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On December 6, U.S. District Judge for the Southern District of Florida, Judge Robin L. Rosenberg granted summary judgment in favor of defendants Pfizer, Boehringer Ingelheim, GlaxoSmithKline (GSK) and Sanofi, in MDL 2924 – In Re: Zantac (Ranitidine) Products Liability Litigation. The judge determined that the science supporting plaintiffs’ claims that Zantac, a popular heartburn medication, causes cancer was unreliable. The move effectively dismisses thousands of claims pending in both the MDL and the registry against the drug manufacturers. The ruling did not impact lawsuits filed against the manufacturers in state courts around the country.
Plaintiffs had alleged that their cancers, including esophageal, bladder, gastrointestinal, liver and pancreatic cancers, were caused by the active ingredient in Zantac, ranitidine, which degrades over time and produces a carcinogen known as NDMA. Zantac, once the best-selling drug in the world with eventual sales reaching $1 billion, was first approved in 1983, but was pulled from the market in 2019 by some manufacturers and pharmacies and was later the subject of a voluntary recall by the Federal Drug Administration (FDA) in 2020 after research indicating the level of NDMA in the drug increased over time, rendering the drug potentially unsafe. By the time of the recall, there were also a number of manufacturers making generic versions of ranitidine in prescription and OTC forms.
In a 341-page opinion, Judge Rosenberg found that the plaintiffs’ science experts used unreliable methodologies in reaching their conclusions that Zantac and ranitidine could cause cancer. She noted that the “admissibility of expert testimony is governed by Federal Rule of Evidence 702”, which combined with the ruling in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), rules that “expert testimony is admissible only if it is both reliable and relevant.” In granting the defendants’ motion for summary judgment, the judge ruled that:
“Federal Rule of Civil Procedure 56 requires a court to grant summary judgment for a moving party when the party proves that there is no genuine dispute of material fact and that the party is entitled to judgment as a matter of law. In a products liability MDL, the plaintiff must have admissible primary evidence with which to establish general causation. See Chapman, 766 F.3d at 1308, 1316. As a result, if the plaintiff does not have this evidence, then there is no genuine dispute of material fact, and the defendant is entitled to judgment as a matter of law.”
In the wake of the decision, plaintiffs’ counsel have stated that will appeal to the Eleventh Circuit to seek reversal of Judge Rosenberg’s ruling.
Read more of our Zantac litigation updates here.
