plaintiff “clearly” alleged a reasonable alternative design, because an alternative design for a pacemaker without protective coating would be a design that included the coating.  In other words, according to the court, the plaintiff was not required to identify the alternative design because it was the obvious “flip side” of the defect he alleged.  We find troubling, even in dicta, the suggestion that a court can scrap a pleading requirement because a reader can figure out the missing piece from the surrounding allegations.  This isn’t what Twiqbal requires, and it presents all manner of slippery slopes.

We think Feeser is an interesting mix of holdings hinting at some over-generous plaintiff leanings.  We will watch for further motion practice in this case, and we will keep you posted.  In the meantime, stay safe out there.