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BABY SUNAINA UK DEATH INVESTIGATION

Pharmacist second Expert Report 080608

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Neelu Chaudhari, aunt of baby Sunaina, a pharmacist, in her second Expert Report dated 08 June 2008, below, challenges Professor Weindling's second Expert report dated 15 August 2004, in which he changed his earlier opinion that the care given to baby Sunaina was of an "exceptionally high standard", admitting that "mistakes were made by doctors, pharmacists and nurses" but claims that these "did not harm Sunaina". 

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SECOND EXPERT REPORT

 

& WITNESS STATEMENT 

 

Death of Baby Sunaina Chaudhari

b. 25/05/2000 d. 26/10/2000

 

08 June 2008

  

MISS NEELU CHAUDHARI

 BPharm. MRPSGB, Cert. Ed.

Pharmacist Reg No 075777

Ilford, Essex UK.

 

I have compiled my second report in response to the second report of Professor Weindling dated 15/08/2004.  In his second report, Professor Weindling had sight of my evidence based first Expert Report dated 24 March 2004.

 

1.         Diagnosis

In point 2, Professor Weindling wrongly states that Sunaina Chaudhari suffered from multiple congenital abnormalities and the chromosome abnormality Trisomy 18 (Edward's syndrome).  The only abnormality Sunaina was affected by was a diaphragmatic Hernia, where her stomach had slipped through the diaphragm into the chest area next to left lung during pregnancy.  As a result, both the stomach and left lung were under-developed as commonly occurs in premature babies.  In Sunaina's case, the hernia was corrected successfully on 01/06/2000, by pulling the stomach back into the abdomen.  Sunaina was said by doctors to have made a remarkably recovery and was discharged home at 2 months of age on low flow oxygen.

 

 2.         Out-patient clinic 07/09/2000: During the 2 months following discharge, Sunaina's oxygen requirements had progressively reduced.  During an outpatient's clinic appointment on 07/09/2000 with Dr Shirsalkar, she was said to have "done very well since her discharge home" and an x-ray found both lungs were the same size.  Dr Shirsalkar also noted that the ventricular septal defect (commonly known as hole in the heart) was closing up.  No further referral was thought necessary for cardiology.  Apart from an eye infection, the rest of the examination was found to be normal.  Sunaina was to be seen again after 4 months.

 

3.         Syndrome Vs Chromosome abnormality: In point 5, Professor Weindling wrongly states that a chromosome abnormality is charcterised by trisomy 18 and known as Edwards syndrome.  A chromosome abnormality can only be confirmed by looking at the chromosomes under a microscope.  Whenever an abnormality is found, it is routine to compile a cytogenetics report that includes chromosomal photographs of the 23 pairs of chromosomes found in all humans.  In Sunaina's case, no such photographs were found in the file and no such cytogenetics report was compiled.  Edwards syndrome is a collection of symptoms in patients who have had a confirmation of Trisomy 18, namely an extra chromosome at no 18.  In the absence of a confirmation of Trisomy 18, no disgnosis of Edwards Syndrome can be made.  A reputable pathologist, Dr Stephen Gould, told the family that he was equally wrong on occasions when he thought that a child looked as if it had a chromosome abnormality but was found to have normal chromosomes, as often as when he looked at the cells of normal looking infants, and found that in fact they did have the chromosome abnormality.  Hence it is not possible to say that a child has a chromosome abnormality by looking at their external appearance without looking at their chromosomes.   The diagnosis of Edward's syndrome is an opinion based diagnosis once the scientific based diagnosis of Trisomy has been established.  In the absence of a scientific diagnosis, the diagnosis of Edward's syndrome is only a hypothesis until verified scientifically.  Several doctors had queried the diagnosis of Edwards Syndrome.  Dr Loiuse Wilson also wrote in an email that a confirmation was awaited after birth.  No confirmation was found in the file.

 

4.         Normal Baby with repaired hernia: Since no chromosome photographs or cytogenetics report were found in the file, and the Cytogenetics laboratory admitted that they do not routinely do photographs of the chromosomes because it is expensive, there is no evidence to suggest that Sunaina had Trisomy 18.  Clinical evidence from the outpatients appointment on 07/09/2000 at 4 months of age confirms that Sunaina was behaving like any other baby.  She was found to have "done very well since discharge home", "following and fixing", smiling and cooing and showing normal signs of intelligence for a baby of her age.

 

5.         Gaining Weight, sitting up: Sunaina could sit up unaided at 4 and a half months.  Her rate of growth was above average in that she had gained weight from 1.92kg to 4.5kg.  Children affected by Trisomy 18 gain weight less rapidly and cannot sit up unaided until much later, if at all.

 

6.         Overdose by GP: In point 6-21, Professor Weindling wrongly concludes that the ranitidine overdoses were unlikely to harm Sunaina.  Professor Weindling omits to consider the effects of the GP, Dr Suri, prescribing an adult dose of ranitidine, namely, 150mg twice daily for 4 month old baby Sunaina between the period of dispensing on 26/09/2000 to the date of hospital admission on 01/10/2000.  Professor Weindling omits to note the increased oxygen requirements on admission and critical blood oxygen levels of 58%.

 

7.         The manufacturer states that ranitidine is not licensed in children under 2 years of age.  This means that the manufacturer takes no legal responsibility for the prescribing of therapeutic doses (i.e. 3 mg three times a day) let alone doses that are higher.  Professor Weindling cites no scientific data to back his opinion in point 21.  Prior to the ranitidine overdose prescribed by Dr Suri on 26/09/2000, Sunaina's low flow oxygen requirements at home were decreasing over the 2 months period from 0.25 to 0.1 litres per minute.  By the 01/10/2000, Sunaina's oxygen requirements had increased eight fold to 2 litres per minute, for the first time since discharge home.  Ranitidine is known to cause bronchospasm, or constriction of the airways.  This side-effect of ranitidine occurs even when ranitidine is given at the therapeutic dose.   In Sunaina's case, it occurred in over-dose.  This makes it a toxic effect from an overdose rather than a side-effect of a therapeutic dose.  Professor Weindling is scientifically wrong to refute that bronchospasm did not occur as a result of the overdose of ranitidne, because it is stated as a side-effect at therapeutic doses in the literature.  Effects in over-dose would be critical.

 

8.         Accumulative effects of overdoses: Professor Weindling fails to note that once an overdose is given, all doses given subsequently, have an accumulative effect, such that the total number of doses and the period over which they are given become relevant.  Professor Weindling fails to calculate the total dose that would have accumulated in Sunaina's body over the 4 week period since the overdose was never allowed to leave her body even after the overdose was acknowledged.  Ranitidine blood levels were not measured and the therapeutic dose of 3mg three times daily over the subsequent 3 week period would have resulted in the 240 times toxic effects of the ranitidine to continue until the time of death.

 

9.         Adult dose prescribed for 4 month old baby: In point 22, Professor Weindling fails to mention the adult dose of ranitidine prescribed by the GP Dr Suri on 26/09/2000 and dispensed by Tesco Pharmacy Barkingside on the same morning.  It is a serious omission that Professor Weindling fails to note the overdose prescribed by the GP as a possible cause of increased oxygen requirements, bronchospasm and admission to hospital.

   

10.       Mistakes and errors found: In point 23, Professor Weindling admits that such mistakes do happen, yet fails to consider how it was possible that so many mistakes were made consecutively and consistently on the same baby by so many professionals; doctors, nurses and pharmacists, at the same time and place.  He fails to draw his attention to the out-patient clinic report of 07/09/2000 and fails to comment on how or wy these mistakes were made in Sunaina's case.  Had he looked at Sunaina's case objectively, he would have considered the co-incidence that the same doctor had advised termination.  The same doctor had failed to arrange for the child to be delivered at a hospital with proper facilities to carry out the diaphragmatic hernia operation.  The same doctor failed to acknowledge the drug overdose and repeated switched the oxygen off when it was indicated from the overdose.  The same doctor implemented the withholding and withdrawing of treatment and water, unlawfully, without an order of the court.  Days before the overdose, the Home Care Team had advised the mother to re-wash the oral syringes due to costs.  The GP also worked at King George Hospital.

 

11.       Other omissions and failures: In point 26,  Professor Weindling fails to consider the effect of continuing to prescribe ranitidine in a baby recovering from a diaphragmatic hernia, with toxic levels of ranitidine already in the body from 8 days of 240 times accumulated drug overdoses that continued over further period of 3 weeks until death.   Professor Weindling fails to comment that the overdose should have been picked up on admission.  It is hospital policy to review all medication on admission to rule out the possibility of drug overdose as a cause of admission.  Professor Weindling fails to consider the ill effects on the heart and breathing on a baby recovering from a diaphragmatic hernia operation, and of subsequently disconnecting oxygen causing blood oxygen level to fall to 37.4% by the fifth day of hospital admission.  Professor Weindling fails to comment on why no incident report was completed once the overdose had been acknowledged.

 

12.       No Independent investigation to date: In point 27, Professor Weindling appears to have been given the assurance that a professional standards investigation is being conducted by the Royal Pharmaceutical Society of Great Britain into the hospital pharmacists.  No such investigation has to date taken place.  The Royal Pharmaceutical Society of Great Britain has stated that is has been unable to identify the pharmacist responsible for the ranitidine overdoses.

 

13.       False information given to Poisons Unit about overdose: In point 28, Professor Weindling should have calculated the exact overdose that should have been conveyed to the Poisons Unit, as having been administered to Sunaina prior to and subsequent to hospital admission.   A ninety times accumulated overdose following admission and a hundred and fifty times overdose prior to admission means that a two hundred and forty times overdose of ranitidine was actually administered to Sunaina as prescribed by doctors over the period 26/09/2000 to 5/10/2000 and this overdose remained at that level for another 3 weeks because the overdose was never given the opportunity to leave her body.  Professor Weindling should have considered why the wrong information was given and why the correct information was withheld. 

 

14.       Advise of Poison’s Unit ignored: Professor Weindling should also have considered the effects of not following the advice of the Poison's unit to monitor the baby.  He should have noted that the child's blood oxygen levels further deteriorated to 37.4% hours after the advice since no monitoring was carried out and no CPAP oxygen was given despite being indicated during this time.  The baby was already recovering from a major operation and toxic side-effects of an overdose followed by oxygen deprivation.  Sunaina should have been transferred to an acute unit with proper monitoring facilities but was left in a cubicle on an ordinary ward without proper monitoring facilities.

 

15.       Concealment of drug overdoses prescribed by false diagnosis: In point 29, Professor Weindling fails to note that the five consultants were not made aware of the two hundred and forty times toxic drug overdoses of ranitidine followed by oxygen deprivation to 37.4% and fails to consider why this relevant fact was deliberately withheld.   It should have been known by the doctors that the low oxygen would have put a strain on the heart and lungs in a normal child let alone one recovering from an operation a few months earlier.   On 5/10/2000, Sunaina's heart was found enlarged on an x-ray for the first time. This was after the 240 times overdose of ranitidine.

 

16.       Spironolactone Vs Potassium Chloride: In point 30, Professor Weindling fails to consider the effects of prescribing potassium chloride in a child recovering from a diaphragmatic hernia, who had been prescribed toxic 240 times overdose of ranitidine and denied CPAP oxygen, until 37.4% blood oxygen level, despite it being indicated.  Potassium chloride is lethal if given at a rapid rate as it stops the heart.  The doctors should have known that no normal patient cold survive such low levels of oxygen (normally 100%), let alone a child born with a premature lung and recovering from a left diaphragmatic hernia operation. 

 

17.       Contradictory action by doctors: In point 30, Professor Weindling justifies the prescribing of potassium chloride, contradicting his own opinion that the advice of the Great Ormond Street Consultants was correct in that the baby was not to be given new treatment and that her current active treatment was to be withdrawn. 

 

18.       Obliterations of signatures on drug chart: In point 31, Professor Weindling fails to comment on the 2 additional signatures on the drug chart for potassium chloride at 13.00 and 22.00 hrs on 26/10/2000 .  These were subsequently crossed out.  These additional doses must have been given before death at 11.10 on 26/10/2000 because the signatures were inserted at the time of administration whilst Sunaina was alive. 

 

19.       Needle mark in neck and six needle marks on the hands: In point 32, Professor Weindling fails to consider the possibility that potassium chloride was given in the jugular vein at a rapid rate.  A needle puncture was found in Sunaina's neck in the Police photographs.  Both pathologists failed to mention it or consider it as a cause of death in their reports.  The Coroner also failed to investigate it.  Potassium chloride given at a fast rate causes the heart to stop.  Dr Solebo confirmed that Sunaina's heart stopped suddenly.  Dr Rager and Chris McMenamin signed for the two additional doses of potassium chloride given immediately before death.  They were both in Sunaina's cubicle  immediately before Dr Solebo arrived.  Dr Solebo says he tried to insert a cannula in Sunaina's hand on 3 occasions, yet Sunaina was found to have 6 needle punctures, 3 on each hand.  Repeated puncturing of veins is known cause of death in babies.  Professor Weindling failed to consider this.

 

20.       Removal of final drug charts from file: In point 33, Professor Weindling again contradicts himself.  In his first report, he admitted that he did not have sight of the drug chart after 16/10/2000 .  He fails to consider that this must have been removed because I have seen the original file and King George Hospital and it should have been there unless it had deliberately been removed.

 

21.       No confirmation of Edwards syndrome or Trisomy 18 found: In point 35, Professor Weindling fails to verify in the medical file that there is no confirmation in the way of chromosome photographs to substantiate a diagnosis of Edwards Syndrome from Trisomy 18.  All of Sunaina's organs were functioning normally.  There were no concerns with the heart.  The VSD had clinically closed.  She was gaining weight and thriving at home.  She became ill after the GP prescribed a massive overdose of ranitidine that caused bronchospasm requiring admission to hospital.  Following admission, the overdose was not picked up, but continued by several doctors.  Sunaina was denied CPAP oxygen until her blood oxygen levels fell to critical 37.4%.  The details of the prescribed overdoses were suspiciously withheld from the Poisons Unit and Great Ormond Street consultants.  The condition of the child was allowed to deteriorate despite the advice of the Poisons Unit to monitor the child.

 

22.       Multiple assaults on vulnerable baby: In point 38 (i), for the reasons given above, Professor Weindling has failed to consider the total accumulative effect on the child from the 240 times ranitidine drug overdoses, lack of monitoring to blood oxygen levels of 37.4% over a period of several days followed by deprivation of oxygen between 26/09/2000 to 26/10/2000, in a vulnerable child recovering from a diaphragmatic hernia operation a few months earlier.

 

23.       CPAP oxygen denied: In point 38 (ii), Professor Weindling was asked to respond to the family complaint that CPAP was withheld for several hours on 05/10/2000.  Mistakingly, Professor Weindling is referring to the advice given by Great Ormond Street Consultants on the 20/10/2000

 

24.       “DNR implemented without order of the High Court and against the wishes of parents: In point 39 (iii), Professor Weindling is wrtong to consider whether the DNR policy was correct.  He should have considered whether the King George hospital doctors should have informed the Great Ormond Street hospital consultants that Sunaina had been given 240 times ranitidine drug overdose and that the increased oxygen requirements were actually due to the bronchospasm from the ranitidine overdose.

 

25.       Social Services secret application to remove mother from baby in hospital: It appears that Professor Weindling has not been given the correct facts nor had sight of the complete medical file.  Had this been the case, he would have noted that Sunaina's CPAP oxygen and water was stopped immediately after the Emergency Protection Order was obtained to isolate Sunaina in hospital so that her mother could not reconnect the oxygen as she had been trained to do.   Sunaina was dehydrated in the 6 days leading to her death because her water was stopped at the same time as CPAP oxygen.

 

26. Limitations: Finally, I would like to comment that Professor Weindling, Paediatrician, was limited in his investigation to the questions set by the Police.  In his first report, he admitted that he did not have the complete file.  Professor Risden, pathologist, also admitted that he did not have the complete file.  It is unacceptable that the most relevant period of the medical file, i.e. the 9 days before death, were not available to the Experts involved in the reports. 

 

27.  Other issues: There are other aspects that require further investigation:-

The eyeballs were suspiciously removed from their sockets.  No-one has explained to the family why these were removed, who removed them and where they are.  The vitreous test on the eye jelly determines the exact concentration of drugs in the body at the time of death.  This test was suspiciously omitted by both pathologists and Coroner.  Professor Weindling also fails to comment on it.

 

27.       Relevant facts and documentation concealed: Thus the information presented to the jury at the Inquest of 11 September 2001 was not accurate or complete.  The correct information was suspiciously concealed, facts were withheld and the conclusions were not only fabricated but known by those involved to be wrong.

 

The above report is written in my capacity as a qualified pharmacist, to add to my previous report dated 24/03/2004).

 

 Miss Neelu Chaudhari

Pharmacist

MRPSGB, Cert. Ed.

SIGNED                                                                           Ilford, Essex UK.

 

Baby Sunaina died suddenly on 26 October 2000, aged 5 months, in a UK hospital, after UK paediatricians decided it was in "her best interests to die" against the parents wishes and without a High Court Order.  Pathologists found three needle marks on each hand, white food material in the airways and a wound in the arm, yet an Inquest concluded she died of natural causes.  The family expatriated the body to India after UK authorities hid the body for several years and threatened to destroy the body.  There is evidence that all internal organs including eyeballs were removed unlawfully to hide the cause of death.  Police appointed paediatrician took 4 years to admit doctors, pharmacists and nurses gave deliberate drug overdoses over a period of a month preceding death.  The family want the body brought back to the UK for a second Inquest after UK Police refused to make a request to India authorities to investigate.  A needle puncture in the neck has been omitted from all UK investigations.