Zantac-Cancer Link To Be Considered For Bellwether Selection

Zantac-Cancer Link To Be Considered For Bellwether Selection

Introduction

The U.S. District Judge Robin L. Rosenberg, presiding over all Zantac litigation, indicated that the court would weigh on the admissibility of expert witness testimony concerning the link between Zantac and cancer before moving forward with bellwether trials.

Last week two orders were issued by the court, one establishing deadlines for the proceeding’s Initial Census and another laying out a path for moving the cases forward.

According to an Order issued on May 27, the deadlines for submission of Census Plus Forms are set as follows:

1. Plaintiffs whose case is filed on or before May 31, 2020 (whether filed in the MDL or transferred or removed to the MDL), must file his/her Census Plus Form no later than July 21, 2020. For any Plaintiff whose case is filed on or after June 1, 2020, the Census Plus Form shall be due 60 days from the date of such filing. 
2. Individuals who retain counsel on or before June 30, 2020, and seek to participate voluntarily in the Registry as a claimant must file his/her Census Plus Form no later than August 17, 2020. For any individual who retains counsel on or after July 1, 2020, the Census Plus Form shall be due either 30 days from the end of the calendar-year quarter in which he/she retained counsel, or 45 days from the date of retention, whichever is later. 

According to another Order issued on May 28, an initial phase of discovery centered on general causation issues about the link between Zantac and cancer will be completed over the next 18 months, post which the parties will file Daubert challenges to the admissibility of expert witness testimony.

In September 2019, public concerns about the Zantac cancer risk emerged when an independent on-line pharmacy Valisure discovered that each pill may expose users to NDMA levels higher than the permissible daily intake limits set by the FDA. The pharmacy found that some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, while the daily limit deemed safe by the FDA is only 96 ng.

In April 2021, Sanofi informed the investors that it was planning to bring back Zantac with the generic pharmaceutical ingredient found in Pepcid; famotidine. The spokesperson for Sanofi announced on April 28, 2021, that the company will launch a new product named Zantac 360. The company even notified that it will use famotidine, which is the active ingredient in Pepcid instead of ranitidine to manufacture the new product. The company announced it will release two versions of the new Zantac drug on the U.S. market in June 2021. The products include a 10 mg famotidine “Original Strength” version, and a 20 mg “Maximum Strength” version.

More than 230 Zantac lawsuits are pending in the Southern District of Florida, and it is estimated that the numbers would rise in the coming years. Each lawsuit claims that ranitidine, an active ingredient in Zantac, produces high levels of the known human carcinogen Nitrosodimethylamine (NDMA), which leads to various types of cancers, including breast cancer, bladder cancer, stomach cancer, testicular cancer, and other injuries.