Stop us if you have heard this before. A group of plaintiffs bring a purported class action under a range of California consumer protection laws seeking damages related to the purchase of a medical product (or collection of somewhat related medical products) that they claimed failed to comply with FDA requirements. The defendants raise preemption and/or primary jurisdiction in a motion to dismiss. We blog about the resulting decision. While the problem may be with the last step, our blogging, it does seem like these economic injury classes have to get by a number of legal hurdles that should trip them up. We suspect—gasp—that the lawyers who bring these cases look for things to sue over first and then find their putative class representatives later, suggesting a business model for imposing costs on the manufacturers of medical products.
This applies to supplements too. While we do think there is something fundamentally different about prescription medical products from the brightly-packaged products on the counter at convenience stores or sold over the television or internet with vague claims of what the products actually do, the class actions brought against the manufacturers of the latter group of products often seem contrived. We do not offer this from the vantage point of having defended those cases or as prelude to offering a detailed recap of the treatment of dietary supplements under the FDCA. Rather, we surmise that many purchasers of such products buy them—the ones who buy them to use them, not buy them to serve as class reps—because they have not been evaluated by FDA, because they can take them without prescriptions or required monitoring, because they are curious about trying something, and/or because shiny packaging catches their eye at the check-out counter. We doubt these purchaser care much about whether sound scientific evidence and regulatory evaluation were required before the supplement entered the stream of commerce. We could be wrong. There is a rumor than we have been before.
Rosas v. Hi-Tech Pharms., No CV 20-00433-DOC-DFM, 202 U.S. Dist. LEXIS 164565 (C.D. Cal. July 29, 2020), involves a proposed class under an alphabet soup of California consumer statutes and common law misrepresentation for four supplements made by defendant that contain combinations of three chemicals—two old decongestants/stimulants denoted as DMAA and DMHA and an amphetamine called methylsynephrine. The supplements have names suggesting they might help someone work out and/or lose weight. The gravamen of the complaint was that it was not legal to sell supplements in the U.S. containing any of these chemicals, particularly after FDA issued a warning letter to the defendant in April 2019 about its use of DMHA and to other manufacturers over the last eight years or so about the use of DMAA and methylsynephrine. (It takes a few seconds to find various statements from FDA about these chemicals and their use in supplements.) Defendant moved to dismiss on primary jurisdiction, preemption, standing, pleadings, and judicial abstention, but the court only reached the first one.
Swap in CBD for these stimulants and adjust the regulatory facts a bit, but keep the basic claims, defenses, applicable law, and the court the say, and you might experience a little déjà vu for a post from over the summer on the Colette case. In that post, we harkened back to prior posts on the origin of the primary jurisdiction doctrine and whether FDA warning letters count as final agency actions. In Colette, the non-final nature of what FDA had done to that point on CBD-containing supplements was what made the primary jurisdiction doctrine require putting the case on ice. A mere two months later, the Rosas court did not cite Colette in deciding very similar primary jurisdiction issues.
In some ways, Rosas was an even easier application. The defendant had sued FDA over its actions with regard to DMHA and, a month before Rosas was decided, the D.D.C. had dismissed the case because there was not yet a final agency action to review, presumably under the Administrative Procedure Act. Given the way primary jurisdiction works, that dismissal provided a little foreshadowing for the result in Rosas. The Ninth Circuit spelled out the factors for primary jurisdiction as follows:
(1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory scheme that (4) requires expertise or uniformity in administration.
Id. at *6 (citation omitted). The middle two factors were conceded, but the plaintiffs offered creative opposition to the other two.
Although FDA makes clear that its warning letters are not final as far as it is concerned—which the court noted—plaintiffs argued that an outlier Ninth Circuit case rejecting primary jurisdiction had concluded that FDA warning letters could be final actions. Id. at **8-10. The court noted that the warning letters in that case had built on an interim rule, but no such rule existed as to the supplements at issue here. Accordingly, the court followed the general rule and concluded that no final agency action had occurred, despite the issuance of warning letters. Id. at **10-11. (If you want more musings on warning letters in cases like this, then try here.)
The last factor—that the regulatory scheme requires expertise or uniformity in administration—might have seemed like a walkover, but the plaintiffs claimed the Dietary Supplement Health and Education Act (“DHSEA”) was not so complicated that the court could not decide the issues plaintiffs would need to win. Plaintiffs relied on an Eleventh Circuit seizure case, which decided on the application of the DHSEA to supplements containing DMAA. Id. at *12. The Rosas court declined, finding the issues presented in the case under the DHSEA were “‘technical and scientific questions’ best left to the FDA.” Id. at *13 (citation omitted). The court also noted the risk of differing interpretations that would undermine the regulatory scheme, something we know many courts do not think twice about. Id.
With that, primary jurisdiction required that the complaint be dismissed. The dismissal, of course, was without prejudice until there is a final agency action. Once that happens, if the state law claims are based solely on FDA violations, then they may run into the preemption issue the court punted on here.