Issued: 1 June 2024, London UK
Statement: Zantac (ranitidine) litigation - Delaware State Court Daubert Ruling
· Scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer and GSK will continue to vigorously defend itself against all claims
· Ruling to permit claims is not consistent with the Federal Court's Multidistrict Litigation (MDL) ruling under the same legal standard
· GSK disagrees with ruling by the Delaware State Court and will immediately seek an appeal
GSK plc (LSE/NYSE: GSK) disagrees with the ruling by the Delaware State Court and will immediately seek an appeal. The decision by the State Court contradicts the Federal Court's MDL ruling under the same legal standard, which dismissed all cases alleging five cancer types, in December 2022.
Following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.
The litigation in Delaware remains at an early stage, and the ruling, under the Daubert standard, relates only to the question of whether the methodology used by plaintiffs' experts is sufficiently reliable to allow them to present their evidence at trial.
The ruling does not mean that the Court agrees with plaintiffs' experts' scientific conclusions, and it does not determine liability.
GSK will continue to vigorously defend itself against all claims and manage this litigation in the best interests of shareholders. Alongside immediately seeking an appeal to the Delaware Supreme Court, the Company will file motions for dismissal pressing additional defenses, severance of cases, and proof-of-use by claimants; and, at the same time, the Company will progress to trials of individual cases.
GSK's capital allocation priorities remain unchanged, and the ruling has no impact on the Company's investment plans for growth.
About GSK
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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 Q1 Results for 2024.
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