The federal litigation established earlier this year for Zantac cancer lawsuits finally convened an Initial Conference last month, following a delay necessitated by the global coronavirus pandemic.
The conference took place over a period of two days, May 12th and 13th, and was conducted via Zoom to comply with continuing social distancing requirements.
During the proceeding, the Court adopted the parties’ proposed case management schedule, which called for an initial phase of discovery to take place over the next 18 months. Once that phase is completed, the parties will file Daubert challenges to the admissibility of expert witness testimony regarding the alleged link between Zantac and cancer.
According to a Pretrial Order dated May 28th, the Court will take up those challenges before the litigation proceeds with bellwether case selection. However, the parties are to begin discussing possible protocols for the selection process during the 18-month discovery period. All fact discovery from the drug makers, including document discovery and fact deposition, will also be completed during the 18-month period.
“The first Case Management Conference following the Initial Conference will be scheduled for early July 2020,” the Order states. “By separate order, the Court will communicate the date and means of attendance, which the Court anticipates will likely be through Zoom videoconference, given the continuing COVID-19 situation.”
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 litigation surrounding Zantac began to gain steam last September, after 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.
Valisure, an online pharmacy that batch tests every drug it sells, had notified the FDA of the contamination several months earlier, after detecting 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.
Months later, Emery Pharma disclosed 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 finally confirmed that NDMA can increase in Zantac over time and ordered the immediate recall of all ranitidine-containing heartburn drugs remaining on the market.