Zantac Problems Weigh Heavily On Drug Maker Amid NDMA Recalls, Cancer Lawsuits

Widespread Zantac recalls issued over the last several months have reportedly cost the French drug maker Sanofi $186 million last quarter, as a growing number of product liability lawsuits continue to be filed by individuals diagnosed with cancer following use of the popular heartburn drug.

Zantac (ranitidine) has been a top selling heartburn and acid reflux drug since it was introduced in the early 1980s, but most versions have been removed from the market over the past few months, after the independent online pharmacy Valisure found that it exposes users to high levels of the cancer-causing impurity N-nitrosodimethylamine (NDMA), which may be produced by the drug during storage or as it travels through the body.

Excessive levels were detected across all brands of Zantac and all lots, and it now appears the drug makers have been aware of the potential Zantac problem for decades, yet ignored warning signs.

In a quarterly report (PDF) issued on February 6, Sanofi notes it has taken a $186 million write-down following a recall of Zantac OTC (over-the-counter) versions sold by the French drug maker, resulting in an overall drop in the company’s consumer healthcare (CHC) sales of 5.2% in the fourth quarter of 2019.

“Over half of the decline was related to the voluntary recall of Zantac,” the report states. “In addition, divestments of non-core products and product suspensions due to changing regulatory requirements impacted sales performance. These factors are expected to have a dampening effect on CHC performance throughout the first half of 2020.”

While the problems with Zantac have hit several companies that manufactured or sold name-brand or generic versions of the drug since it first hit the market in 1986, Sanofi has owned the rights to the Zantac OTC brand for several years. As a result, the company has also been named in dozens of Zantac lawsuits filed by users who indicate that exposure to NDMA result in the diagnosis of stomach cancer, bladder cancer, esophageal cancer, liver cancer or other cancers along the digestive tract.

To deal with the growing number of complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation recently decided to consolidate and centralize the claims in the U.S. District Court for the Southern District of Florida, where one judge will preside over coordinated discovery and pretrial proceedings to avoid duplicative discovery into common issues, prevent conflicting schedules and serve the convenience of the parties, witnesses and court system.

However, if Zantac settlements or another resolution for the claims is not reached during the pretrial litigation and any bellwether trials, each lawsuit will later be remanded back to different U.S. District Courts nationwide, where Sanofi could face massive litigation costs and damage awards.