Court to assess expert testimony linking Zantac side effects and cancer next week
As part of this process, both parties have proposed expert witnesses who will testify about the link between Zantac and cancer, as well as other scientific issues in the cases.
Earlier this year, a decision was made by leading attorneys involved with Zantac MDL to only progress on five specific types of NDMA-related cancer, bladder cancer, esophageal cancer, gastric cancer , liver cancer and pancreatic cancer.
Named for a U.S. Supreme Court decision that established standards for the admissibility of expert testimony in the federal court system, Daubert v Merrell Dow Pharmaceuticals, Inc., hearings are intended to allow the judge to act as a “gatekeeper” to assess whether opinions are sufficiently strong and reliable. If the defendants succeed in convincing the court to exclude the expert testimony proposed by the plaintiffs, it could leave the former users unable to establish that their cancer was caused by Zantac. Similarly, if the Court excludes defense experts, it could prevent drugmakers from challenging key elements of plaintiffs’ claims.
According to a joint motion (PDF) filed September 12, hearings for Zantac Daubert will be held September 21 and 22, with additional hearings set for September 30.
Zantac Cancer Risks
Public concerns about the link between Zantac and cancer first emerged in September 2019, when an online pharmacy discovered that each pill could expose users to high levels of NDMA, which is a known carcinogen often used to cause cancer in laboratory animals.
While the FDA found that the safe daily limit for exposure to NDMA in pharmaceutical drugs is only 96 nanograms (NG), the pills tested by the independent pharmacy revealed that users may be exposed to over 3 million nanograms of each Zantac pill.
Investigations confirmed that the problems were not caused by contamination or changes in the manufacturing process, but appeared to be part of the inherent molecular structure of Zantac’s active pharmaceutical ingredient, ranitidine.
The plaintiffs allege that the makers of Zantac knew or should have known about these problems for decades, but aggressively marketed and sold prescription, generic, and over-the-counter versions of Zantac for years, without warning users that it could develop. as the pills are stored or travel through the body, increasing Zantac’s long-term cancer risk.
Zantac September 2022 Trial Update
As the parties head to Zantac Daubert hearings next week, the outcome could have a profound impact on ongoing litigation in the federal court system, where most US litigation is based. However, thousands of lawsuits regarding the link between Zantac and cancer have also been filed in various state courts, which will not be affected by the federal ruling.
At the outset of litigation, to help manage the growing number of cases filed, a Zantac Registry was established within the MDL, allowing individuals to register their claims and provide certain information about the type of cancer caused by Zantac, in order to preserve the statute of limitations without filing a lawsuit.
This month, Judge Rosenberg issued a court order (PDF) granting a request from the drugmakers to finalize and close the registry on September 14, three years after the first warnings that linked Zantac to exposure to the NDMA.
After this September 2022 update, lawsuits against Zantac must be filed in state or federal court before the expiration of the individual statutes of limitations that apply to each claim.