GSK Knew About Zantac Cancer Risk, Attorneys Tell Jury In First Trial

Zantac Cancer Risk Trial

U.S. attorneys representing a woman who alleges her colon cancer stems from the now-discontinued heartburn drug Zantac told a Chicago jury on Thursday that pharmaceutical giants GSK and Boehringer Ingelheim were aware that improper handling of the product could lead to cancer but failed to issue warnings to the public.

Mikal Watts, representing 89-year-old Angela Valadez, asserted that the companies knew the drug’s active ingredient, ranitidine, could transform into the cancer-causing substance NDMA over time or with exposure to extreme temperatures. However, they neglected to ensure proper handling by transporters, distributors, and retailers.

Valadez’s case is among the thousands against GSK, Boehringer Ingelheim, and other pharmaceutical firms. It marks the first trial to test whether cancer allegations in this long-standing litigation will sway a jury, as all previous cases set for trial settled or were dismissed. GSK and Boehringer Ingelheim are the sole defendants in this trial after other companies reached settlements.

Watts informed the jury that the pills would change color as they degraded, but the companies concealed this. “They know we’re not going to take a product that looks bad, so they put a paint job on it,” Watts stated.

Attorneys for GSK, the developer of Zantac’s active ingredient, and Boehringer Ingelheim, the drug’s seller from 2006 to 2017, countered that Zantac has repeatedly been proven safe and effective, with no scientific or medical study linking it to cancer.

GSK’s attorney, Tarek Ismail, told the jury, “There is no objective evidence linking Ms. Valadez’s cancer to Zantac.” Ismail emphasized that Valadez had multiple risk factors predisposing her to colon cancer and that no tests or studies corroborated the link to Zantac.

Initially approved in 1983, Zantac soared to become the world’s best-selling medicine by 1988, surpassing $1 billion in annual sales. It was initially marketed by a predecessor of GSK before changing hands to other companies.

In 2020, the FDA requested the removal of Zantac and its generics from the market due to NDMA contamination. This led to thousands of lawsuits across federal and state courts.

Despite a significant victory in 2022 when a judge dismissed around 50,000 centralized claims in federal court in Florida, over 70,000 Zantac cases remain pending in the U.S., with many in Delaware state court. These cases await a judge’s decision on whether plaintiffs’ expert testimony should be admitted.

Several cases were settled previously, including individual cases just before trial, and approximately 4,000 state court lawsuits outside Delaware against French drugmaker Sanofi SA.