Next stage in GSK’s Zantac defense gets underway today

A hearing will get underway in Delaware later today in the latest phase of GSK’s attempts to defend itself from allegations that its Zantac drug caused cancer in patients.

The three-day hearing comes a few months after GSK decided to settle a complaint brought in California on similar grounds, rather than proceed with a jury trial, without admitting any liability. It said at the time that the decision to settle was taken to “avoid distraction related to protracted litigation” over the claimed link to cancer, which first hit the headlines in 2022.

The common claim in the lawsuits is that a contaminant in Zantac (ranitidine) called N-nitrosodimethylamine (NDMA) – as well as other ranitidine products – increased the risk of cancer.

Last May, Delaware judge Vivian Medinilla laid out a way forward to handle approximately 77,000 Zantac lawsuits filed in the state, including a process for identifying so-called ‘bellwether’ plaintiffs that can be used for a trial to determine whether Zantac products caused cancer.

Federal court Zantac lawsuits were dismissed after a hearing last year in a judgment that has gone to appeal, while in Canada the Supreme Court of British Columbia ruled that lawsuits against GSK and Sanofi lacked sufficient evidence of a link.

Zantac was originated by GSK and launched by the company in the early 1980s, which sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion over the years, before selling off rights to other companies. Along with GSK, Pfizer, Boehringer Ingelheim, Sanofi, and Patheon are appearing as defendants at the hearing.

Ranitidine was also widely available in generic form from several manufacturers before the NDMA contamination was identified and the FDA banned sales in 2020. The link with cancer has been disputed by the FDA as well as other regulators, including the EMA in Europe.

The Delaware hearings are viewed as the greatest near-term chance that the class actions against ranitidine manufacturers will be revived, and whether GSK may consider additional settlements.

They will include testimony claiming that “testing by regulators, ranitidine manufacturers, and independent laboratories shows that one ranitidine 300 mg tablet can contain tens of thousands of nanograms (ng) of NDMA, greatly exceeding the FDA’s daily acceptable intake limit of 96 ng,” according to law firm Wisner Baum, which is representing plaintiffs in the litigation.

A recent update from analysts at Shore Capital argued that concerns about the Zantac litigation were weighing too heavily on the stock, pointing out that it is given that its stock is trading at around nine times earnings, well below the approximately 15 multiple seen with its peers.

The investment group said that the federal multi-district litigation (MDL) ruling in favour of GSK suggests the worst-case scenario of tens of billions of dollars in liability is unlikely to materialise.

A spokesman for GSK said: "We’re very confident in our position and continue to vigorously defend ourselves based on the facts and science of this litigation. Since 2019, there have been 15 peer-reviewed epidemiological studies on the effects of ranitidine use on humans which reflect the scientific consensus that there is no consistent or reliable evidence that ranitidine increases the risk for any type of cancer. 
 
“In Delaware, GSK is arguing that the court should follow the federal MDL court’s comprehensive Daubert ruling which, based on the scientific evidence, effectively dismissed all cases and claims related to the federal case’s five designated cancers. Like the federal courts, Delaware state courts apply the Daubert standard to determine the admissibility of expert evidence.  

“The Delaware court are also considering the admissibility of evidence concerning five additional cancers, all of which should be rejected under the standards set by the MDL court, especially given that the MDL plaintiffs previously abandoned those claims due to a lack of scientific evidence."