Zantac Settlement Reached By Certain Generic Drug Makers Before Trial Against GSK Dropped: Report

In advance of a state court trial set to begin in Illinois, which would have been the first Zantac lawsuit over cancer caused by the heartburn drug to go before a jury, a group of generic drug makers reportedly reached a settlement agreement with the plaintiff, who then dismissed remaining claims against makers of the name-brand version of the medication this week.

While no official details about the Zantac settlement have been released, Bloomberg News reports that at least four generic drug makers contributed to pay more than $500,000 combined to resolve claims brought by Joseph Bayer, leaving GlaxoSmithKline, Pfizer and Boehringer Ingelheim as the only remaining defendants, over their role in the development and sale of name-brand Zantac pills.

Zantac and generic ranitidine equivalents were used by millions of Americans on a regular basis before all versions of the heartburn drug were recalled from the market in late 2019, following a discovery that the active pharmaceutical ingredient is inherently unstable, and produces high levels of the cancer-causing chemical byproduct N-Nitrosodimethylamine (NDMA).

Thousands of former users are now pursuing lawsuits against the makers of name-brand Zantac and generic ranitidine, alleging that they are responsible for selling a dangerous and defective drug, which caused them to develop various various different types of cancer, including bladder cancer, esophageal cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries.

The lawsuit filed by Joseph Bayer was scheduled for the first Zantac trial in the country, and was expected to start on August 22, involving allegations that Zantac caused his esophageal cancer diagnosis.

Days before trial was to begin, GlaxoSmithKline released a statement indicating that Bayer voluntarily dismissed his lawsuit this week, confirming that the they did not contribute to any settlement or pay any money in exchange for the dismissal.

Bayer’s lawyers have indicated that the case was dropped for “personal health reasons”, according to a statement published by Reuters, which pointed out that he had the right to refile his case within a year.

Bloomberg News now reports that prior to the dismissal, generic drug manufacturers Teva Pharmaceuticals, Perrigo Co., Sun Pharmaceutical Industries Inc., and Dr. Reddy’s Laboratories combined to pay more than $500,000, as part of a Zantac settlement to resolve their role in the lawsuit. GSK, Pfizer and Boehringer Ingelheim did not participate in the deal, according to the report.

Additional Zantac Trials Approaching in Early 2023

Following the generic ranitidine settlement and dismissal of remaining claims against the brand name manufacturers, the next Zantac trials are now expected to begin in California state court and the federal court system in early 2023.

The U.S. District Judge presiding over all Zantac cancer lawsuits in the federal court system is expected to hold a series of hearings next month, to evaluate the strength and reliability of expert witness testimony about the link between five specific cancers and Zantac, including bladder, esophageal, liver, pancreatic and stomach cancer.

Following rulings on the Daubert challenges brought over the admissibility of the expert opinions under the federal standard, it is expected that a series of early “bellwether” trials will be scheduled in early 2023 to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.

In California, series of four Zantac cancer lawsuits are scheduled to begin in February 2023.

While the outcomes of these trial dates will not have any binding impact on tens of thousands of other claims pending, they are expected to play an important role in any negotiations by the drug makers to reach more global Zantac settlements, which would avoid the need for thousands of individual cases to be set for trial in the coming years.

Concerns About Link Between Zantac and Cancer

Public concerns about Zantac cancer risks first emerged in September 2019, when Valisure, an online pharmacy, determined each pill may expose users to levels of the known human carcinogen Nitrosodimethylamine (NDMA) that are drastically higher than the permissible and safe.

The FDA has previously found the daily safe limit for NDMA exposure is only 96 nanograms (ng). However, pills tested by the independent pharmacy found that users may be exposed to more than 3 million ng from each Zantac pill.

For decades before the recall, Zantac was one of the most widely recognized brand name medications on the market in the U.S., with millions of Americans taking the drug for treatment of heartburn and acid reflux. As Zantac injury lawyers continue to review and file claims over the coming years, it is widely expected that the litigation may be one of the largest mass torts by the time the first cases go before a jury.

Following the bellwether trials, if the drug makers fail to reach Zantac settlements or another resolution for the cases, each individual lawsuit may end up remanded back to courts nationwide for individual trial dates in future years, which could expose the drug makers to billions in liability, according to the recent analysts reports.