These cases are part of a larger wave of litigation against GSK and other drugmakers following the U.S. Food and Drug Administration’s September 2019 warning about NDMA in Zantac. The FDA ordered the removal of all ranitidine products from the market in April 2020.
Gross’s Claims Against Boehringer
At trial, Gross argued that internal communications from Boehringer indicated the company should have known about the carcinogenic impurity in its heartburn medication well before the FDA’s warning. Gross’s counsel cited a 2007 email from a Boehringer executive questioning why some Zantac tablets were darkening after two years, a phenomenon later linked to ranitidine degradation.
Kenzo Kawanabe, Gross’s attorney, stated that Boehringer conducted tests in 2010 but never determined a definitive cause for the discoloration. It wasn’t until after the federal recall that Boehringer’s risk assessment revealed a high risk of NDMA in Zantac.
Zantac Cancer Trial : Boehringer’s Defense
Boehringer’s counsel, Ursula Henninger, argued that Gross’s claims lacked scientific support. She emphasized that no evidence ties Zantac discoloration and degradation to NDMA production or that Zantac is a recognized risk factor for prostate cancer. Henninger pointed out Gross’s other risk factors, including age, race, weight, and smoking history.
