Delaware’s top court is set to hear an appeal from GSK and other pharmaceutical giants to throw out over 70,000 lawsuits alleging that the now-discontinued heartburn drug Zantac caused cancer.
The companies, which also include Pfizer and Sanofi, are challenging a lower court ruling that allowed expert testimony claiming Zantac causes cancer – a link they say is not credible.
First approved by US regulators in 1983, Zantac had become the world’s best-selling drug less than five years after hitting the market, surpassing $1bn in sales.
The drug, sold by four major companies, now faces thousands of lawsuits.
The litigation came after the FDA’s 2020 removal of Zantac from the market due to concerns that its active ingredient, ranitidine, could degrade into the carcinogen NDMA under certain conditions.
Following Tuesday’s US court decision to take up the appeal, GSK said: “Since 2019, there are 16 epidemiological studies looking at human data regarding the use of ranitidine, including outcomes for more than 1m patients using ranitidine, supporting this consensus. GSK is committed to vigorously defending itself and managing this litigation in the best interests of the company and its shareholders.”
In December 2022, approximately 50,000 Zantac cases were dismissed during a pre-trial hearing in Florida.
Judge Robin Rosenberg stated in her ruling that the scientific evidence presented by plaintiffs was unreliable, writing in her judgement: “There is no scientist outside this litigation who concluded ranitidine causes cancer, and the plaintiffs’ scientists within this litigation systemically utilised unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data.”
Following the court’s decision to hear the appeal, GSK’s shares on Nasdaq rose by 4 per cent to $44.22 (£33.45), while in London, shares ended the day up 1 per cent at £16.18.
In a statement issued on Tuesday, GSK said: “GSK plc welcomes today’s decision by the Delaware Supreme Court that it will review the Delaware Superior Court’s decision allowing the introduction of plaintiffs’ expert evidence at trial.
“Interlocutory reviews are granted in exceptional circumstances, and GSK is pleased that the Supreme Court is of the view that such circumstances are present here.
“The scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.
“Since 2019, there are 16 epidemiological studies looking at human data regarding the use of ranitidine, including outcomes for more than 1m patients using ranitidine, supporting this consensus.
“GSK is committed to vigorously defending itself and managing this litigation in the best interests of the Company and its shareholders.
“The Delaware litigation will progress in parallel with the Delaware Supreme Court review. Alongside review by the Delaware Supreme Court, the Company will press additional defences in the litigation, including failure to provide proof of use and proof of diagnosis requirements recently ordered by the Court.”