FDA Zantac

Zantac Attorneys Sue FDA to Force Release of ‘Flawed’ Study Docs

Zantac lawsuit attorneys from the prominent law firm of Baum Hedlund Aristei & Goldman have sued the U.S. Food and Drug Administration (FDA) under the Freedom of Information Act (FOIA) to compel the FDA to release certain documents regarding an agency-sponsored study on Zantac (generic: ranitidine) that “has a number of alarming and jarring flaws.”

Attorney R. Brent Wisner, who serves on the plaintiffs’ leadership in the Zantac Judicial Council Coordinated Proceeding (JCCP) in California State Court filed the complaint last week on behalf of plaintiff James E. Goetz in U.S. District Court for the Norther District of California. Mr. Goetz’s case is scheduled to go to trial in Alameda County Superior Court on February 13, 2023, making it the first bellwether trial for many thousands of Zantac claims that are consolidated in the California JCCP.

The lawsuit seeks FDA emails and any other communications—internally amongst the authorship team as well as with any third parties—about the FDA study entitled, “Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA),” plus initial drafts of the work from June 2019 to June 2022. 

Published in the Journal of the American Medical Association (JAMA) in June of 2021, the FDA study has been used by the Defendants in the JCCP to argue that Zantac does not cause cancer. The findings of the study were puzzling because the agency issued a Zantac recall in April 2020 after the drug was found to contain unsafe levels of NDMA, a potent, probable human carcinogen.

The recall on ranitidine helped lead many thousands of Americans to file Zantac lawsuits in courts throughout the country alleging the once popular heartburn medication causes cancer. The drug companies named in the Zantac cancer lawsuits are:

  • GlaxoSmithKline, LLC (GSK)
  • Pfizer, Inc. (Pfizer)
  • Sanofi-Aventis U.S., LLC and Sanofi-US Services Inc.
  • Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim USA Corporation

Attorneys are seeking documents related to the FDA study for several reasons. Most importantly is that the FDA study—funded with taxpayer dollars—is being used by the Zantac manufacturers to defend the underlying lawsuits brought by thousands of plaintiffs in the JCCP. According to the complaint, the drug companies are leveraging the FDA’s color of office and the agency’s appearance of regulatory neutrality and expertise as a central part of their defense narrative.

“The FDA has a mandate to protect people from harmful drugs,” says Zantac cancer attorney R. Brent Wisner. “We believe the FDA designed a flawed and potentially biased study. The agency’s lack of transparency surrounding the release of these documents makes it clear that it is more interested in carrying water for drug companies than fulfilling its mandate. My client and the many thousands of other people stricken with cancer after taking Zantac have the right to know why the FDA injected itself into the scientific discussion of Zantac’s carcinogenicity using taxpayer money on behalf of the drug companies they are supposed to regulate.”

The complaint alleges that the FDA Zantac study has several key flaws. First, it makes bizarre comparisons, equating the amount of NDMA in a Zantac pill to common foods such as cured meats like bacon. While it is true that bacon tends to contain NDMA, the amount of NDMA in one pill of Zantac would be equal to the consumption of six pounds of bacon in a single day, attorneys say.

Furthermore, the FDA Zantac study used a protocol that was seemingly designed to obscure any formation of NDMA inside the body. For example, the FDA study required participants to ingest unusually high levels of vitamins C & E, which are known to stop NDMA formation. Additionally, the FDA study focused on urinary excretion of NDMA, even though it is well known that practically no NDMA is excreted in the urine.

The issues with the FDA Zantac study call into question the results. As per the complaint: “All of these issues must be explored, and that cannot be done without access to the underlying documents.”

After the FDA study was released, attorneys in the Zantac litigation filed a FOIA request for documents related to the study’s “concept and design,” among other things. In response to the FOIA request, the FDA said the earliest the documents could be approved for release to the plaintiffs is June 2025. This would be roughly three years after the first Zantac bellwether trial is scheduled to take place in California state court and after every single scheduled bellwether trial in the thousands of cancer cases at issue in the JCCP process. According to the complaint, the agency’s response to the documents request has been “deficient and in clear violation of its statutory deadlines for responding and producing documents or justifying their withholding.”

“The FDA has flouted the law and eschewed transparency and accountability by wrongfully withholding documents from our client,” says Wisner. “We need these documents to put this study in its proper, overall context. Did the study use a valid methodology? Was there any bias in the design? We believe there are answers in the documents we requested, which will be crucial to evaluate liability and causation in the Zantac litigation.”

The complaint asks for the FDA to “expeditiously provide copies of the requested records” within 30 days. The case is captioned James E. Goetz v. U.S. Food and Drug Administration (Case 3:22-cv-04768-TSH).

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