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On May 24, 2024, in the first U.S. jury trial held involving the popular heartburn medication Zantac, a Cook Court, Illinois circuit court jury found in favor of drug makers GlaxoSmithKline (GSK) and Boehringer Ingelheim and against plaintiff Angela Valadez. Seeking $640 million in damages, Ms. Valadez argued that her colon cancer was the result of the defendants’ negligence, negligent representation and failure to warn that under some conditions the drug could turn into the carcinogen nitrosodimethylamine, (NDMA). Ms. Valadez claimed to have taken over the counter Zantac or its generic version ranitidine daily from 1996 to 2014. Her suit, along with thousands of others, followed the 2019 warning by the U.S Food and Drug Administration (FDA) that trace amounts of NDMA were found in both Zantac and its generic form ranitidine. Subsequent to the warning, the FDA then called for the removal from the shelves of all ranitidine products.
After a four hour deliberation, the Chicago jury found that the drug makers were not responsible for the plaintiff’s cancer, rejecting the plaintiff’s contention the companies were at fault for failing to conduct long term studies on the effect of ranitidine and failing to warn consumers that when exposed to high temperatures the ranitidine was more likely to develop into the carcinogen NDMA. In its defense, GSK pointed out that the plaintiff had a number of other risk factors that could have led to her developing colon cancer.
This verdict follows the 2022 decision of Judge Robin L. Rosenberg of the U.S.D.C. for the Southern District of Florida who while presiding over the Zantac MDL dismissed over 50,000 claims on the basis that the opinions of plaintiffs’ experts linking Zantac and cancer could not be supported by sound science.
Zantac became a blockbuster drug for GSK when it was first introduced in 1983, becoming the bestselling drug in the world by 1988.
In response to the verdict a spokesperson for GSK stated:
GSK plc welcomes today’s jury verdict in the Valadez case in Illinois state court finding in GSK’s favour in the first Zantac case to go to trial. This outcome is consistent with the scientific consensus that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, supported by 16 epidemiological studies looking at human data regarding the use of ranitidine. GSK will continue to vigorously defend itself against all other claims.
Counsel for the plaintiff stated that he was hopeful that future juries would evaluate each case individually and determine that GSK and Boehringer Ingelheim would be found liable; it should be noted however that this verdict may have larger implications for the thousands of cases still awaiting resolution.
In a markedly different result, on May 31, in a 102-page order, Judge Vivian Medinilla of the Superior Court of Delaware, ruled against the defendant manufacturers’ Daubert challenges and denied their motion to exclude the testimony of the plaintiffs’ expert witnesses that links Zantac to cancer, allowing nearly 75,000 cases to proceed. Drug makers GSK, Pfizer, Sanofi and Boehringer Ingelheim had argued that the expert witnesses’ testimony was not credible or grounded in science. The judge ruled that the strength and validity of each sides scientific arguments should be evaluated by juries and not usurped by the courts.
In denying the motion to exclude, Judge Medinilla stated:
In Delaware, our jurisprudence counsels that, subject to earnest deliberation, trial courts entrust questions of science to the scientists. Here, opposing teams of highly educated, skilled expert medical witnesses offer competing opinions. Through well-trained counsel, their efforts only clarify the distinct opposition that defines their respective positions. It would be improper to simply dismiss these experts as “poseurs or witnesses for hire. They are serious scientists.” As gatekeeper, the Court has found that each side has carried its required burden of demonstrating the reliability of its proffered Rule 702 evidence. Any remaining challenges will be made at trial via cross-examination and introduction of counter evidence.
The defendants have indicated they will appeal the decision.
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