A news report on blumberg.com states that French drug manufacturer Sanofi allegedly destroyed company emails that were connected to a 2019 recall of the company’s heartburn medication Zantac. The allegations come from plaintiffs’ attorneys who are representing 70,000 former users of Zantac who have filed a lawsuit against the company in the United States.
According to the news report, some of the Deleted emails were from Michael Bailey. Michael Bailey is the head of regulatory affairs for Sanofi’s U.S. Consumer Healthcare Division. The deleted emails allegedly make it more difficult for the complaints to prove that Sanofi, along with other drug manufacturers, allowed a known carcinogen to contaminate its Zantac, over-the-counter heartburn medication. The allegations were part of May 7, 2021, court filing by plaintiffs’ attorneys.
Patient plaintiffs’ attorneys in the case stated that the deletion of the emails caused the postponement and delay of several important Sanofi depositions. The plaintiffs’ attorneys in the case also petition the judge to extend the Trial date, which is to begin next year.
The News report states that Sanofi officials began an internal investigation into its companies’ email destruction. Those officials are required to deliver their findings in a report to the judge overseeing the Zantac lawsuits. According to Ashley Koss, a US-based spokeswoman for Sanofi, the company has provided hundreds of thousands of documents and relevant discovery to the plaintiffs’ attorneys. In addition, Sanofi had voluntarily disclosed that some email requests by plaintiffs’ attorneys “were not preserved as intended.” Koss stated that the data was not intentionally destroyed, and the company is working hard to recover as much of that data as they can from alternative sources.
Santa Fe, Boehringer Ingelheim, Glaxo Smith Kline PLC, and 33 generic drug manufacturers, 25 retailers, and four major distributors have the name do defendants in lawsuits alleging the companies failed to warn consumers about Zantac’s health risks adequately. In 2018, the FDA discovered the medication contains dangerous levels of N-Nitrosodimethylamine or NDMA. All Zantac products were then removed from retail shelves in the United States and Canada.
According to the news article, over 1,300 lawsuits involving allegations made by over 70,000 former users of Zantac were consolidated before U.S. District Judge Robin Rosenberg in Florida. The lawsuits allege that FDA regulators set and an allowable daily limit of 96 ng of MDMA. However, some lots of Zantac contain more than 3,000,000 ng per dose.
The news report also states that Zantac is not the only medication that has been recalled over the NMDA contamination problem. The FDA warns that extended-release Metformin was also recalled for dangerous levels of NDMA.
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