Zantac Cancer Risks Concealed By GlaxoSmithKline for Decades, Whistleblower Lawsuit Alleges

GlaxoSmithKline faces a whistleblower lawsuit brought by an independent testing laboratory, which discovered high rates of a cancer-causing chemical in Zantac in 2019, which led to a massive recall and tens of thousands of Zantac cancer lawsuits against the various manufacturers of the heartburn drug.

Zantac (ranitidine) was used by millions of Americans before it was removed from the market by the U.S. Food and Drug Administration (FDA) in late 2019, following the discovery that the active pharmaceutical ingredient is inherently unstable and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a potent human carcinogen.

The problem was first revealed by Valisure, an independent laboratory that regularly investigates popular consumer products for chemical and health risks. Valisure’s investigations have also uncovered the presence of benzene in aerosol sprays, leading to lawsuits against sunscreen products, deodorants and other products.

In the wake of the Zantac recall, GlaxoSmithKline, Boehringer Ingelheim Pfizer, Sanofi and various other manufacturers, distributors, and retailers have faced more than 80,000 Zantac lawsuits brought throughout the U.S., including claims brought by former users who indicate were diagnosed with bladder cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries after taking brand name Zantac or one of its generic equivalents.

The original whistleblower lawsuit was filed under seal against GlaxoSmithKline in 2019. However, an amended complaint (PDF) was publicly released on the docket on May 20, after the U.S. government declined to intercede in the case.

Valisure alleges that GlaxoSmithKline knew for decades about the cancer risks that may result from excessive levels of NDMA generated in the body after Zantac use, but concealed that information from federal regulators and the medical community, violating false claims act laws by the federal government and 25 states.

One study indicated that GlaxoSmithKline, then known as just Glaxo, detected NDMA in Zantac as early as 1982, but failed to make the FDA aware of those results until after Valisure’s investigation in 2019.

“When the FDA ordered GSK to disclose all its data about this issue due to the FDA’s concerns about the chemical structure of the ranitidine molecule, GSK concealed its data,” the lawsuit states. “In fact, GSK fabricated a different study, designed to conceal any NDMA connection, and then used that study to mislead the FDA and other independent researchers. GSK knowingly and deliberately lied to the FDA and the government so that it could get ranitidine approved.”

While GSK has maintained that Valisure’s testing methods were faulty, it has agreed to make Zantac settlement payouts in several cases just before trial was set to begin. However, the drug maker did allow a recent claim brought by a woman diagnosed with colorectal cancer to go before a jury this month in Illinois state court, which is being closely watched to gauge how juries may respond to evidence over the Zantac cancer risks that will be repeated throughout thousands of other claims.

May 2024 Zantac Cancer Lawsuit Update

For several years, most of the litigation was focused in the federal court system, where all Zantac cancer lawsuits were centralized before Judge Robin L. Rosenberg in the U.S. District Court for the Southern District of Florida, for coordinated discovery and pretrial proceedings. However, in 2022 Judge Rosenberg issued a controversial ruling, determining that all of the plaintiffs’ expert witnesses were excluded from testifying at trial under federal evidentiary rules.

While appeals have been filed to challenge Judge Rosenberg’s ruling, the decision has left federal plaintiffs without any means of proving the recalled Zantac pills caused their cancer, and all Zantac lawsuits pending in the federal court system have been dismissed. However, the federal ruling did not have any impact on lawsuits filed in Illinois, Delaware and various other state courts, where different standards for the admissibility of expert witness testimony apply.

Large Zantac settlement agreements have been reached by both Pfizer and Sanofi, hoping to resolve their part in the litigation before having to undergo thousands of jury trials which could have varying, and expensive, results. Pfizer recently acknowledged that it intends to pay up to $250 million to resolve about 10,000 Zantac lawsuits in state courts. That came shortly after Sanofi announced a similar agreement to settle 4,000 Zantac cancer lawsuits for more than $100 million.

Most of the remaining unresolved Zantac lawsuits involve claims against GlaxoSmithKline and Boehringer Ingelheim, who have failed to reach widespread settlements to resolve claims.