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THE HIGH COURT

12010 No.937 Pl

MARK DUFFY, A MINOR, SUING BY HIS MOTHER AND NEXT FRIEND,

LII{DA DUFFY

PLAINTIFF

AND

NATIONAL MATERNITY HOSPITAL

DEFE,NDANT

JUDGMENT of Mr. Justice Sean Ryan delivered the L4th Ausust 2012

The plaintiff Mark Duffy was born prematurely at the National Maternity

Hospital on the 18fr July, 2002. He was delivered by Caesarean section at 30 weeks

gestational age because of matemal bleeding. In addition to being premature, he was

of very low birth weight at 1.3 kg, two features made Mark vulnerable to infection.

During his second week of life he contracted meningitis which caused severe

brain damage and left him with profound physical and mental disabilities. This action

for damages concerns Mark's treatment in the National Matemity Hospital on the 30th

and 3l't JuIy20o2.

The plaintiff s experts say that the way the baby was treated in the National

Matemity Hospital on the 30th and 3l't July, 2002, was sub-standard. They criticise

the hospital for not suspecting meningitis and carrying out a lumbar puncture, the

essential test to confirm or exclude that disease. If that test had been done, it would

have revealed that Mark was infected by meningitis and he would have been treated

for that infection.

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The plaintiff s case is that if he had been properly treated when he first

showed signs of infection he would have escaped all or almost all of the damage that

was wreaked by the disease.

The hospital's experts reject this theory. They argue that there is no evidence

to support the hypothesis of Professor Fleming and Dr Hill, who are the plaintiffls

experts. It is not standard practice to perform lumbar puncture if you suspect that a

neonate has an infection. Whether to do a lumbar puncture is a clinical decision for

the treating doctor. The medical world is divided on the question: some doctors

advocate routine lumbar punctures in diagnostic work-ups but there is no consensus

and practice varies in reputable centres around the world. Both sides appeal to the

literature and medical texts and journals.

The first principal question that arises is whether the National Maternity

Hospital was negligent in failing to carry out a lumbar puncture on the plaintiff on the

night of the 30th and/or the morning of the 3l't July, 2002. It that is answered in the

negative, the action must fail. If the answer is yes, a series of complex issues arises as

relating to causation and the aetiology of the disease process that brought about the

baby's condition. The question whether lumbar puncture would have made any

difference can be simply stated, but it involves difficult questions of pathology,

pharmacology and even of logic that were argued over at length in the course of the

hearing.

This part of the case is concerned only with liability.

The facts

The plaintiff Mark DuffY was born prematurely at the National Maternity

Hospital on the 18th July, 2002. He was delivered by Caesarean section at 30 weeks
gestational age because of maternal bleeding. In addition to being premature, he was

of very low birth weight at 1.3 kg. These two features made the baby vulnerable to

infection. He was given antibiotics for 48 hours.

On day 7 of life, the 25th July,2002,Mark became unwell and it was thought

he might be infected. He was given broad spectrum antibiotics and his condition

improved. The treatment was discontinued after 48 hours in response to negative test

results.

On the 26th July,Prof O'Keeffe, consultant ophthalmologist, carried out a

routine eye examination which was normal.

On the 30th July, 2002, a paediatric Registrar, Dr Risha Bhatia, examined the

plaintiff at around 4 pm. Dr Bhatia did not give evidence but sent a letter from

Australia where she is working:-

"On clinical examination, I noted he was pale. His vital signs were stable and
normal (temp 37.1, HR l45ll62,RR 50/60). As is my routine practice, I
examined his head and neck looking for abnormalities in fontanels,
spontaneous eye opening, facial asymmetry, evidence of discharge from eyes

or oral thrush or any other abnormalities. No abnormalities were noted on

examination of his head and neck. His cardiovascular examination was
normal with no evidence of murmurs or added sounds and his pulses were
normal. He had no evidence of respiratory distress or apnoea or bardycardiac
events and was breathing in air. His abdominal examination was normal with

a soft non tender abdomen. He was tolerating his feeds. He was wetting his

nappies and was stooling. He was active and tolerated handling during the

examination well. There appeared to be no apparent reason for his pallor.

However, in view of his pallor, I sent a FBC to the laboratory. A request for a
CRp was added to the sample also. My involvement in this case ended at this
point.

The FBC and CRP results were abnormal. Mark had a repeat FBC and CRP

as well as a blood culture performed and was commenced on the antibiotics on

the same night."
 Dr Bhatia's comments about the results of the tests suggest that she did not get

them on that day in the hospital in the course of her shift. She was concerned with the

baby's pallor and for that reason sent a full blood count to the laboratory and

requested a C-Reactive Protein test. The latter was reported as being "Positive
>6

mg/l Insufficient for quantification". The CRP figure, although stated to be abnormal,

was more or less discounted by the defence experts as having no or practically no

significance particularly in view of the comment.

Another examination took place one or two hours before midnight on the same

day. The hospital records suggest it was at about I I pm when Dr Donal O'Brien, a

Senior House Officer in the hospital, saw Mark. He said in a letter that he thought it

was about 10.00 pm. The Registrar on duty told him that the baby had low grade

pyrexia and could he take blood samples from the baby for testing. Dr O'Brien's note

said that the baby had low grade pyrexia at37.4 degrees and a positive CRP, that

Gentamycin plus Benezykpencillin were started and that there was no obvious source

of infection. Dr O'Brien gives other information about the baby including the CRP

readings which is as follows "CRP equals > 96 < 192" The CRP reading was

abnormal and indicated infection. Gentamycin was begun at2.00 am and

Benezykpencillin at 3.00 am. His letter says:

"I reviewed the baby, I listened to his heart and lungs. I palpated his abdomen
and I found no abnormality. The baby handled normally and was not initable.
I took the blood samples.
I did not take the baby out of the incubator and did not examine the baby's
eyes/retina nor did I think it was warranted.
The bloods retumed showing a WCC of 18.5 and aCRP of between 96 and
lg2. linformed the reg. duty and was told to prescribe IV Benzylpenicillin

65mg tds and gentamicin 4mg IV which I prescribed and was given at 02.00'
 The baby remained stable overnight. I did not review the baby again nor was

there any concem raised until the ward round the following day."

Later that day, 3l't July, at 12.00 noon Dr clodagh o'Gorman, a Registrar,

examined Mark. Following the examination she consulted Dr John Murphy, the

Consultant Neonatologist, who came and examined him and they were both very

concerned about Mark's right eYe.

She canied out a thorough examination and made a full note. She noted that

overnight the baby had had low grade pyrexia between 37.3 and 37.4 degrees

centigrade; the blood tests suggested infection. There was no focus for infection

evident. In recording this overnight situation Dr O'Gorman is referring to Dr

O'Brien's examination at 11.00 pm. She recorded that Mark had been noted by the

nursing staff to-day to be having more frequent desaturations and that he still had low

grade temperature. She also noted that the CRP was raised during the night which is

in reference to Dr O'Brien's examination.

On her examination, the baby's temperature was 37.05 degrees centigrade -

raised to some degree. She found Mark to be alert, his eyes were opened

spontaneously and she gave him a variety of tests that were satisfactory. That was

reassuring to her and also - at least one ofthe defence experts has pointed out - Prof.
was a
Tom Matthews - that the fact that the baby could undergo such examination
reassuring sign.

Dr O'Gorman was very concerned about Mark's right eye. As to his left eye

she thought that there was a query about it perhaps having a sluggish light reflex.

However, with the right eye her concern was very specific, she records as follows

about the right eye: + Proptosis [bulging]

+ Corneal opacification > cannot differentiate pupil from iris

 + Conjunjuctivial injxn [injection ie. blood]

+ Pus discharge

No light reflexes could be elicited"

Dr O'Gorman went on to set out her differential diagnosis which listed

?congential glaucoma?; panophthalmitis; and query lesion posterior to the eye which

might have resulted in the proptosis. In this retrospective note made at2.00 pm Dr

O'Gorman referred to the fact that the baby had been seen by Dr Murphy who had

directed that he be transferred to Temple Street Hospital for ophthalmic review and

that he was "not for LP now".

At 1.30 pm, Dr John Murphy examined Mark. He noted that the baby had a

swollen right eye; the right eye appeared more prominent than the left; the right

cornea was very cloudy; he could not identiff the pupil; there was some conjunctival

injection; "small/moderate discharge present". Dr Murphy diagnosed comeal

opacification and that the eye was more prominent and decided on a reference for

ophthalmological opinion. At the end of his note, Dr Murphy put some telephone

numbers and references staff in Temple Street, which I think is an indication of the

nrgency that he felt was present atthat stage.

Preparations were made to transfer the baby. Dr Murphy telephoned Temple

Street and Dr O'Gorman wrote a transfer letter to go with the baby.

At 3 pm, a nursing note records the situation at the time when Mark left Holles

Street for Temple Street. It says that he was in an incubator, that he was now

lethargic looking (whereas Dr O'Gorman at12.00 found him alert and active). His

right eye was reddish puffr with "pus discharge minimal".

Mark left Holles Street at 5 pm with an ambulance team and was handed over

to a staff nurse in Temple Street at 5.25 pm.

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The doctors in the National Matemity Hospital thought that the baby had a

very serious eye infection that required urgent specialist ophthalmic opinion.

However, as it transpired, Professor O'Keeffe, the ophthalmic consultant in Temple

Street, did not find any infection in the eye and even thought of returning the baby to

Holles Street but changed his mind and decided to keep him ovemight. This is an area

of controversy in the case that is an important part of the causation theory proposed

by the plaintiff s expert, Prof Fleming. A crucial element of his analysis is that the

baby's eye was not infected on arrival at Temple Street and if that is correct it cannot

have been infected earlier in the day at Holles Street.

Dr O'Gorman is now the Professor of Paediatrics in the University of Limerick

and a Consultant Paediatrician at the University Hospital, Limerick. She was in her first

month as a Registrar in Holles Street at the time of these events. She went there from

the Coombe I{ospital where she had spent six months as a Senior House Officer

working in neonatology. Dr O'Gorman did post-graduate qualification and training at

Oxford Universitv and in North America.

In her evidence. Dr O'Gorman said that she remembered the circumstances in

which she came to examine the plaintiff. On the rounds that morning, there wirs a

brief discussion about Mark having been a little bit unwell during the night and she

went back to examine him at the end of the ward round.

When she pulled out the incubator tray, she saw that there was a problem with

his eye. The abnormalities in the right eye were very obvious and were the first thing she

noticed. Dr O'Gorman recalled doing a very thorough examination of Mark. She

thought that ovemight and during the day there were some minor signs of instability,

which she noted, with slightly raised temperature, the CRP measurement and

desaturations but it was the babv's eye that was the real concern.
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The doctor's note said that the left eye was morphologically normal, that she

could see the retina but she had a query over the light reflex. The other eye by contrast

was very abnormal. She noted: proptosis, that is, the eye was bulging or appearing to

be pushed forward; corneal opacification - she could not differentiate the pupil from

the iris; conjunctival injection (bleeding); pus discharge; and that she could not elicit a

light reflex.

Dr O'Gorman said that the moment that she saw that the baby's eye looked

abnormal, she called Dr Murphy, the consultant neonatologist, or asked for somebody

else to call him for a further evaluation. He also thought that the eye looked very

abnormal and decided to transfer the baby to Temple Street Hospital for

ophthalmological assessment. Her note says "Not for LP now" and she recalled that

they talked about a lumbar puncture and felt that the baby would not have been

appropriate for one.

Dr O'Gorman wrote a detailed referral letter including relevant history and

medications and the following: "Righteye proptosed,conjunctival injection,pus

dischargeoneyelids and eyelashes,comeal opacificatio4 cannot differentiate between

corneaand pupif nored reflex"

The doctor said that she remembered seeing an eye that looked like there was a

lot of pus in it, a very infected looking eye. She noticed how it was bulging and was

unable to get a red reflex.

Dr O'Gorman was challenged in cross-examination as to why she did not

record the absence of red reflex in the notes. She pointed out that she had put it in the

transfer letter which was itself part of the baby's chart. Doing a red reflex test is part

of a standard normal neonatal examination and as a paediatrician or at the time as a

Registrar in neonatology, having previous been an SHO in neonatology, she would

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have done a lot of red reflex tests in newborn babies as part of her normal examination.

She said that she would have been able to tell the difference between a normal test and

one that was not.

Dr O'Gorman acknowledged that she did not observe the corneal defect in the

baby's right eye that Prof. O'Keeffe and Dr Fitzsimons, who examined him first in

Temple Street found.

It was put to this witness that the fact that Professor O'Keeffe did not find any

infection in this eye must mean that what she thought she saw, including the pus, could

not have been pus and that she was mistaken -and perhaps understandably mistaken

given that she was not an ophthalmologist -about this eye being very infected. Dr

O'Gorman said that, although she was not an ophthalmologist and it was her first year

as a Registrar in neonatology, nevertheless, after ten years she could still remember

examining Mark that day and specifically seeing the abnormalities in Mark's eye and

she insisted that the eye examination was abnormal when she performed it. She said

that it was hard for her to rationalise the description of Prof O'Keeffe's findings with

what she remembered distinctlY.

Dr Murphy in his evidence dealt with his examination of the baby and

confirmed the note he made and his role as described by Dr O'Gorman. He shared her

concem about Mark's right eye and it was his decision to transfer him to Temple St

Hospital, which he did not make lightly but did so because he felt it was essential. He

was afraid that Mark might lose the eye if he did not get immediate ophthalmic

attention.

This witness has been a Consultant Neonatologist in the National Maternity

Hospital since 1986 and was highly lauded by Prof O'Keeffe. He also testified about
the policy of the hospital in regard to lumbar punctures, which is a major area of

controversy in the case. That part of his evidence is set out later in this judgment.

When the baby arrived in Temple St he was examined by Dr Fitzsimons, a

Consultant Ophthalmologist. She noted that his right eye was slightly proptosed and

that there was a poor red reflex, an important test of abnormality. She also found a

comeal abrasion that she described as total.

Professor O'Keeffe examined Mark at around 6 pm. The nursing note says

that drops to dilate the eye for his examination were given as prescribed by the

consultant. He said in his note that there was good red reflex -this was of course with

the benefit of the dilation medication. There was a large comeal defect-he stopped

short of total. Then he noted: "No infection". He prescribed a topical antibiotic to

cover the comeal defect and lubricants. The nursing note says that he instructed the

nurses to commence the drug treatment and transfer the baby back to Holles Street but

that he phoned an hour later to keep baby in Temple Street.

In his evidence, Prof O'Keeffe said he had the highest regard for Dr Murphy

with whom he had worked for many years so he obviously would take his views very

seriously. Nevertheless, when he examined Mark he could not confirm any of the

suggested possible diagnoses. He could not find evidence of an infection, which

would include discharge, the cornea would be opacified, there would be some

infiltrate in the cornea. He found an intact anterior chamber and good red reflex. If the

baby did have infection in his eye, he would have to go to the Operating Room to

have samples taken for laboratory testing and intra-ocular antibiotics would be

injected. But that did not arise.

Obviously, the very things that Prof O'Keeffe identifies as indicators of

infection are recorded by Dr O'Gorman as being evident at midday. So the

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possibilities are, first, that Dr O'Gorman and Dr Murphy did not see what they

thought they saw and what they recorded as having seen or, secondly, Prof O'Keeffe

missed what was there to be seen in the baby's eye and which he should have been

looking out for or, thirdly, the conditiopn of the baby's eye changed in the time

between 12 noonlI.30 pm and around 6 pm.

Mark became very seriously ill during the night of the 31't July/l't August

2002 inTemple Street Hospital. He was in danger of death. He had a severe multi-

system disorder. He was moved to the intensive care unit. His parents were notified.

He had convulsions during the moming. He was given new drugs in addition to those

prescribed in Holles Street, including an anti-meningitis antibiotic, Cefotaxime which

he received at 00.05 am on the I't.

He continued to be seen by Prof O'Keeffe. He was aware when he saw Mark

at 9.30 am that the baby had collapsed during the night and he was astonished that the

baby he had seen the previous evening was moribund and flat in the ICU the next

moming. He saw the baby againon the evening of the 1't, at which stage he was

getting worried about infections getting into the eye and he prescribed ceftazidime, a

much more powerful antibiotic. In regard to infection he still couldn't find any hard

evidence, he did not see any discharge or any infiltrate on the cornea.

However, on the 2nd August the situation was different. There was now real

evidence of infection. Keratitis means that there was infiltrate on the comea. There

was a whitish material forming on it. It was infiltrate so it was now real evidence that

this eye was getting infected.

The note on 3td August said "opaque right comea, no improvement; no view of

anterior chamber" and Professor O'Keeffe commented that the eye was now badly

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infected. It was not possible to see through the cornea anymore because there was no

view of the front chamber of the eye so things were getting worse.

The professor was contacted during the day by Doctor Fitzsimons about

antifungal eye drops and the significance of that was they were dealing with a very

fundamental infection in the eye and were wondering if it was an organism that was

not responding to powerful medications. She decided to put the child on antifungal

chemotherapy. At this stage Prof O'Keeffe and his colleagues were throwing

everything at the infection.

On the 4ft August Dr Fitzsimons recorded that the cornea was opaque and

there was a small perforation. Prof O'Keeffe commented that now the eye was

perforated, the cornea had broken down and there was an opening going from the

outside into the inside of the eye. It is very strange and Prof O'Keeffe could not

understand or explain how the swab that was taken on this date appears to have been

o'scanty growth of commensals" on the

reported as normal: - the sample was collected
4th at atime when the baby's eye was in a disastrous condition.

A note on the 6th August made by a Registrar records the impression that the

baby has right endophthalmitis, opaque cornea, a small perforation and no red reflex.

On the 7th August Prof O'Keeffe carried out an operation to eviscerate the

baby's right eye. On the 8th August the note says: pseudomonas endophthalmitis. Prof

O'Keeffe said that were beginning to suspect for some time prior to that that this was

probably a pseudomonas and when they sent the eye specimen to the pathologist and

microbiologist, they were able to say it was pseudomonas. He said that this was a

devastating organism with a very poor prognosis. It is generally a disease that comes

from outside although he had seen an endogenous pseudomonas.

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 In cross-examination Prof O'Keeffe was referred to the notes where the

medical Registrar on call noted right eye comeal opacification plus discharge and the

professor agreed that it was possible that there had been a discharge from the eye

which had been cleared up.

The National Matemity Hospital notes of the examinations on the 3l't prior to

the transfer to Temple Street gave very specific information about the condition of the

baby's right eye and the records demonstrated that Dr O'Gorman, Dr Murphy and the

nurse who was caring for the baby while awaiting transfer all noticed that there was a

discharge from the baby's right eye. Prof O'Keeffe said that the subsequent sequence

of events in the baby's eye did not tally with what the doctors in Holles Street found.

In other words, if what they saw was the beginning of the process that led to the

destruction of the eye, that timescale didn't make sense to him.

During the night of the 31't/ l't the baby was extremely ill and in danger of

death. Doctor Corcoran saw the baby at 4:30 am and he noted "infected right eye". He

thought that the eye was a possible source of infection and the abdomen was another

possibility. When Prof O'Keefe saw the baby on the afternoon of the I't, that was

when he began to think that the eye was infected. The nursing notes showed that

between 5 am and 8 am on the l't the nurse recorded that that was pus in the baby's

right eye. Counsel put it to Prof O'Keefe that there were now 5 persons who had

observed pus in the eye from 12 midday on the 3l't up to 8 AM on the 1". He said that

pus in the eye would indicate infection. If you get an eye with pus, it is most likely to

be an infection in the eye.

The professor said that he saw no evidence of orbital cellulitis. It was put to

him that Prof Tom Matthews was of the opinion that the most likely explanation was

that the baby had infection of the orbit of the eye, orbital cellulitis, which would

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explain the proptosis and the other things seen by Dr O'Gorman others and that it

spread into the brain and caused meningitis.

Prof O'Keefe said that his view of the connection between the meningitis and

the infection of the eye is that the child was carrying pseudomonas, which got into the

eye. It was a vulnerable because of the corneal abrasion and the pseudomonas was

able to colonise and infect the eye and "I suspect strongly that maybe the child also

had pseudomonas in its bloodstream. That is what I think is the connection here."

Although Mark's right eye deteriorated disastrously as described, he did begin

to recover and his general condition gradually got better. He was well enough to have

a lumbar puncture taken on the 2nd August. It was sterile but it revealed that Mark had

had meningitis. It subsequently became clear that this disease has left Mark with

profound mental and physical disabilities resulting from brain damage.

The case

The plaintiff s experts say that the way the baby was treated in the National

Matemity Hospital on the night of the 30th and on the 31't July, 2002, was sub-

standard. They are somewhat critical (but this is not a big element in the case) of the

examination by Dr Bhatia that took place around 4.00 pm on the 30ft July. They

focus on the situation that existed at and after Dr O'Brien's examination of Mark at

I I pm on the 30th. They criticise the hospital for not suspecting meningitis and

carrying out a lumbar puncture, the essential test to confirm or exclude that disease.

If the test could not be done, a specific anti-meningitis antibiotic should have been

administered. If the test confirmed the presence of the disease in the baby's cerebro-

spinal fluid, the drug would have a head start in treating it. If not, it could be

discontinued and/or replaced. This approach they say is standard practice.

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 Lumbar puncture means putting a needle into the baby's spinal column and

drawing a small quantity of cerebro-spinal fluid for laboratory testing. Supporters of

lumbar puncture acknowledge that it is not always possible to carry out the procedure

because the baby may be too sick to tolerate it or too unstable for it to be done safely

and properly. In such cases it is acceptable to forego the test but it is then mandatory

according to these experts to administer drugs on the assumption that the baby does

indeed have meningitis.

In the absence of knowledge of the specific infection, the baby was put on

broad spectrum antibiotics that were not directed to or effective against meningitis. In

the result, on this theory, it was only when Mark was in Temple Street Hospital that

he got specific anti-meningitis medication that proved successful. That was

cefotaxime, which was first given at 00.05 am on the 1't. They argue that if Mark had

been given the effective antibiotic in the National Maternity Hospital instead of or in

addition to the broad spectrum drugs, he would have overcome the meningitis sooner

and have escaped all or almost all of the devastating brain damage that was wreaked

by the dreadful infection.

The hospital's experts reject this theory. It is not standard practice to perform

lumbar puncture if you suspect that aneonate has an infection. Whether to do a

lumbar puncture or not is a clinical decision for the treating doctor. The medical

world is divided on the question: some doctors advocate routine lumbar punctures in

diagnostic work-ups but there is no consensus and practice varies in reputable centres

around the world. Both sides appeal to the literature and medical texts and journals.

On the issue of causation they also disagree with the plaintiff s experts'

theory. They argue that there is no evidence to support the hypothesis of Professor

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Fleming and Dr Hill, who are the plaintiff s experts. It is also contended that the

factual basis for Prof Fleming's causation argument is unsound.

The first principal question that arises is whether the National Maternity

Hospital was negligent in failing to carry out a lumbar puncture on the plaintiff on the

night of the 30ft and/or the morning of the 3l't July, 2002. It that is answered in the

negative, the action must fail. If the answer is yes, a series of complex issues arises as

relating to causation and the aetiology ofthe disease process that brought about the

baby's condition. The question whether lumbar puncture would have made any

difference can be simply stated, but it involves difficult questions of pathology,

pharmacology and even of logic that were argued over at length in the course of the

hearing.

Central to this second question is the fact that the only pathogen that was ever

cultured from samples taken from the baby was pseudomonas aeruginosa. This was

grown in slight tracesl from the baby's eye and from his left little finger. The

defendants' expert witnesses say that what happened was that this infection,

pseudomonas aeruginosa, began in the baby's right eye. He was ill but Dr O'Brien

could not find any obvious source of infection. The reason the baby was ill at that

time was because he was infected or becoming infected. That started in his right eye

but symptoms were not immediately apparent there. During the morning of the 3l't

July, signs of infection in the eye became obvious and the eye was getting worse. As

a result, Mark was transferred to Temple Street Hospital for a review of the eye- The

explanation for what happened to the baby is pseudomonas aeruginosa, which began

in the right eye and spread directly or indirectly to the meninges. Notwithstanding the

t 'A scanty growth' is the expression used

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appropriate treatment the baby was receiving in Temple Street, the virulent infection

consolidated its invasion of the eye and ultimately destroyed it.

The plaintiff s expert, Prof. Fleming relies on Prof O'Keeffe's findings on

examination of the baby at 6.00 pm on the 3l't July in Temple Street Hospital, the

clear cerebro-spinal fluid on the 2"d August, from the lumbar puncture done that day

at 5 pm, the history of drug administration and of the progression of the baby's

condition. These facts, he says, establish firstly that the eye was not infected when

Mark left the National Matemity Hospital; second, another organism caused the

meningitis; third, the meningitis was cleared by a drug that got across the blood brain

barrier into the meninges; fourth, that drug was Cefotaxime which is not effective to

treat pseudomonas aeruginosa. Therefore, a different infection caused meningitis. It

was effectively treated so that the CSF was clear. At some later point to the

meningitis, when the baby was in Temple Street Hospital, he contracted the

pseudomonas eye infection that proved so damaging. He might even have got

pseudomonas because of the antibiotic drugs he was getting' in a sense, in that

pseudomonas is an opportunistic bacterium that is found in hospitals. All the experts

are agreed that it is very difficult to treat pseudomonas aeruginosa.

This is the context for the only area of factual dispute in the case. Did Mark

have an eye infection when he left the National Maternity Hospital for Temple Street

Hospital? If he did, it supports the defendants' theory. It is an important part of Prof.

Fleming's reasoning that he did not have an infection in his eye at that time.

Cefotaxime was given in Temple Street Hospital at 00.05 on the I't August,

2002. It is the only specific anti-meningitis drug that Mark had got up to that time. It

is an effective antibiotic that crosses the blood brain barrier to get into the CSF.

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The defence experts protest that it is irrational and illogical to look for a

second infection where you have clear evidence of a virulent Gram negative infection

(pseudomonas aeruginosa) that is known to have devastating consequences on

neonates in the rare cases where it is found. They challenge the logic in Prof.

Fleming's argument and propose that there is simply no basis for inventing another

unknown infective agent that is different from the one that has been shown to exist.

Prof. Fleming seeks to establish that the pseudomonas came inat alater stage and also

that there may well be a connection between the two in that the drug therapy for the

other infection could have suppressed the baby's immune system and made it

vulnerable to a nosocomial, opportunistic organism such as pseudomonas.

If the evidence of Dr O'Gorman and Dr Murphy is accepted as establising that

Mark did indeed have an eye infection when he left Holles St at 5 pm on the 31't, it

represents a fundamental blow to the Fleming hypothesis on causation. It also must be

said that the defence theories are not without their issues and some inconvenient facts.

The principal inconvenient fact is the clear CSF on the 2nd August. The lumbar

puncture was done at 5 pm on the 2nd August. It was clear when reported. But the

fact that it was clear at 5 pm does not tell how long before that time it became clear.

If one or more of the drugs cleared infection from the CSF, it is not possible to know

when it actually achieved its result. This makes Prof. Fleming's argument even more

diffrcult it seems to me. But on the other hand if the CSF was indeed clear, it is not

easy either to account for the continuing impact of pseudomonas in Mark's right eye.

These reflections indicate how difficult it is to find a complete or satisfactory

explanation for what happened to the plaintiff. No theory can accommodate all of the

relevant known facts. Dr Patrick Gavin, one of the defence experts, raised the

possibility that the lumbar puncture test might not have given a definitive result. In a

18
t
I

tiny baby, the procedure may yield a minuscule quantity of CSF which might not

actually contain the bacteria and one cannot put too much importance and certainly

cannot regard as utterly decisive the report that the fluid was sterile at that time. And

Prof Fleming described how it may take considerable study of a sample of CSF to

identify an invading organism.

Another suggestion is that an infection located deep in the eye is extremely

difficult to treat because it is so hard to access with antibiotics whereas the CSF is

more accessible. Dr Gavin proposed that the medication managed to damp down the

flames of the infection caused by pseudomonas but failed to extinguish it completely

and it remained in the eye, where it progressed to such devastating effect in that

organ, having already done its substantial measure of damage in the baby's brain

tissues.

Issues

The questions that arise for decision on liability are as follows:

Was the defendant negligent in not performing a lumbar puncture on 30th July

2002?

If so, did that affect the outcome of the plaintiff s condition?

Lumbar puncture is the test for meningitis. So the real question is whether the

National Maternity Hospital should have suspected the presence of that disease and

tested for it or decided on treatment on the assumption that the baby had it. It is not

so much a case of arguing about lumbar puncture but rather about suspecting

meningitis. On this question, the plaintiff s experts Prof. Peter Fleming and Dr Alan

Hill argue that meningitis is such a devastating condition that it is no more than

T9
ordinary prudence to be alert for the possibility that a neonate may have that disease if
he or she is infected at all. The other side of that argument is that lumbar puncture is

quite an invasive procedure and doctors - many of them - are reluctant to do it unless

there is some apparent clinical need to do so. It is not such a routine harmless little

procedure or test that it is no trouble to do it and of no risk to the baby and yields

valuable information in all cases. Moreover, it may be possible that one can suspect

meningitis too often. If babies are regularly treated on the assumption that they have

meningitis and given the drugs that will cross the blood brain barrier, there will be

many cases where babies get those drugs unnecessarily.

National Maternity Hospital Policy on Lumbar Puncture

Dr John Murphy, Consultant Neonatologist at the defendant hospital since

1986, gave evidence of the policy of the National Maternity Hospital in regard to

lumbar puncture. He also said that this case was not one that warranted that procedure.

Finally, he dealt with the use of the drug Gentamicin in cases of meningitis or where it

was suspected.

He said they did not have a policy of assuming that meningitis was present.

Such a practice would have serious disadvantages. He instanced immunity to drugs.

He also said that in the hospital they get one case of meningitis a year. He was not

complacent about the one case but was seeking to put in context the proposal advanced

on behalf of the plaintiff. If that were to be adopted, it would mean that a large

number of lumbar punctures would be ca:ried out and a lot of babies would be

subjected to an invasive test or treated for meningitis when they did not have it.

The context is critical. The hospital's practice would be to assess a baby, do

a blood culture, do some basic tests, put him on the standard antibiotics used in the unit

and then wait and see how he does over a period of a few hours. He is in an intensive

20
care unit, in a situation where he is being observed carefi.rlly by the nursing staff and

they will wait and see how he progresses and then do further investigations or take

further measures as they see how the baby gets on. In this particular case, the baby

began to show signs ofan eye infection.

That was the general approach in Holles Street in2002. They are dealing

with very high risk, very fragile lifile babies who can have episodes of destabilisation,

desaturations, maybe four or five times during their period in hospital. Babies may be

there for as long as three months and one could end up doing five or six lumbar

punctures. They could do lumbar punctures on any number of babies if the regime

proposed by Prof Fleming were to be followed.

In fact, they do about 150 lumbar punctures ayear but they have leamed to do

them judiciously they destabilise the infants. The nurses who look after these babies do

not value lumbar punctures on these babies. They feel that they are very destabilised

afterwards and it takes them a long time to get them back on track. The initial phase is

to see the baby, do an assessment, do the basic non-invasive things like a blood culture

and so forth and then wait and see. Of the tests they do on small babies, the lumbar

puncture is the most invasive test one could do on a newbom infant.

In this case, in the early moming of the 31st July where the baby had mild

pyrexia, raised CRP and increased desaturations, that would be a common presentation.

It was not the practice to do a lumbar puncture every time it happens. They do

the blood cultures and would start them on antibiotics and then observe and see what the

baby's progress is like over a number of hours. He is in a high dependency unit so you

can wait and see. There is one nurse looking after two babies. It is not like a ward where

maybe a mnse might look after 20 or 30 babies, these babies are under constant

surveillance and you wait and see what the baby does. If the baby settles down or picks

2l
up and is alert and responsive, then you know that everything is going to be okay. It is if
the baby persists or there are some signs that you are getting increasingly worried about,

then you might consider doing a lumbar puncture.

If you implemented a policy in Holles Street to do a lumbar puncture every time

you saw that presentation it would greatly increase them. It would become untenable' A

doctor has to balance risks and probabitities. The hospital sees one case of meningitis

per yeil. You know, it is a big hospital, 10,000 births, there is a lot of transfers from

other hospitals and we had one case of meningitis last year, we had none in 2009 and we

had one in 2008. These cases were easily flagged because the mothers were carrying

what is called Group B streP.

Running a neonate nursery, the reason why they use penicillin and gentamicin

is not to grow resistant organisms and it has been shown that if you use cephalosporins,

like cefotaxime, that you quite quickly get overgrowth of fungal infections and candida

organisms and candida septicaemia and higher mortality rates. So the hospital

microbiologists guide them not to use it. The doctors are very much guided by them

and they advise against such drugs.

The benefits of gentamicin, specifically, and benzylpenicillin are that they give

good cover for Gram-positive and Gram-negative organisms, the two variety organisms

that you see, and don't breed the resistance that you would get from other antibiotics

like cephalosporins and they have been tried and trusted and they have been used in

nurseries for a long time. As long as Dr Murphy has been there, they have been the

antibiotics they have used. They have been very pleased with them as effective

antimicrobial agents, as a holding agent for septicaemia.

The circumstances in which they would use cefotaxime were if they

considered that the baby's condition had begun to slip earlier on and they had no

22
obvious source of infection and if they had done a lumbar puncture and had seen an

organism, then they would put the baby on cefotaxime. Or if they had a

bloodstained sample that was difficult to interpret, because about 30Vo or 35% of

the CSFs would be bloodstained because thev are technicallv verv difficult.

The doctors do lumbar puncture if they suspect meningitis. If the sample

is blood-stained and not capable of being interpreted, the hope then is that the

laboratory might grow the bug and that will take24 hours or 48 hours. During that

intervening period, they would put the baby on cephalosporin.

A lumbar puncture first and a foremost is a disturbance of the infant and the

doctor has to take the incubator, get the tray out and then the baby may get cold and then

the doctor or nurse has to bend the baby over well if you are going to separate the spinal

process to get through the space and to keep the baby there because the needle is going

in at a right angle, otherwise it will miss the space. Babies are diaphragmatic breathers,

they do not expand their chests very well and you quite often they go apneic during the

procedure. They struggle, they go off colour and they get disturbed during that period of

time so it is a tough test for them.

23
The expert evidence

Professor Peter Fleming

Prof Fleming is a Consultant Paediatrician and Professor of Infant Health and

Development Physiology at the University of Bristol.

Prof Fleming first asserted a fundamental standard of neonatal treatment,

namely, that symptoms or diagnosis of infection mandate urgent exclusion of

meningitis by doing a lumbar puncture or, altematively, the baby must be treated on

the assumption that he has that disease. Second, he says that what happened in this

case as can be deduced from the contemporary evidence demonstrates that the baby's

condition would have been improved enormously if the policy he advocates had been

followed. The issues therefore concern (a) the proper treatment and (b) whether that

would have made a difference to the baby's outcome. For the second question the

issue of causation gives rise to a diffrcult and complex debate about the course of the

infective process that afflicted the plaintiff over the short critical period between 11

pm on the 30th July 2002 and 5 pm on the 2nd August and some days beyond until

7th August.

He said it was absolutely standard neo-natal intensive care practice that any

pre-term infant showing signs suggestive of infection (beyond the first24 hours after

birth)

o should be considered as being at risk of meningitis

o a lumbar puncture should therefore routinely be performed in order to

establish whether or not meningitis is present.

Prof Fleming cited Neo-Natal Vademecum - 3'd Ed. - 1998

24
After the first24 hours, all children who are placed on broad spectrum antibiotics

must have a lumbar puncture [may be delayed by a few hours if a child is particularly

unstablel

He also referred to A Manual of Intensive care 2"d Ed.1986, by Dr N.R.C.

Roberton, where atp.174,the author refers to investigations which should be carried

out in most situations and says that

Lumbar puncture should be carried out . . .

in any infants in whom meningitis seems to be even a remote

possibility and

in all infants in whom it is intended to start systemic antibiotics [except

antibiotics started at birth and . . .l

Prof. Fleming's first and principal report is dated the 4ft November,2009. At

p. 9,line 420he says:-

"It has therefore, for well over 30 years (certainly throughout the period of my

involvement in neo-natal intensive care), been absolutely standard neo-natal

intensive care practice that any pre-term infant showing signs suggestive of

infection beyond the first 24 hours after birth should be considered as being at

risk of meningitis and a lumbar puncture should therefore routinely be

performed in order to establish whether or not meningitis is present."

He goes on to refer to Neo-Natsl Vademecum - 3'd Ed. - 1998 which he says is "a

very widely used practical handbook of neo-natal care of which I am one of the

authors" and he cites a passage from p. 301 as follows:-

o'After the first 24 hours, all children who are placed on a broad spectrum

antibiotics must have a lumbar puncture. This may be delayed by a few hours

25
 if a child is particularly unstable, but should not be left without discussion

with the consultant. Lumbar puncture in children who are unstable should be

performed by an experienced Dr and not a junior Dr in the first few weeks of

his or her new Post."

The work says that the procedure should be carried out within an hour of the

2nd Ed'
decision being made. Next Prof. Fleming cites"A Manual Of Intensive Careo'

1986, Dr N.R.C. Roberton, where atp. 174,the author refers to investigations

which

should be carried out in most situations and says that lumbar puncture should be

carried out in all infants with abnormal temperature, in all infants with neurological

abnormalities, in any infants in whom meningitis seems to be even a remote

possibility and in all infants in whom it is intended to start systemic antibiotics (with

the exception of antibiotics started at birth and the possible exception of infants on

IPPV who develoP lung infection).

prof. Fleming says that in 2002,it had'obeen standard practice in almost all

neo-natal units for many years to perform lumbar puncture before starting antibiotics

in neonates (children under one month of age) showing signs of possible bacterial

sepsis.

prof. Fleming says that in the episodes starting on the 30th July, it is quite clear

that bacterial infection was a very high possibility right from the beginning with

temperature instability, intermittently poor peripheral perfusion and a raised CRP'

prof. Fleming's second report of the 27th November,2}Il, is in the form of a

time to
letter to the plaintiff s solicitor Mr. Boylan. In this letter he refers for the first

the pseudomonas infection that was cultured from Mark's eviscerated right
eye and

from his left little finger. He had not referred to this Gram-negative infection in his

previous report and he was criticised by Mr. Hanratty S.C. in cross examination for

26
that significant failure, as counsel suggested. However, that is not really relevant
to

the lumbar puncture primary issue in the case. In this report Prof. Fleming concludes

to do
that whichever explanation of two that he discusses is the correct one, the failure

a lumbar puncture meant that there was a delay of at least "32 hours in starting

long term
appropriate treatment" and that that contributed very significantly to Mark's

adverse outcome. In other words his condition would not have been anything
like as

bad if he had been treated in time. The delay of 32 hours refers to Dr Bhatia's

examination at 4.00 pm and 24 hours or so would be appropriate if it was

Dr

this
O,Brien,s examination late on the night of the 30ft July. The final paragraph of

report is as fbllows:-

..The published literature (see references I and2, as well as the standard

textbook referred to in my original report) shows that failure to either carry out

a lumbar puncture or to treat with appropriate antibiotics places very low birth

weight infants who develop possible sepsis after one week of age at risk of

untreated meningitis."

The references are to two articles: (1) Stoll E.J. et al: to tap or not to tap: high

(2)
likelihood of meningitis without sepsis among many low birth weight infants.

Paediatrics 2004;113: 1181 - 1186, Malbon et al. Should a neonate with possible
late onset sepsis always have a lumbar puncture?/Arch dis childh, 2005; DOI

10. 1 136/adc 2005. 08755 1.

prof. Fleming's final written contribution is in the form of another letter, this

given by Dr
time dated the 21't May,201Z His letter was in response to the evidence

John Murphy, consultant paediatrician at NMH, set out above. At the end of p' 3,

Prof. Fleming has a short paragraph encapsulating his view of Dr Murphy's

position:-

27
 .,An approach based on avoiding both lumbar punctures and cefotaxime

cannot be justified on clinical, ethical or epidemiological grounds. It

potentially exposes infants to increased risk with no identifiable benefit to the

infant or to the intensive care unit in which they are being cared for'

Prof Fleming's evidence may be summarised as follows'

The plaintiff got meningitis on 30th July in NMH. On the evening of 30th he
was

developing meningitis. On the night of the 30tW31st he showed signs compatible

with

.,One of the points . . . is that any sign that is compatible with infection in
meningitis:

a very low birth weight infant is compatible with meningitis because there are no

then to
specific signs, they do not exist. If a baby is showing signs of being infected

ecause there are

assume they do not have meningitis is a very dangerous assumption

no specific signs in the great majority of them to tell you whether they do or
don't

have meningitis."

By 7 pm on the 30th the hospital had c-RP "saying this is infection".

The consequences of meningitis are devastating. Routine LP should have been

done in NMH at 11 pm on the 30th. It is standard practice to do lumbar puncture.

That is the only way to check for meningitis and the only question is when
to do it'

reason you don't, it is obligatory to treat the baby as if he had meningitis, in

If for any

which case he should be given cefotaxime.

prof Fleming did not agree with the hospital guidelines, which say that a lumbar

puncture should be done if there are neurological features and the source of infection

is unclear. There were not neurological features present in this case'

The doctor explained how it could be difficult to find the organism when

and
examining a sample of CSF, that it could take an hour or more looking repeatedly

even after going back four or five times one might not be able to find it'

28
 On the second issue, that of causation or what difference it would have made to

the plaintiff s condition if a lumbar puncture had been done and cefotaxime

administered, Prof Fleming began with the result of the lumbar puncture that was

done at 5 pm on the 2nd August. The meningitis was cleared by that time because the

cerebro-spinal fluid was sterile but it confirmed meningitis. Meningitis needs specific

antibiotics to treat it. Benzylpenicillin & gentamicin would not treat meningitis.

Gentamicin did not clear the meningitis:

i. even in very high doses does not get into CSF very well;

ii. it has a narrow therapeutic window

iii. ". . . it is completely unsuitable, in fact it is totally useless for

treating meningitis, you know, there aren't many things in

medicine one can be clear about but gentamicin is of no value

at all when given intravenously to treat meningitis because it

just doesn't get into the spinal fluid in sufficient amounts'"

Cefotaxime cleared the meningitis between 00.05 am on lst Aug and 5 pm on the

2nd, aperiod of 41 hours. If a lumbar puncture had been done at 11 pm on the 30th,

meningitis would have been diagnosed & cefotaxime administered c. 22hrs earlier.

That would have made a big difference to the plaintiff-if cefotaxime was given then,

he would have escaped all or almost all of the devastating brain damage that the

meningitis caused.

The meningitis was not caused by pseudomonas but by another, different

unknown, infective agent which was sensitive to the drug regime the baby was put on,

specifically, to cefotaxime. That is because the organism that caused the meningitis

had been killed by 42 hours of cefotaxime at the point of the lumbar puncture,

29
whereas pseudomonas had not been killed by eight days or at least six days of

appropriate antibiotic treatment, including two antibiotics to which it would

apparently be sensitive.

The two commonest causes of meningitis are enterococci (gram positive) & e-coli,

gram-negative, each sensitive to cefotaxime. There was no positive blood culture and

so nothing to suggest that bacteria in the blood got into the brain.

The meningitis-causing organism was treated successfully by drugs that are

usually no good for pseudomonas meningitis [i.e. cefotaxime & gentamicin]'

The baby got a pseudomonas infection in his right eye in Temple St Hospital-

He did not have a right eye infection on arrival there on the 31st.

pseudomonas is not a multiresistant organism -5140; could be either resistant to

cefotaxime or sensitive to it. Gram negatives like pseudomonas are much harder to

treat; pseudomonas is an exceptionally difficult Gram-negative infection, one of

the

worst.

In cross-examination, Prof Fleming was challenged on his evidence that it was

mandatory in the circumstances to do a lumbar puncture, by reference to the defence

experts and to the literature.

On his theory of causation, he acknowledged that an important supportive fact

was that there was no infection in the eye when the baby arrived in Temple Street.

the
Another was the belief that Gentamicin does not treat pseudomonal infections in

spinal fluid.

The meningitis and the eye condition do have an association and perhaps some

causal connection in a different manner. The eye bacterium (pseudomonas) did

not

cause the meningitis, to repeat, but the connection may well have worked in the

opposite direction: the antibiotics that were given in NMH and added to in Temple

30
Street cleared the csF so that it was sterile by 5.00 pm on the2"d but they may well

have cleared other bugs out the way leaving the door open for pseudomonas,
which is

nosocomial and notoriously opportunistic. It got in by infecting the damage cornea

and progressed rapidly and fulminantly.

Dr Alan Hill
Dr Alan Hill is a Consultant Paediatric Neurologist at British Columbia

Children' s Hospital, Vancouver.

Dr Alan Hill endorsed the evidence of Prof Fleming as to theimportance of

doing a lumbar puncture in this case. It was sub-standard care not to do so

in response

to Dr O'Brien's examination at2300hours on the 30th'

Dr Hill,s report is dated the l2th November,2009. His second report is dated

the 9ft November,20ll,and p. 2 of his second report is relevant on the

question of

lumbar puncture. Dr Hill says:-

.,It is important to emphasise, that, in the new born infant in general,

and in the premature newborn infant in particular' a very high index of

suspicion for sepsis/meningitis is essential in the presence of abnormal clinical

signs. A sceptic work up should include a lumbar puncture, to permit

examination of the cerbro-spinal fluid to rule out meningitis. If the infant

is

too unstable to perform a lumbar puncture, then the choice and dosage of

antibiotic medication used should be adequate to effectively treat meningitis."

baby
Thus, Dr Hill's position is that you either do a lumbar puncture or you treat the

as if he had meningitis.

The witness confirmed these views in evidence. Newboms do not localise

infections well. It is important to examine the CSF in any work-up. The premature

31
A

infant's blood brain barrier is not as efficient as a full term baby's or an adult's. They

are more vulnerable to infection. If you do not do a lumbar puncture, you must cover

the possibility of meningitis. The earlier you can identiff the organism, the better you

can select the most appropriate antibiotic.

Dr Hill's opinion was that Mark had sustained a severe brain insult that

resulted in the seizures and the catastrophic collapse that he underwent in Temple St.

he thought that the process began on the 3l't when he became ill. The damage

progressed rapidly. He endorsed Prof Fleming's opinion that if cefotaxime had been

given earlier, the brain damage the baby suffered would have been very much less. In

his first report Dr Hill had referred to the cultures of pseudomonas from Mark's finger

and eye and said that it was not clear bacteria spread from the blood to the eye or the

eye became infected first with subsequent spread to the blood and CSF. He was

making the clear connection that the defence experts say is the case. He said he would

now modify that paragraph.

In cross-examination, Dr Hill agreed that the eye condition reported by Dr

O'Gorman indicated infection. He said that some infection began on the 30th. If

pseudomonas was the operative bacterium, cefotaxime would not have treated it.

Dr Hill did not satisfactorily address the point put to him by Mr Hanratty SC for

the defendant that the journal articles cited by Prof Fleming confirmed what counsel

proposed was the reality, namely, that there was wide divergence on the

appropriateness of routine lumbar puncture in all cases of infection or suspected

infection in neonates. The witness insisted however that the circumstances in the

instant case mandated the procedure.

Defendant's experts

32
a

The defendant's experts addressed the two issues in the case, namely, (a) whether

lumbar puncture was mandatory and the hospital's care was sub-standard because it

failed to carry out the test when infection was evident or suspected and (b) causation,

if the first question was answered affirmatively. Dr Gavin engaged in the most

detailed examination of the causation question in a medico-scientific context'

On lumbar puncture these experts were of opinion that it was not mandatory. It

was not negligent not to do that test on the 30th July. Dr Murphy's reasons for not

doing LP routinely are legitimate,reasonable and sensible'

The theory and facts as to causation relied on by Prof. Fleming do not make

medical sense or logic.

(a) The problem began in the eye and spread to the brain directly or

alternatively through the blood: the movement was either from the back of

the eye into the brain or from the eye into the blood and then into the

brain.

(b) There is no reason to look for another infection and there is no basis for

doing so; pseudomonas aeruginosa was cultured from the baby's eye and

finger and that is the bacterium that caused meningitis'

(c) Logic and common sense support this analysis'

(d) The plaintiff s argument is inconsistent with the findings and the evidence

of Doctors Murphy and O'Gorman.

Dr Andrew Lvon

Dr Lyon is a Consultant Neonatologist. His frrst report is dated the 30ft

August, 20II. He says atPara.44:.-

aa
JJ
I

..There is always much debate about whether a lumbar puncture should

be done as part of every infection screen in a newborn baby.

The

possibility of meningitis must always be considered, but if the baby is

not showing ongoing signs of deterioration, it may be more appropriate

to delay lumbar puncture while observing the clinical course' In

problem at
retrospect it is clear that Mark did not have any significant

this time and a lumbar puncture would not have altered a clinical

management. I am not critical of his management at this time' [This is

a reference to the 25th July, 2002]'"

about
However, the point is that Dr Lyon is making a general observation

approach to the
lumbar puncture which is the relevance. Dr Lyon had a different

62;-
situation on the 30th July, 2002,which he deals with at para.

,.Although I am critical that alumbar puncture was not done on the 30th July' I

am of the opinion that, even though this was likely to have been
abnormal, it

would not have altered the outcome in this case'"

Dr Lyon clarified his views in response to a letter from the defendants'

in Novembet'2011'
solicitors and he did this in the course of a further one page report
,oln
my report I discussed his management around the time he became

on the 30th July, 2002. It was my opinion that a lumbar

puncture
ill
that
should have been done at that time. I also expressed an opinion

failure to carry out this test at that time had no effect on the outcome
in

his case.
I

..I acknowledged in my report that there is a wide body of opinion on

neo-
whether lumbar puncture should be done in all cases of suspected

natal sepsis. I wish to make it clear that, although I feel that alumbar

34
a

puncture should have been done on the 30th July, this is very much my

own personal opinion based purely on reading the notes. I recognise

that there is a reasonable body of paediatricians caring for the newbom

who would not consider a lumbar puncture was necessary atthe time.

I agree that this is a reasonable clinical approach in these cases."

Dr Lyon said that the possibility of a lumbar puncture must always be

considered but it is a matter of clinical opinion: does this baby need a lumbar

puncture? It is not susceptible of an absolute rule. Most things in medicine were a

question of balancing risk and benefit. It was not a knee-jerk reaction to do athe test

every time. There was a body of respectable opinion that would not do it in the

circumstances of the 30tr. The question was debated in the medical literature which

revealed divided opinions on the matter. A doctor goes in stages from step to step and

at some point that process crosses the threshold for lumbar puncture. But where that

line is differs among doctors. There is no single thing.

On what actually happened in this case, Dr Lyon said that there was no

evidence to support a second infection. Prof Fleming's theory introduced one

randomly. It was unnecessary to suggest that process in order to understand what

happened to Mark.

He specifically disagreed with the proposition that gentamicin did not work

and with the conclusion drawn by Prof Fleming that the negative CSF culture from

the sample taken on the 2nd August meant there was no infection.

He believed that the infective process began in Mark's eye and travelled into

the brain.

35
t
I
a

Dr Patrick Gavin

Dr Gavin is a consultant in Paediatric Infectious Diseases.

Dr Gavin's report says that this is a complex and unusual case. What seems most

likely according to this expert is that Mark developed pseudomonas aeruginosa

endophthalmitis of his right eye, leading to orbital cellulitis and subsequent

he
subclinical spread to the meninges causing pseudomonas meningitis. In evidence

said orbital cellulitis was less likely because the baby's eye was eviscerated
not

enucleated.

,.Endophthalmitis is a devastating infection particularly if it is caused by

pseudomonas and especially when it occurs in premature newborns that are

inherently immunocompromised. Rare cases are described in the literature

where acute fulminant pseudomonas aeruginosa endophthalmitis spreads to

is
the meninges and causes severe neonatal meningitis. In such cases the eye

really saved and mortality approaches 50%. Gram negative neonatal

meningitis, particularly due to pseudomonas is associated with similarly high

mortality and morbiditY."

What happened according to Dr Gavin is that there was a break in the cornea

of the baby's right eye which allowed pseudomonas to get into the eye. The comeal

defect was not apparent at first. It would have been diffrcult to detect clinically
and

even on swab culturesbecause it is a deep-seated infection. It is also extremely

difficult to treat for the same reason. Cultures of eye swabs taken on the ltt and 4th of

process that
August were nonnal despite the fact that there was an ongoing infectious

ultimately destroyed the eye. The right eye was eviscerated at operation on August
7th

so it is obvious that the process was well advanced on the 4th. PseudomonrN infiltrated

through the layers of the eye and infected the orbital cavity causing orbital cellulitis.
It

36
 a

caused the site to be pushed forward and the infection can spread
backwards along the

meningitis'
path of the optic nerve and blood vessels to infect the meninges causing

Dr Gavin thought it was less likely that the process worked in the opposite

all the blood

direction, from infection of the blood to infection of the eye, because

cultures were sterile.

was given, Dr
On the question of the appropriateness of the drugs that Mark

at appropriate
Gavin,s report says that gentamicin was prescribed and administered

the children's
levels of dose and frequency in the National Maternity Hospital and

treatment of
University Hospital. Gentamicin is one of the mainstays of antimicrobial

pseudomonas infections. It was probably this drug that sterilised

the CSF' In evidence

he said this pseudomonas organism was sensitive to gentamicin,

citing the laboratory

report from Temple St at pp25819 of the notes on swabs from the

baby's right eye

where a scanty growth was reported as to gentamicin'

It is unlikely that the single dose of Meropenem that Mark received in Temple

Street before the lumbar puncture was performed could have

sterilised the CSF'

commonly
"Gram negative meningitis, particularly that caused by pseudomonas,

takes days to sterilise despite appropriate antimicrobial treatment'"

in the
Dr Gavin says that it was appropriate not to perform a lumbar puncture
from meningitis
National maternity Hospital on July 30th. There was a low suspicion
Similarly,
in a baby with isolated low-grade fever and no obvious source of infection.

the decision by Dr Murphy not to do a lumbar puncture on the 3l't

was appropriate'

..The fact that CSF cultures from lumbar puncture on 2nd August were sterile reflects

that it is notable that

the efficacy of Mark's management up to that point. I also think

so much of Mark care was delivered directly or led by consultants in both hospitals'"

37
 t

The sequence of events in Dr Gavin's opinion is that the I't thing that happened
was

that endophthalmitis began in the baby's right eye a short time before he developed
a

not
fever. ophthalmology examination was nonnal on July 26th.The infection did

for low-
smoulder but progressed rapidly. The baby's vital signs were stable except

grade fever until soon after he arrived in Temple Street. Thereafter he showed
signs of

florid sepsis and around this time the infection spread from deep within marks right

eye to the meninges resulting in meningitis.

not
Dr Gavin thought that the treatment Mark received a saved his life but could

save his eye and nor could it prevent the devastating consequences. He was infected

by a virulent organism that first located itself deep in his eye and spread undetectably'

,,The outcome did not hinge on the decision to perform or timing of a lumbar

puncture or choice of empiric antimicrobials'"

Dr Gavin said in evidence that there is no doubt this child had

endophthalmitis. If you take away orbital cellulitis, whether it was endophthalmitis

and orbital cellulitis or endophthalmitis alone, there is a potential mechanism

for

endophthalmitis to cause meningitis, irrespective of orbital cellulitis. He suspected

that the infection in the eye led to bloodstream infection, that probably
happened

his brain at
around his massive decompensation in Temple Street and then he seeded

that time or some time later and similarly seeded his finger to produce osteomyelitis'

pseudomonas endophthalmitis is a rare entlty but it is complicated. Up to 40 or

50% of cases in some of the series were associated with death and meningitis
and

septicaemia.

He did not think that the CRP result was definitive. It is nonspecific and

nonsensitive. In some hospitals it is no longer in use and they are still looking
for an

adequate laboratory index to actually help selecting out the patients who
should get

38
 tl

lumbar punctures.
was
In this case there was no suspicion of meningitis and a lumbar puncture

says that,
not mandatory. In some centres they would choose to do, and the literature

some centres choose to but it is not mandatory. The literature and the textbooks do not

say that lumbar punctures should be done in the circumstances

which arose in this

case. He said that where there is a suspicion of meningitis the

literature is clear.

Dr Gavin said that pseudomonas in the eye is an occult infection.

He referred to the findings of Dr O'Gorman and Dr Murphy, in the National

with the eye

Maternity Hospital, who both considered that there was something wrong

was pus or secretions in

and that a number of the nurses made a note saying that there

some comment
the eye as well. Also, Dr Corcoran in Temple Street may have made

that the eye might have been an issue.

he said it was
In response to the fact that Prof O'Keeffe said there was no infection,

difficult for him to say but it was his opinion that the infection started in the eye and

apparent in the eye

spread from there. He agreed that the infection must have been

however, because of
before anywhere else but immediately qualified that by saying

detect' His
the nature of the eye as a source of infection, it could be difficult to

opinion on the basis of his reading of the notes is that the eye was the
first source of

of entry of
infection absolutely. The corneal abrasion supports the exogenous route

pseudomonas into the eYe.

Professor Tom Matthews

prof. Matthews is Emeritus Professor of Paediatrics of University College,

Dublin.

prof. Matthews' report is dated the2gth October, 2010. Prof. Matthews says at

p.6:-

39
t

,.Mark was seen by several experienced neo-natal Doctors immediately before

and after transfer and not one thought that an urgent lumbar puncture should

be performed.

In making the decision to perform a lumbar puncture, the responsible Dr

would always weigh up the trauma of an invasive of procedure in an unstable infant

against the possibility of missing a rare condition (meningitis).

My own practice, and that of my colleagues in the Rotunda, was not to

perform a lumbar puncture routinely as part of a sceptic work up unless there

were some specific indicators of a possible blame infection, (abnormal

neurolo gical examo seizures, bul ging anterior fontanel)' "

procedure
Prof. Matthews' point is that a lumbar puncture is an invasive, traumatic

is
which is not done as a matter of routine but when the doctor considers that there

sufficient reason for doing so.

He said that there was no evidence to suggest that this baby was seriously ill ot

was not
that infection was taking hold until around 9 am on the 3lst. The temperature

about
significantly raised. The baby was feeding normally. There was no real concern

his general health, as distinct from the right eye concem. If there had been, the doctors

would not have transferred him.

By the evening of the 31't, however, the baby's general condition had changed

He
for the worse, as evident from the clinical notes made by Dr Sarar in Temple St'

deteriorated rapidly. All the clinicians who saw him that night thought he had
an

infection. At 4.30 am on the ls he had circulatory collapse. His condition stabilised

later in the morning.

40
 t

Prof Matthews was critical of the Fleming theory. It was not credible. He

thought the argument put forward by Prof Fleming was fantastic. It was wrong to

assume that anegative CSF result out-ruled infection.

If Mark had been generally unwell in Holles St, he would not have been able

to tolerate the thorough examination that Dr O'Gorman carried out. Indeed, Prof

Matthews thought that the baby's responses including the Moro reflex test was

actually inconsistent with meningitis being present at that time.

On lumbar puncture, the witness agreed with the other defence experts. There

was in his view no reason to do that procedure in the absence of any concern or any

reason for concem about meningitis.

As with the other defence experts, Prof Matthews also disagreed with Prof

Fleming on the use of gentamicin.

Discussion

The tests to be applied were set out by the Supreme Court in Dunne v National

Maternity Hospital & anor i,989 I IR 9I:

(a) A practitioner was negligent in diagnosis or treatment only if guilty of such

failure as no other practitioner of equal specialist or general status and skill

would be guilty of if acting with ordinary care.

(b) A plaintiff establishes negligence against a medical practitioner by proving

his deviation from a general and approved practice only upon proving also that

the course taken was one which no other medical practitioner of like

specialisation and skill would have followed when taking the ordinary care

required from a person of his qualifications.

4l
I
I

(c) A medical practitioner who establishes that he followed a practice which

was general and approved by his colleagues of similar specialisation and skill

is nevertheless negligent if the plaintiff thereupon establishes that such

practice has inherent defects which ought to be obvious to any person giving

the matter due consideration.

(d) An honest difference of opinion between doctors as to which is the better

of two ways of treating a patient does not provide any ground for leaving a

question to the jury as to whether the defendant who has followed one course

rather than the other has been negligent.

(e) It is not for a jury (or for a judge) to decide which of two alternative

cogrses of treatment is in their (or his) opinion preferable, but their (or his)

function is merely to decide whether the course of treatment followed, on the

evidence, complied with the careful conduct of a medical practitioner of like

specialisation and skill to that professed by the defendant.

(g) Where there is an issue of fact, the determination of which is necessary to

ecide whether a particular medical practice is or is not general and approved,

that issue must be left to the jury.

2.Thatfor a practice to be "general and approved" it need not be universal but

must be approved of and adhered to by a substantial number of reputable

practitioners holding the relevant specialist or general qualifications. Where

certain statements of principle have referred to "treatment" only, those

principles must apply in identical fashion to questions of diagnosis.

42
a

,
!

1. l4/as it neslieent not to do a lumbar puncture in this cose?

2. If so. did the failure to do lumbar puncture affect the outcome?

Was there a mandatory rule of medical practice that required a lumbar

puncture in this case?

There is, of course, a certain amount of logic in what Prof' Fleming and Dr

Hill say. Meningitis is such a serious condition that doctors have to be on the look out

for it. It is apparent that there are advocates of the use of the procedure as a

diagnostic tool. They consider that it should be employed more often. Its use will

reduce the risk of failure to diagnose this devastating disease. There is

general

agreement that if meningitis is suspected, the doctor should do a lumbar puncture. But

that position is far short of where Prof Fleming makes his stand. He argued that
once

there was any evidence of infection there had to be a lumbar puncture'

All of the doctors who were called by the defendant testified to the contrary.
These
And Dr Murphy described the policy of the hospital which is to the same effect.

experts do not agree that it is mandatory but say it is a matter for the clinical judgment
was
of the doctors in the circumstances of the particular case. Prof Matthews said that

the practice in the Rotunda Hospital. Dr Lyon said that he would have done
lumbar

puncture in the circumstances of Dr O'Brien's examination but accepted that other

employed
competent doctors would not. Prof Matthews and Dr Gavin would not have

by Prof
the test in the situation. The approach of waiting and seeing was condemned

Fleming but the evidence of the other experts contradicts him.

Dr Hill was unable to address the point that was put to him in cross-

examination that there was indeed a school of thought among doctors of undoubted

expertise that did not follow the mandatory test policy'

43
D

ll

The joumal articles that Prof Fleming cited did not support his contention.

While they favoured greater use of lumbar puncture and advocated its adoption more

generally in the fight against meningitis, the factual information supplied by the

writers actually made the case for the existence of a wide variety of views and

practices among clinicians. I instance the following passages that were referred to in

the course ofthe evidence.

1. "should a neonate with possible late-onset infection always have a lumbar

puncture?"

Archimedes 2005.

'oExcept for the study by Visser and colleagues, LPs were not performed

routinely for investigation of infection. There were more likely to be

performed if the blood cultures were positive, and even then only 60Yo of such

babies had LPs Performed."

Clinical bottom line: "Lumbar puncture should be considered as part of the routine

investigation of late onset infection (after 48 hours) in neonates."

2. Archives of disease in childhood-z00z.

"An LP should be done in all neonates with suspected meningitis, and should

be considered in all neonates in whom sepsis is a possibility."

3. Paediatrics 1995.

"No Lumbar puncture in the evaluation for early neonatal sepsis: will

meningitis be missed?"-Wiswell & others

This is a retrospective study of a very small number of babies who suffered meningitis

out ofavery large cohort: 43 babies out ofnearly 170,000. The authors advocate the

44
 t

,
I

use of lumbar puncture as a diagnostic tool. They consider some of the

reasons why

clinicians may not opt for this procedure.

,.potential risks of LP include trauma (' bloody tap'), infectious complications,

intraventricular haemorrhage, and spinal epidermoid tumor' Traumatic LP

occurs inl4Yoto 4SYoofinfants undergoingthe procedure' The other

complications represent a few anecdotal reports. There are no adequately

documented cases of bacterial meningitis being induced by a contaminated

needle during an LP."

puncture.
The authors conclude with the recommendation in favour of using lumbar

o'currently a<lvocated selective criteria to omit LPs in the

They say that using

evaluation for early neonatal sepsis will result in missed or delayed diagnosis
of

bacterial meningitis in some infants." Until better methods are developed

for

predicting meningitis, "the benefits of early diagnosis and appropriate therapy

outweigh the risks of this important procedure."

4. Paediatrics 2004.

"To tap or not to tap: high likelihood of meningitis without sepsis ilmong very low

birth weight infants" -Stoll & others

..The importance of a lumbar puncture (LP) as part of the diagnostic

evaluation of the neonate with suspected sepsis has been the subject of
debate,

and clinical practice varies. Neonatologists often defer the LP when evaluating

their very low birth weight (VLBW) infant."

45
a

t
F

This study was undertaken to review the epidemiology of late onset meningitis in very

low birth weight infants and to evaluate the concordance of cerebrospinal fluid and

blood culture results. Nearly 10,000 babies were included in the study. The study

concluded that meningitis in this description of babies may be under-diagnosed and

the authors recommend the use of lumbar puncture. However, what is clear from the

published paper is that there is wide variation in the practice of this test. The

information in the article includes the following: --

63%o of theinfants had a least one blood culture performed whereas only 30%

had a lumbar puncture

infants with a positive blood culture were significantly more likely than those

with negative blood cultures to have lumbar puncture

54Vo of infants who had seizures had a lumbar puncture

only one half of all infants who had blood cultures performed also had a

lumbar puncture

o the percentage of infants who had a blood culture and a lumbar puncture

performed ranges from22ohto 85oh across centres

. only 66Yo of the infants with culture confirmed sepsis had a lumbar puncture

The authors say that the importance of lumbar puncture in the evaluation of very low

birth weight infants with suspected late-onset infection remains controversial. There

are major practice differences among physicians in regard to lumbar puncture.

l. Archives of disease in childhood 1989-"When to do a lumbar puncture in a

neonate"- HL Halliday

46
t

Lumbar punctures or spinal taps are performed for either diagnostic or

therapeutic reasons. The procedure in the neonate, however, is not

without risk and the costs can outweigh the benefits. Stated indications

for lumbar puncture range from routine sepsis work up to a more

conservative approach reserving the procedure for the investigation of

very ill babies. There is little consensus of opinion and no controlled

trials comparing outcomes when different indications for lumbar

puncture have been used.

Traum atic tap and unsuccessful lumbar puncture are quite frequent

occurrences in the neonate with only 45 - 54% being successfully

completed.

Conclusions

The indications for lumbar puncture in the newbom are not as clear-cut

as previously believed. Considerable doubt exists about whether they

should be performed routinely in the baby with suspected sepsis or the

ill baby with respiratory distress or unless there are other pointers

towards a diagnosis of meningitis.

Although there are arguments for more general and perhaps even mandatory

use of lumbar puncture, there are also considerations that point the other way. The test

is invasive and can be difficult and even painful. Advocates say that morbidity

associated with it may be overstated but that may be a reason for reluctance by some

doctors to use it more freely in routine diagnosis. It is not always successful in

47
 a

producing clear fluid for testing and it takes time to culture any organism that may be

present in a blood-stained sample. In the meantime the baby must be treated as if he

has meningitis.

Dr Murphy dealt with that in his evidence and he also said that it was

undesirable that doctors should unnecessarily or too rapidly assume that a baby may

have meningitis because there are downsides to using the anti-meningitis antibiotics

more or less as cover in every case and one serious risk was of creating immunity to

those specialist drugs in the unit where that approach is taken.

He also said that it was undesirable to carry out lumbar punctures as a matter

of routine and there is of course a reference in Dr O'Gorman's final comments just

before Mark was transferred to Temple Street Hospital to consideration of a lumbar

puncture, which Dr Murphy thought should not be done at that stage.

It seems to me that the Fleming/Hill position may perhaps represent one end

of the scale where doctors take a radical view that in every case of sepsis or suspected

sepsis in neonates, or perhaps it should be more correctly be said in every such case

where the neonate is pre-term and of very low birth weight, cases of suspected sepsis

must be dealt with by lumbar puncture.

My conclusion is that the most that can be said is that there is a school of

thought in favour of routine lumbar punctures in diagnosis of infection in certain

neonates and perhaps even mandatory use of the test, unless the baby's condition

contra-indicates it. This school proposes that meningitis must be considered likely in

all such cases and the babies treated accordingly. However, there is clear, direct

evidence of an opposite view and indeed it would seem that there is a wide variety of

practices among competent clinicians. There are arguments on each side but no

general and approved practice.

48
tF

In regard to the specific circumstances of the examinations by Dr Bhatia and

Dr O'Brien, the evidence does not establish that there was any failure of care because

they did not do a lumbar puncture. If it is a matter of clinical judgment, as in my view

it is, there is no basis for holding that there was negligence. I accept the evidence of

Drs Murphy, Lyon, Matthews and Gavin on that issue. There was nothing in the

presentation of the baby that indicated the likelihood of meningitis and it was

reasonable to wait and see how the situation developed. Not all doctors would have

done that; Dr Lyon, for one, would have acted differently. But that is an area of
reasonable difference of opinion among doctors. It is not for a court with the benefit

of hindsight to prefer one reasonable view and to condemn another as negligent. The

situation did change at alater stage, when Drs O'Gorman and Mu.phy considered that

there was a specific focus of infection. At that time they discussed and in the exercise

of clinical judgment decided not to do the test.

Applying the tests in Dunne v National Maternity Hospital that are set out

above, the plaintiff must fail on this primary and fundamental question.

Causation

The question of causation --whether it would probably have made a difference

if a lumbar puncture had been done--is secondary: it arises to test the hypothesis of

Prof Fleming if the first issue is answered otherwise than I have done. I propose

nevertheless to consider the question as if the plaintiff had succeeded in establishing a

failure of care by the defendant in not carrying out a lumbar puncture at the time of Dr

O'Brien's examination at 11 pm on the 30th July.

Prof. Fleming's theory on causation does not rest on any firm foundation of
fact. First, I accept the evidence of Dr O'Gorman and Dr Murphy as to Mark's eye

49
s

\
when they saw him in Holles St around mid-day on the 3l't. The detailed, recorded

findings of a thorough examination by a competent clinician cannot be ignored. It is

absurd to suggest that she wrote down that she saw pus around the baby's eye when it

was not there. The baby's eye was the first thing the doctor noticed when she opened

the incubator. She was so worried about his eye that she sent for the consultant. He

was just as concerned, worring not about the baby's general condition but rather that

he might lose the eye. They thought the eye was infected; that was its presentation.

The nurse noted the pus.

Dr Murphy decided to transfer the baby to another hospital specifically and

exclusively for ophthalmic care. He phoned the hospital to alert them that the baby

was coming.

How can Prof O'Keeffe's examination be reconciled with this evidence? The

only possibility as it seems to me is that somehow the eye altered in appearance

during the time lapse between the examinations. Perhaps, as was suggested by

Counsel, a nurse or doctor might have wiped away pus bhut that does not explain why

Prof O'Keeffe declared unequivocally that there was no infection.

In my judgment there was infection in Mark's eye when he left the National

Matemity Hospital. I think that somehow Prof O'Keeffe was mistaken. All the other

doctors and nurses are not wrong. The positive recorded details of the baby's eye

must be preferred over the negative conclusion in this case. And I accept Dr

O'Gorman's evidence that she could recall her examination of this baby.

I think that Prof Fleming is also on unsafe ground in saying that the CSF result

is proof that the meningitis had passed out of the baby's brain by 5 pm on the 2nd

August. I accept the evidence of Drs Lyon, Gavin and Matthews on that. Indeed, the

50
{
a

testimony of Prof Fleming himself demonstrates how difficult it can be to discover the

infecting organism in a test sample. This proposition is unscientific.

In addition to the three doctors I have mentioned, Dr Murphy confirms the

value of gentamicin in dealing with meningitis. And the discussion in medical

literature of the effectiveness of this drug in treating meningitis is evidence of its

employment by doctors and hospitals.

My view is that the path of causation charted by Prof Fleming is not founded

in fact or medical science.

It is probably impossible to know precisely what the mechanism of infection

was in this case or to know with certainty how it progressed. Having said that, I am

satisfied on the balance of probabilities that the defendant's experts are correct in

saying that there was one infective process that began in the baby's eye and

progressed to his brain.

On this issue also, the plaintiff fails.

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