GSK To Pay $2.2 Billion To Settle Zantac Cancer Lawsuits Brought by 80,000 Consumers

Zantac settlement must still be approved by individual plaintiffs, but is expected to resolve vast majority of cancer lawsuits filed in state courts.

GlaxoSmithKline has announced that it will spend about $2.2 billion to resolve about 93% of the remaining Zantac cancer lawsuits filed against the manufacturer in U.S. state courts, following years of litigation involving toxic chemical byproducts that contaminated the recalled heartburn drug.

The company issued a press release on October 9, announcing that the Zantac settlement deal involves about 80,000 product liability lawsuits. In addition, GSK will pay $70 million to resolve a whistleblower lawsuit by Valisure, the independent laboratory that first raised the alarm about Zantac cancer risks more than five years ago.

Zantac (ranitidine) was a widely used over-the-counter drug approved for treatment of heartburn and acid reflux, which was sold at different times by GSK, Pfizer, Sanofi, Boehringer Ingelheim and various generic manufacturers, until all versions of Zantac were removed from the market in early 2020.

Zantac Cancer Litigation

The litigation emerged after Valisure discovered that the active pharmaceutical ingredient in the pills, ranitidine, is inherently unstable and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a known human carcinogen.

Plaintiffs maintain that GSK and other drug makers knew or should have known about the Zantac cancer risks, yet failed to reformulate their products and continued to market the drug for treatment of heartburn and acid reflux for years.

Most Zantac lawsuits were initially focused in the federal court system, where claims brought in U.S. District Courts nationwide were centralized before U.S. District Judge Robin L. Rosenberg for coordinated discovery and pretrial proceedings. However, before the first federal case ever reached trial, Judge Rosenberg issued a controversial ruling determining that there was not sufficiently reliable expert testimony to establish that Zantac caused any cancer diagnosis among plaintiffs.

Judge Rosenberg’s decision was based on an interpretation of the federal rules regarding the admissibility of expert testimony, resulting in the dismissal of all federal Zantac lawsuits. However, the ruling had no impact on claims that continued to be filed in various different state court systems, including Delaware, Illinois and Connecticut, where judges have already determined that different standards for the admissibility of expert witness testimony apply.

While the dismissal of the federal claims is still pending on appeal, the GSK Zantac settlement is expected to resolve the vast majority of all claims pending in state courts nationwide. However, the individual plaintiffs must still accept their offers, and the whistleblower settlement involving Valisure must be approved by the U.S. Department of Justice.

“GSK has not admitted any liability in the State Courts Settlement or in the agreement in principle for the Qui Tam Settlement,” the press release states. “While the scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, GSK strongly believes that these settlements are in the best long-term interests of the company and its shareholders as they remove significant financial uncertainty, risk and distraction associated with protracted litigation.”

The drug maker has faced several Zantac trials in Illinois state court, where the first two cases to go before a jury ended in a defense verdict, but GSK was expected to face a steady stream of future trials if this global settlement were not reached.

GSK is at least the third major drug manufacturer to reach an agreement to settle Zantac cancer lawsuits. Following extensive discovery and pretrial proceedings, Pfizer and Sanofi previously agreed to pay hundreds of millions in Zantac settlements to resolve their role in the development and marketing of the heartburn drug. However, GSK did not participate in those agreements, and faced the largest remaining liability in the litigation.