Parallel Claims – The Government's Position Revealed İn Allergan v Athena

A Clarion call for an industry poised to win the battle but lose the war?

We said it before and it bears repeating: there is something inherently troubling when a prescription drug manufacturer wants a jury to decide a product claim under state law that should be decided by the Food and Drug Administration (FDA) under federal law. Not enough has been written about this case but, with the Supreme Court poised to decide what is almost certain to be a landmark case, all eyes should be on Allergan et al. v Athena, No. 2013-1286, 2013 U.S. App. LEXIS 25746 (Fed. Cir. Dec. 30, 2013) (here).

Why is this case so bad for the industry?

Manufacturers of FDA regulated products have generally enjoyed a decade of favorable rulings on the issue of federal preemption and the primacy of jurisdiction of the FDA, but the political climate and emerging new approaches by the Courts threaten to reshape the litigation landscape. The FDA itself has flip-flopped from its prior view favoring preemption to its position that now assists private litigants in pursuing private tort and Lanham Act "labeling" claims under the Food Drug and Cosmetic Act (FDCA). However, unlike many parallel claim cases where an individual litigates against a manufacturer—and human outcomes and injuries tend to factor into the court's search for a remedy—here, a manufacturer has sued a manufacturer. For a detailed discussion of the underlying case please see our prior post ( here).

The issue in Allergan is whether the FDA has exclusive authority to determine a product's regulatory classification. Determining a product's regulatory status is a difficult and complex matter. Even those well versed in the complexities of FDA practice often wrangle with the FDA over whether a product is a food, supplement, cosmetic, device, drug or combination product. There is no clearer example of the complexity of the process than in the June 8, 2015 letter that FDA served and filed in Amarin v FDA wherein FDA details the complexity of the analysis FDA employs when considering whether a claim rises to the level of requiring new drug approval and that the analysis differs whether the product is a drug or a product not requiring FDA approval, such as a dietary supplement or cosmetic. See Amarin v FDA 1:15-cv-03588, Doc. # 24 (SDNY). Leaving the classification decision to the ipse dixit of state court juries is an invitation for litigation chaos.

First things first: Does Allergan v. Athena involve a "Parallel...