French drugmaker Sanofi and numerous other drug manufacturers, retailers, and pharmacies are currently defending lawsuits related to Zantac. At the center of the action are allegations that the drug contained potentially cancer-causing carcinogens. More than 70,000 former patients have sued the companies for their alleged failure to warn consumers about the risks associated with taking the over-the-counter (OTC) medication.
In a motion and incorporated memorandum, the plaintiffs argue the defendants’ production delays have hindered discovery. The plaintiffs claim this makes it impossible to build their cases within the discovery period initially designated by Pretrial Order No. 30 (PTO 30). These delays include Sanofi’s deletion of internal emails and pushing off key depositions during remediation efforts.
A Brief History of Zantac in the U.S.
The U.S. Food and Drug Administration (FDA) approved Glaxo Holding Ltd. to sell Zantac in 1983. By 1988, many people used the medication to treat ulcers, heartburn, and gastroesophageal reflux disease (GERD). In 1997, Glaxo’s patent expired and drugmakers began selling generic versions of the drug. Pfizer received FDA approval to sell Zantac over the counter in the U.S. in 2004. This led to an agreement with Sanofi to distribute Zantac in the U.S.
In 2018, the FDA found Zantac contained high levels of N-nitrosodimethylamine (NDMA), a known carcinogen. Low levels of NDMA are common in food and water and aren’t harmful. However, the FDA warns that high levels of NDMA may increase cancer risks.
Through independent third-party testing and FDA testing, the FDA found NDMA increased in ranitidine over time when stored at higher than room temperatures. This could happen during distribution and under normal conditions. As such, the rising NDMA levels could expose consumers to dangerous toxin levels.
By September 2019, the FDA warned consumers of the potential risks and urged them to used alternative OTC treatments for ulcers, heartburn, and GERD. In April 2020, the agency formally requested the immediate removal of all OTC and prescription ranitidine products from the market.
In Re: Zantac (Ranitidine) Products Liability Litigation
Plaintiffs have filed more than 1,300 suits against Sanofi, GlaxoSmithKline Plc (GSK), Boehringer Ingelheim GmbH (BI), 33 generic drugmakers, and over two dozen other parties. Cases were consolidated before the U.S. District Judge Robin L. Rosenberg in the Southern District of Florida as one of the largest multidistrict consolidations in U.S. history.
Discovery Delays Hinder Plaintiffs’ Progress
Discovery began in 2020, however, on May 7, 2021, the plaintiffs alleged Sanofi’s destruction of evidence and other actions have significantly delayed and hindered discovery efforts. In the plaintiffs’ motion to modify the 18-month discovery timeline, they claim the defendants’ “delays are too extensive to fully discuss in the context of this motion.” They argue that the defendants’ document production is “significantly incomplete.” Additionally, they claim three of the four brand drugmakers have violated court-ordered deadlines.
Sanofi agreed to produce non-custodial documents by December 20, 2020. By the date of the plaintiffs’ motion, Sanofi had produced 36,618 non-custodial documents, over half of which were late. Of the 55,925 custodial documents produced during Tranche 1—due by December 31, 2020—Sanofi produced over one-third late. The plaintiffs also note that Wockhardt, a generic drugmaker, produced more documents in April 2021 than GSK, BI, Sanofi, or Pfizer have produced throughout the entire litigation.
The plaintiffs state Sanofi told them of the “widespread destruction of employees’ emails in violation of three Preservation Orders dating back to November 2019” in December 2020. These emails include those of Michael Baily, head of Regulatory Affairs for Sanofi’s U.S. Consumer Healthcare division.
Sanofi won’t complete its remediation efforts related to the deleted emails until July 30, 2021, postponing key Sanofi depositions. The plaintiffs also allege Sanofi made large last-minute productions of custodial documents, further delaying depositions.
The production delays and destruction of evidence hamper the plaintiff’s ability to hold essential depositions, review historical documents. This includes clinical trial results, additional analysis, and preparation for expert testimony.
Destruction of Documents Could Lead to Sanctions
Given Sanofi’s destruction of emails in violation of preservation orders, the plaintiffs have the opportunity to bring a motion for sanctions. Spoliation of evidence occurs when a party deliberately, negligently, or accidentally destroys evidence relevant to a case, including electronically stored information (ESI).
Federal Rule of Civil Procedure 37(e) sets out potential sanctions for a party failing to take reasonable steps to preserve ESI during or in anticipation of litigation. The court “upon finding prejudice to another party from loss of the information, may order measures no greater than necessary to cure the prejudice.” Alternatively, should the court find a party deliberately tried to block the information from litigation, it may:
- Presume that the lost information was unfavorable to the party
- Instruct the jury that it may or must presume the information was unfavorable to the party
- Dismiss the action or enter a default judgment
What Comes Next in Zantac Litigation
In the ongoing litigation, the plaintiffs made a good faith effort to confer with the defendants regarding a new discovery schedule. They provided the defendants with a proposed schedule, which would extend discovery through April 2022. The major manufacturers opposed this schedule, and the generic drugmakers did not reply.
The court previously vacated the PTO 30 deadlines at a Case Management Conference on April 20, 2021. Next, the court will reset discovery deadlines after considering the plaintiff’s motion.
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