He didn’t win, but he sure looked beautiful. Luca, that is. Faithful readers know that our beautiful standard poodle puppy made his show debut last weekend in Massachusetts. He is learning the ropes and settling down – winning will come in time. We can’t express how thrilled we were to be ringside for these first shows and how wonderful it felt to hug him after several weeks of missing him. He shows again next week in Arkansas – we will keep you posted. Here is a short video of his very first time in the ring. He is the second puppy – handler in gold dress – prancing happily with his tail up and wagging.
Today’s case wasn’t a “win” for either side, either. In Desch v. Merz North America, Inc., 2023 WL 2734671 (E.D.N.Y. Mar. 31, 2023), the plaintiff alleged that she was injured by the defendant’s device, which “uses ultrasound to provide a non-invasive alternative to face lifts.” Desch, 2023 WL 2734671 at *1. She filed suit in New York state court, asserting claims for breaches of express and implied warranties, negligence, misrepresentation by omission, and strict liability manufacturing defect and warnings claims. The defendant removed the suit to the Eastern District of New York and moved to dismiss it.
The device in question was a Class II medical device, subject to the FDA’s 510(k) clearance standard, not to the full premarket approval (“PMA”) process. As readers know, FDA reviews Class II devices for “substantial equivalence” to devices that are on the market. The FDA originally cleared the defendant’s device “as a Class II medical device to lift the eyebrow.” Id. (internal punctuation and citation omitted). But, during FDA’s review process, the agency decided that the device was not “substantially equivalent” to devices that were on the market. Accordingly, it “reviewed the device according to a de novo standard,” not the “substantial equivalence” standard. That’s a distinction that we think should make a difference. When the FDA ultimately cleared the device, it “published a ‘special controls’ document with recommendations that future devices of the same type” were required to address. Id. After the FDA cleared the device for lifting eyebrows, the defendant obtained clearance to market it “to lift skin on the neck, lift skin under the chin, and to reduce lines and wrinkles on the chest.” But the FDA denied clearance to market the device for use on the “full face and neck,” stating that the “new indication for use [was] not acceptable.” Id. (citations omitted).
The defendant argued that all of the plaintiff’s claims were preempted. Although the Medical Device Amendments to the Food, Drug, and Cosmetic Act expressly preempt product liability claims only against manufacturers of Class III devices subject to full PMA, the defendant argued that the heightened “de novo” review and “special controls” document “impose[d] the type of specific requirements that trigger[ed] express preemption under the MDA. “ Id. at *4.
The argument fell on deaf ears. Desch held that the plaintiff’s claims were not preempted because the special controls document did not impose any specific requirements on the device in question. Rather, it “recommend[ed] the types of tests other manufacturers should perform when applying to the FDA for clearance to sell substantially equivalent devices.” Id. The only cases the defendant cited in support of its preemption argument were cases in which courts held that plaintiffs’ labeling claims related to Class II devices were preempted because the FDA “had specifically defined the content required to the devices label through a regulation or a specific requirement in a special controls document.” Id. None of those cases dealt with a Class II device that received de novo review, so there was no precedent for the argument that that process triggered express preemption. And none of the Desch plaintiff’s claims that survived dismissal challenged the adequacy of the device’s label. So, the court held, the cases defendant cited did not support applying express preemption to the plaintiff’s claims.
The defendant argued that, whether or not the plaintiff’s claims were preempted, they were not adequately pled and failed to state claims. With respect to the manufacturing defect claim, the court agreed, holding that the allegations were “conclusory and fail[ed] to allege the applicable manufacturing defect.” Id. at *5. The court explained that, to assert a manufacturing defect claim, the plaintiff was required to “allege that the particular unit [in question] had a defect as compared to other samples of that product” and that the specific unit “was defective as a result of some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction, and that the defect was the cause of [the] plaintiff’s injury.” Id. (citation omitted). In Desch, the plaintiff alleged only that the defendant did not comply with the FDA’s Current Good Manufacturing Process (“CGMP”) regulation, which lists examples of types of issues the manufacturer should implement procedures to address but does not mandate specific procedures. Moreover, even if the defendant did violate the CGMP regulation, the plaintiff did not establish a causal link between the defendant’s failure to follow whar amounted to purely procedural CGMPs and any defect in the product. So the court dismissed the manufacturing defect claim, along with the aspects of the negligence and implied warranty claims that were based on an alleged manufacturing defect.
Claims Based on Misrepresentation and Failure to Warn
As the court explained, the plaintiff’s “remaining claims, regardless of how they [were] styled, [were] all based on [the defendant’s] alleged statements” that the device would not cause serious adverse effects, could be used on the ‘full face,’ and had been ‘approved’ by the FDA. Id. at 86. The plaintiff had incorporate these arguments into her express warranty, negligence, misrepresentation by omission, and strict liability/failure to warn claims. The court dismissed the plaintiff’s claims to extent that they were based on the defendant’s alleged off-label marketing of the device for full-face use. The court explained, “Even though the FDA declined to clear [the defendant’s] marketing of the [device] for this particular use,” SCOTUS’s Buckman decision held that it was the province of the FDA, not a private plaintiff, to decide “whether to enforce prohibitions related to off-label promotion.” Id. (citation omitted). As such, the plaintiff could not “use a private cause of action to enforce federal prohibitions against off-label promotion,” and the claims were impliedly preempted unless the plaintiff could demonstrate that New York law recognized a tort that prohibited such promotion. We are not sure why it would matter whether New York law recognized such a tort, since there is no “parallel claim” exception to implied federal preemption. Whatever the court’s reasoning the plaintiff could not meet it, and the court dismissed the claims to the extent that they relied on the defendant’s alleged off-label promotion.
The court denied the defendant’s motion, however, to the extent that the plaintiff’s claims were based on the defendant’s alleged failure to report adverse events associated with the device to the FDA. Contrary to the Second Circuit’s adherence to Erie conservatism in predicting state law, e.g. Runner v. New York Stock Exchange, Inc., 568 F.3d 383, 386 (2d Cir. 2009) (“our role as a federal court sitting in diversity is not to adopt innovative theories that may distort established state law”), and to most New York caselaw, the court held that “multiple courts” in the Second Circuit had predicted that New York would “impose liability on a medical device manufacturer for failing to provide the FDA with a warning required by federal law.” Id. at *7 (citations omitted). The court also allowed the plaintiff’s claim that the defendant failed to warn the medical community at large, though it cited cases that seemed to allege prescriber-specific reliance.
Finally, the court held that New York’s learned intermediary doctrine barred the plaintiff’s claim that the defendant failed to warn her directly and also required dismissal of the claims based on allegations that the defendant promoted the device as “FDA approved,” rather than “cleared.” According to the court, the doctrine required the plaintiff to plead her doctors’ reliance on the alleged misrepresentation, not her own reliance, and “unlike a patient, any reasonable doctor would have understood that the FDA’s review process for Class II devices does not represent ‘approval’. . . .”
Desch is a mixed bag. The surviving claims will move forward, and we will keep you posted on further developments. In the meantime, stay safe out there, and stay tuned for Luca news.