NEWARK, N.J.--(BUSINESS WIRE)--
Law firm calls out FDA’s “highly questionable” recommendations, urges Zantac users to find out their rights against drug maker
Class-action law firm Hagens Berman has filed a second lawsuit regarding Sanofi and Boehringer Ingelheim’s intentionally concealed cancer risks in its popular heartburn medication, Zantac. Attorneys are also calling the Food and Drug Administration’s consumer-facing recommendations regarding the instance of a carcinogenic chemical in Zantac “highly questionable,” and are urging those who take Zantac to consult with their doctors before continuing to take the medicine.
The complaint also alleges that scientific testing that employs the FDA’s own protocols shows that a single tablet of Zantac may react to form up to 26,000 times the FDA-approved limit of N‑nitrosodimethylamine (NDMA), a chemical which the FDA, EPA and World Health Organization classify as a carcinogen. Although the FDA has announced that it too found NDMA in Zantac and generic ranitidine, albeit at lower levels, the FDA has not urged companies to recall the drug, nor has it recommended that consumers stop taking Zantac.
According to the firm’s complaint, when one 150 mg tablet of Zantac is ingested, it undergoes a chemical reaction in the stomach to create more than 3,100 times the FDA-approved limit of NDMA.
“There is no debate about the toxicity of NDMA. The EPA, World Health Organization, and the FDA itself have labeled it a carcinogen,” said Steve Berman, managing partner of Hagens Berman and attorney leading the case for consumers. “That the FDA is recommending that consumers continue to take over-the-counter Zantac, instead of consulting with their physician, or encouraging individuals to take one of the many alternative medications over which there are no safety concerns, is questionable at best.”
“Virtually every other regulator across the world investigating ranitidine has either recalled the drug, or at the very least, encouraged persons to speak with their physician before taking any further ranitidine. For example, Canada’s FDA-equivalent, Health Canada, is urging manufacturers to stop the sale of drugs containing ranitidine,” Berman added. “We too urge consumers consult with their doctors before taking any further ranitidine. We understand that the FDA has to conduct a proper investigation and encourage it to do so, but its meek recommendations merely create confusion and put consumers in danger before the FDA has determined whether these drugs are in fact safe. That’s just wrong."
Sandoz had agreed to recall its ranitidine products worldwide including in the U.S.
The lawsuit, filed Sept. 20, 2019, in the U.S. District Court for the District of New Jersey, accuses Sanofi and Boehringer Ingelheim of knowingly manufacturing and selling over-the-counter Zantac containing a concealed carcinogen to millions in the U.S. suffering from heartburn and other gastrointestinal issues, including sour stomach, acid reflux or gastroesophageal reflux disease (GERD).
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.
According to the lawsuit, “Zantac’s unprecedented sales were possible only because of a deception perpetrated by the drug’s manufacturers on consumers…”
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.” 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.
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.