As we approach the end of the year, we turn to reflecting on the events of the passing year. We do it here on the DDL blog with our best of and worst of posts. It is often a time to consider just how much (or how little) was accomplished in the course of a year. How much has changed (or stayed the same). In any event, a year marks a significant passage of time. Enough time to say – file a complaint with sufficient facts to support your claims (or not).
In Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. MD. Nov. 15, 2019), the court was analyzing plaintiffs’ amended complaint. That’s because almost one year earlier the first complaint was dismissed for lacking “sufficient detail for the Court to determine the applicable limitations period . . . or whether any of the claims are preempted.” Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. MD. Nov. 29, 2018). Back then, plaintiffs complained that “a more robust pleading is impossible absent discovery.” Id. at 4. The court disagreed. Specifically, the court noted that plaintiffs had the publicly available FDA Class III information on the device and they retained possession of the allegedly defective part of the device. Plaintiffs, therefore, had the tools to “exercise[e] due diligence,” amend their complaint, and then allow the court to analyze the question of preemption. Id. Well, two out of three of those things took place.
Plaintiffs filed their amended complaint. It contained causes of action for negligent manufacture, failure to warn, breach of warranty, strict liability, and wrongful death. Winkler, 2019 WL 6052702 at *3. At issue was a ventricular assistive system that had been implanted in the decedent’s heart to provide ventricular function while decedent awaited a heart transplant. A power failure caused the device to stop working and decedent suffered a fatal cardiac arrest. Id. at *1. The device was a pre-market approved, Class III device. Having gone through the rigors of pre-market approval, only a parallel violation claim may survive preemption.
Therefore, as an initial matter, the complaint must allege violations of FDA regulations related to the device at issue. The amended complaint contained only this single sentence with a vague reference to an unidentified FDA-standard: “Defectively manufactured batteries which fail to hold a charge due to faulty cells violate the standards required by the FDA for premarket approval of the [device].” Id. at *3. Where’s the specificity? Where’s the due diligence?
Simply stating that the defect you allege caused injury also violated a non-specific FDA standard, “is simply insufficient for this Court to infer plausibly that the claims are parallel, and not in addition, to the pertinent FDA regulations. Id. That is simply too low a bar to allow plaintiffs to escape statutory preemption.
Not in their amended complaint, but in their response to defendant’s motion, plaintiffs allege that the subsequent FDA recall “saves the claim.” Id. Even if that could be considered as part of the amended complaint, it still didn’t solve plaintiffs’ problem of failing to plausibly allege a violation of a specific FDA regulation. The recall may support that the device was defective, but it “does not shed any light on the applicable FDA regulations” or how those arguably violated by defendant. Id.
One year ago the court gave plaintiffs a roadmap. Look at the regulations applicable to the device and look at the device itself. Allege facts supporting that the device implanted in the decedent deviated from or violated any specific FDA standards. Use due diligence. Plaintiffs ignored that advice, added one vague reference to a violation, and tried to toss in the recall at the last minute. In other words, since last year almost nothing changed. So, neither did the result. Case dismissed.