Wednesday, November 28, 2012

Primary Jurisdiction: A Natural Alternative to Preemption


 

There was much gnashing of teeth among members of the defense bar in the wake of Wyeth v. Levine's curtailment of FDA preemption.  It felt like a missed opportunity.   But some of our more persistent and creative colleagues insisted that a lot of the facts and factors we typically seized upon to argue for preemption - extensive FDA regulation, the need for expertise and uniformity -- might still be helpful in setting up other defenses.  What other defenses, you ask?  Primary jurisdiction is the first one that comes to mind. 

 

Last week supplied a short and adorable example in Astiana v. The Hain Celestial Group, Inc., 2012 U.S. Dist. LEXIS 165368 (N.D. Cal. Nov. 19, 2012).  The plaintiffs contended that the defendants' use of the word "natural" on their cosmetic products was false and misleading.  The plaintiffs asserted causes of action under California law for common law fraud, unlawful, unfair, and fraudulent business practices in violation of California's Unfair Competition Law, false advertising, and violation of California's Consumer Legal Remedies Act.  That's a familiar face, isn't it? 

 

Of course, we normally talk about the "D" in FDA - drugs.  Sometimes, when we hunger for adventure, we chew on a case involving the "F" - food.  There is no C-word in FDA, but there is in the FDCA, the Food, Drug, and Cosmetic Act.   We do not often discuss cosmetics cases, but since the theme of today's post is putting lipstick on the Wyeth v. Levine pig, maybe it is appropriate that the Astiana case concerns cosmetics. 

 

No matter the subject matter, we have all seen Astiana-type assertions before.  Look here, for example.   Come to think of it, we had the feeling that we have seen similar allegations before with a plaintiff named Astiana.  It is not as if it is a common name.  After a little Googling, we confirmed our suspicion.  It turns out that Astiana has gone around suing various companies in California courts for adorning their product labels with the word "natural."  Naturally, we wondered how the same person can be constantly fooled in exactly the same way. It is like that old gag where it is reported that every day a man gets run over by a bus.  A wag then exclaims how awful it must be to be that unfortunate man.  Well, here it apparently really is the same person. In one case, Astiana complained about the use of the word "natural" on an ice cream container.  In its defense, the manufacturer pointed out, perhaps reluctantly, that ice cream does not exist at all in nature.  

 

The FDCA governs the labeling of cosmetics, but does not say much beyond a general prohibition on labels that are "false and misleading in any particular."  21 U.S.C. section 362.  The FDA has issued no policy, informal or otherwise, regarding use of the term "natural" in cosmetics.  Not surprisingly, the plaintiffs argued that the court did not need to await any guidance from the FDA, because courts routinely decide what is misleading.

 

But in the wonderful Pom Wonderful case (which we blogged about several times, including here), the occasionally wonderful Ninth Circuit held that courts should not decide such issues when such a decision would "undermin[e], through private litigation, the FDA's considered judgments. " Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170, 1178 (9th Cir. 2012).  Last week, we griped about a not-so-wonderful lower court decision that failed to apply Pom Wonderful with appropriate vigor.  But Astiana is a much better decision.  It is, not to put too fine a point on it, simply wonderful.  All it has to do is flutter its fattened eyelashes at us and we swoon.  It had us at Hello.  Actually, it had us at the all caps “DISMISSES” near the end.  Astiana is like a makeup call for last week’s Pom Wonderful not-quite-progeny. 

 

The Astiana court read Pom Wonderful to stand for the proposition that courts should not butt in where Congress had entrusted the task of guarding against deception to the FDA.  According to the Astiana court, Pom Wonderful was not about preemption.  Rather, it was about primary jurisdiction.   The doctrine of primary jurisdiction applies when there is (1) a need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.   Astiana, 2012 U.S. Dist. LEXIS 165368 at *6. 

 

The Astiana court concluded that all of those factors applied to the issue of whether a cosmetics label was false or misleading.  It did not matter that the FDA has so far been silent as to what the word "natural" means in the context of cosmetics.  Every once in a while the FDA drops hints as to what it takes to call a food "natural," but the FDA has never done so for cosmetics. Moreover, cosmetics are regulated separately from food, and cosmetics, unlike foods, "are by their nature artificial and/or synthetic." Id. at *8.   Why is the FDA so coy about the meaning of the word “natural”?   Is it playing hard to get?  Is it just busy washing its hair?  Whatever the reason for the FDA's reticence on what a "natural" cosmetic is, the court declined to fill in the vacuum.   The court believed that imposing its judgment on whether "natural" was misleading would undercut the FDA's judgments and authority.   Id. at *9, citing Pom Wonderful.  And then the court gives us that same feeling that Chris Matthews says candidate Obama gave him in 2008 when it “DISMISSES the complaint.”   Id.  But the dismissal is without prejudice.  Darn it.  Sometimes we have to wonder whether  the Astiana case loves us as much as we love it.     

 

What animated Pom Wonderful and Astiana was deference to the FDA.   Naturally, we wonder why such deference is not equally warranted with respect to drugs and medical devices. Surely, drugs and devices require as much expertise and uniformity as fruit juice, ice cream or eyeliner. 

 

No comments: