CHICAGO - A Cook County jury has rejected a woman's claims that her use of Zantac caused her colon cancer, becoming the latest court to reject what have been called anti-scientific claims of a link between the once-popular anti-heartburn medication and cancer.
The jury returned the verdict on May 23 in the case lodged by plaintiff Angela Valadez against some of the world's largest pharmaceutical companies, including GlaxoSmithKline and Boehringer Engelheim, who manufactured and marketed the medication ranitidine, once more commonly known as the active ingredient in the brand name medication, Zantac.
Valadez, who is now 89 years old, and her lawyers from the firm of Keller Postman, of Chicago, had claimed the defendants owed her $640 million, because she claimed her use of ranitidine had caused her to become ill with colorectal cancer.
The verdict brought to a close the first trial among a mass of thousands of lawsuits lodged against the drugmakers over similar claims of a causal link between medications containing ranitidine and certain cancers.
For most of its commercial existence, Zantac's active ingredient was ranitidine. The medication was also sold generically over the counter. However, in 2020, the Food and Drug Administration recalled ranitidine, allegedly over its potential link to cancer.
A heartburn medication is still sold under the Zantac brand name, but it now contains a different active ingredient.
The recall was based on testing conducted by an organization known as Valisure LLC.
In recent years, a report produced by Valisure in 2019 spawned both headlines and tens of thousands of lawsuits nationwide, when it claimed its testing showed the heartburn medicine contained an ingredient that changed to a compound known as NDMA, a known carcinogen.
In court filings, plaintiffs' lawyers have repeatedly cited Valisure's report in their filings, calling Valisue an "independent" lab.
However, the FDA and the federal judge have since found fault with Valisure's methods. To cause ranitidine to break down into NDMA, for instance, the tests reportedly required subjecting the medication to temperatures as high as 260 degrees and lethal levels of salt in a so-called "artificial stomach."
According to court documents, Valisure detected no NDMA in ranitidine when testing it under normal human conditions.
The FDA declared Valisure's testing methods were unreliable, and a Florida federal judge in 2022 dismissed about 50,000 lawsuits after finding Valisure's methods didn't fit expert witness standards.
Judges in Delaware and California disagreed with those conclusions, allowing lawsuits there to proceed.
Valisure has also added its name to those filing suit, using a legal procedure known as qui tam to lodge fraud claims against GSK ostensibly on behalf of the federal government and U.S. states who purchased Zantac and ranitidine through their health insurance and managed benefits plans.
In that action, Valisure and their lawyers with the firm of Wisner Baum claimed GSK misled Medicare and Medicaid over the alleged cancer risk caused by Zantac.
In that action, Valisure referred to itself as a "whistleblower," and could stand to win a percentage of whatever amount GSK may ultimately pay to the governments through a settlement or judgment.
In the meanwhile, litigation has proceeded elsewhere in the country on behalf of individual plaintiffs who assert their use of ranitidine caused cancers.
Drugmaker Pfizer earlier in May agreed to pay $250 million to settle more than 10,000 lawsuits lodged over ranitidine claims.
And in Cook County Circuit Court in Chicago, Valadez's case, which was filed in 2023, became the first in the nation to proceed to trial.
At trial, plaintiffs' lawyers told jurors Valadez's condition has caused her to suffer, and was caused by NDMA, which they said she ingested as part of taking ranitidine for years.
According to published reports, during arguments in court, one of her lawyers called NDMA "the Terminator of cancer," referring to the fictional robotic assassin from the future portrayed by actor Arnold Schwarzenegger in the classic science fiction film, "The Terminator."
Attorneys for GSK and Boehringer Ingelman, however, told jurors the claims presented by Valadez's lawyers cannot be supported by scientific evidence.
After several hours of deliberations, jurors sided with the pharmaceutical companies.
In response to the verdict, GSK issued a statement, saying:
"GSK welcomes today’s jury verdict ... finding in GSK’s favor 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.
"Prior to this verdict, the court rejected the Plaintiff's ability to request punitive damages."
The company further noted another case which had been set to go to trial on May 23 had been dismissed, with the judge in that case determining "GSK was not the brand manufacturer of over-the-counter Zantac at the time the Plaintiff allegedly used it and should not be liable for any subsequent over-the-counter Zantac use."
Boehringer Ingelman also issued a statement saying:
"While Boehringer Ingelheim sympathizes with Mrs. Valadez, the outcome of this case is entirely consistent with the totality of the scientific evidence – including numerous recently conducted epidemiological studies – which shows that Zantac does not cause any type of cancer.
"At Boehringer Ingelheim, the patients we serve, and their safety remain our top priority today and into the future. We are pleased with the jury’s verdict and will vigorously defend all remaining cases."
Valadez's attorneys at the firm of Keller Postman declined comment, including declining to say whether they will appeal or seek a new trial.
John O'Brien, editor of Legal Newsline, contributed to this report.