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Zantac Maker accused of destroying Recall Emails

Zantac maker Sanofi has been accused of destroying emails linked to its 2019 Zantac recall. Lawyers representing thousands of former Zantac users in cancer lawsuits made the accusation in a court filing last month.

According to the Plaintiffs’ Motion to Modify Pretrial Order No. 30 filed on May 7, 2021, Sanofi’s “widespread destruction of employees’ emails” violated document preservation orders dating back to November 2019.

The plaintiffs’ lawyers further said that the destruction of emails and failure to produce other requested documents has “resulted in the delay and/or postponement of many key Sanofi depositions (some more than once).”

Zantac lawsuits accuse several brand-name and generic drug makers of failing to warn patients that Zantac’s key ingredient, ranitidine, could contain unsafe levels of the carcinogen N-Nitrosodimethylamine, or NDMA, which caused them to develop cancer.

1,300 Cases filed; 70,000 registered

Plaintiff’s attorneys have called the Zantac litigation “one of the largest and most complex multidistrict proceedings in history.”
Zantac litigation has thus far seen roughly 1,300 cases filed. Some 70,000 claims have been registered that involve 10 different cancers, including: bladder, breast, colon, kidney, liver, stomach, ovarian, esophageal, prostate, melanoma.

Sanofi Response

A Sanofi spokeswoman told Bloomberg News in an email: “There was no intentional destruction of data. Sanofi is working to obtain as much of the data as possible from alternative sources. This issue has no impact on the strong defenses Sanofi has in this litigation, and the company remains fully confident in the safety of Zantac.”

Defendants accused of Delays

While only Sanofi is accused of destroying emails, plaintiffs’ lawyers accuse other brand name defendants — including GlaxoSmithKline and Boehringer Ingelheim — of “consistent and widespread” document production delays.
The plaintiffs’ court filing said that in order to keep the litigation on schedule, the Court expected all parties to work together, but “Defendants have not kept their end of the bargain,” and have repeatedly violated Court-ordered deadlines. They further said that delayed documents contain “indispensable information” from clinical trial data, adverse events reports, lab testing and other key science that experts need to provide their opinions.
Because Defense’s delays have altered the scheduling, plaintiffs’ lawyers have asked the Court for more time to review documents once defendants finally deliver them.

Zantac Bellwether Trials

Lawyers on both sides expect bellwether trials in the Zantac litigation to begin in late 2021 or early 2022.

New Study links Ranitidine to Bladder Cancer

In the wake of Zantac lawsuits, recent studies have linked Zantac (ranitidine) to an increased cancer risk. April 2021 saw the latest research published in the American Journal of Gastroenterology. It found and presented evidence of an increased risk of bladder cancer in ranitidine users.

Scientists from the University of Aberdeen identified 3,260 cases and 14,037 controls from bladder cancer cases diagnosed between 1999 and 2011. The risk went up in people who used the drug for more than three years.
In contrast, there was little evidence of increased bladder cancer risk with proton pump inhibitor use. Study authors said more research is needed.

FDA Discovers Carcinogen in Zantac

The U.S. FDA reported on September 13, 2019 that it had discovered the carcinogenic contaminant N-nitrosodimethylamine (NDMA) in Zantac (ranitidine). Zantac is common heartburn medication available in both prescription and over-the-counter versions.

The FDA advisory stated that the level of contamination is “low”; however, the levels the agency called low have been found to be between 3,000 and 26,000 times higher than what the FDA had determined to be “safe.”

The first Zantac lawsuit was filed in California on the same day the FDA issued its advisory. Plaintiffs in Zantac lawsuits accuse drug makers Sanofi and Boerhringer Ingelheim of making, marketing, and selling a product they knew or should have known had been contaminated with an industrial chemical known to cause cancer.

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