In what has become a familiar pattern, a testing lab called Valisure last month told the Food and Drug Administration that Clearasil and other widely used acne medications contain potentially cancer-causing benzene.
The same day Valisure announced it had filed a citizen petition with the FDA detailing its allegations, Bloomberg and CNN ran stories about the “cancer-causing chemical” in benzoyl peroxide-containing acne medicine. A couple of days later, law firms – some of them with a history of working closely with Valisure – began filing class action lawsuits against acne medicine manufacturers as well as retailers including Walmart and Target.
On a single day earlier this month, Lucinda O’Dea of Berwyn, Ill. sued Alchemee, RB Health, L’Oreal, Target and Clinique in federal court in Chicago, saying she had treated her acne with Clearasil, CeraVe, Proactiv and other benzoyl peroxide-based medications over the past two or three years.
“The products are unsafe and illegal to sell under federal law, and therefore worthless,” said O’Dea in each lawsuit. Asked why their client was using so many different acne treatments at the same time, O’Dea’s lawyers at Milberg Coleman Bryson Phillips and Bursor & Fisher declined comment.
Based on past history, the law firms suing over Valisure’s claims can expect to make lots of money in fees, regardless of whether they are successful in court. Milberg Cohen and Bursor & Fisher shared $833,000 in fees on a $3.1 million settlement of Valisure-fueled claims over dry shampoo and $1 million in fees from a $3 million settlement with Walmart over hand sanitizer that Valisure said contained benzene. Other law firms that have filed suits based on Valisure’s acne medicine report include WisnerBaum, most famous for leading litigation claiming the widely used herbicide Roundup causes cancer.
Companies usually settle these cases despite Valisure’s checkered history, including the fact founder David Light served time in prison for possessing a cache of illegal weapons while he was still an undergraduate at Yale. The FDA has criticized Valisure for inconsistent or improper testing techniques and a federal judge in Florida dismissed 50,000 claims based on Valisure’s assertion the heartburn medicine Zantac contained cancer-causing chemicals. The judge ruled Valisure’s methods were unreliable.
Valisure announced a cooperative research agreement with the Defense Department last year, accompanied by praise from U.S. Representative Rosa DeLauro. Despite months of Freedom of Information Act requests, the Pentagon has yet to provide Legal Newsline with any evidence such an agreement exists. Valisure didn’t respond to requests for comment directed to its media relations person and through the company’s website contact portal.
In its latest filing, Valisure says it heated various benzoyl peroxide acne medicines to 170 degrees Fahrenheit and found “concerningly high levels of benzene in only 18 days.” Valisure said the temperature was a reasonable estimation of what might occur in a shipping container or a hot car.
It was a similar process of heating samples that drew criticism from the judge overseeing thousands of Valisure-inspired lawsuits over Zantac, however. The lab heated the drug in an “artificial stomach” to 266 degrees, far above what it would encounter in the human body, and exposed it to a level of salt that would kill a human. No NDMA was detected at normal temperatures, the judge found.
The FDA, in a Dec. 5, 2022, letter following an inspection of Valisure’s lab, said the company “failed to establish and document the accuracy, sensitivity, specificity and reproducibility of its test methods.” Among other things, the agency said Valisure didn’t calibrate instruments correctly, improperly switched methods when results were “out of specification” and entered test data into cloud computing accounts without retaining proper backup documentation.
Defendants have also fired back, accusing Valisure of coordinating efforts with lawyers – including the brother-in-law of Light, Valisure’s chief executive – by sharing reports with them before filing citizen petitions the with the FDA. The lawsuits filed so far over acne medicine contain large passages, including diagrams, copied directly from Valisure’s FDA filing.
Other court documents suggest Valisure has found a profitable niche providing consulting services to companies that might otherwise find themselves in the crosshairs of a lawsuit based on the lab’s testing results. Unilever cited a September 2022 letter from Valisure’s lawyer, Marty Sipple, offering to test Unilever’s aerosol products for benzene for an up-front payment of $1.25 million and $250,000 a month, promising to keep results confidential. In that court filing, Unilever suggested Valisure might have been offering to keep test results for its products out of a petition it later filed with the FDA.
The FDA is required by law to respond to citizen petitions. So far it has responded to two of Valisure’s petitions, rejecting the lab’s demands that products be removed from shelves, relabeled or tested by independent labs like Valisure. Other responses are pending.
Despite its mixed record, Valisure enjoys close relations with the press, including Bloomberg reporter Anna Edney. She has filed several flattering stories on the lab over the years, once calling Valisure “the lab protecting us from dangerous products.” At 6 a.m. the day Valisure announced its latest investigation into acne products, Edney filed a story for Bloomberg with the headline: “Chemical Linked to Cancer Found in Acne Creams.”