[Drug and Device Law] Court Dismisses Nutritional Labeling Class Action on the Basis of Preemption
The preemption clause in the Nutrition Labeling and Education Act of 1990 is clear and direct. It prohibits states from imposing nutritional labeling requirements that are not “identical to” federal requirements. 21 U.S.C §343-1(a). If they’re not identical, they’re preempted.
This came squarely into play last week in Dougherty v. Source Natural, Inc., 2015 U.S. Dist. LEXIS 164117 (E.D. Mo. Dec. 8, 2015). A putative class action plaintiff claimed that a multivitamin distributed by defendant Source Natural, Inc. contained actual nutrient levels for six of its vitamins and minerals that were less than the labeled amount. Id. at *1-2. She requested a refund for her and everyone else in the class. Id. at *2. But she ran into a problem, a big one. Her expert (really, the expert hired by her lawyer) calculated the nutrient levels of the multivitamin using a testing methodology that was different from the FDA’s methodology. Uh-oh.
The FDA’s methodology is laid out in the Code of Federal Regulations. It involves, among other things, sampling from 12 different product cases:
[T]he FDA has enacted regulations pertaining to expressed nutrient content claims. Under 21 C.F.R. § 101.13, "[a] claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under §101.9 or under § 101.36 (that is, nutrient content claim) may not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation." 21 C.F.R. § 101.13(b). Whether the requirements for nutrient content claims comply with the regulations are determined by using the methodology provided in § 101.9. 21 C.F.R. § 101.13(o). Under § 101.9(g), "[t]he sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 randomly chosen shipping cases, to be representative of a lot." 21 C.F.R. § 101.9(g)(2).
Id. at *5-6. Plaintiff’s test didn’t use 12 cases, or even 12 bottles. It used one bottle. That’s a “different” test from the FDA’s. Allowing a plaintiff to hold a manufacturer liable for not meeting that “different” test would impose a requirement on the manufacturer that is different from the FDA’s requirement. And, so, Plaintiff’s claim was preempted:
Because Plaintiff has failed to allege she followed FDA testing protocols, her state law claims that rely on a different methodology to demonstrate such labeling violations are inconsistent with the FDCA and are thus preempted.
Id. at *11. That’s certainly a quick and neat preemption win.
Now, we should say that plaintiff did try to stall, claiming that Source Natural’s preemption motion was premature. She argued that it was an affirmative defense and could not be raised on a motion to dismiss. That’s news to us. In fact, if true, we’d have revisit dozens of our past posts on preemption dismissals and rewrite them. That’d be a lot of work.
Fortunately, we won’t have to do that. They’re still good—legally and procedurally. As it turns out, the Dougherty court has also seen cases granting preemption on motions to dismiss. And so it rejected plaintiff’s attempt to stall things: “[T]he Court finds that Defendant's motion to dismiss on the basis of federal preemption is properly before the Court.” Id. at *7.
The plaintiff, however, asked for an opportunity to replead, and the court gave it to her. It will be interesting to see whether she repleads using data from a test conducted according to FDA protocols and, if so, whether that can survive a motion to dismiss.
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Posted By John J. Sullivan to Drug and Device Law at 12/14/2015 04:28:00 PM --
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