A newly filed class-action lawsuit accuses international drug maker Sanofi of intentionally concealing risks in its popular heartburn medication, Zantac, which has been found to contain a carcinogenic chemical at 26,000 times the FDA-approved limit, according to the lawsuit filed by Hagens Berman.
The lawsuit, filed Sept. 13, 2019, in the U.S. District Court for the Northern District of California accuses Sanofi and Boehringer Ingelheim of knowingly manufacturing and selling over-the-counter Zantac containing a concealed carcinogen to millions of people in the U.S. suffering from heartburn and other gastrointestinal issues, including sour stomach, acid reflux or gastroesophageal reflux disease (GERD).
According to the complaint, Zantac contains the active ingredient ranitidine. When ingested, ranitidine metabolizes into N-nitrosodimethylamine (NDMA) which the FDA, EPA and World Health Organization (WHO) classify as a carcinogen.
The FDA has established a permissible daily intake limit of 96ng of NDMA, but recent testing using FDA-approved methods detected more than 2,500,000ng of NDMA per 150mg tablet of Zantac. Each Zantac tablet has been found to contain 26,000 times the FDA-approved amount of NDMA that can be safely ingested daily.
"Millions of people in the U.S. suffer from heartburn, and for years, Zantac has been sold to the masses as a safe and easy-to-find remedy for that common ailment," said Steve Berman, managing partner of Hagens Berman and attorney leading the case for consumers. "We're certain that if those millions of consumers knew that the Zantac they take contains known carcinogens, they would be rightfully outraged."
"Sanofi knew that Zantac contains a carcinogen, yet it chose to conceal these risks to the public to line its own pockets," Berman added.
Zantac was the first drug to total $1 billion in sales.
According to the lawsuit, "Zantac's unprecedented sales were possible only because of a deception perpetrated by the drug's manufacturers on consumers..."
What Big Pharma Knew About Zantac's Carcinogenic Risks
The dangers of NDMA have been publicly known for more than 40 years, according to the lawsuit, and the WHO has described NDMA as "clearly carcinogenic." NDMA itself belongs to a family of chemicals called N-nitrosamines, which the EPA refers to as "potent carcinogens."
During the period that Sanofi and Boehringer manufactured and sold Zantac, numerous scientific studies were published showing, among other things, that ranitidine forms NDMA when placed in drinking water, and that a person who consumes the drug has a 400?fold increase of NDMA concentration in their urine, according to the lawsuit.
Attorneys say that despite the accumulating scientific evidence showing Zantac exposed users to extremely high levels of NDMA, neither Sanofi nor Boehringer disclosed this risk.
"Had Defendants disclosed that Zantac results in unsafe levels of NDMA in the human body, no person, let alone a reasonable person, would have purchased and consumed Zantac," the complaint states.
The lawsuit seeks to represent anyone who purchased over-the-counter Zantac between Jan. 1, 2010 and the present. Attorneys hope to secure repayment for those who purchased the drug, as well as a permanent injunction from the court under the Legal Remedies Act requiring the drug makers to either cease selling Zantac or add a warning to the label.
The suit accuses Sanofi and Boehringer of violating state consumer-protection laws in its failure to disclose the harmful levels of NDMA in Zantac.
Both the U.S. FDA and European Commission recently announced that they are also investigating Zantac and ranitidine for NDMA.
If you have concerns about any potential adverse health risks associated with Zantac (or generic ranitidine consumption), Hagens Berman recommends that you discuss the allegations in this lawsuit with your physician.
Hagens Berman Sobol Shapiro LLP is a consumer-rights class-action law firm with nine offices across the country. The firm's tenacious drive for plaintiffs' rights has earned it numerous national accolades, awards and titles of "Most Feared Plaintiff's Firm," and MVPs and Trailblazers of class-action law. More about the law firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.