GSK, Boehringer Put Profits Over User Safety, Zantac Jury Told

Drugmakers GSK Plc and Boehringer Ingelheim GmbH prioritized profits over consumer safety by hiding the cancer risks of their once-blockbuster heartburn drug Zantac, according to lawyers representing a Chicago woman in the first of thousands of such claims to go before a US jury.

Angela Valadez, 89, used over-the-counter Zantac religiously for 18 years before being diagnosed with colorectal cancer, she said in her lawsuit. She’s now seeking at least $640 million in compensatory damages. Both GSK and Boehringer sold Zantac at different times during 30 years that the drug was one of the top-selling antacids in the US.

London-based GSK, which developed Zantac in 1983, knew early on the drug could cause cancer and sold it anyway without warnings, Mikal Watts, Valadez’s lawyer, told an Illinois state court jury Thursday in Chicago. In his opening statement, Watts said internal files show a study laying out the drug’s risks were withheld from US regulators by GSK executives for 37 years.

“A whole lot of Zantac got sold over that period,” Watts told the nine-woman, three-man panel in a tiny Cook County Circuit Court room. Internal documents also show Zantac generated more revenue in 1983 than all of GSK’s other drugs combined, he said. “Zantac was bigger than the whole company.”

Valadez’s suit is one of tens of thousands pending against GSK, Boehringer, Pfizer Inc. and Sanofi, which all sold Zantac at different times. The potential of costly legal risks has been a concern for investors in the companies.

GSK and Boehringer are the only defendants in the Valadez case, after Pfizer agreed earlier to a settlement. Sanofi wasn’t named in her suit.

Blockbuster Drug

Zantac hit the US market as a prescription drug in 1983 before becoming an over-the-counter product in 1996. It was the world’s top-selling medicine five years later and recognized as one of the first blockbuster drugs to rack up more than $1 billion in annual sales.

Paris-based Sanofi agreed to pay more than $100 million to settle about 4,000 lawsuits claiming it failed to warn users that Zantac could cause cancer, Bloomberg News reported last month. The French drugmaker still faces claims in other state courts.

GSK has settled some cases before they went to trial, but it opted to let jurors hear the claim by Valadez. She argues Zantac’s former active ingredient, ranitidine, formed the likely carcinogen NDMA over time or when stored in elevated temperatures. The US Food and Drug Administration recalled Zantac in 2019 over the NDMA discovery.

Tarek Ismail, one of GSK’s lawyers, told jurors in his opening statement that no scientific studies have linked Zantac or NDMA to colorectal cancer. He said Valadez likely developed the illness — which affects millions of Americans every year — because of other risk factors. He said Valadez didn’t get a colonoscopy until she was 80.

GSK said it decided to take the case to trial to defend itself against “unfair and unwarranted allegations” that Valadez developed the potentially fatal disease from the heartburn medication.

No Liability

Andy Bayman, one of Boehringer’s lawyers, told jurors that the German drugmaker had no liability. Valadez had been taking Zantac for two decades before the company acquired the rights to the drug in 2006, Bayman said. Boehringer “never picked up any signs” Zantac was tainted with NDMA while it owned the drug, he said. Boehringer sold the Zantac rights to Sanofi in 2017.

After the FDA recall, Sanofi won approval to return Zantac to US store shelves, but without ranitidine. It’s now made with famotidine, the active ingredient in competitor Pepcid, which is marketed jointly by Johnson & Johnson and Merck & Co.

All the Zantac makers got a boost in 2022 when a federal judge threw out more than 5,000 suits filed in federal court in Florida, saying the science behind the cancer claims was flawed. Many of those cases later were refiled in state court in Delaware.

Judge Vivian Medinilla in Wilmington is weighing the validity of the scientific evidence underlying the more than 70,000 Zantac cases filed in her court and is expected to rule soon on whether juries can hear those suits.

Top photo: Zantac Photographer: Drew Angerer/Getty Images.