CHICAGO (Legal Newsline) - The woman who filed five class action lawsuits in one day over acne medication now faces a dismissal motion in her case against Target.
On April 5 in Chicago federal court, Lucinda O'Dea sued companies selling acne medicine that can allegedly evolve into containing benzene. Her lawsuits were the result of a study by a drug-testing lab called Valisure, which has kickstarted other mass torts by submitting citizen petitions to the FDA.
The FDA rejected Valisure's methods, however, and federal and state governments have declined to join its whistleblower lawsuit over the heartburn drug Zantac.
Target's motion to dismiss notes that Valisure's study admitted it did not test every acne product containing benzoyl peroxide. Valisure heated the drugs to 170 degrees Fahrenheit for extended periods of time, saying it was a reasonable estimation of what might occur in a shipping container or hot car.
The growing number of lawsuits do not allege exposure to benzene, only that customers would not have bought them had they known of the potential for the carcinogen to be in them.
"Valisure did not test every BPO acne product," Target's motion to dismiss says. "The Valisure study, at best, indicates that some BPO acne drugs can degrade when exposed to high heat for weeks.
"But Plaintiff alleges no facts showing that her BPO products contained benzene. Because Plaintiff's theory of deception relies on the assumption that her product was unsafe, Plaintiff has failed to allege injury-in-fact or state a claim."
Target also alleges its labels were compliant with federal regulations and that the FDA has primary jurisdiction to determine drugs' safety.
O'Dea is represented by Gary Klinger and others at Milberg Coleman and Bursor & Fisher. She has also sued Clinique, Alchemee, RB Health and L'Oreal. Target is represented by Greenberg Traurig.
The heating process of acne medication is similar to what Valisure did to Zantac to produce chemical called NDMA, which led to tens of thousands of lawsuits.
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, a judge who rejected the study 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.
David Light, Valisure's CEO, ran afoul of the law while at Yale University when police discovered an illegal arsenal of weapons and explosives that led to a one-year prison sentence.
The lab has said it scored a drug-testing contract with the Department of Defense, though Legal Newsline's efforts to track it down have so-far been rejected. Several FOIA requests are pending.
Defendants in other cases have fired back at the lab, accusing Valisure of coordinating efforts with lawyers – including the brother-in-law of Light – 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.