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,

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.

After the first post-POM Lanham Act decision, Catheter Connections, Inc., v. Ivera Medical Corp., 2014 WL 3536573 (D. Utah July 17, 2014), all we can say is “so far so good.”  A lot of Catheter Connections concerned claims that only affected the “attractiveness” of the defendant’s product in the marketplace (the Lanham Act does not allow recovery for personal injury; it applies solely to commercial competitors), but one claim did more than that.  It challenged the FDA’s approval of the product.  That kind of private enforcement attempt concerns us, no matter what the source.


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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.


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It’s Memorial Day weekend, and it’s time for barbeques.  While many of us will choose an alcoholic drink to enjoy during the festivities, there may be non-alcoholic drinks involved too.  Maybe a nice juice drink.  That usually means grape, apple or cranberry juice, or some combination of them.  Lately some people are even choosing pomegranate