A recent opinion crossed our desk: Independence County v. Pfizer, Inc., ___ F. Supp.2d ___, 2008 WL 398980 (E.D. Ark. Feb. 11, 2008). The opinion has generated a bit of interest because of the unusual nature of the claim – which is, we suppose, to be expected where, as here, a local government has enlisted a private plaintiff’s lawyer to sue defendants for alleged product-related conduct. We’ve decried these latter day letters of marque and reprisal issued to latter day privateers before.

The Independence County claims involved FDA-approved drugs (OTC cold remedies) marketed for FDA-approved uses. Apparently, though, the active ingredients in these products are used by criminals to make methamphetamine (“speed”). In what has to be one of the most blatant examples of state law being used to attack marketing that the FDA considers legal, the lawyer loaned use of the county’s name charged that, because of the likelihood of third-party criminal product misuse, FDA approved OTC marketing violates the state’s (Arkansas) consumer protection statutes and also constitutes a public nuisance.

And you wonder why federal preemption is such a hot topic?

The consumer fraud claim was dismissed on the quite logical ground that, because the product was sold in accordance with FDA approval, and was only misused after sale by criminals, there was no unconscionable “trade practice” by the defendant:

The [FDA] approved pseudoephedrine as an active ingredient in cold and cough remedies for over the counter human use. The FDA regulates the labeling of nasal decongestants, including dosage warnings. The [DEA] regulates manufacturers and distributors of products containing pseudoephedrine. Plaintiffs did not allege that Defendants’ actions violated any federal regulation in connection with the labeling or distribution of their products, or that Defendants’ actions violated Arkansas laws regulating who can possess and sell [these] products…. Plaintiffs’ allegation … is that it is unconscionable to produce and distribute medicine containing ephedrine and pseudoephedrine-that but-for Defendants’ products, methamphetamine production and use would be sharply reduced. Nothing in the record shows that Defendants’ trade practices are unconscionable, and the application of the ADTPA is limited to trade practice.

2008 WL 398980, at *2. The consumer fraud claim was also dismissed – as these pseudo-suits farmed out by local governments to private attorneys often are – on the ground that the purported injuries are too “remote” by virtue of intervening third-party criminality. Id. at *3.

But what caught our eye even more was the inclusion of a public nuisance allegation. Id. at *4. That claim got short shrift in the opinion because, under Arkansas law, public nuisance is limited to conduct involving ownership of land.

Independence County is the first reported case that we know of alleging that lawful distribution of an FDA-approved product is a “public nuisance.” We’ve already encountered this type of claim in other products cases (we’ve also represented alcohol, tobacco, and firearms manufacturers), so we already have a post describing several defenses to product-related public nuisance that we’ve found useful. But in the prescription drug area our primary reaction to the notion of public nuisance is very simple.

Public nuisance claims involving FDA-approved products are preempted – period.

There’s an inherent and unavoidable conflict between the FDA imposing the conditions under which the products it approves may be marketed and a state saying that, when marketed in accordance with those conditions, the product constitutes a nuisance to the public. The conflict is total and absolute – “impossibility” preemption of the most fundamental sort. Shades of McDermott v. Wisconsin, 228 U.S. 115, 137 (1913), where a state purported to “forbid” the use of FDA-approved labeling.

Fraud on the FDA is preempted, most fundamentally, because there is an inherent conflict between an in-force FDA decision, and any state law cause of action that tells a jury, in effect, that it can ignore that FDA decision because it was improperly obtained. A unanimous court found preemption in Buckman, and at the Kent oral argument, that essential consensus did not appear much changed. The debate in Kent was primarily over how much further – towards the concept of FDA compliance as a general defense – the Buckman principle could, or should, be extended.

Well, public nuisance presents a worse conflict than even claims of administrative fraud. Public nuisance doesn’t even come with the fig leaf of claimed improprieties in the FDA decision process. Public nuisance alleges that, taking the FDA’s marketing approval on its face, the conduct that the agency has authorized is a “nuisance” under state law and can be enjoined. It’s hard to get a more direct conflict than that.

The more preemption decisions we can get in the prescription medical product context, the happier we are. Such decisions help “settle” the law. If plaintiffs (whether “governmental” or private) wish to bring the misbegotten public nuisance concept into the FDA’s bailiwick, we’ll be ready.