77,000 Zantac Lawsuits, Trials Start Feb 2023
On Wednesday, November 2nd, CFO Iain Mackay told reporters during a press briefing that GlaxoSmithKline is currently facing approximately 77,000+ cancer-related lawsuits spanning more than 4,000 cases in federal and state courts.
GlaxoSmithKline set aside $50 million in the 3rd quarter in preparation for the legal battle.
Mackay also told reporters that the legal fees mostly reflect Zantac, but no steps have been taken for a possible settlement. GSK is still very early in Zantac’s litigation process; most cases haven’t even been examined.
In August, the plaintiff in the first Zantac trial moved for voluntary dismissal in an early win for GlaxoSmithKline.
GSK expects the first trial to start in California on Feb. 13, 2023.
The case will provide insight for both the plaintiffs and GSK.
On the federal front, the claims are going through what’s known as Daubert hearings in front of District Judge Robin Rosenberg in Florida.
A trial judge uses the Daubert standard to assess whether an expert witness’s scientific testimony is based on scientifically valid reasoning that can properly be applied to the facts at issue.Cornell Law School
The judge is deciding what expert evidence can be admitted into trial.
Last year in a federal court in Florida, Judge Robin Rosenberg denied requests by the companies to throw out lawsuits by former Zantac patients asking for medical monitoring and compensation for their financial losses.
Lawsuits alleging personal injury from the drug can continue as well.
The investigation into cancer-causing impurities in the drug began last year, and the FDA ordered the removal of Zantac and all generics from the market.
In making that order, the agency said the drug could contain the contaminant N-Nitrosodimethylamine, which increases over time during warm storage.
N-Nitrosodimethylamine, also known as dimethylnitrosamine, is an organic compound with the formula (CH₃)₂NNO. NDMA has attracted wide attention as being highly hepatotoxic and a known carcinogen in laboratory animals.Wikipedia
That could “result in consumer exposure to unacceptable levels,” the FDA said last year.
Before the order, the companies had already begun a worldwide process to pull the drug from shelves.
Amid the controversy, people started filing lawsuits.
Even before the FDA’s order in 2019, law firms sued the renowned drugmakers for allegedly deceiving consumers about the potential risks of taking the medication.
“Manufacturers including GlaxoSmithKline, Sanofi, Boehringer Ingelheim and Pfizer engaged in a decades-long scheme to conceal the inherent dangers and risks associated with Zantac use despite abundant medical and scientific literature that linked ranitidine to NDMA, and we look forward to holding them accountable,” lawyers for the plaintiffs said in a statement (Sept 2021)
GlaxoSmithKline declined to comment on the litigation.