United States: Primary Jurisdiction Forecloses Lanham Act Challenging Medical Device Classification

Last Updated: November 8 2019
Article by Stephen J. McConnell

The focus of this blog is on product liability cases, but every once in a while a case from another subject matter area tugs at our elbow, begging for attention. Today's case, Kurin, Inc. v. Magnolia Medical Technologies, Inc., 2019 U.S. Dist. LEXIS 184382 (S.D. Cal. Oct. 23, 2019), is an interesting – albeit somewhat baffling – Lanham Act/state unfair competition decision. Both the plaintiff and defendant manufactured and marketed blood collection devices designed to reduce false positive blood culture results. The plaintiff and defendant were competitors. The plaintiff challenged the defendant's representations to customers that the defendant's device was registered as a class I device. The plaintiff also challenged the defendant's packaging of its device as "Rx only." According to the plaintiff, these representations falsely implied that the defendant's device had been FDA reviewed and approved when, in fact, it had only gone through 510(k) clearance. The defendant filed a Rule 12(c) motion for partial judgment on the pleadings, contending that the Lanham Act and state law claims should be dismissed because they raised issues over which the FDA has primary jurisdiction and/or were preempted by the Food Drug and Cosmetic Act.

We've written about primary jurisdiction before – here, for example. It is not exactly the same thing as preemption, but it is preemption-adjacent. Just as a reminder, here are the four criteria for applying primary jurisdiction: (1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority, (3) pursuant to a statute that subjects an industry or activity to a comprehensive scheme, and that (4) requires expertise or uniformity in administration. We have also written about the meh POM Wonderful SCOTUS case before, and it was the authority chiefly relied upon by the Kurin case in holding that at least some of the plaintiff's Lanham Act claims fell within the primary jurisdiction of the FDA, and at least some of the state-law claims were preempted by the FDCA.

The Kurin case involves an intersection between the Lanham Act and the FDCA. The former protects commercial interests against unfair competition, while the latter protects health and safety. In the POM Wonderful case, SCOTUS described how to navigate that intersection. There might be complexity in doing so, but this much is clear: "actions in conflict with an FDA policy choice are barred." That is a vital principle, and the Kurin court pledges allegiance to it. In Kurin, the defendant argued, and the court agreed, that the plaintiff's claims of misrepresentation required the court "to improperly interpret and enforce FDA regulations." While we hate the split infinitive, we like the logic of the court's ruling. Thus, to the extent the plaintiff was claiming that the defendant's medical device was misclassified, the court dismissed such claims.

But the court left some wiggle room for the plaintiff: "Notwithstanding, to the extent Kurin's allegations merely infer that the market or consumers has been misled by Magnolia's representation that the Steripath device is 'listed and registered' a Class I device, those allegations remain." Hmmmm. Let's right away confess that we do not exactly know what the court is saying. Is that use of "infer" even correct? And has the court actually left the heart of the plaintiff's claim, whatever it is, intact? That ambiguity also resides in the court's disposition of the "Rx only" claim. The defendant argued that the plaintiff's beef with the "Rx only" language was verboten because the FDCA required the defendant to include the "Rx only" language in the product's labelling. The defendant's argument seems correct to us.

Yet perhaps you’ve noticed that none of the authors of this blog is, or ever has been, a judge. What seems correct to us is by no means guaranteed to persuade someone who actually is a judge. So it is, sadly, here. The Kurin court held that the plaintiff, as a competitor, could bring an action alleging that consumers were misled by the "Rx language." That makes no sense. It makes even less sense after the Kurin court acknowledged "that any remedial measures involving the label is likely in the FDA's domain." So why does the claim survive? The court tells us that the issue of consumer reliance "is not within the FDA's primary jurisdiction." Maybe. But if the falsity of the representation is within such primary jurisdiction, what is really left for the court? Those question marks hang in mid-air, because the Kurin court ultimately held that the "Rx only" allegations were merely conclusory and, therefore, insufficiently pleaded. The opinion trails off, like someone who runs out of thought and breath simultaneously, croaking out a weak "anyway...."

As we said at the outset, the Kurin case was like someone tugging on our sleeve, begging for attention. Sometimes that person tugging on our sleeve exudes more excitement than sense. Sometimes the tugs are in service of something useful and important. To the extent that the Kurin case recognizes and applies primary jurisdiction, it offers something useful and important.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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