Issued: 10 June 2024, London
UK
Statement: Zantac (ranitidine) litigation - GSK starts process
for appeal of recent Delaware Daubert decision
· Delaware Superior Court's ruling inconsistent with how Daubert
standard* has previously been applied in Delaware and federal
courts
· Application has been filed seeking right of appeal to the
Delaware Supreme Court
· GSK, Pfizer, Sanofi, and Boehringer Ingelheim are all parties
to the application
· Scientific consensus remains that there is no consistent or
reliable evidence that ranitidine increases the risk of any
cancer
GSK plc (LSE/NYSE: GSK) today
confirms that the Company has taken the first step to seek appeal
of the recent Daubert ruling, made by the Delaware Superior Court,
which permits plaintiff expert testimony as part of the Zantac
(ranitidine) litigation in Delaware. GSK strongly disagrees with
the Delaware Superior Court's ruling and has filed an application
with the court to appeal to the Delaware Supreme Court for
interlocutory review of the decision. Pfizer, Sanofi, and
Boehringer Ingelheim are all parties to the application.
While interlocutory reviews are
granted in exceptional circumstances, GSK believes such
circumstances are present here and that it is important to raise
these matters now to the Delaware Supreme Court.
The Superior Court's ruling is
inconsistent with how the Daubert standard has been applied
previously in Delaware and federal courts. As such, differing
rulings interpreting how the Daubert standard is to be applied to
litigation before Delaware Courts, now exist. The Superior Court's
ruling would therefore have profound implications for all companies
and businesses incorporated in Delaware.
If the Delaware Superior Court grants
the application for appeal, the case for interlocutory review of
the decision will proceed to the Delaware Supreme Court for
consideration.
If the Delaware Superior Court
rejects the application, GSK and the other defendants will seek
leave to appeal directly to the Delaware Supreme Court.
A decision, on whether to grant
interlocutory review and hear the appeal, would be expected from
the Delaware Supreme Court sometime later this year.
The scientific consensus remains that
there is no consistent or reliable evidence that ranitidine
increases the risk of any cancer. 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 remains committed to vigorously
defending itself and managing this litigation in the best interests
of the Company and its shareholders.
Notes to Editors
* Also known as the "Daubert Test,"
the Daubert standard is a method used by US courts to determine
whether or not expert testimony should be admissible at trial. This
standard applies to both civil and criminal cases and can be raised
by either the defendant or plaintiff. The standard came about
because Federal Rule of Evidence 702 requires that expert testimony
consists of scientific, technical or other specialised knowledge
that legitimately helps the judge or jury understand the evidence
or issues that have been raised in the case. A Daubert ruling,
issued by the court, determines whether or not the testimony is
admissible.
The term "Daubert Standard" comes
from the United States Supreme Court case: Daubert v Merrell Dow Pharmaceuticals
Inc 509 US 579 (1993)
About GSK
GSK is a global biopharma company
with a purpose to unite science, technology, and talent to get
ahead of disease together. Find out more at gsk.com.
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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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