Primodos

PRIMODOS ACTION GROUP

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WHY YOU SHOULD TAKE ACTION

Don’t Be Invisible. Fight for Justice. Get the Compensation You Deserve.

Are you among the victims in the UK born with a birth malformation as a result of Primodos or other Hormone Pregnancy Test (HPT)?  If so, you may be eligible to join our group action and claim compensation.

 

The most widely used HPT in the UK was Primodos, manufactured by Schering, now Bayer  PLC. Primodos was a hormone-based pregnancy test that consisted of two pills.  It detected pregnancy by inducing a period in a woman who was not pregnant.  Primodos was first made available for sale in the UK in 1956 and was withdrawn from sale in 1978.

 

Amenorone Forte, manufactured by Roussel, now Sanofi,  was also prescribed by GPs as a HPT.  It acted in much the same was as Primodos except it comprised of 3 tablets to be taken over a 3 day period.

 

If you were born between 1956 and 1978, your mother took a hormone pregnancy test and you were born with birth defects or malformations then you may be eligible for compensation for your pain and suffering.

We see you and understand your pain.

 

For decades your pain has been ignored and dismissed by manufacturers and the Government whilst evidence shows that concerns were raised by health professionals of the drug’s risk of causing birth defects as early as 1967.

 

A recent Sky News investigation has found evidence that Schering, the original manufacturer of Primodos, was warned by UK regulators of the drug’s link to causing severe birth malformations and deliberately destroyed records of this to prohibit future legal action. 

 

Moreover, last year an Oxford University team produced an analysis of all of the significant studies related to HPTs and found that the drug caused 2x to 3x the risk of catastrophic birth defects to children.

 

CHECK IF YOU CAN CLAIM
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SPG Law is dedicated to amplifying Your Voice and championing You.

We have assembled a powerful team of the UK’s leading solicitors and barristers reinforced with the financial resources and tested expertise of American class-action lawyers to ensure that your case is aggressively litigated against manufacturers and the Government. 

 

We are passionate about winning this group action!  SPG Law’s American partners has already won over $1 billion of compensation for consumers in similar cases. 

 

We operate on a no-win, no-fee basis, and unlike other law firms, we cap our fees and aim to secure the maximum compensation owed to you for your pain and suffering and financial losses.  We do everything for you and make your claim simple.

 

Join together with hundreds of others in the UK and hold the manufacturers and the Government to account!

 

Check If You Can Claim
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    Be Heard

    Stop suffering in silence and join thousands of others to stand against Primodos’s manufacturer and let your voice be heard.

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    FINANCIAL GAIN

    Receive compensation for your pain and suffering and medical expenses.

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AM I ELIGIBLE TO FILE AN PRIMODOS CLAIM?

Evidence suggests that the manufacturers failed to properly research and test  HPTs before selling this unnecessarily dangerous pregnancy test. 

 

In addition, the Government did not have appropriate checks and balances to ensure that a drug like this was prevented from being placed onto the market without satisfying itself, as Regulators, that the drug was safe for use in pregnancy.

 

The Government are also at fault for failing to act quickly enough when concerns were first raised.

 

It is important to remember that this drug had no therapeutic effect.

 

In the UK and around the world, thousands of people have been harmed as a result. 

 

SPG Law is committed to seeking justice for those affected.  If you were born with a birth defect or malformation, you may be eligible for compensation. Typical injuries include:

Nervous system malformations

Gastrointestinal malformations

Musculoskeletal malformations

Congenital heart malformations

Brain injury

VACTERL syndrome (vertebral defects, anal atresia, cardiovascular anomalies, tracheoesophageal fistula, oesophageal atresia, renal anomalies and limb defects)

 

We also represent a number of parents that have experienced late miscarriage or stillbirth.

 

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WHAT KIND OF COMPENSATION WILL I RECEIVE?

SPG Law understands that no amount of money can repair irreversible birth defects, broken families or the loss of loved ones that has resulted from  HPT toxicity.  In many cases, compensation can pay for the extensive treatments and multiple surgeries needed to survive and improve your quality of life.  It can also provide financial assistance for the lifelong care necessary to look after victims.  For many of our clients, compensation is more than money: it’s public vindication that the medical community should have listened to you and taken your concerns seriously.  It’s a way to hold manufacturers and the Government to account.

 

We have litigated thousands of similar cases in the USA and have secured compensation for our clients for the following:

Medical expenses

Pain and suffering

Lower quality of life

Care and assistance

Loss of earnings

 

We are committed to achieving the same levels of maximum compensation for your claim.

 

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REASONS YOU SHOULD TAKE ACTION

Be Heard:

stop suffering in silence and join thousands of others to stand against manufacturers and the Government and let your voice be heard.

 

Raise awareness:

help other people learn about the dangers of HPTs.

 

Financial award:

receive compensation for your pain and suffering and medical expenses.

 

We make it simple:

SPG will ensure that the process is simple and straightforward.

 

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Q. What is the group action about?

The group action relates to Hormone Pregnancy Tests (HPT) that were available for use between 1958 and 1978 in the UK.

The drug contained synthetic versions of two female sex hormones which occur naturally in the body namely estrogen and progestogen.

HPTs were prescribed to over 1,000,000 in the UK.  The most widely used HPT in the UK was Primodos, manufactured by Schering, now Bayer.  Primodos contained 10 mg Norethisterone Acetate and 0.02 mg of Ethinylestradiol.  1 tablet was to be taken on each of two consecutive days.  Bleeding follows in 3-6 days if there is no pregnancy.  If the pregnancy test was positive there should be no bleed.

The other well known HPT was Amenorone Forte, manufactured by Roussell.  This contained 0.05 mg Ethinylestradiol and 50 mg Ethisterone.  1 tablet was to be taken daily for 3 days.  This operated in much the same way in terms of indications for a positive and negative result.

A few doctors expressed concern as early as 1956 that HPTs would be used in the early weeks of pregnancy at a time when the main structures were being laid down in the embryo and when the embryo was most susceptible to noxious influences.

In 1967 Dr Isabel Gal, Paediatrician, published a letter in Nature warning of a possible association between HPTs and birth defects.

In 1970 Schering removed the indication for use as a pregnancy test from the Primodos datasheet and stopped providing free samples to healthcare professionals.

In 1975 the Primodos product information was updated to include a warning about the possible risk of congenital anomalies and a contraindication in pregnancy.  The warning stated as follows:

‘Warning:  A possibility exists of an association between the use of Primodos during early pregnancy and increased incidence of congenital abnormalities.  Because of this possible hazard, Primodos must not be taken unless it is certain that the patient is not pregnant.’ 

On 13th June 1975 the Committee on safety of Medicines (CSM) issued a warning regarding the possible association between HPTs and an increased incidence of congenital abnormalities.

The Committee on Safety of Medicines (CSM) issued a second health warning in 1977 as the product was still being used.

In 1978 the manufacturers of Primodos voluntarily stopped marketing the product.

Legal action was brought by some victims in the 1980’s but this had to be discontinued because of the lack of evidence on causation and the fact that some of the Claimant’s key experts had deflected to the opposition.

 

EWG Report

 In 2014 the MHRA initiated a review of the literature to investigate all available evidence on the possible association between exposure in pregnancy to HPTs and adverse outcomes in pregnancy.  They set up an Expert Working Group (EWG) who published their report in 2017.

The EWG concluded that the evidence did not support a causal association between the use of HPTs such as Primodos during early pregnancy and congenital anomalies in the child.

They also concluded that there was no evidence that the administration of these hormones in early pregnancy were associated with an increased risk of miscarriage.

 

Meta-Analysis

 On 29th January 2019 Prof Carl Heneghan, Jeffrey Aronson & Ors published a meta-analysis of ‘Oral hormone pregnancy test s and the risks of congenital malformations: a systematic review and meta-analysis’.

This systematic review and meta-analysis demonstrated that the use of oral HPTs in pregnancy is associated with increased risks of congenital malformations, contrary to the findings of the EWG.


SPG Law is committed to seeking justice for the victims of HPT’s.

Q. Who is classed as the Claimant?

Victim alive

The Claimant will be the child affected by the Hormone Pregnancy Test, rather than the child’s parents.

 

Victim deceased

In the event the child survived birth but later sadly died, either as a child or in adulthood, it will be necessary for the victims next of kin to bring a claim on behalf of the deceased’s estate.

Letters of Administration (or a Grant of Probate if the deceased died with a will) will need to be obtained from your local probate registry. We will need a copy of these documents as soon as possible.

 

Miscarriage/stillbirth

In the event the mother given the HPT sadly miscarried or delivered a stillborn baby, the mother will be classed as the Claimant, bringing a claim in her own right for psychiatric injury.

Q. Who are the Defendants?

We intend to take action against the following defendants;

  1. Secretary of State for Health and Social Care (in relation to regulatory failures)
  2. Bayer (successors to Schering), manufacturers of Primodos
  3. Sanofi UK (successors to Roussel),  manufacturers of Amenorone Forte

Q. How can I join?

You can join the group action by registering with the team at SPG Law using the chatbot on this page. Just press any of the red buttons to get started.

Q. Will I be liable for any costs if the case is unsuccessful?

We operate on a no-win, no-fee basis, and unlike other law firms, we cap our fees and aim to secure the maximum compensation owed to you for your pain and suffering and financial losses. We do everything for you and make your claim simple. In terms of the no-win, no-fee, or what we call a conditional fee agreement, this means that we can only charge a fee on the condition that we obtain compensation for you.

In a nutshell, if your claim is unsuccessful there will be no charge to you. If your claim is successful, there will be a charge; however this is a capped percentage which will be deducted from your damages. You will always receive a minimum of 65% of your damages.

Q. What are the next steps?

The first thing you need to do is to contact the team at SPG Law and sign up as a new client using the chatbot on this page. We will take some initial information from you and you will be sent an online survey to complete.

It will then be necessary to obtain a full set of the victims medical records, and a copy of their mothers GP records (to ascertain whether there is documented evidence a HPT was given).  

Once we have a full set of records, these will be sent to an independent pagination company who will sort and paginate the notes and prepare a chronology.

Our priority is to raise awareness of the fact that SPG is preparing to file a group action in relation to Hormone Pregnancy Tests.

We are very lucky to have the expertise from the American litigation which our sister firms are intimately involved with.

Q. If there is no evidence in the medical records a HPT was given, can I still bring a claim?

You should still sign-up and we will assess this on a case-by-case basis. We do not believe that this would bar you from making a claim and receiving the compensation you deserve given the number of clients this affects.

Q. I am outside the 3 year limitation period. Can I still bring a claim?

We do not consider this will necessarily be a bar to you bringing a claim. If you acquired knowledge of the possible association between HPT’s and birth anomalies more than 3 years ago, please contact us to discuss further.

Q. How long would the case take?

As with any litigation there is no exact set time frame.  This being a group action you should expect that it will take several years for this case to conclude.  No matter how long this takes you should be aware that we have capped any legal fees at 35% as a safeguard to our potential claimants. This means no matter what you will receive 65% of any compensation.

Q. Can victims outside of the UK join?

You won’t be able to join the Group Litigation unless you were given a HPT in the UK.

Q. Why are we asking living victims to undergo genetics testing?

All of our living victims have been advised to undergo genetic testing, specifically to undergo a Microarray Test.  This test is a chromosomal analysis which will detect irregularities that could result in genetic diseases such as missing or repeated sections of genetic code.

The purpose of the test is to rule in or out a potential genetic cause for the birth defect in question.

Q. Previous representation dropped my case, why should I try again?

Different law firms specialize in different types of litigations.  At SPG we take pride in our ability to bring actions against some of the largest corporations in the world.  Other firms may have a different philosophy and not wish to venture down this path.  Therefore, just because one firm may have decided against moving forward with your case does in no way mean we will.