WASHINGTON (Legal Newsline) - The 28 class action lawsuits alleging acne medications turn into benzene won't be bundled, as a federal court panel has found too much variance among the allegations.
Plaintiffs in 11 cases asked the U.S. Judicial Panel on Multidistrict Litigation to create an MDL somewhere in California to handle the pending cases but were rejected on Aug. 1. The litigation started after the laboratory Valisure complained that benzoyl peroxide in acne medicine turns into benzene, a known carcinogen, under extreme heat.
Valisure created tens of thousands of lawsuits with its findings on an ingredient in heartburn medication Zantac when it heated it to 266 degrees Fahrenheit in an artificial stomach to create NDMA. It also exposed Zantac to salt levels that would kill a human.
For the acne medicines, it heated them to 170 degrees for extended periods of time, saying it was a reasonable estimation of what might occur in a shipping container or hot car.
When it presented its findings to the FDA in a citizen petition, lawsuits followed. They don't allege injuries from benzene exposure - only that customers would not have bought them had they known of the potential for the chemical to be in them.
One woman - Lucinda O'Dea - filed five lawsuits in one day. But they are against five separate companies regarding five different products.
Every suit filed so far except one is against an individual defendant or a group of related defendants. There are at least 12 different defendants, though none face more than six cases, and products vary too, in how much benzoyl peroxide they contain and how they are stored, labeled and marketed.
"Despite these variations among the actions, plaintiffs seek creation of an industry-wide MDL. We have been cautious when considering such requests," MDL panel acting chair Nathaniel Gorton wrote
"Plaintiffs here do not allege an industry-wide conspiracy or an indivisible physical injury caused by multiple defendants' products or conduct. Nor is this a situation were all parties support centralization."
Defendant companies have instead asked for cases against them to be transferred to their home jurisdictions. Plaintiffs had argued their lawsuits were reminiscent of Zantac cases, which ultimately met a massive roadblock in Florida federal court when Judge Robin Rosenberg threw out expert opinions based on Valisure's findings.
The MDL panel said the two litigations were very different, as the Zantac suits were each against multiple defendants and the products did not have widely varying formulations.
"Such variations here could result in an unwieldy MDL and require separate discovery tracks to safeguard the confidentiality of defendants' unique formulations," Gorton wrote.
Target was the first to file a motion to dismiss one of the acne medicine cases. On April 5 in Chicago federal court, the company said Valisure admitted it did not test every acne product.
"The Valisure study, at best, indicates that some BPO acne drugs can degrade when exposed to high heat for weeks," attorneys for Target wrote.
"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.
The FDA has not responded to Valisure's acne medicine petition. It did, however, order a brief recall after the Zantac petition, only to later find fault with the lab's testing methods.
That didn't stop state judges in California and Delaware from letting tens of thousands of lawsuits proceed with expert testimony that was bought and paid-for intact.
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.