Previously Debunked Lab at Center of New Litigation

This week plaintiffs filed litigation against Walgreens and Kenvue, among others, in Massachusetts, California and Nevada, alleging that their acne products contain unhealthy amounts of benzene and the companies failed to warn consumers in the products’ labels.

The filings come almost immediately following Valisure, a private lab, submitting a citizen’s petition to the FDA requesting an immediate recall of these products due to a “detected high level of benzene, a known human carcinogen, in many specific batches of BPO products…” 

What follows should raise eyebrows for everyone reviewing the credibility of this litigation.  The petition goes on to say, “the current evidence suggests that on-market BPO products could produce substantial amounts of benzene when stored at above-ambient temperatures, specifically 37°C (98.6°F), 50°C (122°F) and 70°C (158°F).”  Temperatures well above those found in a consumer’s home or storage space. 

This isn’t the first time Valisure has created concerns over products when heated to unrealistic temperatures.  Multi-district litigation involving Zantac was dismissed last year after the flaws behind the science of Valisure’s claims were exposed by Judge Robin Rosenberg, which, as she pointed out in her opinion, “undermines the credibility of their findings.”

Valisure’s testing methodology involved heating the product to well over 200 degrees, which is clearly not a realistic scenario for how an individual would consume the drug, considering that is double the temperature of the average healthy person.

Besides heating the product to temperatures it would not otherwise be subjected to, Valisure also tested the product with an artificial stomach containing unusually high amounts of salt – amounts that humans could not safely ingest.

Judge Rosenberg wrote in her opinion that “the Plaintiffs’ scientists within this litigation systemically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data.”

Given the unlikelihood of consumers storing their acne medication at temperatures above 90°F, let alone 100°F+, federal judges evaluating this new wave of litigation must rigorously review the science put forth by the plaintiffs and prevent junk science from entering their courts.