Back in 2020, we noted the possible broad implications of a Buckman preemption decision in a somewhat unusual economic loss case that turned on whether a compounded pharmaceutical needed FDA approval through an NDA.  When that case, Nexus Pharms., Inc. v. Cent. Admixture Pharm. Servs., Inc., 48 F.4th 1040 (9th Cir. 2022), was affirmed in the Ninth Circuit, we bestowed on the decision to distinct honor of being our third best decision of 2022.  Part of our thinking was that California had a number of statutes that facilitated economic loss lawsuits over food labeling and, thus, had a bunch of such cases in its state and federal courts.  We have posted on a number of these cases over the years and, if we can summarize them, they are often over pretty piddly issues and have inconsistent results when it comes to what claims are preempted.  The reliance in Nexus on the provision in 21 U.S.C. § 337(a) that essentially bars private enforcement of purported violations of the FDCA promised to impliedly preempt a number of claims under California law that turn on FDA regulatory status.  

It has.  Not long ago, we posted on a California federal court decision relying on Nexus to preempt all claims in a case about additives in a cosmetic product, even where the complaint had been amended to pretend the FDCA did not exist.  The decision in Bubak v. GOLO, LLC, No. 1:21-cv-00492-DAD-AC, 2024 WL 86315 (E.D. Cal. Jan. 8, 2024), relates to another second chance.  The decision on defendant’s original motion to dismiss based on Buckman left some purportedly parallel claims standing.  Then Nexus came out and the defendant moved to reconsider.  The motion to reconsider was pending for more than a year, but that delay allowed the Bubak court to survey the federal court decisions following Nexus.  Although only three are cited by name—including the cosmetic case mentioned above—there were apparently five, one of which was from the Ninth Circuit itself.  None of the three cited decisions looks like it came from a food labeling case.  That is enough to show us that Nexus is having some ripples on California state law claims that used to escape the reach of preemption.

The facts of Bubak included in the decision are sparse, so we used the magic of the internet to find out a little more.  The plaintiff claimed that defendant’s supplement was really a drug that needed an NDA approval before it could be marketed and then would have to be labeled like a drug.  The supplement at issue, with the somewhat oblique name Release Supplement, has as its “active” ingredients zinc, magnesium, chromium, a sugar alcohol, and extracts from six plants (e.g., apples).  Elements, simple naturally occurring compounds, and plant extracts tend not to be treated as drugs.  The combination of them in this supplement was marketed as helping with a range of things like losing weight, improving energy, and reducing stress.  Those sound more like supplement claims than drug claims about specific disease states.  It is also pretty fundamental that whether a substance does or does not require an NDA is a matter for FDA to decide.

As in Nexus, the California state laws under which the Bubak plaintiff sought to proceed were laws that said “in substance ‘comply with the FDCA.’”  That meant that the plaintiff was trying to enforce the FDCA, which ran afoul of § 337(a) and impliedly preempted the claims.  The court characterized its reversal of the prior decision because of an intervening change in the law as a “reluctant[]” one.  This stemmed from the fact that Nexus did not address California’s Sherman Law and pre-Nexus cases had often held claims under that law not to be preempted.  Given our known views on the over-use of the appellation “parallel claim” as a way to get around obvious and appropriate preemption, we do not share the court’s reluctance.  However, given how many cases there are based on this and similar California laws that piggyback on the FDCA, we do expect there will be another decision from the Ninth Circuit in the not-too-distant future address the issues the Bubak court wanted, maybe even in an appeal of Bubak itself.