Even after the global Zantac recalls of 2019 and 2020 and the associated controversy, the courtroom saga over the medicine's risk is just getting started. This week, branded drugmakers GlaxoSmithKline, Sanofi, Pfizer and Boehringer Ingelheim lost an attempt to escape class-action lawsuits over their marketing of the decades-old drug.
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 cases stem back to the investigation into cancer-causing impurities in the drug and last year's FDA order demanding the removal of Zantac and all generics from the market. In making that order, the agency said the drug can contain the contaminant N-Nitrosodimethylamine, which increases over time during warm storage. 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, lawsuits started flying. Back in 2019, even before the FDA's order, law firms sued the branded drugmakers for allegedly misleading consumers about the drug's risks.
"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 following the court's decision this week.
GlaxoSmithKline declined to comment on the litigation. Representatives for Sanofi and Boehringer Ingelheim said the companies "remain confident in the strength of our defenses."
"In particular, as both FDA and the European Medicines Agency have recently published, the weight of the scientific evidence does not support the plaintiffs’ claims that Zantac causes cancer," Sanofi's spokesperson added.
Generics companies also faced lawsuits over Zantac copycats, but those companies scored a major win in July when Rosenberg threw out claims against those defendants. The following month, some generics companies told the court they planned to pursue reimbursement of defense costs from the plaintiffs, Reuters reported.
As for the branded companies, they're likely looking at a complex legal fight in the months and years to come. In a statement, lawyers for the plaintiffs said they're pursuing claims on behalf of more than 100,000 people who took Zantac and now have cancer. In addition, hundreds of thousands of people nationwide have taken or purchased the drug, the lawyers said.
As the litigation has unfolded since the initial filings, at least one drugmaker has faced new allegations of not being transparent. In May, lawyers for the plaintiffs accused Sanofi of "widespread" destruction of employee emails tied to its 2019 Zantac recall. Sanofi "did not intentionally destroy any emails related to the Zantac litigation," a spokesperson said at the time.
Editor's note: This story was updated with comments from Sanofi and Boehringer Ingelheim.