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UK: Government faces legal action over claims pregnancy drug ‘damaged babies’

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Lawyers
representing more than 200 claimants accuse two drug companies and UK
regulators of putting patients at risk.

Parents who
say their babies were damaged by a pregnancy test drug have warned
manufacturers and the government that they are preparing to take legal action.

Lawyers
representing more than 200 claimants have written letters accusing two drug
companies and the UK regulators of being negligent and putting patients at
risk.

The drug
Primodos was given to women in the 1960s and 70s. It was made up of two pills
which would induce a period in women who were not pregnant. However, many
families believe that if the mother was pregnant, it damaged or even killed
their children in the womb.

If
successful the claim could be worth millions as the alleged victims all suffer
with a variety of life-changing difficulties, including limb malformations,
musculoskeletal abnormalities, heart defects and brain injuries. Some parents
are also claiming still births were caused by the drug.

The proposed
legal action follows a Sky News investigation in 2017 where documents were found
in German archives showing manufacturers were warned by UK regulators that
those using the drug had an increased risk of malformations – and that records
from that study appeared to have been deliberately destroyed in order to
frustrate any future legal action.

Marie Lyon,
from the Association For Children Damaged by Hormone Pregnancy Tests, said:
“My overwhelming feeling is relief that we finally have the opportunity to
expose the truth about these drugs and the failures of the regulators.

“We are
so grateful SPG Law has chosen to represent us but unbearably sad that many of
our members are no longer alive to see justice finally served.

“We
first started our campaign in 1978. It has taken 41 years to reach this
milestone but today makes it all worthwhile. Our day in court will finally
reveal the truth and allow us to move on with our lives.”

Lawyers
representing the families said that they are also investigating whether GPs
followed advice to destroy prescription records to protect themselves from
legal action.

Recipients
of the letters include German pharmaceutical giant Bayer, who took over
Schering, the manufacturers of the drug Primodos. Also, Sanofi, whose
predecessor company Roussel produced a similar drug called Amenorone Forte.

The
manufacturers are accused of marketing the pills without establishing whether
they were safe. Lawyers also say they delayed removing the drug when concerns
first emerged about the risks it posed to the unborn fetus.

The claim
made against the Department of Health also accuses UK regulators of not taking
the appropriate steps when the potential risks of the drug first emerged.

Lisa Lunt,
from SPG Law, represents the claimants.

She told Sky
News: “They placed the drug on to the market without any prior toxicology
testing. I find that astonishing considering that this was a pregnancy test
given to women and it had no therapeutic benefit whatsoever.

“And
when concerns were first raised about the safety of the test they didn’t act
quickly enough either suspending the drug or removing it from the market.”

A previous
claim by families was abandoned in 1982, and a government review published in
2017 found there was insufficient evidence to show a causal association between
the drug and defects to babies in the womb.

However,
last year an Oxford University team led by professor of evidence
based medicine, Carl Heneghan, produced an analysis of data relating to
Primodos and found “a clear association” with several forms of
malformation.

Also in
2018, Neil Vargesson, senior lecturer at Aberdeen university’s Institute of
Medical Sciences, published research showing deformations to zebra fish embryos
just hours after they received a dose of Primodos components.

In a
statement, Bayer told Sky News it denies Primodos was responsible for causing
any deformities in children.

It said:
“Since the discontinuation of the legal action in 1982, no new scientific
knowledge has been produced, which would call into question the validity of the
previous assessment of there being no link between the use of Primodos and the
occurrence of such congenital abnormalities.”

In response
to the Oxford University research, it added: “The UK (through the
Medicines and Healthcare products Regulatory Agency) asked that the Committee
for Human Medicinal Products, which is the main expert scientific body of the
European Medicines Agency, to conduct an independent assessment of these
publications.

“In
opinions of 2018 and 2019 respectively, these studies have been found by the
CHMP to have many limitations such that it was not appropriate to treat the results
as reliable.

“Therefore
we believe this action to be without merits and will defend our position
vigorously and, if necessary, in court.”

Sanofi said:
“The Commission on Human Medicines Expert Working Group on Hormone Based
Pregnancy Tests (HPTs) concluded in 2017 that the available scientific evidence
does not support a causal association between the use of HPTs during early
pregnancy and adverse outcomes, either with regard to miscarriage, stillbirth
or congenital abnormalities.

“Sanofi
heritage companies ceased the commercialisation of HTP products over 40 years
ago and have no evidence that can add to the conclusions reached by the CHM
Expert Working Group.”

Source: skynews.com

The post UK: Government faces legal action over claims pregnancy drug ‘damaged babies’ appeared first on maltawinds.com.

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