Although the Supreme Court’s recent decision in POM Wonderful, which we blogged about here, didn’t involve preemption, we were worried that, at least in Lanham Act cases, it might erode the protection afforded prescription medical products (POM was a food case) by 21 C.F.R. §337(a), granting exclusive enforcement authority to the FDA.
Fortunately, the Catheter Connections decision got it right.
The product at issue – “disinfectant caps incorporated into intravenous (IV) lines that deliver fluids and drugs to patients” – was cleared for marketing by the FDA under its §510(k) “substantial equivalence” process. 2014 WL 3536573, at *1. Marketing of the first version of this product was enjoined earlier in the litigation on completely non-FDCA-related, patent infringement grounds. Id. at *2. The defendant responded by redesigning the product to avoid the alleged infringement, but did not resubmit the device to the FDA, taking the position that the modifications did not affect the safety and effectiveness of the product.
The plaintiff then attacked that decision (not to resubmit to FDA) under the Lanham Act, alleging that the defendant’s statements that it had FDA clearance were now “false.” Id. at *3. That’s where in our minds, the rubber meets the road. If a plaintiff in private litigation can challenge the lack of an FDA submission, then the same plaintiff could challenge the existence of an FDA submission. Either situation would set a dangerous precedent breaching the FDA exclusivity provided by § 337(a).
The court refused to allow the claim:
Under the FDCA, the FDA has exclusive jurisdiction over approval of medical devices and courts do not have the authority to decide issues that fall under the FDA’s administrative authority. To that end, the FDCA provides that no private right of action exists to enforce provisions of the FDCA because the FDA has the exclusive power and discretion to enforce the FDCA. See 21 U.S.C. § 337(a)
2014 WL 3536573, at *3 (citing §337(a)). It recognized that to decide whether the defendant’s failure to return to the FDA to obtain supplemental clearance would require it to impinge on the FDA’s prerogative to decide what kinds of modifications required additional action.
The relevant regulation (21 C.F.R. §807.81(a)(3)), requires resubmission of “any change” to a device that “could significantly affect the safety or effectiveness.” Observing that “[t]he FDA allows the manufacturer to make this decision in the first instance,” 2014 WL 3536573, at *3, the court refused to be drawn into the thicket of making safety and effectiveness decisions under the guise of Lanham Act enforcement.
As one would expect, the plaintiff argued that this allegation was allowed under POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014), claiming that it involved nothing more than statutory “overlap.” Catheter Connection, 2014 WL 3536573, at *4. The court held that nothing in POM vitiated the previous distinction drawn by almost every court between claims requiring “direct interpretation” of the FDCA (or FDA regulations) and those where the FDA’s regulation is incidental to the competition-related claim. Id. at *5-6 (relying upon PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 922 (9th Cir. 2010), and Cottrell, Ltd. v. Biotrol International, Inc., 191 F.3d 1248, 1254-55 (10th Cir. 1999)). The mere fact that the defendant admitted that changes to the device had been made did not speak to safety and effectiveness:
The statements simply acknowledge that changes to the design have been made. [Defendant], by making those statements, does not in any way admit that those changes could result in a change in the performance of the device that would require a new 510(k) submission. The court would still need to determine whether [defendant] made the correct choice under the FDA regulations to refrain from submitting another 510(k) notice for FDA approval. That decision is within the FDA’s exclusive jurisdiction.
Catheter Connection, 2014 WL 3536573, at *5.
“[E]ssentially,” the plaintiff was accusing the defendant of “not compl[ying] with FDCA Section 510(k).” Id. at *6. That it cannot do under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). The “FDA permits Defendants to determine whether their . . . device was covered by clearance previously given.” Id. (citation and quotation marks omitted). Since that is how the FDA has chosen to regulate, it is not for a private litigant to countermand the FDA’s procedure in private litigation; the plaintiff’s remedy is to go to the FDA:
The initial decision lay in [defendant’s] hands. If that decision was wrong, the next step lies with the FDA, which may enforce the section and require a new submission.
The remaining misrepresentation claims were different. They did not require second-guessing of anything the FDA did or allegedly failed to do. Two of them did not involve FDA regulation at all – whether the device operated as claimed and whether it was an effective sterilizer against certain microorganisms. Id. The final claim demonstrates the traditional division between FDA-related claims and other claims that merely touch on FDA issues. It was a variant of the above “microorganisms” claim, with the precise allegation being that the defendant falsely claimed that the FDA had found the device effective against those agents.
Well before POM, most courts had held that Lanham Act claims requiring only a “yes or no” answer, i.e., whether or not the FDA had cleared/approved something, were not precluded by §337(a). As long as all that was necessary was determining whether a Lanham Act defendant was telling the truth about what the FDA actually cleared/approved, then a court in private litigation is not precluded. That’s what happened here: “[A]ffirmative FDA approval of the device’s effectiveness is another characteristic of the product that would attract customers. The question is not whether the FDA should have granted approval, but whether FDA made a finding of fact about the product.” Catheter Connection, 2014 WL 3536573, at *7 (emphasis added).
Finally, the court held that the “analysis of the preclusion issue applies with equal force to the state law claims” brought under Utah and California consumer protection statutes (there’s no FDCA express preemption under Lohr). That’s effectively a finding of Buckman preemption of the disguised FDCA private enforcement claim. Id.
So so far so good. We have no doubt that plaintiffs of all sorts will try to stretch POM in ways that the Supreme Court did not intend, but if other courts are as discerning as the Catheter Connection decision, our clients should be okay.