Following FDA investigations on a contaminant suspected of causing cancer, Zantac, a renowned medication for acid reflux, was officially taken off the market in the United States in April. The dilemma is far from over for Sanofi and other firms facing litigation related to the saga.
Sanofi has been blamed for the ‘widespread’ devastation of the employee’s emails related to drug recall in 2019, followed by an official ban by the FDA in 2020, according to a recent report by lawyers who are representing over 70,000 patients. The company, along with many others, is facing litigation arguing that they failed to disclose the cancer risks associated with the drug, and the latest report has highlighted the obstacles erected by drugmakers to stall the judicial proceedings, according to plaintiffs’ lawyers.
According to the lawyers, the alleged email tampering by the company “has resulted in the delay and/or postponement of many key Sanofi depositions.” They have now requested additional time to prepare for their upcoming hearings, which are set to begin next year.
Sanofi “did not intentionally destroy any emails related to the Zantac litigation,” a spokeswoman told. “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.
Besides Sanofi, other drug manufacturing companies including Boehringer Ingelheim, GSK, and hundreds of generic firms have been blamed for failing to warn the consumers about the drug’s possible risks. In their request to the court to postpone the judicial proceedings, the plaintiffs’ lawyers expressed concerns over the expurgated documents that were initially provided by GSK including other issues.
Sanofi had announced in late 2019 that OTC ( Over-the-counter) Zantac will be discontinued in the United States and Canada due to the possibility of contamination with the alleged carcinogen NDMA ( N-nitrosodimethylamine). The FDA had instructed that the medication and all of its generic versions be removed from the market by April 2020.
In the meantime, Sanofi unveiled in August 2020 that the company was being investigated by the Department of Justice over alleged False Claim Act violations related to the Zantac recall. Sanofi and GSK also revealed that the Attorney General of New Mexico had filed Zantac-related litigation against them. The drugmakers are accused of misleading advertising, negligence and, community nuisance in the complaint, which says they breached the state’s unfair practices act.