Death of Baby Sunaina Chaudhari
Expert Report
by Neelu Chaudhari (075777)
|
EXPERT
REPORT &
WITNESS STATEMENT DEATH OF
BABY SUNAINA CHAUDHARI b. NEELU
CHAUDHARI BPharm MRPSGB Cert Ed PHARMACIST Reg No 075777 Tel/Fax 00
44 (0) 208 550 8312 Email: sunaina@newsguy.com |
I have been a qualified pharmacist
and a member of the Royal Pharmaceutical Society of Great Britain for over 20
years. My experience has been as
Senior hospital pharmacist: advising Consultants on the most appropriate and
effective prescribing; as Pharmacist Manager: managing a retail pharmacy giving
advice to patients; and as Pharmacist Facilitator on behalf of health
authorities, training other pharmacists to implement joint projects with
doctors. A copy of my membership certificate is attached, see page 37.
I am compiling this expert
report in respect of Sunaina Chaudhari, who was born on
I have studied two medical
files held for the child at
I was unable to confirm the
diagnosis of Trisomy 18 or Edwards syndrome based on verbal diagnosis, in the
absence of a Cytogenetics Laboratory report in the medical files.
Apart from a brief summary
about the medical care provided, for the purposes of this report, I intend to
focus primarily on drug treatment in the period of two months prior to the
death,
SUMMARY
This is a most horrific case
of clinical and criminal negligence involving a large number of medical
professionals, causing the death of a 5 month old baby by drug overdoses and
lethal poisoning over a four week period.
Those medical professionals defied all procedures, failed to follow the
advice of the Guy’s Poison’s Unit, and continued to with ranitidine
drug overdoses for another 3 weeks in a way which they knew would cause the
death of the child. Further, on
A) Birth to disharge home (
Sunaina was born on
25/05/2000 at King George Hospital, Ilford, Essex, full term +13days, by normal
delivery, weighing 1.92kg, requiring ventilation pending surgery for a
diaphragmatic hernia repair (to reposition the stomach back into the abdomen
which had slipped through the diaphragm into the chest area onto the left lung,
prior to birth). She was intubated
and ventilated for 7 days prior to a transfer to
Ranitidine
IV and IV fluids were commenced on arrival. On
The nasal CPAP was gradually
weaned off onto low flow oxygen from
B) AT HOME
“Dear Dr Suri, …Sunaina was reviewed in the clinic today. She has done very well since
discharge home. Initially she was being fed hourly but now she is on continuous
24 hour pump feeds and seems to be coping very well with this. In clinic today
she was fixing and following, there was right sided eye infection for which I
have prescribed Chloramphenicol eyedrops. The rest of her examination was
normal. Liver was 2cm palpable; I couldn’t hear a murmur in the heart, it
looks like the VSD is closing up. Plan: 1. Continue with same dose of
Frusemide and Spironolactone (she will grow out of it).2. Continue with
oxygen. 3. Review in 4 months. Yours sincerely Dr A Shirsalkar
Consultant Paediatrician cc. Michelle Riceman, CNS, Home Care Team”
The plan was to continue with
low flow oxygen at home, Frusemide 1ml (1mg) daily and spironolactone 0.35mls
(1.75mg) daily. Ranitidine was not
part of this plan and was discontinued by Consultant Dr Shirsalkar. See BHR 011 on pages 11
and BHR 012 on page 12. A chest x-ray on
On
Ranitidine is unlicensed for use in children
under 2 years of age. See BHR 03 page 14. Manufacturers for ranitidine (Zantac),
Glaxo, list serious toxic effects on the heart and breathing and recommend it
should be stopped immediately with “sudden wheeziness or tightness in the
chest”. They refer to
specialist paediatric guidelines for correct dosages when it is considered
absolutely necessary. The
dose in these cases is 1mg/kg three times daily, the child’s usual dose
was 3mg three times daily.
The adult dose of ranitidine was dispensed by Tesco
Instore Pharmacy, Barkingside at 08.29 hours on
“Ranitidine syrup 300ml, Two 5ml
spoonfuls to be taken Twice daily”.
Two 5ml spoonfuls, or 10mls is 150mg, an adult
dose. This is fifty times the
previous dose of 0.2mls prescribed for Sunaina, which had been stopped on
The pharmacist was negligent in dispensing an
adult dose, 10mls twice daily for a 4 month old baby. The pharmacist was negligent in dispensing
300ml for a 4 month old baby. The
large volume in itself should have raised alarm bells. Computers are programmed to give
warnings to pharmacists when dispensing medicines for children under 12 years
of age. To avoid errors, the age
has to be entered and the overdose warning over-ridden before the label can be
printed. The time of the enquiry to
Tesco was
Sadhana Chaudhari queried the excessive volume
for ranitidine with Michelle Riceman and was advised on an amount to be
administered. As a result of the
advice, the mother continued to administer an overdose of rantidine to her
baby. Michelle Riceman was
negligent in advising on the administration whilst she had notification from
Consultant Dr Shirsalkar that the ranitidine had been discontinued. She was negligent in giving advice she
was not qualified to give and she should have referred the mother back to the
hospital, GP or pharmacist.
Later the same day,
“26/09/2000: Increased temperature,
excessive crying…oxygen 0.2-0.3 L…Meds – Ranitidine 30mg tds,
frusemide 1ml od, spironolactone 0.35ml od, Abidec, Calpol PRN suppository PR
od.”
During this assessment, Ranitidine overdose
was overlooked as well as the fact that Consultant Dr Shirsalkar, had discontinued
it on
C) FIRST HOSPITAL ADMISSION LEADING TO DEATH
Dr Padoa was negligent in failing to review
the use of ranitidine on admission when it was not indicated or
recommended. She was also negligent
in failing to refer to the letter by Consultant Dr Shirsalkar in the medical
file dated
At 01.54hrs, pH 7.09, pCO2 10.2 kPa, pO2 5.1 kPa, HC03a 23.0mmol/L tCO2
25.3mmol/L, BEvt -9.2mmol/L, O2sat 51.5%.
Dr Kathy Padoa was negligent in failing to
commence nasal CPAP (Continuous Positive Airways pressure) which was indicated
for severe suffocation and critically low blood oxygen levels of 51.5%
(normally 98%-100%). She was negligent
to in allowing the child to continue to suffocate at critical levels for over
12 hours.
Dr Padoa was negligent in prescribing
ranitidine 0.2ml three times daily on the drug chart whilst Sunaina was having
difficulty in breathing and increased oxygen requirements from ranitidine
overdoses. See BHR 06 on page 19.
Later the same day, at 14.30hrs, the child was
still suffering severe effects of ranitidine overdoses, See BHR 05 page 17.
“Temp, resp distress, increased
secretions…increased oxygen requirement, normal 0.2L/min, now needing
about 2L to keep sats above 91%...grunting, crying, irritable, oropharyngeal
secretions ++, pyrexial, HR 160-180/m, Chest: marked intercostal subcostal
recession of chest ++ CVS: No heart
murmur.”
On 01/10/2000, Dr Fran Harrowes altered
the dose of ranitidine from 0.2ml three times daily to 30 mg three times daily
on the drug chart. As a result, the child received nine overdoses of ranitidine
of ten times overdose each, a total of ninety times overdose, whilst admitted
to Clover Ward,
On
The pharmacist, Rachel Soffe was the
clinical pharmacist responsible for Clover Ward and visited Clover ward daily
where Sunaina was admitted. Rachel
Soffe failed in her professional duty to intervene the nine overdoses of
ranitidine prescribed and administered to Sunaina whilst admitted on Clover
Ward. Rachel Soffe was negligent in
failing to set up recommended procedures to review medication on admission to
hospital to identify drug overdoses as a cause of admission and to halt a
continuation of any drug overdoses administered prior to admission.
On
“Phoned Guys Poisons Unit, can be a
problem in renal problems, Noted in the past have been bradycardia, AV block,
hypotension. Plan: Monitor …signed V Gavel”. See BHR 08 page 22, top of
page.
Dr Gavel was negligent in misinforming the
Guys Poisons Unit at 15.49hrs that 1) the child had come into accident and emergency,
2) she had received one single 30mg dose of ranitidine in error, 3) the dose
was given over 9 hours earlier, and 4) that the child was currently well. Dr Gavel was negligent in not informing
the Guys Poisons Unit that 5) the child was prescribed the overdoses during an
in-patient stay over several days.
He was negligent in giving them 6) the wrong information as to the time
of the last doses, 30mg ranitidine at 06.00hrs and a dose of 3mg at 14.00 hrs on
In fact, Dr Gavel was negligent in not
informing the Guys Poisons Unit that 7) Sunaina had been administered some nine
doses of ten times overdose each as prescribed by doctors followed by 8) an
additional prescription on the drug chart for 3mg ranitidine three times daily
since 14.00hrs, within two hours of his communication with Guys Poisons Unit,
to be continued indefinitely, 9) the first 3mg dose having been prescribed
within the last 2 hours. Dr Gavel
then 10) failed to follow the advice by the Guys Poisons Unit to monitor the child. See BHR 07 page 21, BHR 08 page 22, BHR 08 page 23, BHR 08 page 24 & BHR 08 page 25.
The label on the bottle dispensed by Tesco
pharmacy, brought in by the mother was confirmed as having an adult dose of
ranitidine, See BHR 07 page 21and BHR 08 page 22, middle
of page. No clinical incident form
was found completed in the medical file.
Rachel Soffe was negligent in not completing a
clinical incident form in respect of ranitidine drug overdoses administered
during hospital admission even after the Guys Poisons Unit intervened on
At 05.41hrs, pH 7.12, pCO2 7.7 kPa, pO2 5.3 kPa, HC03a 18.9mmol/L tCO2
20.7mmol/L, BEvt -11.5mmol/L, O2sat 57.5%.
At 06.25hrs, pH 7.06, pCO2 15.9 kPa, pO2 4.2 kPa, HC03a 33.7mmol/L tCO2
37.4mmol/L, BEvt -1.4mmol/L, O2sat 37.4%.
The pharmacist Rachel Soffe was further
negligent in not intervening whilst the child was continued with ranitidine at
3mg three times daily for another 3 week requiring nasal CPAP oxygen and
excessive suctioning for the resulting suffocation. See BHR 10 on page 28. The symptoms were worsening by
D)
Fax “Second Opinion” from Great Ormond Street Hospital: Consultants Dr Shirsalkar and Dr Robinson, King George Hospital,
were negligent in advising 5 Consultants Drs Petros, Peters, Kenny, Pierce
and Mok, Great Ormond Street Hospital to issue a “Do Not
Resuscitate”, “withhold and withdraw active treatment”
and “Palliative Care”
order for Sunaina, without an examination, without reviewing the medical file,
without a Court Order, without discussions with parents and whilst they knew
she was suffering the toxic effects of ranitidine. See BHR 12 on page 30 & BHR 12 on page 31.
The advice contradicted the medical
examination and findings of two doctors at King George hospital on
A visit made on
During the “DNR”, on
N 136, K 3.3, U 5.8, C 4.5, bile 6, alkP 905, prot 60, alb 37, glob 23,
AST 550, ajCa 276 ph 169
The child’s potassium level of 3.3mmol/L
was due to frusemide being prescribed and indicated the prescribing of
spironolactone. Potassium Chloride
is a known lethal poison with a narrow therapeutic range. This means that it can become lethal
with small increases in levels and therefore requires blood monitoring before
each dose and constant monitoring of the heart during administration. It is also lethal when given at high
speed, therefore it must be administered very slowly. It must not be prescribed regularly
– only if required. It is
normally administered in an acute setting, when levels fall below 2.2mmol/L,
not on a general ward. No such
monitoring was done. Dr Gavel was
negligent in prescribing “KCL” in the clinical notes on a regular
basis, long term, without specifying any monitoring or review. The “KCL” is an abbreviation
not normally used. His entry for
“Plan KCL 2mmol/kg added to feeds” has been tampered with by
obliterating “KCL”.
Dr Thomas Rager was negligent in
prescribing potassium chloride, “KCL” on the drug chart on
25/10/2000 at a dose of 2mmol/kg/day, or 4.7mmol to be given regularly twice
daily via NGT, regularly, without any monitoring or review, when it was not
indicated.. Dr Thomas Rager
was negligent in administering Potassium chloride without monitoring or
review. . Dr Thomas Rager was negligent in
administering an additional dose of potassium chloride prior to death - this
dose appears on the drug chart at 22.00hrs on
Nurse Chris McMenamin was negligent in
administering a dose of potassium chloride at 13.30 hours on
E) DEATH BY POTASSIUM CHLORIDE:
Dr Samarasekara was negligent in
administering a dose of 4.7mmol potassium chloride at 10.00hrs on
Dr Samarasekara as paediatric consultant, in
charge of Clover Ward on the morning of 26/10/2000, was negligent in
transferring Sunaina’s care to a more junior doctor, Dr Solebo, SHO, who
was on duty on another ward, SCBU, some 200m away, to enter Clover Ward so as
to take over Sunaina’s care at 10.52hrs, seconds before her heart
stopped. Dr Samarasekara was negligent
in supervising Dr Solebo to make repeated needle punctures in attempts at
cannulation, without monitoring the heart and breathing. Dr Samarasekara failed to document in
the medical file, details of monitoring and drug administrations in the last
hour of Sunaina’s life.
Pharmacist Rachel Soffe was negligent
in failing to advise doctors that potassium chloride was inappropriate for the
child, that spironolactone was appropriate, that that regular doses of
potassium chloride without monitoring could be lethal. Rachel Soffe was negligent in supplying
a bottle of potassium chloride from pharmacy to the doctors without giving
advice on its correct use, review and monitoring, knowing that its use would be
lethal.
Lack of chromosome evidence of Trisomy 18
I contacted the
Lack of evidence of Edwards Syndrome
“Edwards
Syndrome” is a condition, a hypothetical collection of possible symptoms,
which may or may not be present in a person confirmed as having Trisomy
18. In the absence of a confirmed
diagnosis of Trisomy 18, the term is a theoretical invention in much the same
way as Professor Sir Roy Meadows’ Munchausen Syndrome by Proxy. “Edwards Syndrome” is
neither an illness, nor a disease, nor a possible cause of death. In the
absence of a diagnosis of Trisomy 18 in Sunaina, any reference that she had
Edwards Syndrome is therefore not justified.
Massive evidence that Sunaina was a normal baby
All predictions by various
doctors were proved wrong when Sunaina did not die inside her mother’s
womb, did not die during birth, immediately after birth or during the
diaphragmatic hernia operation. In
fact she amazed doctors with the speed of her recovery, returning to
Inquest Evidence on ranitidine overdoses and lethal potassium chloride
Consultant Dr Shirsalkar gave evidence at the
inquest that Sunaina was given several overdoses of ranitidine in error. He further gave evidence that he would
not have prescribed potassium chloride as it is lethal and could stop the
heart. See BHR 15 page 34, BHR 15 page 35, BHR 15 page 36. Dr Solebo gave evidence at the inquest
that the child’s heart did stop suddenly.
Evidence of tampering of Medical File & Forgery
Having inspected the original medical file
held at
F) CONCLUSION:
NOTE: The ECHR ruled on
The above report finds the above named were
negligent clinically and criminally in their medical, clinical pharmacy and
nursing care provided to baby Sunaina Chaudhari leading to her death by
ranitidine overdoses and lethal potassium chloride poisoning.
Signed:
……………………………………………
Neelu Chaudhari
BPharm MRPSGB Cert Ed.,
