Glaxosmithkline Regulatory News (GSK)

Issued: 27 August 2024, London UK

Statement: Zantac (ranitidine) litigation - Delaware Supreme Court to review Superior Court's Daubert decision

GSK plc (LSE/NYSE: 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. 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 1 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 defenses in the litigation, including failure to provide proof of use and proof of diagnosis requirements recently ordered by the Court.

Notes to Editors

* The Daubert standard, established in the U.S. Supreme Court case Daubert v. Merrell Dow Pharmaceuticals, Inc. 509 US 579 (1993) provides criteria for evaluating whether expert testimony is admissible under Federal Rule of Evidence 702. Under Rule 702 and Daubert, an expert may offer testimony if he or she is qualified by knowledge, education, training or experience in a given area and the testimony offered is reliable, relevant and helpful to the jury. In applying the Daubert standard, the Court acts as a gatekeeper, ensuring that expert opinions meet certain standards for reliability and that speculative or unreliable opinions are not presented to the jury. In Daubert, the Supreme Court identified four factors to guide assessment of an expert's methodology: (1) whether the expert's methodology has been tested or is capable of being tested; (2) whether the theory or technique used by the expert has been subjected to peer review and publication; (3) whether there is a known or potential error rate of the methodology; and (4) whether the technique has been generally accepted in the relevant scientific community. The Daubert standard is applicable to expert testimony in all federal cases. Many states also have adopted standards identical to the federal Daubert standard.

The term "Daubert Standard" comes from the United States Supreme Court case: Daubert v Merrell Dow Pharmaceuticals Inc 509 US 579 (1993).

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Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q2 Results for 2024.

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