Form 6-K GSK PLC For: Aug 17
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of August 2022
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 16 August 2022, London UK
Statement: Zantac (ranitidine) U.S. litigation
●
Notice
of Voluntary Dismissal to be filed in Bayer case, first scheduled
Zantac trial
●
GSK
did not settle
●
Plaintiff
ongoing litigation inconsistent with scientific consensus, GSK will
continue to defend all claims vigorously
GSK plc (LSE/NYSE: GSK) today
issued the following statement regarding U.S. Zantac (ranitidine)
litigation.
The Plaintiff's counsel for Joseph Bayer, whose case was scheduled
to be the first Zantac trial, informed the court and the parties
yesterday that he will file a Notice of Voluntary
Dismissal. GSK did not settle Mr. Bayer's claim and has not
paid anything in exchange for the voluntary dismissal. GSK
welcomes this outcome and believes the dismissal of Mr. Bayer's
case is the correct result. The overwhelming weight of the
scientific evidence supports the conclusion that there is no
increased cancer risk associated with the use of ranitidine. GSK
will continue to vigorously defend itself against all claims
alleging otherwise.
Litigation update
GSK has been named as a defendant in approximately 3,000 filed
personal injury cases in federal and state court. Class actions
alleging economic injury and a third-party payer class action also
has been filed in federal court.
On 6 February 2020, the US product liability litigation was
assigned Multidistrict Litigation (MDL) status in the Southern
District of Florida. In the MDL, plaintiffs were required to
identify the types of cancer they wished to pursue and identified
10 different types. In November 2021, plaintiffs withdrew from
consideration breast cancer and kidney cancer, reducing the number
of types of cancer from 10 to eight. In January 2022, the MDL
plaintiffs withdrew from consideration colorectal, prostate, and
lung and will proceed only as to the following five types of
cancer: bladder, esophageal, gastric, liver, and pancreatic,
although plaintiffs in state courts continue to pursue claims based
on types of cancers withdrawn from the
MDL.
Unfiled claims have also been registered in a census established by
the Court presiding over the MDL and the parties. The information
in this registry is preliminary, unverified, subject to change, and
it is unknown at this time if many of these unfiled claimants will
proceed with filing suit. In the most recent review of unfiled
claimants, conducted on behalf of GSK, it is estimated that the
number of unfiled registry claims in the federal MDL Court have
reduced to approximately 55,000 total claims. Not all the unfiled
claims relate to GSK and there will be many claims involving
multiple parties given that Zantac OTC has been owned and marketed
by multiple companies.
These filed and unfiled counts are subject to
change.
The MDL Court is scheduled to hold a hearing on defendants' motion
to exclude plaintiffs' causation experts under Daubert on 20-21
September 2022.
Among the state court cases naming GSK, a trial in California is
currently scheduled to begin 13 February 2023 and a trial is
currently scheduled to begin in Madison County, Illinois in
February 2023.
Given the early stage of this litigation, it is not possible to
quantify or reliably estimate what liability (if any) GSK or any
other parties may have in this litigation. Further announcements
will be made as there are significant developments in the
litigation.
Regulatory review and scientific research
GSK, independent cancer researchers, the U.S. Food & Drug
Administration (FDA), and the European Medicines Agency (EMA), have
all undertaken extensive reviews of available data and conducted
numerous investigations into this issue since 2019. Based on
these investigations and experiments, GSK, the FDA, and the EMA
have all independently concluded that there is no evidence of a
causal association between ranitidine therapy and the development
of cancer in patients. These conclusions pertain to all forms
of cancer, including but not limited to bladder, breast,
colorectal, esophageal, kidney, liver, lung, pancreatic, prostate,
and stomach.
Since the issue concerning the presence of NDMA in ranitidine arose
in 2019, the scientific community has actively focused on
understanding whether there is a link between ranitidine and
cancer. There have been 11 epidemiological studies conducted in
that time looking at human data regarding the use of ranitidine,
with the resulting scientific consensus, that the totality of the
reliable evidence does not support that ranitidine increases the
risk of any type of cancer.
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/company
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GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Madeleine Breckon
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered
in England & Wales:
No. 3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8 9GS
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: August
17, 2022
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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