The Zantac litigation currently underway in the U.S. District Court, Southern District of Florida, continues to move forward, following the issuance of an order establishing deadlines for the proceeding’s Initial Census.
There are currently more than 230 Zantac lawsuits pending in the Southern District of Florida. The docket includes personal injury claims filed on behalf of individuals who allegedly developed cancer related to the use of name-brand and generic versions of Zantac, as well as class actions that seek funds for medical monitoring and other economic damages on behalf of consumers who purchased tainted heartburn medications.
The judge overseeing the federal Zantac litigation ordered a 2-phase Initial Census last month. The exercise is intended to provide the Court with preliminary information on all filed Zantac lawsuits and create a voluntary Census Registry of potential unfiled claims.
According to an Order dated May 27th, any plaintiff whose case is filed before May 31, 2020 (whether filed in the MDL or transferred or removed to the MDL) must submit a Census Plus Form no later than June 21, 2020. A Census Plus Form must be filed within 60 days of filing for any case filed on or after June 1, 2020.
Plaintiffs who retain a Zantac lawyer on or before June 30, 2020, and who wish to participate in the litigation’s voluntarily Census Registry must file a Census Plus Form no later than August 17, 2020. Those who retain an attorney on or after July 1, 2020 should submit their form either 30 days from the end of the calendar-year quarter in which counsel was retained, or 45 days from the date of retention, whichever is later.
Zantac lawsuits have been mounting in courts across the United States since last September, when the U.S. Food & Drug Administration (FDA) warned that some ranitidine-containing heartburn drugs might contain excessive levels of N-Nitrosodimethylamine (NDMA). NDMA is designated a probable human carcinogen due to animal studies that suggest exposure to high levels may increase the risk for various cancers, including kidney cancer, liver cancer, gastrointestinal cancer, and breast cancer.
The online pharmacy Valisure alerted the FDA to the contamination several months earlier, after its own testing program detected NDMA in every sample of Zantac and ranitidine tested, and often at levels far above agency’s recommended daily limit of 96 nanograms. Valisure also warned the FDA that the contamination was likely due to the ranitidine molecule’s instability, which resulted in the production of NDMA when Zantac was subjected to conditions that mimicked human digestion.
Emery Pharma later reported that its own testing suggested NDMA was produced when Zantac products were exposed to high temperatures typically encountered during shipment and storage.
On April 1st. the FDA confirmed that levels of NDMA in ranitidine can increase over time. The agency ordered the immediate recall of all Zantac and generic ranitidine medications remaining on the market and urged consumers to stop using over-the-counter versions. Those taking prescription products were advised to speak with their doctors before ceasing treatment.