Tuesday, December 11, 2018

Pleading compliance w/test rules doesn't plausibly plead compliance for consumer plaintiffs

Anglin v. Edgewell Personal Care Co., 2018 WL 6434424, No. 4:18-CV-00639-NCC (E.D. Mo. Dec. 7, 2018)

Are there people who believe that Twiqbal improved consistency?  Because I do not understand the level of detail required. Here, the magistrate holds that pleading that one’s testing complied with FDA regulations is not sufficient to plausibly plead that one’s testing complied with FDA regulations.  I would have thought that, if it’s enough of a fact to be determined by a court and not trigger preemption, then it’s enough of a fact to be pled on its own, even if it is a potentially dispositive issue.  But I don’t see non-advertising Twiqbal cases, so I might be overly critical.

The plaintiffs sought to represent a class of Banana Boat “SPF 50” or “SPF 50+” product purchasers. They alleged that “rigorous scientific testing has revealed that the Products do not provide an SPF of 50, much less ‘50+’.” Consumer Reports magazine reported in May 2016 that “its own testing had revealed that Banana Boat Kids SPF 50 sunscreen lotion had an SPF of only 8.” Further, plaintiffs alleged that their own independent testing using FDA methods demonstrated the Products had SPFs lower than listed on the label. They brought various state law false avertising claims.

The court rejected defendants’ primary jurisdiction argument. The FDA published a “sunscreen Final Rule” allegedly “mandating a whole host of highly specialized, highly scientific, and precise technical and scientific protocols that manufacturers must follow relating to testing and labeling.”  Agency expertise is “the most common reason for applying the doctrine,” which is also used “to promote uniformity and consistency with the particular field of regulation.” Other cases have rejected applying the doctrine to sunscreen labeling, given that plaintiffs allegedly relied on long-established SPF testing procedures and standards, rendering their labels false and misleading, which is a routine factual question for courts. Defendants argued that the court would have to determine whether the parties’ tests followed the technical and scientific requirements of the sunscreen Final Rule. But “this Court is equipped to address such technical and scientific questions, as this and other courts routinely do on a regular basis.” Even if the FDA was in the “best” position to interpret the Final Rule, the court could do so too.  In terms of uniformity and consistency, it was merely speculative that the FDA would be taking further action, much less formal action, or that any such action would be retroactive. Though the FDA had solicited bids for testing sunscreens over two years ago, there was no indication that further action was forthcoming.

However, the preemption argument did better in that it helped kick out the case, although not definitively. The court found that the FDA testing requirements meant that no non-FDA compliant testing could be used to establish the true SPF of a sunscreen, making the Consumer Reports testing irrelevant. If and only if plaintiffs’ testing was FDA-compliant, then their claims were not preempted.  The relevant allegations:

…. Plaintiffs conducted their own independent testing of the Products, utilizing the methodology for SPF testing mandated by the FDA.
Specifically, the independent testing conducted by Plaintiffs was conducted in compliance with all FDA testing methods embodied in FDA Final Rule, 21 CFR Parts 201 and 310, (Federal Register/Vol 76, No 117/Friday, June 17, 2011/Rules and Regulations, including 21 CFR 201.327).
The results of the independent testing conducted by Plaintiffs were consistent with the results suggested by Consumer Reports’ test results and confirmed that the Products had actual SPFs substantially lower than the claimed SPF 50 or “50+”.
Plaintiffs’ investigation concluded that all three products, clearly labeled as containing SPF 50 or “50+”, contained an SPF of less than 37.8 and no more than a 30.1.

This wasn’t sufficient (though plaintiffs said they were prepared to file an amended pleading). The complaint was 34 pages long and only 4 paragraphs were devoted to this crucial issue (this comparison strikes me as a bad measurement tool). Only one paragraph mentioned the specific methodology. There was a need for more than a “conclusory statement that the testing complied with the FDA Final Rule, an ultimate question this Court may be called upon to decide in the future.” And it was unclear whether plaintiffs had FDA-compliant test results relating to all three challenged products. Thus, the court found it prudent to allow an amended complaint.

The court also commented that plaintiffs would likely have difficulty satisfying the predominance requirements on their nationwide claims, but declined to dismiss the class certification parts of the case at this time.

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