PHILADELPHIA (Legal Newsline) - A drug-testing lab's war on Zantac, which spawned tens of thousands of lawsuits despite claims of "junk science," will earn it millions of dollars.
Valisure, twice rebuffed by the Food and Drug Administration after super-heating both the heartburn medicine and acne drugs to create dangerous chemicals, will get a significant chunk of a $67.5 million settlement GlaxoSmithKline is paying to the federal government and several states.
The lab put Zantac in an artificial stomach and heated it to a level about 70 degrees lower than the average temperature of the planet Mercury, then introduced an amount of salt that would kill a human being. The result was Zantac producing a known carcinogen called NDMA.
Plaintiff lawyers picked up on the study and spent millions on advertising to find clients. Meanwhile, Valisure filed a lawsuit of its own, acting as a "whistleblower" in a False Claims Act lawsuit that alleged state and federal governments were forced to pay for Zantac prescriptions that they shouldn't have.
And though all states and the feds refused to join the case and the Food and Drug Administration criticized the lab's findings, the case was settled for $67.5 million, court documents filed April 3 show.
States get only $5.6 million, while the federal government gets $61.9 million. It is not yet known how much Valisure will pocket, but the governments' refusal to join the action could yield more for the lab.
Rewards top out at 25% of the recovery when the government joins, but 30% when it does not. Valisure's attorneys include former U.S. Rep. Conor Lamb, now a lawyer at Kline & Specter.
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.
Valisure had 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.
Last week Legal Newsline reported the FDA again rejected Valisure's testing methods, after it heated acne meds to 170 degrees to produce benzene. After testing 95 products, the FDA found slightly elevated levels in only six.
"Even with daily use of these products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is very low," the FDA wrote.
The FDA went on to warn labs like Valisure to use validated testing methods, saying Valisure's processes may result in much higher reported levels of contaminants like benzene.
"FDA has continued to raise concern that use of unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion," the FDA said.
Valisure CEO David Light started the company following his time at Yale University and a prison stint for possessing an illegal cache of weapons.