Zantac Lawsuits: “In Extremis” Depositions Protocol Outlined

Zantac Lawsuits: “In Extremis” Depositions Protocol Outlined

Introduction

Last week, U.S. District Judge Robin L. Rosenberg, overseeing the federal multidistrict Zantac litigation, issued a pretrial order indicating that protocol for “In Extremis” depositions has been established for preserving the testimony of plaintiffs suffering from extreme health problems, who may not survive to see their cancer claims reach a courtroom.

Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.

According to the pretrial order, a plaintiff will be considered “In Extremis” based on medical evidence or affidavits by a physician or the plaintiff, if he/she:

• Has reached, or is expected to reach within the next six months, the state or condition of being no longer capable of testifying competently in a deposition.
• Is not expected to survive beyond the next twelve months.

The plaintiff must provide the following documents to the defense counsel at least thirty days before the in extremis deposition:

• Any available medical records within the plaintiff’s possession that are not already produced to Defendants.
• Any available records within the plaintiff’s possession relating to damages claims.
• A completed version of any plaintiff Fact Sheet, standard interrogatories, or other written discovery that plaintiffs are required to produce in this litigation, including any documents required to be produced therewith, if not already provided to Defendants.
• Executed records authorizations and documents required by any Order in this litigation or by any of the plaintiff’s medical providers.

Last month, in a Q3 report, Sanofi-Aventis US LLC and GlaxoSmithKline LLC indicated that they are facing a probe by the U.S. Department of Justice (DOJ) over the heartburn drug.

The DOJ will be investigating whether the drug makers knew about the presence of the known carcinogenic chemical byproduct N-nitrosodimethylamine (NDMA) in Zantac and still failed to adequately inform regulators about the potential risks. It will also look into when the manufacturers discovered that the main ingredient in the recalled heartburn drug causes cancer.

Currently, about 300 Zantac lawsuits are pending in the Southern District of Florida. The lawsuits are consolidated and centralized under MDL No: 2924, for coordinated discovery and pretrial proceedings.