Two class actions have been brought against GOJO, the maker of Purell hand sanitizer, in the U.S. District Court for the Northern District of Ohio. https://www.nbcnews.com/health/health-news/maker-purell-accused-misleading-customers-class-action-lawsuit-n1165461. The first was filed in February, the second on March 13th. The second complaint specifically points to Purell’s claim that it can kill “99.9 percent of illness-causing germs,” alleging that this is misleading because it implies “sound scientific support when none exists.”
Both lawsuits reference a warning letter that the FDA sent to GOJO on January 17, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020. It’s quite a long letter, listing multiple claims on Purell’s website that the FDA says are not supported by scientific evidence, and I’m not going to quote it extensively. Two points, however, are particularly worth noting. First, “FDA is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus.” Second, in a rule entitled “Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” the FDA announced that it has deferred rulemaking on a number of topical antiseptics, including ethyl alcohol (the active ingredient in Purell). Consequently, the FDA will not object to the marketing of such products, “provided they meet the proposed formulation and labeling conditions described in the relevant tentative final monograph (TFM)” – but Purell products, says the FDA in its letter to GOJO, do not meet the requirements of the relevant TFM.
In a statement released after the first lawsuit was filed in February, “GOJO spokesperson Samantha Williams [says the company] ‘took immediate action’ following the January 17 letter and immediately began updating its digital marketing and website to comply with the FDA’s letter.” https://www.ehstoday.com/industrial-hygiene/article/21126483/fda-warns-purell-following-misleading-effectiveness-claims. Presumably, the extent to which GOJO has actually complied with the FDA’s warning letter, and the nature of the harm (if any) caused by Purell’s misleading marketing, will come out in discovery – assuming the lawsuits survive the motions to dismiss, motions to deny class action certification, etc. that the defendant will undoubtedly file. Meanwhile, this litigation serves as a timely reminder that the CDC has told us all along that thorough, frequent handwashing with soap and water is the best defense, and that hand sanitizer should only be used when soap and water are not available.
Finally, we at Vident Partners would like to take this opportunity to salute our medical experts, and indeed all healthcare providers and staff throughout the nation, who are on the front lines of the battle to contain COVID-19, risking their own health every day to help protect the health of the community. Our prayers and our profound gratitude go out to them.
