Sanofi Accused of Destroying Emails Tied to Zantac Recall
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 consumers to show Sanofi and other drug makers allowed a suspected carcinogen to taint Zantac, an over-the-counter medication, according to a May 7 court filing.
The mishandling of emails has “resulted in the delay and/or postponement of many key Sanofi depositions,” lawyers for former patients said. They asked a judge for more time to prepare for their first trials, which are set to start next year.
Sanofi officials began an internal probe about the email destruction and are scheduled to deliver a report to a judge overseeing Zantac cases in August, the filings show.
“Although Sanofi has already provided hundreds of thousands of pages of relevant discovery to the plaintiffs, Sanofi has voluntarily disclosed that certain emails requested by plaintiffs were not preserved as intended,” Ashleigh Koss, a U.S.-based spokeswoman, said in an email Tuesday.
“There was no intentional destruction of data,” Koss said. “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.”
Read More: Glaxo, Sanofi, Peers’ Zantac Legal Exposure May Be Multibillions
Sanofi, GlaxoSmithKline Plc and Boehringer Ingelheim GmbH -- along with 33 generic drug makers, 25 retailers and four distributors -- are accused in the lawsuits of failing to properly warn users about Zantac’s health risks. In 2018, the U.S. Food and Drug Administration found the drug contained dangerous levels of nitrosodimethylamine, or NDMA. It was pulled from shelves in the U.S. and Canada at the request of regulators.
Only Sanofi has been accused in the filings of mishandling emails. Former users also complain Glaxo and Boehringer officials have been slow to hand over records in the pre-trial stage of the case. Sanofi sold Zantac in the U.S. and Canada under a license from Glaxo.
More than 1,300 suits -- involving claims by more than 70,000 former Zantac users -- have been consolidated before U.S. District Judge Robin Rosenberg in Florida. It’s one of the largest such consolidations in the U.S. She’s overseeing information exchanges and early trials to test the merits of the cases. Rosenberg has already thrown out some claims, including those alleging Zantac was defectively designed.
Former Zantac users argue FDA regulators set an allowable daily limit of 96 nanograms of NDMA, but researchers found more than 3 million nanograms in a dose of the heartburn treatment.
Plaintiffs’ attorneys want Rosenberg to set up two class-action cases for ex-Zantac users. The first would include cancer patients who suffered economic losses tied to the heartburn drug. The second would encompass former users who haven’t been diagnosed with the disease and seek compensation for medical monitoring in the future.
Zantac isn’t the only drug recalled over NDMA contamination. FDA officials found the potential carcinogen in some extended-release versions of Metformin, a popular diabetes drug. Regulators requested drug makers such as Amneal Pharmaceuticals Inc., Actavis Pharma Inc., Apotex Corp., Lupin Pharma and Marksans Pharma Ltd. to recall certain lots of the pills last year.
The Zantac case is In Re Zantac (Ranitidine) Products Liability Litigation, 20-MD-2924, U.S. District Court for the Southern District of Florida (West Palm Beach).
©2021 Bloomberg L.P.