GSK settles second Zantac case in a month in California amid slew of US litigation

Firm wishes to avoid ‘protracted litigation’ with confidential settlement | Counsel for GSK told Delaware judge in January that lawsuits are ‘way ahead of the science’.

GSK announced today (February 29) that it had settled another lawsuit over discontinued heartburn medication Zantac (ranitidine) in California, wishing to avoid “the distraction related to protracted litigation”.

This follows a similar settlement made by the global biopharma firm in a case over Zantac in the state earlier in the month, and leaves tens of thousands of other cases about the drug in the US still pending.

Claims have been brought against GSK and other ranitidine manufacturers following the discovery in 2019 that the drug could contain unacceptably high levels of N-Nitrosodimethylamine (NDMA), which can be carcinogenic.

In today’s statement, GSK said it did not admit any liability in the settlement made with claimants Boyd/Steenvoord, the terms of which were confidential.

It said it would “continue to vigorously defend itself based on the facts and science in all other Zantac cases”.

‘Way ahead of the science’

The US Food and Drug Administration withdrew Zantac from the market in April 2020. It said it had determined that NDMA levels in some ranitidine products increased over time and when stored at higher temperatures.

Low levels of NDMA are present in some foods and water and considered harmless, but sustained exposure to higher levels can increase the risk of cancer.

In October last year, GSK was facing around 79,000 cases related to Zantac in the US, with 73,000 of them in Delaware, Reuters reported.

Citi analysts estimated at the time that the London-headquartered firm would settle all Zantac cases against it for a total of around $5 billion in the first quarter of 2024.

In January this year, lawyers for GSK, Pfizer and other pharmaceutical companies told a Delaware judge that evidence to be used in about 72,000 lawsuits regarding ranitidine was not supported by science.

Representing GSK, Mark Cheffo of Dechert said that the litigation was “a case of lawyers and lawsuits getting ahead of the science—way, way ahead of the science”.

Defendants said that no reliable studies linked Zantac to cancer, and that the levels of NDMA that might appear in Zantac were similar to those found in common foods.

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