Wednesday, September 15, 2021

two "kills 99.9% of germs" cases, divergent results

Mier v. CVS Pharmacy, Inc., 2021 WL 1559367, No. SA CV 20-01979-DOC-ADS (C.D. Cal. Mar. 22, 2021)

Another pandemic case, this one alleging that CVS’s Advanced Formula Hand Sanitizer misleads consumers by representing that it kills 99.99% of germs. The front label read “Kills 99.99% of Germs*.” The asterisk referred to language on the back label: “*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.” Mier alleged that many types of germs are not killed by alcohol-based hand sanitizers and that no scientific evidence supports the claim that alcohol-based hand sanitizers kill 99.99% of all germs.

He properly alleged an injury in fact, and plausibly alleged misleadingness. This was not a lack of substantiation claim: Mier alleged the existence of scientific studies that show that hand sanitizer doesn’t kill 99.99% of all germs, that certain types of bacteria are becoming alcohol-resistant, and that alcohol-based hand sanitizers do not kill many non-enveloped viruses, bacterial spores, and protozoan cysts.

But would a reasonable consumer, reading the labels as a whole, interpret them to mean that the product “kill[s] every conceivable disease-causing microorganism”? The back label couldn’t, for purposes of a motion to dismiss, take away the alleged falsity of the front. “If anything, as the Plaintiff suggests, the mention of the Product’s speed and efficiency on the back label may be read as an additional claim, having the effect of reassuring a consumer of the Product’s efficacy.” Anyway, reasonable consumers aren’t required to look for corrections to the front in small print on the back.

There was also no preemption by the FDCA, despite a lot of regulation of antimicrobial products. Nothing about the case required interpretation of federal law or regulation.

Under Sonner, Mier could seek equitable relief under FAL and UCL to the extent that his claims are premised on alleged future harm.

Souter v. Edgewell Personal Care Company, --- F.Supp.3d ----, 2021 WL 3892670, No. 20-CV-1486 TWR (BLM) (S.D. Cal. Jun. 7, 2021)

Plaintiff alleged that advertising for Wet Ones misrepresented that the hand wipes kill 99.99 percent of germs and that the hand wipes are “hypoallergenic” and gentle.” The court dismissed the claims.

For the efficacy representations, plaintiff alleged that the active ingredient in these hand wipes, benzalkonium chloride, is ineffective against certain viruses, bacteria, and spores, which comprise more than 0.01 percent of germs and can cause serious diseases. “Some of those diseases include polio, norovirus, human papillomavirus, picornavirus, crypotosporidium, and C. difficile,” as well as COVID-19. For the skin safety representations, plaintiff alleged that the hand wipes contained ingredients that are “known allergens or skin irritants.”

The court first got rid of defendants’ dumb argument against standing: that Souter never got sick or suffered skin damage due to the hand wipes, which of course is not required for constitutional or statutory standing under the usual California statutes. Likewise, Rule 9(b) was satisfied.

However, the allegations didn’t plausibly plead that a reasonable consumer would be misled.

Efficacy:

No reasonable consumer would believe that a hand wipe advertised to kill 99.99 percent of germs would be effective against the bacteria and viruses that Plaintiff names. For example, Plaintiff does not explain how or why a reasonable consumer would take a hand wipe’s representation that it kills 99.99 percent of germs to mean that it would also be effective against HPV, a sexually transmitted disease, or the norovirus and polyomavirus, which are food-borne illnesses. It also seems implausible that a reasonable consumer would believe that a hand wipe would be effective against polio, a virus that has not had an active case in the United States since 1979. … If anything, a reasonable consumer would likely suspect that a hand wipe would be effective against bacteria often found on hands, and Plaintiff has not alleged how likely these strains of bacteria appear on hands.

Skin safety:

No reasonable consumer would read “hypoallergenic” and “gentle” to mean that it is completely free of ingredients that can cause an allergic reaction. … And what is more, a reasonable consumer may not even think those words suggest anything about the hand wipes’ ingredients as opposed to the hand wipes’ performance. In other words, a reasonable consumer may take “hypoallergenic” and “gentle” to mean something about the effect of the hand wipes when applied on the skin—i.e., that it would not cause skin irritation and be smooth and gentle—regardless of its ingredients, such as whether they contain skin irritants. Either way, “hypoallergenic” and “gentle” do not suggest anything about how the hand wipes may affect the central nervous system, lungs, eyes, kidneys, or the liver, as Plaintiff argues here.

However, there was no preemption, and the doctrine of primary jurisdiction didn’t warrant avoiding a decision. As to the latter, misleadingness is “not a technical area in which the FDA [has] greater technical expertise than the courts.” As to preemption, the plaintiff wasn’t asking the court to impose additional labeling requirements, but challenging the present label as misleading.

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