PHILADELPHIA - The product-testing lab whose research has created tens of thousands of lawsuits still works to settle a case it brought itself and received no support from the federal government and more than two dozen states refusing to participate.
Valisure LLC has used testing methods criticized by the Food and Drug Administration to show chemicals in products like acne medicate and Zantac can turn into carcinogens. Plaintiff lawyers routinely cite its work when filing lawsuits, some of which are proposed class actions.
For five years, it was secretly the plaintiff in its own case against GlaxoSmithKline over Zantac. Its "whistleblower" lawsuit was filed in 2019 under seal under the False Claims Act, alleging programs like Medicare and Medicaid provided Zantac to patients while concealing the chance it could turn into NDMA.
In a March 3 filing about a year after the case was unsealed in Philadelphia federal court, the sides disclosed a settlement has been reached but not finished.
"The parties have been working diligently to finalize the settlement agreement, but they are still in the process of finalizing the settlement documents and obtaining necessary approvals from the Department of Justice and the representatives of the named plaintiff states," the document says.
Whistleblowers, or relators, win a percentage of whatever is successfully recovered. In addition to filing the case on behalf of the United States of America, Valisure also seeks to represent 27 states and the District of Columbia. Under the FCA, a whistleblower notifies these governments when filing, which allows them to decide whether to join the whistleblower's case.
All governments declined to intervene, according to a March 11, 2024, document, leaving Valisure and its lawyers, who include former U.S. Rep. Conor Lamb (now a lawyer at Kline & Specter) to pursue the case on their own. Maryland rules require dismissal of the state from the case because it didn't wish to join.
When the feds and states choose not to intervene, the whistleblower is entitled to a higher percentage of any recovery than if they received help from governments.
Valisure LLC created headlines and tens of thousands of lawsuits in 2019 when it claimed its testing showed the heartburn medicine contained an ingredient that changed to a known carcinogen called NDMA. Lawyers cited its study in ensuing litigation, calling Valisure an "independent" lab.
A federal judge and the Food and Drug Administration eventually found fault with Valisure's testing, which included heating an artificial stomach to a level about 70 degrees lower than the average temperature of the planet Mercury and introducing a lethal amount of salt.
Valisure brought its findings in a citizen petition to the FDA, which ordered a short-lived recall. The FDA said Valisure's methods were unreliable, saying the lab's "artificial stomach" was heated to 260 degrees and subjected to lethal levels of salt to create NDMA from Zantac.
Valisure detected no NDMA in the drug when testing it under normal human conditions, and a Florida federal judge in 2022 dismissed about 50,000 lawsuits after finding Valisure's methods didn't fit expert witness standards.
Delaware and California federal judges reached the opposite conclusions and allowed lawsuits there to proceed. None of this matters to its whistleblower case, Valisure says, as it is based on the actions of GSK.
GSK settled 80,000 cases for $2.2 billion last year while denying all claims against it. Last month, plaintiff lawyers representing company investors sued the company over its Zantac disclosures, citing Valisure's study.
Another study by Valisure turned into dozens of lawsuits alleging acne medication turned into benzene. Facing similar claims over dry shampoo, Unilever recently decided to settle.
Valisure founder David Light ran afoul of the law more than 15 years ago for possessing a cache of illegal weapons while he was still an undergraduate at Yale.
Valisure announced a cooperative research agreement with the Defense Department in 2023, accompanied by praise from U.S. Representative Rosa DeLauro. The Pentagon has yet to provide Legal Newsline with any evidence such an agreement exists.