Birth injury news

 

Valproate and birth defects: were you told the facts?

The anti-convulsant drug, sodium valproate, is used to treat epilepsy. It is also used as a mood stabiliser for people with bipolar disorder. Valproate is also known by various trade names, including Epilim and Epival.

Valproate is very effective at reducing fits or seizures in epileptics. For some people it is the only effective way to manage their disabling epileptic condition. However, use of valproate during pregnancy is known to carry a high risk of serious injury to the unborn baby. Prescription of valproate to women of childbearing potential has now been banned for all except those women for whom no other equivalent drug works, and even then, only on the condition that they are using contraception under a pregnancy prevention programme (PPP).

How does sodium valproate affect babies in pregnancy?

1. 10% risk of birth defects or physical disabilities

Babies who are exposed in pregnancy, via their mother, to valproate, are known to be at increased risk of serious birth defects (physical disabilities) and long-term developmental problems.

The risk of physical disabilities is approximately 10%. That means one in ten valproate babies are born with these disabilities. These include:

  • minor malformations, such as small fingers and toes;
  • major malformations:
    • of the spine, such as spina bifida;
    • of the face and skull, such as cleft palate;
    • of the limbs;
    • of the organs, such as the heart, kidneys and sexual organs.

2. 40% risk of developmental or learning difficulties

There is also a 40% risk of persistent learning and developmental issues. That’s four of every ten babies. These learning and developmental problems are sometimes known as fetal valproate syndrome, fetal anti-convulsant syndrome (FACS), or fetal valproate spectrum disorder.

What is fetal anti-convulsant syndrome (FACS)?

Fetal anti-convulsant syndrome describes the developmental or learning difficulties suffered by babies who were exposed to valproate during pregnancy. Unlike physical birth defects which are often apparent at birth, developmental issues may not be noticeable until the child grows older and struggles to meet developmental milestones. Learning and developmental problems caused by fetal anti-convulsant syndrome include:

  • delayed walking and talking;
  • impaired speech and language;
  • problems with memory;
  • lower intelligence than other children of the same age;
  • valproate-affected babies are also more likely to be on the autistic spectrum.

How long has it been known that sodium valproate is not safe to take in pregnancy?

When valproate was first marketed in the 1970s, animal studies had already shown that it carried serious risks of birth defects in the unborn baby if used by the mother in pregnancy.

Campaigners have also identified evidence that in 1973 the Committee on the Safety of Medicines decided it was best not to mention the risk of birth defects in the information supplied with the medicine. Instead, doctors were informed of the risks and were expected to weigh up the benefits and risks of prescribing the drug and use their discretion in informing the patient about the side effects.

As more evidence became available of other risks to the unborn baby, firstly of developmental delay and later of autism, further warnings were repeatedly issued to prescribers over the next 40 years. By 2013, long-term follow up of affected children had provided clear evidence of the extent of the risks to babies in valproate pregnancies.

The Medicines and Healthcare products Regulatory Agency (MHRA) then began a Europe-wide safety review of valproate in pregnancy which concluded, in November 2014, that the benefits of valproate to women of childbearing potential could only be justified against the risks where no other drugs were effective in treating their epilepsy or bipolar disorder.

In March 2016, MHRA developed a valproate toolkit, containing information presented in various forms to help healthcare professionals, including GPs and pharmacists, share information with patients about the risks of valproate in pregnancy. However, despite coordinated efforts by the government and the MHRA to promote the use of the toolkit to encourage healthcare practitioners to raise awareness amongst patients, a survey by INFACT, the National Valproate Campaign, later discovered that 80% of patients had not received the toolkit booklet and 90% had not received the toolkit pharmacy card. In many cases GPs had not even been given the booklets to distribute but had been left to download them from the manufacturer’s website and the information was not reaching potentially vulnerable women.

Concerns about the limited impact of the toolkit in raising awareness in the UK led to a further EU safety review which strengthened the rules relating to safe prescription of valproate in potentially childbearing women. These new rules came into force in the UK in April 2018 when the MHRA changed the licensing rules controlling the prescription of valproate. The new rules banned the use of the drug for women of childbearing potential (whether or not they are currently sexually active) unless other drugs were not effective and they were using highly effective, (preferably user-independent) contraception via a pregnancy prevention programme (PPP). The regulations also required patients to have been told about and understand the risks of pregnancy, to be reviewed by their specialist at least once a year and to have signed a risk acknowledgement form.

Valproate campaign group, INFACT, carried out a further survey from December 2018 to February 2019. This revealed that despite the stringent requirements laid down by MHRA in April 2018, high percentages of women taking valproate were still not receiving information about the risk of pregnancy from their GPs and pharmacists. 40% had never discussed a pregnancy prevention programme with their doctor and more than 60% not been asked to sign an acknowledgement of risk form. This survey highlighted the ongoing failure by valproate prescribers and healthcare professionals, such as GPs and pharmacists, to comply with their obligations to inform and safeguard their patients against the risks of valproate-affected pregnancy.

What is being done to reduce harm to babies from valproate in pregnancy?

  • Repeated warnings and drug safety updates to GPs and pharmacists

The MHRA continues to issue warnings and drug safety updates to pharmacists and doctors reminding them of their responsibilities towards patients and that they must comply with the new valproate licensing regulations.

  • NICE easy reference summary guideline

In March 2019, the National Institute for Health and Care Excellence (NICE) issued a new summary guideline which brings together in one short, easy-reference, visual summary all the key information and advice on safe prescribing of valproate from various sources, including MHRA safety alerts, BNF (British National Formulary – a pharmaceutical reference book containing drug information used by GPs) and NICE’s own amended guideline following the April 2018 licensing changes.

  • Valproate compliance now incentivised through GP contracts

NHS England’s General Practitioner (GP) contract framework – the GP contract – now includes a quality indicator for safe valproate prescribing to incentivise GPs to comply with their obligations.

  • CQC inspections include valproate compliance

The Care Quality Commission now includes valproate compliance in its inspections.

  • Studies into possible risks from paternal valproate

Studies are also being undertaken into the risks to the unborn baby caused by the father taking valproate following possible associations between birth defects and developmental disorders and paternal valproate use at the time of conception.

  • Independent Medicines and Medical Devices Safety Review

In February 2018, following patient-led campaigns, the Department of Health and Social Care set up The Independent Medicines and Medical Devices Safety (IMMDS) Review to look into how the NHS handled complaints and emerging awareness of problems with three NHS treatments, one of which is sodium valproate. The review is led by Baroness Julia Cumberlege and is independent from government, the NHS, regulatory or public bodies, and the pharmaceutical industry.

The IMMDS review will assess the evidence surrounding the use of valproate, including:

  • what was known about valproate;
  • the decisions and actions taken by the manufacturers, regulators, clinicians and policy makers;
  • whether proper consent (based on clear information) was taken from patients;
  • whether the response to safety concerns raised by patients and others has been satisfactory;
  • the licensing and treatment of women of childbearing age with valproate given the evidence of its teratogenicity (harmfulness to the unborn baby or fetus);
  • how the knowledge of the drug’s potential effect on the fetus was or should have been communicated between manufacturers, regulators, healthcare practitioners and patients and acted upon.

In addition, the review will:

  • clarify the characteristics of fetal valproate spectrum disorders and the implications of this condition so that those affected receive a proper diagnosis and assessment of their needs;
  • make recommendations about what action is now required and who must take it.

It will publish its report later this year. 

Will the IMMDS review give compensation to children affected by valproate in pregnancy?

No. The aim of the review is to help the healthcare system learn and improve. The review won’t allocate compensation to any individual but it may make recommendations if it concludes that there is a moral, social or ethical responsibility to consider a system of compensation if avoidable harm has been suffered.

If your child has suffered serious physical or developmental injuries as a result of negligent medical prescription of sodium valproate during pregnancy and you would like to find out more about bringing a claim, contact Boyes Turner’s birth injury experts by email at mednegclaims@boyesturner.com.

Landmark court ruling: Confirmation that mother of brain-damaged baby is primary victim

YAH v Medway NHS Foundation Trust [2018]

Richard Money-Kyrle represented the mother of a 5-year-old girl who was brain damaged at birth, in her own claim for the psychiatric injuries she suffered as a mother to the injured child during and after the negligently managed labour.

Whilst the NHS defendant admitted liability for the child’s severe injuries, they contested the mother’s own claim, which Richard successfully took to trial.

The circumstances of the case

The baby’s delivery had been negligently delayed for several hours when the maternity staff failed to take a fetal blood sample to check the baby’s condition after the CTG monitor showed abnormalities in the fetal heart rate. If they had carried out the blood test the result would have prompted an urgent caesarean section which would have saved the baby from two hours of further chronic partial oxygen deprivation and acute hypoxic ischaemia in the final minutes before birth. The baby suffered cerebral palsy and is severely disabled. She has epilepsy, visual impairment, feeding difficulties, significant learning disabilities and will be totally dependent on others for all her needs throughout her shortened life.

Her mother was aware that something was wrong when her baby was born in poor condition and was taken to the special care baby unit for therapeutic cooling and intubation. She saw her baby for the first time, the day after delivery, in a box, surrounded by medical equipment, tubes and monitors, but wasn’t allowed to hold her. She was told that her baby might not survive. Then over the next few months as she gradually realised the severity of the injury that had been done to her child during the labour, she developed a psychiatric injury.

Why has this case attracted so much attention?

The case attracted the interest of the media and the legal profession because it confirmed that the mother whose unborn child was injured as a result of negligence was a ‘primary victim’. Legally, she and her unborn child were one entity at the time that the negligence occurred. She didn’t lose her status as a primary victim when the baby was born and when the combination of the difficult labour, the worry of not knowing whether her baby would survive, and the strain of looking after the severely disabled child caused her to suffer a psychiatric injury.

Why is it important that the mother was a ‘primary victim’?

The defendant argued that the mother was not a ‘primary victim’ when she suffered the psychiatric illness during the baby’s infancy.

If the mother was not a primary victim, then unless she had also suffered physical injury, she would only succeed in her claim for compensation for her psychiatric injury if she could prove that it had been caused by ‘shock’ from witnessing the negligent events, as ‘secondary victims’ are required to do by law. Although our client’s experiences during and after labour were shocking and traumatic, they did not constitute the ‘nervous shock’ that is needed to satisfy the criteria for recovery of damages by secondary victims, as set out by the House of Lords in the Alcock v Chief Constable of South Yorkshire case (which concerned the psychiatric injuries suffered by witnesses of the Hillsborough disaster). Therefore, for our client to be entitled to compensation, it was important that she was found to be a primary victim. If the mother of the unborn child who was injured as a result of the negligently managed labour was merely a ‘secondary victim’, in these circumstances she would not have been entitled to compensation for her own psychiatric injury.

The trial judge awarded our client just under £76,200 for her injury.

If you are caring for a child with cerebral palsy or other birth-related neurological disability, contact us by email on claimsadvice@boyesturner.com.

All #AGloHa for Child Brain Injury Trust

Over the last week, the staff at Boyes Turner Solicitors have been supporting #GloWeek and raising funds in support of the Child Brain Injury Trust. 

As the autumnal evenings draw in, the Child Brain Injury Trust (CBIT) work to highlight the message; “Be seen not hurt”

It is important to educate primary school age children across the UK about the need to stay safe on the roads, given that they will be making their way to and from school in darker conditions at this time of year. 

On Tuesday last week staff, friends and family took part in a #GloZumba event donning fluorescent clothing, fluorescent face paint and waving glow sticks whilst completing an hour-long fitness session. We would like to thank Vodka Revolution for providing a venue for the event, and our fitness instructor from Buzz Gyms for donating her time and giving us a great workout to some very Latin beats! 

On Thursday, solicitors from Boyes Turner’s medical negligence and personal injury claims teams, together with Partner, Laxmi Patel, and her colleague, Janata Ali, from the Special Educational Needs Team attended the #AGloHa event organised by @CBIT to raise funds to help children and families affected by brain injury.

The Child Brain Injury Trust provides invaluable help for parents and families of those affected by an acquired brain injury. They offer a child and family support service, as well as advice and information and online referrals to other organisations that can help support those affected by a brain injury.

Boyes Turner’s brain injury solicitors know that when a childhood brain injury strikes, the whole family is affected, as their entire way of life is irrevocably altered. The road to recovery can seem like a long and bumpy journey.

Boyes Turner are proud to participate in the Child Brain Injury Trust’s efforts to help brain- injured children and their families access invaluable advice and support at what is, for everybody in the affected family, a very difficult time.   

To read more about the work that Boyes Turner specialist solicitors do to help those with a brain injury please click here.

Vaginal birth after caesarean section (VBAC) - risks of rupture and RCOG recommendations

The RCOG Each Baby Counts programme’s recent report into the anaesthetic care which contributed to the serious brain injury, neonatal death and stillbirths suffered by 49 babies in 2015 highlights some of the highest risk areas in maternity patient safety. Aside from the essential teamwork, communication and forward planning which is needed to handle the multiple, time-sensitive, emergencies which occur in maternity units, the report emphasised that trial of vaginal birth after a previous caesarean (VBAC), if incorrectly counselled, undertaken and managed can result in uterine rupture, severely brain damaging the fetus and threatening the life of mother and baby. 

Serious injury was caused to a baby when signs of uterine rupture (including maternal tachycardia, breakthrough pain between contractions and a worrying CTG trace) were missed during a trial of VBAC labour. Despite these warning signs, the mother was incorrectly given syntocinon, a uterine stimulant, increasing the stress on her uterine scar. The report reiterated that pain breaking through a previously effective epidural in a woman with a history of uterine surgery must always trigger an obstetric review for scar rupture.

What are the risks of VBAC compared with a planned repeat caesarean section (ERCS)?

Assuming that delivery takes place at or after 39 weeks gestation in circumstances suitable for VBAC:

  • Planned VBAC has a 1 in 200 (0.5%) risk of uterine rupture, compared with 2 in 10 000 (0.02%) in a previously unscarred uterus. The risk increases when VBAC delivery is induced or labour is augmented with syntocinon.
  • The success rate for planned VBAC is 72-75% but increases if the mother has had a previous vaginal or successful VBAC delivery. If VBAC delivery is successful, it has fewer complications than ERCS.
  • Unsuccessful VBAC resulting in emergency caesarean section carries the greatest risk of adverse outcome.
  • The risk of unsuccessful VBAC and caesarean section increases if VBAC labour is induced or augmented.

Who is suitable for VBAC?

The RCOG guidelines for VBAC list the circumstances most suited to VBAC:

  • Singleton pregnancy (i.e. expecting one baby)
  • Cephalic presentation (baby is head down)
  • Pregnancy at 37 weeks or more
  • Single previous LSCS (lower segment caesarean section - scar across the lower part of the abdomen)

A successful VBAC delivery is more likely where the mother is taller, younger than 40, and has a BMI below 30, and the labour starts spontaneously before 40 weeks, and the baby is in vertex presentation with a birthweight below 4kg.

The risk of uterine rupture during VBAC increases with the mother’s age and the baby’s gestation and size, and where the mother’s last delivery took place less than 12 months previously.

Who can’t have a planned VBAC delivery?

Planned VBAC is contraindicated where there is:

  • A history of uterine rupture
  • Previous classical caesarean scar (scar goes vertically up the middle of the mother’s abdomen)
  • Placenta praevia (i.e. the placenta’s position would obstruct a vaginal delivery)
  • The mother has a history of other uterine surgery

Who decides whether the delivery will be by VBAC or ERCS?

The choice of delivery mode must be agreed by the mother and a senior obstetrician, based on her personal risk factors, before the planned date of delivery and after she has been counselled about the risks and the circumstances in which a trial of VBAC would be abandoned and caesarean section needed. All antenatal counselling must be documented in the medical records. If ERCS is planned, an agreed contingency plan for early spontaneous labour must be written in the records.

What additional safety measures are in place during VBAC delivery?

Labour must take place in a delivery suite equipped for continuous intrapartum care and monitoring, with facilities for immediate caesarean delivery and advanced neonatal resuscitation. The fetal heart must be continuously monitored electronically from onset of regular contractions throughout the VBAC, to ensure early detection of maternal or fetal compromise, obstructed labour or uterine scar rupture. The mother’s condition and progress of labour must be regularly monitored by one-to-one care.

What are the clinical signs of uterine rupture in labour?

The three classic signs of uterine rupture are pain, vaginal bleeding and fetal heart-rate abnormalities, but in 48% of all cases the scar breaks down without any maternal symptoms and is diagnosed later during surgery.

Clinical signs associated with uterine rupture include:

  • Abnormal CTG (most common sign)
  • Severe abdominal pain, particularly if the pain persists between contractions
  • Sudden scar tenderness
  • Abnormal vaginal bleeding
  • Haematuria (blood in the urine)
  • Previously efficient contractions stop 
  • Maternal tachycardia (elevated heart rate), hypotension (low blood pressure), fainting or shock
  • There is a change in abdominal shape and fetal heart-rate not detected at the previous transducer site
  • The fetus is no longer presenting properly

Suspected rupture of the uterine scar is an emergency requiring urgent caesarean section and neonatal resuscitation as the unborn baby is deprived of oxygen, leading to permanent brain damage or death.

As specialists in birth trauma claims, Boyes Turner’s medical negligence team are experienced in helping mothers and babies affected by uterine rupture during inappropriately counselled or managed VBAC deliveries.  

If you or your baby have suffered severe injury as a result of birth-related medical negligence contact one of our specialist solicitors by email mednegclaims@boyesturner.com.

What is a neonatal brain injury and how do I claim?

What is a neonatal brain injury?

Neonatal literally means newborn. In medical terms, the neonatal period relates to the first few weeks of life. A neonate is a newborn baby. Neonatal care is the specialist care of babies – often born prematurely, unwell or who are small for their gestational age – within the first weeks of life. Neonatal care usually takes place in a neonatal unit (NNU) or special care baby unit (SCBU) or a neonatal intensive care unit (NICU), depending on the level of monitoring and treatment and breathing support that is needed.

Can I get Legal Aid for a neonatal brain injury medical negligence claim?

Legal Aid is available for birth injury and neonatal claims resulting in neurological injury where the injury was caused during the mother’s pregnancy, the baby’s birth or the first eight weeks of the baby’s life. Where our specialist brain injury lawyers believe the severely injured child has a viable claim and they are eligible for Legal Aid, Boyes Turner make a Legal Aid application on the child’s behalf.

Does my newborn baby’s admission to NICU, NNU or SCBU mean that they have a claim for negligence?

There are many reasons why a newborn baby might be admitted to a neonatal unit. Some of the more common reasons include:

  • They need help with breathing and maintaining their oxygen levels by ventilation or continuous positive airway pressure (CPAP)
  • They are at risk of hypoglycaemia and need close monitoring and help with feeding to maintain their blood sugar and nutrition
  • Their heart rate needs monitoring
  • They are at risk of kernicterus and need phototherapy for jaundice
  • They are recovering from or are receiving treatment for an infection
  • They are recovering from surgery or other treatment
  • They need therapeutic cooling after suffering HIE (hypoxic ischaemic encephalopathy - brain damage from lack of oxygen)

Premature babies (born before 37 weeks of pregnancy) or those with very low birth weights often need neonatal care as they need more support and are at greater risk of complications.

In full term babies (born after 37 weeks) who have been admitted to a neonatal unit, most admissions relate to problems with respiration, hypoglycaemia (low blood sugar), jaundice or asphyxia. NHS Improvement has identified poor treatment associated with these conditions as potential causes of greatest harm which, where causing serious neurological injury, can give rise to a claim.

In a patient safety alert in 2017, NHS Improvement said: “It is a priority for the NHS to reduce avoidable harm that can lead to full-term babies (babies born after 37 weeks of pregnancy) being admitted to neonatal units. The number of unexpected admissions to neonatal units is seen as a proxy indicator that preventable harm may have been caused at some point along the maternity or neonatal pathway.”

Perinatal asphyxia or HIE, respiratory problems from meconium aspiration during birth, kernicterus from untreated jaundice, delayed treatment of infection and neurological injury from untreated hypoglycaemia are the most common neonatal brain damage claims that we see at Boyes Turner. Our clients come to us at many stages of their child’s development - shortly after birth, in early childhood or in teenage years - depending on when the damage becomes evident. Negligent medical treatment of the newborn child can cause severe disability which lasts far beyond the baby’s first few weeks.

Neonatal brain injury can present with a wide range of features. Once the damage is done, the injured areas of the brain cannot recover and as the baby grows and develops, the full extent of the problems caused by the neonatal injury are gradually revealed. These impairments can range from near normal development to a diagnosis of cerebral palsy and can present as:

  • delayed development
  • missed early years milestones
  • behavioural problems
  • difficulties with feeding or speech
  • impaired fine motor control
  • damage to the senses
  • spasticity
  • athetosis
  • severe cognitive damage. 

If you are caring for a child who has suffered a brain injury from negligent care at birth or in the first few weeks of life, contact us by email mednegclaims@boyesturner.com.

Neonatal hypoglycaemia is a cause of brain damage - how do I know if my child has a claim?

What is neonatal hypoglycaemia?

Neonatal hypoglycaemia is a common metabolic condition in newborn babies which, if left untreated, can cause long-term brain damage and disability. Hypoglycaemia means low blood glucose or sugar. It becomes dangerous when the newborn’s blood sugar drops below safe levels, such as before the baby has established a regular feeding pattern enabling it to keep its blood glucose up in the first few days of life. 

What are the risk factors for neonatal hypoglycaemia?

Until adequate feeding is established all newborn babies are at some risk of hypoglycaemia, which is why it is part of the post-natal midwives’ job to ensure that the baby is receiving enough milk. The baby’s blood sugar is measured by a heel-prick blood test and is carried out routinely in some hospitals but should always be carried out for babies who are known to be at risk.

Those at increased risk include:

  • Newborn babies with birthweights below 2.5kg - the standard threshold level below which the baby’s blood glucose must be monitored
  • Babies with diabetic mothers
  • Babies who are small for dates with intra-uterine growth retardation (IUGR)

Regardless of birthweight or their mother’s state of health, any baby who is not feeding properly could be at risk, for example by:

  • Not waking up for feeds
  • Not sucking properly
  • Demanding feeding very frequently because they are not getting enough food at each feed

Is neonatal hypoglycaemia a medical emergency?

If acted upon quickly, neonatal low blood sugar can be corrected quickly by feeding, either by breastfeeding if that provides enough milk, by expressed breastmilk or formula milk or, if necessary, intravenously by a glucose drip.

In a review of medical negligence claims relating to neonatal hypoglycaemia, NHSLA (the NHS Litigation Authority, now known as NHS Resolution, which represents the NHS in legal claims) found that abnormal feeding behaviour was very closely associated with the condition, both as a cause and as a potential consequence of hypoglycaemia. Maternal concerns about abnormal feeding behaviour were often ignored by health professionals, missing a vital opportunity to take action to prevent hypoglycaemia before permanent damage was done to the infant’s brain.

If neonatal hypoglycaemia is severe or is left untreated, the baby’s condition will deteriorate, demonstrating other signs of illness. Neonatal hypoglycaemia with abnormal clinical signs must be regarded as a medical emergency requiring immediate action to avoid permanent brain damage and severe neurodevelopmental disability. Abnormal signs which are commonly seen with hypoglycaemia include:

  • Hypothermia (low body temperature)
  • Floppiness
  • Fitting or jitteriness
  • Infection
  • Respiratory (breathing) difficulties

Hypoglycaemia can also occur alongside and in combination with other serious conditions.

My baby has brain damage from hypoglycaemia – do I have a claim?

In its review of 25 neonatal hypoglycaemia claims which succeeded against the NHS over a ten year period at a total cost of over £162 million, NHSLA identified the most common errors in clinical care as:

  • Delays in obtaining blood glucose test results
  • Delays in taking action on a low blood glucose result
  • Delays in referring babies to the paediatrician once concerns have been identified
  • Delays in admitting babies who have been diagnosed with clinically significant hypoglycaemia to the neonatal unit (NNU)
  • Delayed administration of intravenous glucose on the NNU
  • Insufficient glucose being administered to correct the hypoglycaemia
  • Delayed attendance by the paediatrician when called by the midwife to review
  • Failing to advise the mother properly when the baby is discharged home.

Unlike asphyxial (oxygen deprivation) causes of perinatal brain injury, neurodevelopmental disability from neonatal hypoglycaemia might not be obvious to the parents in the immediate aftermath of the traumatic birth or the infant’s early childhood. Neurodevelopmental disability from avoidable neonatal hypoglycaemia might be disregarded or downplayed until the child grows and the impact of their injury later becomes evident when they struggle to cope at school.

In its review, NHSLA said it was likely that whilst the cases they knew about were those where the parents had identified potential deficits in care, it is likely that others who were harmed have not been notified to NHSLA via the litigation process.

Boyes Turner’s specialist brain injury solicitors are experienced in obtaining compensation for children and teenagers with neurodevelopmental injury from avoidable neonatal hypoglycaemia. We work with experts to ensure that, where liability for the injury is established, the extent of the injury and the impact on the individual’s mobility, cognition, education, work and independence is properly assessed to ensure that our clients are properly compensated. In addition, our special educational needs (SEN) team can help families with children affected by neonatal brain injury secure the educational support that they need for their child within the school that is right for them.

If you are caring for a child who has suffered neurodevelopmental disability from negligent medical care, contact us by email mednegclaims@boyesturner.com.

Epilepsy medicine Valproate linked to birth defects

The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licensing rules controlling the prescription of valproate drugs for women and girls of childbearing age with epilepsy. The new contraindication of drugs such as Epilim in pregnancy, follows evidence that up to 10% of babies born to mothers prescribed the drug have serious birth defects, with as many as 40% suffering developmental problems.

Birth defects associated with valproate in pregnancy

Birth defects suffered by babies of valproate-medicated mothers during pregnancy include congenital malformation of the spine (spina bifida), face and skull (such as cleft palate), limbs and organs including the heart, kidneys and sexual organs.

The long-term effects of the developmental problems suffered by valproate babies are not yet fully understood but include delayed walking and talking, reduced intelligence, impaired speech and language and memory problems.

Children exposed to valproate in the womb also have an increased risk of autism and attention deficit hyperactivity disorder (ADHD).

Valproate – little change despite warnings

“Valproate is a common treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. The drug was introduced in 1974 and its product information for doctors has always included a warning that it carried a potential risk of birth defects.”

Over time, as more information has been gathered in Europe about the drug’s association with congenital malformations and developmental impairments, the MHRA’s warnings to doctors and pharmacists about the risks to the medicated woman’s unborn child have been strengthened. However, the MHRA’s latest alert confirms that despite the strengthened warnings that they issued to prescribers in 2015 and 2016 against prescribing valproate medicines in girls and women of childbearing age unless other treatments are ineffective and they are using effective contraception, one in five women taking valproate remain unaware of its risks in pregnancy. Without such information, women are unable to make informed decisions about their treatment. They risk becoming pregnant with high risk of serious injury to their child. MHRA’s previous communications appear to have had little impact on prescribing practice.

New regulation of valproate prescription from April 2018

In March 2018, after further research revealed the extent to which previous warnings had not been heeded, the European Medicines Agency, CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human), recommended tougher regulation of the prescription of valproate medicines. The new regulations will come into force at the end of April 2018 and will be backed up by amended guidance from The National Institute for Health and Care Excellence (NICE).

Valproate medicines are now contraindicated in women and girls of childbearing potential unless the conditions of a specified Pregnancy Prevention Programme are met, and only if other treatments are ineffective or not tolerated, as judged by an experienced specialist. The Pregnancy Prevention Programme also applies to female patients who are not sexually active unless there are compelling reasons to indicate that there is no risk of pregnancy.

Compliance with the Pregnancy Prevention Programme means that all female patients taking valproate medicines:

  • have been told and understand the risks of pregnancy and have signed a risk acknowledgement form.
  • are on highly effective, user-independent contraception -  such as long acting reversible contraceptive, a copper intrauterine device (coil), progesterone implant or levonorgestrel intrauterine system – or using two complementary forms of contraception including a barrier method and undergo regular pregnancy testing
  • see their specialist for review and re-evaluation at least once every year.

GPs must now identify and recall all valproate-medicated women and girls of childbearing potential to give them the patient guide, check that they have been reviewed by a specialist within the last year and are on highly effective contraception.  

Specialists are required to review and re-evaluate their patients at least annually, provide clear explanations and complete and sign the risk acknowledgement form which must be copied to the patient or their carer and sent to the patient’s GP.

Pharmacists must ensure that where valproate medicines are dispensed to women and girls of childbearing potential the (ideally whole) packs must bear a pre-printed warning label or the pharmacist must place a warning sticker on the pack.  Pharmacists are also required to discuss the risks in pregnancy with female patients each time they dispense their valproate medicines, and to check that they have the Patient Guide and have discussed their treatment and contraception with their GP or specialist.

I’m on valproate. What do I do now?

All women and girls who are prescribed valproate should now contact their GP and arrange to have their treatment reviewed. Meanwhile, MHRA emphasise that it is important women don’t stop taking valproate without first discussing it with their doctor.

Boyes Turner’s specialist birth injury and cerebral palsy lawyers have decades of experience of helping families whose children have suffered severe disability as a result of inappropriate medical care. We welcome the recent action taken by MHRA and NICE to enforce responsible prescribing practice in the hope that fewer babies will suffer the devastating disability caused by in-utero exposure to valproate drugs.

If you are caring for a child with serious disability arising from negligent medical care please contact us on 0118 952 7219 or email us on mednegclaims@boyesturner.com.

Sports prostheses for children

The Department of Health has announced that £1.5 million has been made available to provide specialised sports prostheses on the NHS for children in England.

Taking his inspiration from Team GB’s outstanding performance at the 2016 Paralympics, the Secretary of State for Health, Jeremy Hunt, says that every child should be able to participate in sport. He believes this investment in children’s specialised sports prosthetics will enable the next generation of children suffering from limb loss to lead more active lives.

Of the £1.5 million of funding, half has been allocated to a Child Prosthesis Research Collaboration, intended to support research and bring the latest prosthetic technology into the NHS. The remaining £750,000 will be made available to Limb Centres, which must apply on a patient by patient basis for grants of up to £5,000 per limb, including fitting and associated costs. Applications must come from Limb Centres which have assessed the child’s prosthetic needs and prescribed a suitable prosthetic limb. Patients cannot apply directly or through their doctor. The funding will be available until March 2018.

In order to qualify for NHS funding towards a specialised sports prosthetic, such as a running blade, the Limb Centre’s application must demonstrate that the child meets the government’s eligibility criteria:

  • The child or teenager must be under 18
  • They must have suffered limb loss or have been born without one or more limbs – either upper or lower limb.
  • They must be medically fit to engage in physical activity, as assessed by the Limb Centre
  • The Limb Centre assesses that the child or teenager will benefit from the prosthesis and from engaging in physical activity, whether that is participating in school sport, organised group sport, recreational activity or active play with other children.
  • For more specialised sport prostheses, it must be demonstrated that the child or teenager has an active interest or past history of participation in that sport
  • The prosthetic limb must have been prescribed by the Limb Centre as suitable for the child and, ideally, should have been trialled by the child before an award is made

The Department of Health’s announcement of 7th January 2016 doesn’t say whether the sports prosthesis grants will be made on a one-off basis or be renewable for further limbs as the child grows and their prosthetic needs inevitably change or the proportion of child amputees who will be able to benefit from the total funds of £750,000. But Boyes Turner welcome this initial move by the Department of Health towards improving mobility, health and accessibility for disabled children in the knowledge that individual lives will be improved, alongside the benefits to all that come from greater understanding, inclusion and facilities for those with disabilities.

Boyes Turner’s clinical negligence and personal injury claims lawyers act for clients who have suffered amputations and limb loss. Our clients have lost limbs as a result of negligent medical care, such as delayed treatment of sepsis, meningitis and infections, mismanaged diabetes and its associated conditions, negligent surgery and mismanagement of vascular conditions, and accidents which were caused by someone else’s fault, either at school, on the roads, on holiday or in the workplace.

We understand the importance of early rehabilitation and the restoration of mobility to our clients, and the essential role that expert prosthetic assessment and correctly fitted and suitable prostheses  play in an amputee’s recovery, dignity and quality of life. We are experts in securing the highest levels of compensation and early interim payments to get your rehabilitation started and your life back on track as soon as possible. Watch a video about how we have helped one of our previous clients here.

£90,000 compensation awarded following tragic stillbirth

The lady’s pregnancy was reported to be normal and all the usual scans were undertaken during the pregnancy. At 36 weeks, the midwife considered that the baby was breech and sent the lady for a scan. The scan confirmed breech presentation but showed normal growth.

Two weeks later, the lady had a further scan which showed that the baby was no longer breech but the sonographer previously failed to pick up that the baby had a growth restriction. Despite this, the lady was informed that her baby was developing normally. The following week, the baby was not moving as much as usual but the midwife advised this was normal as she was close to her due date.

At 40+3 weeks of the pregnancy, the lady had not felt any movement for some time and was sent to the hospital for a scan. The baby’s heartbeat could not be found and the baby was stillborn the next day.

The couple brought a medical negligence claim against the hospital trust alleging that the hospital had not recognised that the baby was growth restricted, but if it had been identified and acted on, the baby would have been born alive.

The hospital trust admitted their mistakes which resulted in the stillbirth. The parents’ legal representatives negotiated a settlement of £90,000 which included a claim for loss of earnings, funeral costs, therapy costs and damages for psychiatric injury.

“Here is a further case of a failure to identify and act on an abnormal growth scan, leading to a devastating stillbirth. It is unclear from this case whether the midwife’s actions were criticised but questions may have arisen as to whether the midwife appropriately took on board the mother’s concerns of reduced movement and whether she acted appropriately”.

Stillbirth negligence claim settled for £68,750

A lady who had a relatively straightforward first pregnancy and attended the usual appointments, sadly lost her baby at 38 weeks gestation. 

When she was 36+5 weeks pregnant, she attended an antenatal appointment at which the fundal height was measured as 33cm. Two weeks later it was measured at 36cm and a further two weeks later, 35cm.

At that final appointment, the baby’s heart rate was monitored and was strong. The following afternoon, however, the lady noticed that the movements of her baby had decreased and she attended the birthing centre. Very sadly, no heart rate could be detected and the baby’s death was confirmed by scan.

The parents attended a meeting with the hospital who told them that a growth scan should have been offered at the appointment when the measurements were 33cm, as the baby’s growth was restricted.

It was alleged that if the baby’s growth had been correctly measured and monitored, the lady would have been referred for a growth scan and had closer monitoring.  She would have been induced at an earlier stage which would have taken place before the baby died.

The hospital admitted the mistakes made in this case and the parents were able to settle the claim for £68,750.  The compensation award included claims for loss of earnings, headstone costs, psychiatric therapy and damages for the psychiatric injury for the mother and the father.

Sita Soni, solicitor with the Boyes Turner Medical Negligence Team, comments:

“It is extremely concerning how many cases we hear of where a baby’s growth is incorrectly plotted on a growth chart or not identified at all, but if it had been identified, closer monitoring and additional scans would have taken place, the baby’s death would have been avoided.  It is important there where hospitals admit their mistakes, lessons are learned to avoid the same errors being repeated.”

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The service was personal, professional and considered. I was treated so kindly and in the end I knew that not only had I found the right organisation but also the right person.

Boyes Turner client

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