By JP Ellison –
We previously posted (here and here) about the Supreme Court case that will be argued next month in which the parties are debating the proper interplay between the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Lanham Act. Briefly, the issue in the case is whether POM’s Lanham Act false and misleading advertising claims against Coke’s Minute Maid product are barred because those claims are based on the labeling of a product regulated by the U.S. Food and Drug Administration (“FDA”) under the FDC Act.
Last week, amicus briefs were filed by the Solicitor General, the Generic Pharmaceutical Association (“GPhA”), several state attorneys general, and the International Trademark Association. The SG’s brief and the GPhA brief were filed in support of neither party. The state attorneys’ general and ITA briefs were filed in support of POM.
Although filed in support of neither party, the SG’s brief was supportive of POM in that it reiterated the view expressed in the brief the SG filed when the Court was deciding whether to take the case that the Lanham Act claim should have been allowed “insofar as it concerns features of the juice’s label that are not specifically addressed by the FDCA or FDA’s regulations.” In the merit brief, the SG argued that the “Lanham Act claim is barred only to the extent the FDCA or FDA regulations specifically require or authorize the challenged aspects of the . . . label.” in further explaining the government’s position, and rejecting the argument that something akin to conflict preemption was required, the SG argued that “impossibility is not the proper standard for finding preclusion here.” Rather, according to the SG, a Lanham Act claim should be barred when “it would directly contravene FDA’s judgment by declaring misleading what the expert agency expressly found nonmisleading.” At the same time, the SG reiterated its view that the 9th Circuit, which had decided the POM case, employed “faulty reasoning” in concluding something akin to “‘so-called field preemption’ cases.” The SG argued that “Congress did not intend the FDCA or its implementing regulations to occupy the field of juice labeling to the exclusion of other federal laws.”
The GPhA amicus brief, although also filed in support of neither party, read as though more aligned with Coca-Cola/Minute Maid’s position. Perhaps more importantly to its members, the GPhA brief stressed that regardless of what the Supreme Court decided with respect to food products, pharmaceuticals and other products such as devices, were regulated and approved differently than foods. Accordingly, GPhA urged the Court, in announcing any rule, to “be cognizant of the differences” among FDA regulated products. The state attorneys general and ITA briefs argued for a more expansive interpretation of the permissible scope of the Lanham Act than either the SG or GPhA.
Typically, other than the SG’s office, amici do not request and are not given oral argument time before the Court, so this is likely the last word for most of those submitting amicus briefs. To date there is no indication whether the SG’s office will participate in the oral argument. If the SG’s office does participate, I’m hoping that one of the Justices asks how the position put forward by the SG would operate in an instance in which the FDA had “specifically authorized” conduct via a guidance document, enforcement discretion, Orange Book listing, or some other action, but not in regulations.
Regardless of the Court’s decision later this year, Lanham Act litigation involving FDA regulated products is unlikely to subside. We’ll be monitoring the oral argument and decision in this case and other Lanham Act cases of interest.