Over 70,000 people have filed claims against Sanofi, the French pharmaceutical company that produced the branded heartburn medication, Zantac until the drug was recalled last year after studies showed that the drug contained the cancer-causing chemical, NDMA.
Zantac litigation is set to begin next year, with a massive consolidation of suits—approximately 1,300—in Florida before U.S. District Judge Robin Rosenberg.
According to Bloomberg.com, Sanofi destroyed internal emails that were tied to the drug’s recall, according to lawyers for people who were prescribed the medication and who sued the company in the U.S.
Bloomberg.com says that according to a May 7 court filing, the deleted emails, including those of Michael Bailey, the head of regulatory affairs for the company’s U.S. Consumer Healthcare division, will make it more difficult for plaintiffs to prove Sanofi and manufacturers of the generic version were aware of the contamination, which is caused when the active ingredient, ranitidine, is exposed to high temperatures or sits on the shelf for a long time (or both).
The allowable daily limit of NDMA set by the FDA was 96 nanograms. But studies showed that one single dose of Zantac exceeded 3 million nanograms. NDMA has been associated with several types of cancers.
Valisure, the online pharmacy and quality-assurance analytical laboratory, was first to sound the alarm about NDMA contamination in Zantac to the FDA, in June 2019. Valisure filed a citizen’s petition three months later requesting that FDA recall all ranitidine products.
Per Bloomberg.com, the mishandling of emails has “resulted in the delay and/or postponement of many key Sanofi depositions,” lawyers for former patients said. Consequently, plaintiff attorneys requested more time to prepare for trial.
In August, Sanofi will present to Judge Rosenberg the results of an internal probe concerning the destruction of the emails.
A company spokesperson said that “Sanofi has already provided hundreds of thousands of pages of relevant discovery to the plaintiffs,” but nonetheless voluntarily disclosed that certain emails requested by plaintiffs were not preserved as intended.
The spokesperson added, “There was no intentional destruction of data,” and the company will attempt to obtain as much of the data as possible from “alternative sources.” Moreover, the spokesperson said that the email destruction “has no impact on the strong defenses Sanofi has in this litigation, and the company remains fully confident in the safety of Zantac.”
In addition to Sanofi, defendants named in the lawsuits include GlaxoSmithKline and Boehringer Ingelheim GmbH, both of which are accused by plaintiff attorneys of being slow to hand over documents for pretrial discovery. Defendants will also include 33 generic drug makers, 25 retailers and four distributors.
Judge Rosenberg is being asked to create two separate class actions for Zantac litigation. The first would involve users who have already developed cancer while the second class would consist of users who have yet to be diagnosed with cancer.
Other drugs have been shown to contain NDMA, such as the popular diabetes medication, Metformin. However, NDMA contamination seems to be the most problematic in Zantac.
