Albert Einstein supposedly said, "Insanity is doing the same thing over and over again and expecting different results." He may not have, but the point is well taken. We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved ("PMA") medical devices with vague, boilerplate complaints. Haven't they heard about preemption and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)? Have some lawyers skipped continuing legal education for over a decade?
Which brings us to Naquin v. Medtronic, Inc., 2020 WL 7060150 (E.D. La. Dec. 2, 2020). The plaintiff sued over an implantable defibrillator that allegedly failed prematurely. Id. at *1. The complaint, which attacked no fewer than seven products comprising or related to this Class III, PMA device, id. at *2 & n.11, featured such boilerplate as: "Upon information and belief [defendant] violated FDA laws and regulations by fraud, recklessness, gross negligence and negligence." Id. at *1 n.7 (quoting complaint). Plaintiff sued under Louisiana's product liability statute and for breach of contract. Id. at *2.
Not surprisingly, the defendant raised preemption. As to each of the plaintiff's product liability claims, the court in Naquin agreed. Plaintiff admitted that six of the seven products (or maybe components, the opinion, and probably the complaint, are not very clear) he was suing over had gone through PMA, Id. at *5. As to the one remaining device: (1) plaintiff "does not allege at any point in his complaint that he used [it]"; and (2) "nowhere in the complaint is [that device] alleged to have been defective or caused harm in any specific way." Id. at *4 n.24.
To avoid preemption, plaintiffs suing over PMA devices have to allege so-called "parallel" claims asserting an FDCA violation that parallels a traditional state-law tort claim. Id. at *6 ("After Riegel, parallel state-law claims are the sole survivors of the broad sweep of federal preemption."). In the Fifth Circuit where Naquin chose to sue:
A complaint will be insufficient when it fails to "specify the manufacturing defect," "specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury," or "tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process."
Id., 2020 WL 7060150 at *6 (quoting Bass v. Stryker Corp., 669 F.3d 501, 509 (5th Cir. 2012)).
Not even close.
"In conclusory fashion, [plaintiff] alleges that his 'state product liability claims do not create requirements that are different from or greater than the FDA requirements.'" Id. How? Plaintiff couldn't say. "He fails to identify any defect in the manufacturing process or any violation of federal regulations that caused his injuries." Id. Instead, plaintiff squawked about "res ipsa loquitur." Id. But res ipsa loquitur "does not 'tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.'" Id. (quoting Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011)). When pressed, plaintiff was forced to "admit" that "[t]he exact cause of the failure is not yet known or determined." Id. (footnote omitted).
As for violations, plaintiff offers only more word salad that the defendant "is in violation of FDA regulations because [it] has not been truthful about the products that are the subject of this litigations [sic]." Id. (quoting plaintiff). "In another example of [plaintiff's] conclusory pleading, he alleges that, '[defendant] has not been truthful in its advertising, brochures, websites, services, etc.,' and that "[defendant] has made express warranties that go beyond the FDA approval.'" Id. (footnote omitted). That's actually two examples, but who's counting? Boilerplate could not defeat preemption:
Since [plaintiff] has not adequately alleged a parallel state-law claim that [defendant] violated a federal regulation and such violation caused his injuries, he does not have a claim against [defendant] as a manufacturer of medical devices that is not preempted by federal law.
Id., 2020 WL 7060150 at *6.
But wait – plaintiff also alleged a breach of contract claim that defendant is liable, not as a manufacturer, but "in its capacity as a provider of services." Id. at *7. Okay, maybe that escapes preemption (maybe it requires an expert affidavit under Louisiana law, but that's not discussed), but once again the complaint is boilerplate.
In order to proceed with this claim, [plaintiff] must amend his complaint to state with specificity the basis of the legal relationship, who is the obligor, what performance was promised, how the contract was breached, and what damages have resulted.
Id., 2020 WL 7060150 at *7.
So how good is that contract claim? Well, in writing this post we noticed that Westlaw has flagged Naquin as having been appealed. That indicates that the contract claim, as well, was not worth the paper it was pleaded on, and that plaintiff appealed rather than attempt to amend the complaint.
This article is presented for informational purposes only and is not intended to constitute legal advice.