Here at the DDL Blog, we write from time to time on food litigation. You might think it’s out of left field, and sometimes we even justify our food posts by pointing out that the “F” in FDCA stands for “Food.” But we need not be so clever. The real reasons why we write on food cases can be summed up in two phrases: federal preemption and class actions. You might throw in preemption’s weaker sibling, primary jurisdiction, but that rarely applies in drug and device cases, so we won’t. (Although we do sometimes write on primary jurisdiction, such as here) You might also say that class actions have gone the way of the horse and buggy in the drug and device space, and you would be doing so with substantial justification. But we write on class actions anyway, both because they are interesting and because even the black swan event of class certification would have devastating consequences for our clients.
A recent food case called Mee v. IA Nutrition, Inc., No. C-14-5006, 2015 U.S. Dist. LEXIS 63038 (N.D. Cal. May 13, 2015), combines our two marquee issues—it is a class action and the plaintiffs pleaded claims that ran squarely into preemption by alleging that the defendants should have followed testing standards different from what appear in FDA regulations. This is a lesson that could translate to drugs and devices, and here is how it sets up: The plaintiffs sued a seller of dietary supplements claiming that the defendant labeled and sold five products in a misleading and deceptive manner under California and Florida law. Id. at **2-6. According to the plaintiffs, the product labels misrepresented the amount of protein and amino acids in the various products, and the labels also allegedly omitted certain amino acids that were in the products and listed others than allegedly were not. Id.
How did the plaintiffs know these facts? They allegedly discovered them through “scientific testing.” Note that the quotation marks are not ours. They were provided by the district court, which used quotations marks every time it mentioned the plaintiffs’ “scientific testing.” According to the style manual that we used in law school, quotation marks can denote a direct quote. Or they can denote that the phrase is being used as a euphemism, sometimes to communicate sarcasm. We do not attribute sarcasm to this learned court, but we suspected things would not go well for the plaintiffs when we saw that the court felt compelled to demarcate their “scientific testing” as something other than “scientific” throughout its order.
Our suspicions were correct. Under the FDCA, states are prohibited from imposing “‘any requirement for the labeling of food that is not identical to’ the federal requirements.” Id. at *6 (quoting 21 U.S.C. § 343-1(a)(5)). This is a particularly strong express preemption provision, as strong or stronger than the “different from or in addition to” standard that we most often deal with in cases involving pre-market approved medical devices. Under the “not identical to” food labeling standard, federal law preempts a state requirement where
the State requirement directly or indirectly imposes obligations or contains provision concerning the composition or labeling of food [that] . . . [a]re not imposed by or contained in the applicable [federal regulation] . . . or [d]iffer from those specifically imposed by or contained in the applicable [federal regulation].
Id. at **6-7 (quoting Lilly v. ConAgra Foods, Inc., 743 F.3d 662 (9th Cir. 2014). That leaves plaintiffs very little room to maneuver.
It also turns out that in connection with food ingredients—and particularly when it comes to protein and nutrients—the FDA’s regulations set forth the methodology for calculating those numbers we see on food labels. That was critical because the plaintiffs’ “scientific testing” did not follow the FDA-specified methods. For claims that the defendant misrepresented protein content, the plaintiffs alleged that the FDA’s method was flat out wrong because it does not result in a “direct measure of the actual protein content.” Id. at *8. If there are gradations of preemption, it is difficult to imagine a claim that is more preempted than a claim that the FDA’s method is wrong and that a defendant should be held liable under state law for complying with it. It does not take a rocket “scientist” to figure that out. As the district court ruled, the claim was “preempted, as it seeks to base liability on defendant’s failure to employ a testing procedure not imposed by or contained in any federal regulation, and, indeed, is a challenge to the very method allowed by the FDA.” Id.
For other claims, the plaintiffs were less direct, but still unsuccessful. They did not specifically allege either way whether their proposed testing method for amino acids complied with FDA regulations, which alone may have been enough to dismiss their claims as preempted. The clincher was that the plaintiffs actually attached their “scientific testing” results to their complaint, and “nothing in the reports suggests that the [testing] method required by [FDA regulations] was employed.” Id. at *12. As a result, those claims were preempted, too. As the district court noted,
[W]here, as here, an FDA regulation provides that the question of compliance must be determined using a method specified therein, a state law claim that seeks to establish a violation of such regulation by a different methodology is preempted.
Id. at *10. This quote is the takeaway point of this case and this blogpost. We have not surveyed FDA regulations, but we expect they sometimes call for certain methods in the development of drugs, medical devices, and their labeling. If a plaintiff alleges that the method is flawed and that a manufacturer should have followed another, that’s preempted. If a plaintiff alleges that a manufacturer’s labeling is misleading on the basis that a different method would produce different information, that’s preempted. In this regard, “science” does not always add up to genuine science.
The district court dismissed the plaintiffs’ complaint, but it granted them leave to amend. Having boxed themselves into claims based on non-compliant “scientific testing,” we are not sure what the plaintiffs can do to resurrect their claims. We are also not sure how these plaintiffs could ever get a class certified, given that most people do not read nutritional labels and even fewer rely on the exact measurements of protein and amino acids. Even in the community of dietary supplement purchasers, it seems that you would have to determine elements of the claim by interviewing each putative class member, which would defeat any semblance of commonality. But who knows, maybe the plaintiffs will offer “scientific testing” on that point, too.