11.06.2013

Lawyer Says Lessons Must Be Learnt After Hospital Admits Mistakes Were Made

By Ashlea McConnell

A mum forced to endure an abortion after her unborn baby was diagnosed with a fatal condition has pleaded for more stringent safe-guarding measures to be put in place across the NHS after it was revealed she was given acne drugs not suitable for pregnant women.

Sarah Sharma, now 27, was given the devastating news by doctors at her 20 week scan that the baby she was carrying was suffering from such serious heart and nervous system abnormalities that she would not survive after birth.

But specialist medical lawyers at Irwin Mitchell representing the distraught mum in her battle for answers say that had dermatologists at Peterborough City Hospital adhered to nationally accepted guidelines she would never have been prescribed the potentially dangerous acne medication, isotretinoin, which was to blame for her daughter’s condition.

Following the diagnosis – later confirmed during an autopsy as fetal isotretinoin syndrome* – medical staff advised Sarah to terminate the pregnancy and she was left with no choice but to deliver baby Indiya just 21 weeks into her pregnancy. Indiya was delivered at Hinchingbrooke Hospital on January 23, 2012.

The Peterborough and Stamford Hospitals NHS Foundation Trust has since admitted that had staff followed basic procedures when prescribing the drug they would have known in advance that Sarah was already in the early stages of pregnancy, and Indiya’s death could have been prevented.

Her solicitor, medical law and patients’ rights expert Anna Manning from Irwin Mitchell, said the Trust had since apologised for the errors which included:
• Failing to prescribe the isotretinoin in accordance with The British National Formulary (BNF) and manufacturers guidelines
• Failing to ensure that Sarah was taking effective oral contraceptive pill for at least one month prior to the prescription.

Anna said: “This is a truly devastating case made all the more horrific given that Indiya’s condition and tragic death could have been avoided had the Trust followed very basic, routine procedures when prescribing the acne medication.

“The BNF** guidelines for prescribing oral isotretinoin clearly states that women must practice effective contraception for at least one month before starting treatment, and that it is started on the first day of a woman’s period.

“Despite the fact that this particular acne drug is associated with such harmful effects in unborn babies medical staff failed to properly advise Sarah and heed the necessary precautions in place to protect her and her daughter.”

Following her ordeal Sarah turned to Irwin Mitchell to help in her battle for answers, and investigations carried out by the firm on her behalf found that medical staff had failed to follow safety requirements by ensuring that Sarah started the drug treatment within her menstrual cycle and within three days of a negative pregnancy test.

Within weeks of taking the acne medication the 26-year-old became increasingly unwell and visited her GP at the end of October suffering nausea and experiencing shaking, and she was referred back to the hospital for tests.

But, unbeknown to Sarah she was pregnant, and by the time it was confirmed on November 16, 2011 the devastating damage done to her baby was already irreversible.

Anna Manning from Irwin Mitchell said: “Appropriate guidelines are already in place that should prevent tragedies such as this occurring but clearly here the system failed.

 “Basic, routine checks could have prevented this tragedy from occurring and it is absolutely imperative that urgent lessons are learnt and shared across the whole of the NHS to ensure this never happens again.”

Sarah and her husband, who have since had a baby girl whom they named Asha – meaning ‘hope’ in Hindi – have since received a undisclosed settlement from the Trust and plan to donate funds to the Hinchingbrooke Hospital in Cambridgeshire where her care was referred following the errors at Peterborough City Hospital.

Sarah Sharma from Huntingdon said: “It has been an incredibly difficult year for us. Losing Indiya was devastating but to find out after that her condition, and subsequent death, could have been prevented is almost unbearable.

“I am pleased that the Trust has now admitted that they made mistakes but what we really want are assurances that no one else will ever have to go through what we did.

“People place their trust in medical professionals all the time; it would never have occurred to me that they were not doing absolutely everything in their power to ensure nothing went wrong.”

Sarah’s husband Varun Sharma added: "As a husband and a father, it was heartbreaking seeing my wife go through the pain of labour, knowing we would never get to take that baby home as parents should at the end of it. We were left with nothing but broken hearts and empty arms.

"I lost all faith in the NHS the day Indiya was born sleeping. They were meant to improve my wife's health, but instead they broke her.

“However we would like to express our sincere thanks to Hinchingbrooke Hospital for all their help and support during our loss, subsequent pregnancy and birth of our second daughter, Asha.”

 

* Fetal retinoid syndrome is a characteristic pattern of physical and mental birth defects that results from maternal use of retinoids during pregnancy.

**BNF – The British National Formulary (BNF) is a pharmaceutical reference book used by medical professionals

The BNF (61) March 2011 sets out the following guidance for the oral isotretinoin:

Isotretinoin – 'The drug is teratogenic and must not be given to women of child-bearing age unless they practice effective contraception...then only after detailed assessment and explanation by the physician. Women must also be registered with the pregnancy prevention programme (see under cautions below).'

Cautions - ‘In women of child-bearing potential, exclude pregnancy up to 3 days before treatment (start treatment on day 2 or 3 if menstrual cycle), every month during treatment (unless there are compelling reasons to indicate that there is no risk of pregnancy), and five weeks after stopping the treatment- perform pregnancy test in the first 3 days of the menstrual cycle.  Women must practice effective contraception for at least 1 month before starting treatment, during treatment for at least one month after stopping treatment.’

For more information on defective drugs and medicines, as well as other claims of this nature, visit the Medical Negligence section of our website.