The federal multidistrict litigation established for all Zantac lawsuits stemming from recent drug recalls continues to move forward, with the issuance of two new pretrial orders in the U.S. District Court, Southern District of Florida.
The first was issued on April 10th and names a defense attorney as “Interim Retailer Liaison Council.”
“The Court understands that, before a Master Complaint is filed, there may be uncertainty for the Retailer Defendants, Generic Defendants, and other Defendants as to the extent and nature of their alleged liability,” the Order states. “The Court will address the appointment of permanent defense leadership at an appropriate point when the parties are more informed as to their needs and the extent of their common interests.”
The second Pretrial Order is dated April 15th, and sets protocols for the production of records needed for the litigation’s Initial Census for deceased and incapacitated Zantac claimants.
At least 229 Zantac lawsuits are pending in the Southern District of Florida. The multidistrict litigation includes both personal injury lawsuits filed on behalf of individuals who developed cancer due to the ingestion of allegedly tainted medications, as well as class action complaints that seek compensation for medical monitoring, refunds, and other economic damages for consumers who purchased recalled heart burn medications.
The federal Zantac litigation has been forced to suspend all proceedings that require travel or in-person interaction due to the global coronavirus pandemic. However, the presiding judge has indicated that the lawsuits will continue to move forward “to the extent possible” until the crisis passes.
To that end, the Court plans to convene an Initial Conference on May 12th via videoconference. Interviews for Plaintiffs’ Leadership Appointments will also be conducted during videoconferences scheduled for May 6th and 7th.
The U.S. Food & Drug Administration (FDA) began investigating name-brand and generic versions of Zantac last fall, after Valisure notified the agency that it had detected Nitrosodimethylamine (NDMA) – a probable human carcinogen – in every sample it tested and often at levels that far exceeded the recommended daily limit of 96 nanograms.
At the time, Valisure asserted that NDMA resulted from the instability of the ranitidine molecule, which appeared to produce the carcinogen when subjected to conditions mimicking human digestion. Ranitidine is the active ingredient in Zantac.
In January, Emery Pharma announced that its own tests suggested ranitidine produced NDMA when subjected to high temperatures typically encountered during shipment and storage.
Earlier this month, the FDA confirmed that levels of NDMA can increase in ranitidine over time and ordered manufacturers to immediately recall all name-brand or generic Zantac products remaining on the market. But by that time, however, many drug makers had already announced voluntary Zantac recalls and several major retailers had pulled all ranitidine-containing medications from store shelves.