Court Update for Zantac: The Popular Heartburn Medication

Apr 01, 2021
By Boesen Law
  • Boesen Law has been closely monitoring the lawsuit involving the popular heartburn medication, Zantac. We monitor medication and pharmaceutical companies because we believe that we can assist people who have been affected by faulty medications and pharmaceutical companies.

    We have been made aware of an update regarding the ruling in Zantac’s multidistrict litigation (MDL) involving labeling claims of carcinogens found in the medication has reduced more claims from the litigation. This means that a Florida federal judge presiding over MDL is holding the defect claims to be barred by federal law.

    The judge in question is U.S. District Judge, Robin L. Rosenberg. Judge Rosenberg reported that the defect claims against Zantac manufacturers like Pfizer Inc. and Sanofi-Aventis U.S. LLC are preempted by the Federal Food Drug and Cosmetic Act because it is impossible for the companies to change the formulation in Zantac without the approval of the FDA. Judge Rosenberg has this to say,

    “ As with generic drugs, a claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA approved.”

    This means, not in legal jargon, that the claims being presented in court about Zantac being misbranded (though the FDA has approved the formulation) aren’t valid claims. The companies that make Zantac can’t go in and change the medication’s formulation because the FDA has approved the existing formula. If any changes are made to the current formulation, companies would have to obtain new approval by the FDA.

    This new ruling comes after several rulings Judge Rosenberg made on New Year’s Eve. The ruling was that Zantac generic makers, packagers, retailers and distributors were preempted by federal law. What this means is that there were lawsuits, accusing companies such as Pfizer Inc. and Sanofi-Aventis U.S., as well as the above mentioned for false advertising and failure to warn people due to the discovery of nitrosodimethylamine (NDMA) which is a cancer-causing chemical. We have talked about this chemical before in our blog post regarding Metformin, a Diabetes medication that has been recalled due to NDMA. Here is the link if you’d like to read more:

    Back in September of 2019, the FDA issued a warning that there were trace amounts of NDMA in Zantac and similar generic drugs. However, in April of 2020, the FDA pulled all prescription and over-the-counter medication that featured ranitidine, the active ingredient found in heartburn medications. It turned out that the medication, when stored above room temperature, could produce an unacceptable amount of NDMA. According to the FDA, the allowable daily limit of NDMA is 96 nanograms but researchers found that in one dose of Zantac, there were more than 3 million nanograms of the carcinogen. It is important to note that NDMA is a naturally occurring chemical that can be found in things such as red meat, tobacco, and beer.

    Since February of this year, plaintiffs for this suit have filed three more master complaints which are a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of the third-party payers. We will continue to monitor the lawsuits and update you with more information as soon as we receive it.

    If you or someone you know has been affected by Zantac or would like more information about your rights, do not hesitate to call Boesen Law at . We are always more than happy to assist and we are always on standby for you.