It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue.  But it does happen, and recently, in both Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), and Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), express medical device preemption carried the day, in decisions issued only four days apart.

That’s worth a blogpost – and two cheers.  Hip hip!

Taking the earlier case first, Warmoth granted a preemption-based motion to dismiss, holding that every claim was either preempted on its face or too poorly pleaded to support any unpreempted “parallel” claims.  The product, an insulin pump, was FDA pre-market approved – no surprise there.  PMA preemption cases remain excellent dismissal candidates despite plaintiffs having spent the last decade and a half trying to chip away at Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).

None of the plaintiff’s claims in Warmoth could make it through the “narrow gap” recognized by the Tenth Circuit between express PMA preemption under Riegel and the implied preemption of private FDCA enforcement attempts recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  2023 WL 3938464, at *3 (quoting Brooks v. Mentor Worldwide LLC, 985 F.3d 1272, 1279 (10th Cir. 2021)).

One of the other side’s favorite PMA preemption dodges is to assert manufacturing defect claims that don’t really involve manufacturing defects, but rather assert purported systemic problems with the device.  That happened, rather belatedly, in Warmoth, but the plaintiff didn’t get away with it:

The Court finds the Complaint did not assert a claim for manufacturing defect. First, to state a manufacturing defect claim in Oklahoma, a plaintiff must allege that the defective product somehow deviated from its intended design, which the Complaint does not do.  Additionally, Plaintiff’s strict liability allegations relate to the design of the product rather than an error in manufacturing.  Aside from a generic reference to a manufacturing defect, Plaintiff made no effort to assert that claim until his Response, and the Court will not consider a new claim which was not alleged in the Complaint.

2023 WL 3938464, at *4 (citations and quotation marks omitted).  Rather than assert new factual allegations in his brief, plaintiff should have pleaded them.  Id. (“the Court will not consider a new claim which was not alleged in the Complaint”).

Why did the Warmoth plaintiff do this?  Because design defect claims are stone-cold losers in PMA preemption cases.  That was certainly the case in Warmoth.  “Plaintiff’s [design] claim is subject to dismissal because neither his Complaint nor his Response identify any parallel federal statute or regulation he contends Defendants failed to comply with.”  Id. at *5.  Simply alleging “three prior recalls” does not “allege a violation of federal law.”  Rather, “reference to a recall without more is not the same thing as alleging a violation of federal law or failure to comply with federal law.”  Id.

Apparently, plaintiff’s briefing in Warmoth flopped about like a fish on a dock with assertions not supported by the complaint.  First, there was “another example of a manufacturing defect allegation which does not appear in the Complaint.”  Id. at *6.  Then there was “refer[ence] to the general MDA prohibition on changes in design specifications or manufacturing processes absent FDA approval . . ., but the Complaint does not allege the design or the manufacturing process . . . changed.”  Id.  Did it matter?  No.  “The result would be the same even if these allegations were in the Complaint because a generic reference to deviation from the FDA approved device is insufficient.”  Id. at 6 n.8 (citations omitted).  In the end:

Plaintiff’s design defect claim would be preempted by federal law even if he had identified a federal statute or regulation he contends was violated.  Plaintiff alleges the [device] was defective in design and unreasonably dangerous when was placed into the stream of commerce.  However, “[o]nce a device survives premarket approval it’s immune from state tort suits that seek to impose different or additional safety-related duties like those alleged here.”

Warmoth, 2023 WL 3938464, at *6 (quoting Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1345 (10th Cir. 2015)).

Negligence was next to go (and who knows, maybe Monaco?) because once again “Plaintiff does not specify what provisions of federal law were violated or indicate how those violations give rise to recovery under state law.”  Id. 

Plaintiff’s warning claim crashed into the other side of the narrow gap – implied preemption – since it was merely a failure to report claim.

Plaintiff still does not identify the federal statute or regulation he contends was violated in connection with the alleged reporting failures. . . .  Plaintiff’s claim is subject to dismissal because he has not offered − and the Court will not seek out − a federal requirement to warn patients. . . .  Moreover, to the extent Plaintiff argues his failure to warn claim is solely premised on failure to report to the FDA, such a claim would be impliedly preempted.

2023 WL 3938464, at *6 (citations and quotation marks omitted).

The next two dominos to fall in Warmoth were express and implied warranty.  Eventually, plaintiffs will learn that “express warranties” that products are “safe for use” simply don’t cut it.  But not yet.  “[T]his claim is preempted because the FDA has already approved the product’s safety and effectiveness, therefore liability would exceed what federal law requires.”  Id. at *7 (citation omitted).  Implied warranty?

Again, Plaintiff does not identify any parallel federal requirement he contends was violated, which likewise subjects this claim to dismissal.  Moreover, Plaintiff’s implied warranty claim rests on allegations that the products were unsafe or inadequately labeled, either of which, if found, would be contrary to the FDA’s approval and therefore preempted.

2023 WL 3938464, at *7 (citations omitted).

The pump itself was accompanied by an infusion set, which Warmoth could not tell was a PMA product or not.  Those claims were all TwIqballed.  (1) Strict liability – plaintiff “has not pleaded any facts related to the design of the product, any flaw with the design, or how that design defect caused his injury.”  (2) Negligence – “Plaintiff’s conclusory allegation that the Infusion Set was defective fails to support a claim for negligence.”  (3) Failure to report – “The Complaint does not contain any allegations regarding a failure to report an adverse event related to the Infusion Set.”  (4) Express warranty – “Plaintiff does not identify any particular affirmations, statements, or warranties as to any product.”  (5) Implied warranty – “Plaintiff does not explain how the [device] he used was defective, unsafe, or inadequately labeled, nor does he plead any plausible connection between the issues with prior recall[s].”  Id. at *9-10.

Finally, Warmoth denied the plaintiff’s perfunctory request for leave to amend was denied.  In violation of local rules, “[plaintiff] includes one sentence requesting leave to amend his Complaint,” but “does not explain what he believes he would clarify or add to an amended complaint with regard to his factual allegations or his legal claims.”  2023 WL 3938464, at *11.

That’s one.

Four days later, in Benn, 2023 WL 3966000, the second shoe dropped.  Not unexpectedly, the plaintiff in Benn also sought to rely on the product recalls, which in Benn occurred a year after the claimed device malfunction.  Id. at *1.  As is common, Benn took judicial notice of FDA online documents concerning both the pre-market device approval and the subsequent recall.  Id. at *2 n.3.

Once again, all of the plaintiff’s claims in Benn were preempted.

Courts within the Third Circuit have consistently held that tort claims based on negligence, manufacturing and design defects, strict liability, breach of warranty, failure to warn, and state consumer fraud statutes are therefore preempted by the MDA.  That encompasses all five of the Complaint’s counts.

Id. at *3 (citations omitted).

Unable to mount a coherent argument against express preemption under PMA preemption cases, the plaintiff in Benn cited only implied preemption cases involving prescription drugs.  Not unexpectedly, that didn’t work well either.  “[Levine] and similar cases cited by Plaintiff relate to drugs (for which Congress did not enact preemption), not medical devices (for which they did).”  Id. (footnote omitted).

Reliance on the recalls as creating some sort of “parallel claim” did not help in Benn either.  That preemption exception “requires more than just a change of terminology; a plaintiff cannot simply incant the magic words ‘[Defendant] violated FDA regulations’ in order to avoid preemption.”  Id. at *3 (citation and quotation marks omitted).  But plaintiff’s recall-based argument “does not allege a deviation from pre-market, FDA-approved specifications; it simply recasts a preempted defect as an actionable deviation.”  Id. at *4 (citation omitted).  A recall simply isn’t proof of an FDCA violation:

Nor does a product recall create an inference that PMA specifications were violated.  Courts have consistently held that a product recall alone, without more, does not suggest a PMA specification violation. Accordingly, Plaintiff’s state law claims are preempted and, because they make up the entirety of the Complaint, dismissal is warranted.

Benn, 2023 WL 3966000, at *4 (string citation omitted).

However, unlike the slapdash request in Warmoth, the Benn plaintiff apparently made a proper request for leave to amend, which was allowed given that no prior amendment had occurred.  Id.

So there you have it.  Two useful preemption wins in the same week.  The word “recall” now appears 84 times in our PMA preemption scorecard.