Craig Rosenbaum | May 6, 2020 | Defective Drugs
The popular heartburn medication Zantac (ranitidine) was recalled and taken off shelves in September of 2019 after the Food and Drug Administration announced that it had found the cancer-causing chemical N-nitrosodimethylamine (NDMA) in samples of Zantac. On February 6, 2020 the Judicial Panel for Multidistrict Litigation formed MDL No. 2924 in the federal court in the Southern District of Florida. Judge Robin L Rosenberg has been assigned preside over the MDL.
In Re: Zantac (Ranitidine) Products Liability Litigation
In the latest pre-trial order, Judge Rosenberg has instituted a process to designate certain individuals as Limited Purpose Representatives of the estates or persons at issue for the purpose of collecting relevant medical records. To be appointed a Limited Purpose Representative, plaintiffs or their counsel must submit a death certificate or proof of incapacitation and certified documentation evidencing their relationship to the decedent or incapacitated individual. Judge Rosenberg has appointed Professor Jaime Lynne Dodge, Director of the Institute of Complex Litigation and Mass Claims at Emory Law School, as the Special Master in this MDL. Special Master Dodge will then review and approve a Limited Purpose Representative’s form.
The Court has worked with both parties in the case to develop an Initial Census Form (“ICF”) and a Census Plus Form (“CPF”) for all of the cases filed in the Multidistrict Litigation, as well as the personal injury and medical monitoring cases in the MDL. Plaintiffs were required to provide documentation regarding their medical diagnosis, as well as a signed statement attesting to the claimed medical diagnosis and/or Zantac use. It is important that the Court has complete and accurate responses so the Court can properly select from the applicants for the leadership and PSC appointments.
COVID-19’s Effect on the Litigation
As this case proceeds into its next phase, the court has noted that it remains increasingly important that counsel continue to work cooperatively and in good faith to resolve issues through virtual meetings and conferrals. Appointed counsel will meet and confer, via video conference, regarding the timing and scope of discovery. The Special Master has been directed to attend these discussions and to assist the Court. The Court has ordered that the parties will appear by videoconference on May 13, 2020, for a preliminary discovery conference. This conference is intended to permit the Court to listen to the presentations from counsel on their visions for discovery, including more informal questions from the Court about the parties’ expectations for the discovery process. This will also be the time at which the Court will take up any specific discovery matters. The Court is continuing to work through the best manner in which to facilitate video and telephonic attendance and will provide connection information whenever new information becomes available. It is the Court’s desire that technology will permit all interested parties to view the proceedings.
Judge Rosenberg has urged counsel to work together effectively in order to keep the MDL moving along during these unprecedented times. “The Court depends on counsel more than ever to work together to advance the interests of the case, even when there may be differing view as to how such progress would occur.”
What is NDMA and What Harm Can It Cause?
NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals, as studies in humans are still developing.
The FDA was made aware in September of 2019 some ranitidine medicines, including Zantac, contained NDMA. The EPA classified NDMA as “extremely hazardous,” and there are strict reporting requirements for companies and individuals who produce, store, or use NDMA in large quantities. To date, the FDA has not found NDMA in some other products, such as famotidine, or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.
Independent testing conducted by the online pharmacy Valisure has revealed that levels of NDMA in one Zantac 150mg tablet may exceed 3,000,000 nanograms (ng), which is 26,000 times higher than the FDA’s permissible daily intake for the chemical. The FDA’s recommendations limit the daily intake for NDMA to 96 ng, but users taking the 150- daily dose of Zantac are exposed to 889,000,000 ng of NDMA over the course of a year. Excessive levels were detected across all brands of Zantac, and Valisure’s studies have indicated that there have been potential warning signs for the presence of NDMA dating back 20 years.
NDMA exposure has been linked to various primary cancers including: stomach, small intestine, colorectal, esophageal, and liver. These have been grouped as the “Tier 1” of most likely cancers, with stomach cancer being the most frequent. In more limited circumstances, exposure to NDMA has also been linked to: early onset prostate cancer, pancreatic cancer, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma. While these “Tier 2” cancers are not as frequent due to NDMA exposure, they are still a possible result.
New Cases Continue to Join the MDL
Despite the difficulties presented by COVID-19, new cases have continued to be filed in the MDL at a rapid clip. For example, as of March 28, the plaintiff in one of the most recent cases to join the MDL had filed his complaint only on March 24, showing that new cases continue to be filed amid the ongoing pandemic.