(Reuters) — Drugmakers GSK PLC, Pfizer Inc, Sanofi SA and Boehringer Ingelheim were on Tuesday spared thousands of U.S. lawsuits alleging heartburn drug Zantac caused cancer, as a judge found the claims were not supported by sound science.
The ruling by U.S. District Judge Robin Rosenberg in West Palm Beach, Fla., strikes out about 50,000 claims in federal court, though it does not directly affect tens of thousands of similar cases pending in state courts around the country.
“We are extremely surprised by this miscarriage of justice,” and “fully expect” the verdict will be overturned on appeal, attorneys for the plaintiffs said in a joint statement.
A Sanofi spokesperson said the decision “significantly reduces the scope of the litigation potentially by over 50%,”; with the remaining litigation only in state court.
A GSK spokesperson said the company welcomed the decision and Pfizer said it was satisfied with the outcome.
Privately held German drugmaker Boehringer said in a statement that it looked forward to “continuing our vigorous defense of the remaining cases in state courts.”
All drug manufacturers have denied that Zantac causes cancer.
First approved in 1983, Zantac became the world’s best-selling drug in 1988 and one of the first drugs ever to top $1 billion in annual sales. Originally marketed by a predecessor of GSK, it was later successively sold to Pfizer, Boehringer Ingelheim and finally Sanofi.
Many generic drugmakers also launched versions of the drug, but none are defendants in the federal court cases.
In 2019, some manufacturers and pharmacies stopped selling the drug over concerns that its active ingredient, ranitidine, was breaking down over time to form a chemical called NDMA. While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts.
In 2020, the US Food and Drug Administration pulled all remaining brand-name Zantac and generic versions from the market, citing research showing that the amount of NDMA in the products increases the longer the drug is stored and could potentially become unsafe.
Lawsuits began piling up soon after the recalls began from people who said they developed cancer after taking Zantac. The plaintiffs said the companies knew, or should have known, that ranitidine posed a cancer risk and failed to warn consumers.
The lawsuit initially included claims of over 10 types of cancer allegedly linked to the drug, but was later narrowed down to five – bladder, esophagus, gastrointestinal, liver and pancreas. Some claims involving other cancers remain pending in state courts.
All cases filed in federal courts nationwide were consolidated before Judge Rosenberg in Florida.
In Tuesday’s order, she found that expert witnesses the plaintiffs planned to use to establish that Zantac can cause cancer were inadmissible in court because they “systematically used unreliable methods” and demonstrated “a lack of internally consistent, objective, science-based standards for even-handed evaluation of data.”
State judges will also have to rule on whether plaintiffs’ experts on Zantac’s alleged cancer risks should be allowed before state cases can go to trial.
The legal standards for evaluating experts in many states are similar to the federal standard used by Judge Rosenberg, but state judges may rule differently.
The first state trial is currently scheduled to begin in February in California.