A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York. We have all suffered through opinions in which judges (or their clerks) painstakingly flog possible outcomes, arguments, and counter-arguments before finally reaching their decisions. And as (once again) McConnell recently pointed out, the result has been some spectacularly bad preemption decisions. But Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), arising in the relatively clear jurisprudence surrounding so-called “PMA preemption,” was what we fondly call a “slam-dunk,” and the court treated it accordingly.
In Olmstead, the plaintiff was implanted with an Essure device, an implantable birth control device manufactured by the defendant. She alleged that, after she was implanted with the device, she experienced months of pain, fatigue, and excessive bleeding culminating in a hospital visit for an episode of severe abdominal pain. Though an initial ultrasound appeared normal, a subsequent ultrasound allegedly revealed that “one of the coils of the Essure was sticking out of the uterus by about one inch.” Olmstead, 2017 WL 3498696 at *2 (internal punctuation and citation omitted). The plaintiff sued in state court, asserting claims for negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranties. The defendants removed the case to federal court and moved to dismiss it, arguing that the plaintiff’s claims were preempted by the Medical Device Act (“MDA”).
As the court explained (and as we have discussed in these pages many times before (like here, also in the context of Essure litigation), Class III medical devices like Essure must undergo FDA’s “rigorous” premarket approval (“PMA”) process before they can be marketed to the public. Id. at *1. Under the MDA, once a Class III device obtains PMA, the manufacturer may not make changes to the device’s design, specifications, or labeling without FDA permission.
The MDA also includes an express preemption clause. Under this clause, as construed by the Supreme Court in Riegel v. Medtronic, 522 U.S. 312 (2008), state laws that impose obligations that are different from or in addition to the requirements of the MDA are expressly preempted. Id. at *3 (citations omitted). A common-law claim challenging the safety of an FDA-approved medical device survives only if it alleges a parallel violation of federal law for which state law provides a damages remedy. Id. (citations omitted).
As such, the Olmstead court explained, the plaintiff’s “onerous task” first required her “to identify a parallel federal law upon which she [had] based her state law claims.” Id. at *4. In response, the plaintiff cited the Current Good Manufacturing Processes (“CGMPs”) described in 21 CFR § 820.1 et seq.. But she failed to explain how the defendants had violated the CGMPs, which, in any event, were intended “to serve only as an umbrella quality system providing general objectives medical device manufacturers must seek to achieve.” Id. (internal punctuation and citations omitted). The court emphasized, “Since these regulations are open to a particular manufacturer’s interpretation, . . . allowing a suit to continue on the basis of the CGMPs would necessarily impose standards that are ‘different from, or in addition to’ those imposed by the MDA – precisely the result that the MDA provision seeks to prevent.” Id. (internal punctuation and citations omitted).
Thus, the court held, because the plaintiff had “failed to identify a single parallel federal statute or regulation related to any of her claims,” the MDA expressly preempted the suit as a matter of law. Id. The court commented that it ordinarily would have allowed the plaintiff to amend her complaint to “attempt to allege a plausible claim that [was] not preempted.” Id. But, in yet another layer of certainty, the court held that New York’s three-year statute of limitations barred the plaintiff’s claims.
Nothing but net. And we are told that this is the twenty-fourth time that an Essure suit has been dismissed or narrowed on preemption grounds. Short, sweet, and correct – hard to beat that. We will keep you posted on further developments.