SAN FRANCISCO (Legal Newsline) - The makers of generic Zantac can't be sued under California's Prop 65, which requires cancer warning labels on products that contain ingredients the State has decided could be carcinogenic.
The First Appellate District made that decision on March 9 in a lawsuit brought by the Center for Environmental Health. An Alameda County judge had ruled generic drug makers, under federal law, must include the same label as the brand-name manufacturers do.
It would be impossible to include a Prop 65 warning if the brand-name manufacturers don't, the courts concluded.
"Although we do not hold that all methods of publicly communicating a warning about a drug necessarily qualify as 'labeling,' CEH fails to identify any method by which the generic-drug defendants could provide a warning about their consumer products that would satisfy both Proposition 65 and the federal duty of sameness," the decision says.
"As a result, until brand-name manufacturers give a Proposition 65 warning on their product' labeling, the generic-drug defendants cannot be required to do so."
The generic Zantac makers are Dr. Reddy's Laboratories, Perrigo Company, Target, Apotex Corp., Granules USA and 7-Eleven. The brand-name defendants, who also won dismissal in the trial court, are Sanofi-Aventis and Chattem.
The trial court's dismissal order did not permit amended claims against the generic-drug companies but did for the brand-name companies.
The lawsuit concerns over-the-counter antacids with the active ingredient ranitidine. An independent lab in 2019 found significant quantities of NDMA in ranitidine-containing antacids, and the FDA released a public alert. NDMA is used to induce tumors in lab animals.
In 2020, the FDA requested manufacturers recall all ranitidine drugs. CEH sued Perrigo and Target in February of that year and added the other defendants later.
But courts have now found the federal laws requiring sameness of labels preempt the Prop 65 claims.