GSK Hid Zantac Cancer Risks for Decades, Lawsuit Alleges

GSK Hid Zantac Cancer Risks for Decades, Lawsuit Alleges

Introduction

GlaxoSmithKline (GSK) is facing a whistleblower lawsuit brought by Valisure, an independent testing laboratory, which uncovered high levels of a cancer-causing chemical in Zantac in 2019.

This discovery led to a massive recall and tens of thousands of Zantac-related cancer lawsuits against the drug's various manufacturers. Zantac, known generically as ranitidine, was widely used by millions of Americans before the U.S. Food and Drug Administration (FDA) pulled it from the market in late 2019. The removal followed revelations that ranitidine is inherently unstable and can produce high levels of N-Nitrosodimethylamine (NDMA), a potent carcinogen.

Valisure, which regularly examines popular consumer products for chemical risks, first exposed the problem. Their investigations have also found benzene in aerosol sprays, sparking lawsuits against several sunscreen, deodorant, and other product manufacturers.

Following the Zantac recall, over 80,000 lawsuits were filed across the U.S. against manufacturers like GlaxoSmithKline, Boehringer Ingelheim, Pfizer, and Sanofi. Plaintiffs, many of whom were diagnosed with cancers such as bladder, liver, pancreatic, and stomach cancer, claimed these injuries were linked to their use of Zantac or its generic versions.

The initial whistleblower lawsuit against GlaxoSmithKline was filed in 2019 under seal but was publicly released in May 2023 after the U.S. government chose not to intervene. Valisure’s lawsuit alleges that GlaxoSmithKline was aware for decades of the cancer risks posed by NDMA generated from Zantac use but deliberately concealed this information from federal regulators and the medical community. This, Valisure claims, violated false claims act laws by the federal government and 25 states.

According to one study, GlaxoSmithKline, then operating as Glaxo, detected NDMA in Zantac as early as 1982 but did not inform the FDA of these findings until Valisure’s 2019 investigation. The lawsuit further alleges that when the FDA demanded GSK disclose all data concerning NDMA, GSK withheld this data and instead fabricated a study to mislead the FDA and independent researchers, thus ensuring ranitidine’s approval by falsifying information.

GSK has disputed the validity of Valisure’s testing methods but has nonetheless made settlements in several cases just before trials were set to begin. Recently, however, GSK allowed a claim by a woman diagnosed with colorectal cancer to proceed to trial in Illinois state court. This trial is being closely observed to understand how juries might respond to evidence concerning Zantac's cancer risks, which will be critical for thousands of similar claims.

For several years, Zantac litigation was centralized in the federal court system, with all lawsuits consolidated under a judge in the U.S. District Court for the Southern District of Florida for coordinated pretrial proceedings. However, in 2022, the judge issued a controversial ruling excluding all plaintiffs’ expert witnesses from testifying at trial under federal evidentiary rules. This decision left federal plaintiffs without means to prove that Zantac caused their cancers, resulting in the dismissal of all federal Zantac lawsuits. Appeals have been filed to challenge this ruling.

Meanwhile, the federal court’s ruling did not affect lawsuits in state courts in Illinois, Delaware, and other jurisdictions, where different standards for expert witness testimony apply. In these courts, large settlement agreements have been reached by Pfizer and Sanofi, aiming to resolve their portions of the litigation without undergoing numerous jury trials, which could result in unpredictable and costly outcomes. Pfizer recently announced it intends to pay up to $250 million to settle about 10,000 Zantac lawsuits in state courts. Similarly, Sanofi has agreed to settle 4,000 Zantac cancer lawsuits for over $100 million.

The majority of unresolved Zantac lawsuits now involve claims against GlaxoSmithKline and Boehringer Ingelheim, who have yet to reach comprehensive settlement agreements. The outcome of ongoing and future trials, particularly the Illinois state court case, will likely influence the resolution of these remaining claims.