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GSK has consistently maintained that the expert testimony which claims that an ingredient in the antacid drug Zantac is linked to cancer cannot be relied upon – Delaware’s highest court is allowing its appeal.
Pharmaceutical giant GlaxoSmithKline (GSK) and rival drug manufacturers, including Sanofi, Pfizer and Boehringer Ingelheim, have won the right to an appeal hearing by the Delaware Supreme Court, regarding the now-discontinued antacid Zantac amid claims that an ingredient in it may cause cancer. There are now more than 70,000 lawsuits regarding the drug.
The appeal is against a lower court judge’s earlier agreement to allow the plaintiffs to offer expert testimony on the alleged cancer link. The drug makers argued the testimony was not supported by sound scientific methods.
The main concerns revolve around ranitidine, Zantac’s active ingredient, which is believed to potentially degrade into N-nitrosodimethylamine (NDMA), a possible carcinogen, if the drug is stored at higher temperatures or left on shelves for a long time.
However, GSK has consistently denied these claims, saying that the expert testimony on which these concerns were based was not reliable.
The Food and Drug Administration (FDA) recalled Zantac in 2020, with Australia and the European Union also opting for voluntary recalls.
Before the recalls, Zantac was sold by GSK, US pharma giant Pfizer, French drug company Sanofi and Boehringer Ingelheim, based in Germany.
Investors react positively to decision
GSK’s shares were up more than 3% by Tuesday’s market close on news of the appeal.
GSK said in a press release on Tuesday: “GSK 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.
“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 one million 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.”
Lack of documentation and unreliable methodology cited in GSK Zantac case
The lack of credible documentation and methodology has been raised on a number of occasions. An earlier case against Zantac brought in December 2022 by some 50,000 plaintiffs at a pre-trial federal court hearing in Florida was dismissed.
US District Judge Robin Rosenberg said in her judgment: “There is no scientist outside this litigation who concluded ranitidine causes cancer, and the plaintiffs’ scientists within this litigation systematically 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 even-handed evaluation of data.”
Hopes for an end in sight
Russ Mould, investment director at AJ Bell, said in an email note: “Legal issues around the Zantac heartburn drug continue to dominate the news agenda for GSK. The saga has been full of twists and turns, with investors trying to second guess if GSK will win or lose tens of thousands of lawsuits claiming Zantac caused cancer.
“The market has reacted positively to news that Delaware’s highest court will hear an appeal by GSK and other drugmakers who sold the product. It’s a positive step forward for the pharmaceutical giant but by no means the end of the story.
“The matter has become a major distraction for GSK’s management and many investors will be hoping it can agree a settlement and move on. GSK is adamant that it has done no wrong, saying there is no evidence that the product caused cancer.”
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