REG - GSK PLC - Statement: Zantac (ranitidine) litigation update

GSKAnnouncement

17/08/2022 07:01

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RNS Number : 2384W  GSK PLC  16 August 2022

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to pursue claims based on types of cancers withdrawn from the MDL.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
(https://www.gsk.com/en-gb/company/)

 

 GSK enquiries
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 Investor Relations:  Nick Stone         +44 (0) 7717 618834   (London)
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                      Josh Williams      +44 (0) 7385 415719   (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)

 

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.

 

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