While the focus of this blog is on product liability cases, we have had occasion to touch upon Lanham Act cases involving litigation between commercial competitors. One reason is because Lanham Act cases provided significant early precedent for the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation
Bexis vividly remembers how he first learned of 21 U.S.C. §337(a). It was early 1995, and he had just joined the Danek Medical legal team in the early going of the Orthopedic Bone Screw MDL. The plaintiffs’ complaints went on and on about “negligence per se” and purported violations of the FDCA. Bexis figured that
Private plaintiffs love to scream “fraud on the FDA”! Agency fraud is their magic potion for dissolving any FDA action that they don’t like. Just assert that the FDA was bamboozled and invite some jury somewhere to ignore what the FDA actually did. Unfortunately for the other side, Buckman Co. v. Plaintiffs Legal Committee,
Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and reputed Breitbart financier), a number of other investors, and just for good measure President and Hillary Clinton.
Larry Klaman
The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race right past the intellectual property section of Lexology, as those cases are seldom relevant to our practice.
Except sometimes they
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.
Today the United States Supreme Court ruled in POM Wonderful v. Coca-Cola Co., No. 12-761, slip op. (U.S. June 12, 2014), that at least in food cases – where “the FDA does not preapprove [product] labels,” id. at 5 – the FDA’s food regulations do not preclude competitor lawsuits under another federal statute, the Lanham Act. The opinion (by Justice Kennedy) was unanimous.
We’re mostly interested in prescription medical products, and in preemption of state product liability litigation, so what does POM mean for our clients? Not a whole lot, at least directly. The Court made sure, right off the bat, to explain what POM was not. Here’s the second paragraph of the legal analysis portion (Part II) of POM:
First, this is not a pre-emption case. In pre-emption cases, the question is whether state law is pre-empted by a federal statute, or in some instances, a federal agency action. This case, however, concerns the alleged preclusion of a cause of action under one federal statute by the provisions of another federal statute. So the state-federal balance does not frame the inquiry. Because this is a preclusion case, any “presumption against pre-emption,” has no force.
POM, slip op. at 7 (citations omitted). So anybody worried that the Court would damage the preemption arguments of either side can rest easy. Nor is the status of the presumption against preemption changed.
Half our readership now clicks away.
Continue Reading Breaking News: No FDCA Preclusion of Lanham Act Food Cases
