The popular heartburn med Zantac officially exited U.S. shelves last April after FDA probes into an impurity believed to cause cancer. For Sanofi and other companies battling lawsuits from the saga, the problem is far from over.
In a new filing from lawyers representing more than 70,000 former patients, Sanofi is accused of “widespread” destruction of employee emails tied to its 2019 recall of the drug, which preceded the FDA’s outright ban in 2020. The company and many others face lawsuits alleging they concealed cancer risks from the drug, and the new filing outlines alleged roadblocks the drugmakers have put up to delay the legal process, the plaintiffs’ lawyers say.
The company’s purported email tampering “has resulted in the delay and/or postponement of many key Sanofi depositions,” the lawyers claim. Now, they’ve asked for more time to prepare for their first trials, which are due to kick off next year.
Sanofi “did not intentionally destroy any emails related to the Zantac litigation,” a spokeswoman told Fierce Pharma via email. “Any suggestion to the contrary is false.”
“Sanofi has provided hundreds of thousands of pages of relevant discovery to the plaintiffs, including internal emails, test results, safety assessments, and correspondence with regulatory authorities,” she added.
Aside from Sanofi, other drugmakers such as GlaxoSmithKline, Boehringer Ingelheim and dozens of generics companies are accused in the Zantac lawsuits of failing to warn customers about the potential dangers of the popular drug. The plaintiffs’ lawyers also raised concerns about GSK initially producing redacted documents, among many other points, in asking the court to delay the legal proceedings.
In late 2019, Sanofi said it would recall Zantac OTC (over-the-counter) in the U.S. and Canada over possible contamination with the suspected carcinogen N-nitrosodimethylamine (NDMA). By April 2020, the FDA had ordered the drug and all its generics off shelves.
Meanwhile, in August 2020, Sanofi revealed that it was the subject of a Department of Justice probe over possible violations of the False Claims Act tied to the Zantac recalls. At the time, both Sanofi and GlaxoSmithKline disclosed a Zantac-related lawsuit from the New Mexico Attorney General. That suit claims the companies violated state’s unfair practices act and charges the drugmakers with false advertising, public nuisance and negligence.