QUEEN'S BENCH DIVISION
B e f o r e :
____________________
MOHAMMED FEZAN SARDAR |
Claimant |
|
- and - |
||
NHS COMMISSIONING BOARD |
Defendant |
____________________
Stephen Miller QC (instructed by Hempsons Manchester) for the Defendant
Hearing dates: 21-25 October 2013
____________________
Crown Copyright ©
MR JUSTICE HADDON-CAVE:
INTRODUCTION
MEDICAL BACKGROUND
Shoulder dystocia
"4. For the purposes of the delivery of a child, the female pelvis has an inlet which is usually oval-shaped, being wider in the transverse diameter (side-to-side) than the anterio-posterior (front-to-back) diameter. The pelvic outlet is also oval, but wider in the anterio-posterior diameter. The normal mechanism of labour is that the foetal head will enter the pelvis through the inlet in a transverse or lateral position (i.e. with the baby's face facing to one side or the other), with the shoulders in the anterio-posterior diameter. The shoulders remain more or less in that diameter, whilst the head, upon reaching the pelvic floor, rotates to the same diameter to facilitate its delivery of the head, reverting to the lateral once it is delivered."5. Usually, the head having been delivered, during the course of the next uterine contraction, the shoulders and body are delivered. Whilst the accoucheur guides the baby's body out, he or she does not impose anything more than modest traction: the baby is spontaneously pushed out by the force of the contraction.
"6. However, where the shoulder girdle of the baby is wide, following delivery of the head, the leading or anterior shoulder can become impacted against the symphysis pubis, preventing the shoulders from spontaneously descending as they should. To enable delivery of the baby, this obstetric emergency (known as "shoulder dystocia") requires manoeuvres other than normal downward traction and episiotomy. The condition is difficult to predict, and its severity cannot be assessed until after the head has been delivered. By its nature, the accoucheur midwife is usually the first clinician to identify the problem. It is uncommon but, understandably, the rate of occurrence rises sharply with foetal size, being perhaps over 10% for babies over 4.5kg. It requires speedy and decisive action when encountered, to prevent foetal hypoxia which may lead to brain damage or death.
"7. Shoulder dystocia is diagnosed by (i) the retraction of the delivered baby's head into the pelvis, known as "turtling", which (said Mrs Fraser) was a sign of more than moderate shoulder dystocia; or (ii) the failure of the delivery of the baby's shoulders and body during the first uterine contraction after the delivery of his or her head. It was common ground between the experts (and agreed by Midwife Haughton) that, if there is any sign of turtling, then any traction of the head would be inappropriate and dangerous. During the first uterine contraction after delivery of the head, it is appropriate for the accoucheur to apply some modest traction to the baby's head unless and until it is apparent that resistance is being encountered. As soon as resistance is apparent, then, again, it is common ground (and, again, agreed by Midwife Haughton) that any further traction to the head would be inappropriate and dangerous.
"8. Once shoulder dystocia is diagnosed or suspected, the first step for the midwife is to summon assistance, because the recognised steps to overcome the problem require more than one clinician. First, the mother's hips are hyperflexed onto or towards her abdomen (the McRobert's manoeuvre): this change of position effectively straightens out the exit passage for the baby. Second, supra-pubic pressure may be applied (the Rubin manoeuvre): this may assist by mechanically disimpacting and hence dislodging the shoulder. One or both of these steps usually result in prompt delivery of the baby. If they do not, then more intrusive manoeuvres are available.
"9. The brachial plexus is a group of nerves emerging from neck region of the spine, which supply the muscles of the shoulder and forearm. When stretched, these nerves may become damaged or even torn, leading to partial or total paralysis of the arm (a condition known as "Erb's palsy"). When the nerves are torn from the spinal cord or otherwise ruptured, the condition is usually permanent. Where there is no rupture, the prognosis is good and full recovery within a short period is common."
THE FACTS
First Stage of Labour
Admission Note
"History of contractions since 14.00 h.
VE [vaginal examination]
Cx[cervix] soft, partially effaced
[cervical] os 4cms dilated, loosely applied to
PP [presenting part] ↑ [above] level of the Ischial Spine
Abdominal examination
Fundus at term, large baby
Single fetus. Long[itudinal] lie, cephalic [head down]
Presentation 3/5ths palpable, "ROA" [right occipito anterior]
FHH Reg [fetal heart heard regular]"
Second vaginal examination
Third vaginal examination
Fourth vaginal examination
At 05.55 hours: "Not pushing effectively. Patient complaining++ but will not accept advice to push properly."
At 06.10 hours: "Dr Ali contacted re lack of progress 2nd stage. Says he will visit in 15 mins."
At 06.20 hours: "Patient complaining++ and refusing to push any more."
Second Stage of Labour
Third Stage of Labour
"Barnes Forceps delivery
For delay in 2nd stage
Cervix fully dilated "OP"
Forceps blades applied easily, the head delivered within 2 contractions.
There was difficulty in delivering of the shoulder which delivered with difficulty.
Placenta and membranes delivered complete....
NB baby weight 11.11
Mother was not cooperative at all during labour and delivery."
"Called to delivery
- Forceps for failure to progress
- Meconium stained liquor
- Shoulder dystocia, difficulty delivering of head, body born at 4 mins
- V large baby
- Apgar[22]5 at 1 min
- Suction or oro/nasopharynx +larynx
- Given O² via IPPV with good effect
- Required further suction → meconium stained liquid seen coming from below cords
- Apgar 9 at 5 minutes
- Chest – good A[ir] E[ntry] few moist sounds, Apgar 10 at 7 mins
→ to SCBU [Special Care Baby Unit]
- Moaning
.............
Good movements in legs and L arm
No movement in R arm, hypotonic."[23]
THE LAW
(1) The test to be applied is the standard of the ordinary skilled man or woman exercising and professing to have that special skill.
(2) It is sufficient if he or she exercises the ordinary skill of an ordinary competent person exercising that particular art.
(3) He or she is not negligent if he or she has acted in accordance with a practice accepted as proper by a responsible body of medical people skilled in that particular art.
(4) The standard by which the individual doctor, nurse or midwife is to be judged is the standard of a reasonably competent doctor, nurse or midwife carrying out the functions expected of him or her in the delivery suite of a general district hospital.
(C.f. the leading cases in this area such as Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582 at 586-7 and Bolitho v City & Hackney Health Authority [1998] AC 232.)
THE WITNESSES
The Factual Witnesses
Mother's evidence
Midwife's evidence
The Expert Witnesses
Claimant's experts
Defendant's experts
THE ISSUES
Allegations not pursued
Claimant's concessions
ANALYSIS
Guidance from the Royal College of Obstetricians and Gynaecologists
"Shoulder dystocia is defined as a delivery that requires additional obstetric manoeuvres to release the shoulders after gentle downwards traction has failed. Shoulder dystocia occurs when either the anterior or, less commonly, the posterior fetal shoulder impacts on the maternal symphysis or sacral promontory."
"Not all injuries are due to excess traction by the accoucheur and there is now a significant body of evidence that maternal propulsive forces may contribute to some of these injuries. Moreover, a substantial minority of brachial plexus injuries are not associated with clinically evidence shoulder dystocia. In one series, 4% of injuries occurred after a caesarean section. Specifically, where there is Erb's palsy, it is important to determine whether the affected shoulder was anterior or posterior at the time of delivery, because damage to the plexus of the posterior shoulder is considered not due to action by the accoucheur."
Standards in 1989
Was the baby "ROA" on admission?
(1) Midwife Bickerdike's evidence
Answers to Claimant's arguments
(2) The Gardberg Paper (1998)
(3) Claimant's 'severity of injury' point
"14. We all agree that if the right shoulder was posterior then the injury was either due to the propulsive force(s) of labour which would be non negligent [and/or] due to non negligent traction during the forceps delivery with the fetal posterior shoulder obstructed over the sacral promontory."
(1) A 1991 paper by Allen, Sorab and Gonik[37] which measured the traction forces applied to 29 random cases, including two case of shoulder dystocia, and recorded that traction is greater for dystocia cases than for uncomplicated births.
(2) A 1994 paper by Allen, Bankoski, Butzin and Nagey[38], which used models to simulate three degrees of birth difficulty, namely 'normal', 'difficult' and 'shoulder dystocia' cases, and found that force levels > 84 N[39] were reached by many clinicians (74% and 82%) for 'difficult' and 'shoulder dystocia' deliveries and for some clinicians (31%) for routine deliveries. Whilst the results did not exactly correlate entirely with the live study (and clinicians' perceptions forces applied during traction were variable), nevertheless the traction forces were (again) higher for the simulated 'shoulder dystocia' cases than the simulated uncomplicated births.
(3) A 2000 paper by Gonik, Walker and Grimm[40] which concluded that clinician-applied traction to the fetal head (i.e. exogenous force) led to an estimated pressure of 22.9 kPa[41] between the fetal neck and the symphysis pubis, whereas uterine and maternal expulsive efforts (i.e. endogenous forces) resulted in contact pressures with the symphysis pubis which ranged from 91.1 to 202.5 kPa; and, accordingly, the latter endogenous forces were 4 to 9 times the former exogenous force.
(4) A 2006 paper by Noble[42] which demonstrated that the Stirrat and Taylor hypothesis in their 2002 paper[43] (that the fetus is protected by the natural forces of labour and that BPI can only be caused by negligent traction), is flawed and cannot stand in the light of recent research which shows that: "We should not be surprised that clinicians sometimes have to use stronger traction when dealing with shoulder dystocia compared with an uncomplicated birth, not least because the baby is often larger than average".
(5) A 2008 paper by Sandmire and DeMott[44] which reported the results of a detailed review of the incidence of BPI and concluded: "The review indicated that maternal labour forces are the most likely cause of BPI".
"7.7… I am not satisfied on the evidence before me that any conclusion can be drawn as to whether the majority of [obstetric brachial plexus injuries] are probably caused by traction, probably caused by propulsion or probably caused by a combination of both." (emphasis in the original).
"Causation of obstetric brachial plexus injury is multifactorial; evidence suggests that while some cases are traction mediated, others may not be. There is growing acceptance in both the medical literature and case law that the propulsive forces of uterine contraction may play a part.
The assumption that the presence of an injury is evidence that traction must have been applied is no longer valid. Injury may occur regardless of best efforts of the accoucheur. Diagnostic traction is acceptable and claimants now need to demonstrate factual evidence of the use of excessive force or other inappropriate management to succeed in arguing negligent management."
CONCLUSION
(1) On admission, the baby's head was "ROA" (as recorded in the notes of Midwife Bickerdike).
(2) On delivery, the baby's head was in "OP" (as recorded by the accoucheur, Dr Ali).
(3) During labour, the baby's head rotated 135o anti-clockwise from "ROA" to "OP", possibly at a late stage (i.e. from an angle of 135 o to 0 o).
(4) On delivery, the baby's injured right shoulder would have been the posterior shoulder.
(5) The Claimant's brachial plexus injury was caused to the posterior right shoulder during labour (i.e. before delivery of the head) as a result of (a) strong cervical contractions, (b) the posterior position of the right injured shoulder and resulting impact with the sacral promontory and/or (c) the sheer size of this exceptionally large (11lb 11oz) baby.
(6) There was no negligence by Hospital staff at any stage during labour (i.e. by failing to apply supra-pubic pressure or the inappropriate application of fundal pressure).
(7) There was no negligence by Hospital staff during delivery (i.e. there is no evidence that the accoucheur, Dr Ali, applied excessive traction to the baby's head and neck during delivery, still less that this caused the Claimant's brachial plexus injury).
(8) The severity of the Claimant's brachial plexus injury (Grade 4) does not give rise to an irresistible presumption that the cause must have been excessive traction by the accoucheur on delivery; cervical contractions can themselves be very powerful.
(9) The recorded difficulty in delivering the baby was due in large part to its exceptionally large size (11lb 11oz).
Professor Max Elstein's Report (1991)
"Shoulder dystocia is a problem that can occur with any large baby and the medical staff clearly did their best in trying to cope with this problem. The fact of the matter is that they were able to deliver this child in spite of this mechanical disadvantage without it having suffered any significant asphyxia is indicative of the rapidity in which they recognise the problem and dealt with it in an expeditious manner. Clearly they were in difficulty and had there been any further delay in the delivery of this child, in addition to the brachial plexus injury, it would have had cerebral damage. There is no evidence of the latter. Indeed, my impression is that Fazad is the brightest of the children."
…
CONCLUSIONIt is going to be very difficult to mount a satisfactory case against the attendants of Mrs Shaheeda in the way in which her labour was conducted. In fact, considering the circumstances, I think the staff at Birch Hill Hospital did extremely well, achieving a live delivery without any cerebral damage of this very large child. Brachial plexus damage is a recognised complication of shoulder dystocia. I can find no evidence of any negligence in the way in which this delivery was conducted and which resulted in the Erb's palsy or the Horner's syndrome. I am therefore unable to support any Action against the Rochdale medical staff for their care of Mrs Shaheeda Gulsham during the events surrounding the birth of her son, Mohammed Fazad."
RESULT
Postcript
Note 1 A brachial plexus injury is an injury or lesion to the network of nerves that conduct signals from the spinal cord to the shoulder, arm and hand. These nerves originate in C5-C8 and T1. Brachial plexus injuries are normally classified as being obstetric (i.e. during birth) or traumatic. [Back] Note 2 Erb's palsy (sometimes know as Erb–Duchennepalsy) is a paralysis of the arm caused by injury to the upper group of the arm's main nerves, specifically the severing of the upper trunk C5–C6 nerves which form part of the brachial plexus. [Back] Note 3 Horner's syndrome (also known asoculosympathetic palsy) is the combination of drooping of the eyelid (ptosis) and constriction of the pupil (miosis), sometimes accompanied by decreased sweating (anhidrosis) of the face on the same side and redness of the eye (conjuntiva). [Back] Note 4 The precise meaning attributed to the term “shoulder dystocia” in 1989 was the subject of debate before me. Shoulder dystocia in its broadest sense simply means difficulty in delivering a baby’s shoulders after the birth of the head. The Royal College of Obstetricians and Gynaecologists gives a more nuanced definition in its Guideline No. 42 published in December 2005 (see further below). [Back] Note 5 Posterior means pointing backwards, i.e. the shoulder proximate to the mother’s spine.
[Back] Note 6 Sacral promontory is the bony protrusion on the posterior side of the pelvis “opposite thesymphysis pubis. [Back] Note 7 Anterior means pointing forwards, i.e. away from to the mother’s spine. [Back] Note 8 “ROA” is the acronym for right occipito anterior, i.e. the back of the baby’s head (occiput) is facing forwards on the right side of the mother. [Back] Note 9 “LOP” is the acronym forleft occipito posterior, i.e. the back of the baby’s head (occiput) is facing backwards on the left side of the mother. [Back] Note 10 Pethidine is a well-known analgesic and the “opioid”of choice for many physicians. [Back] Note 11 The cervix is the lower, narrow portion of the uteruswhere it joins with the top end of the vagina (the Latin “cervix uteri” means literally "neck of the womb"). [Back] Note 12 The amniotic sac is the sac, or double membrane, of amniotic fluid in which the embryo (and laterfetus) develops inamniotes. [Back] Note 13 Partogram is a graphic paper record of maternal and fetal data entered by staff at regular intervals during labour, including measurements of cervical dilation, fetal heart rate etc. [Back] Note 14 A fontanelle (or ‘soft spot’) is an anatomical feature on an infant's skull comprising the soft membranous gaps between the incompletely formed cranial bones of a fetus or an infant, which allows the cranium to stretch and deform as the brain expands often faster than the rate at which the surrounding bone can grow. [Back] Note 15 Amniotic fluid is the protective liquid contained in theamniotic sac. [Back] Note 16 Meconium-staining of the liquor refers to the passage of the fetal bowel contents into theamniotic fluid. The significance of this event varies according to the clinical situation, but it may be a sign of fetal distress. [Back] Note 17 Synoticinon is a synthetic hormone used to stimulate contractions, i.e. to increase the strength and regularity of contractions, and is administered by continuous infusion. [Back] Note 18 Lignocaine is a local anaesthetic. [Back] Note 19 Episiotomy is an incision into the perineum usually to facilitate vaginal birth in cases of suspected fetal compromise and during instrumental delivery to widen the vaginal introitus and prevent significant tearing. [Back] Note 20 The lithonomy position is a common position for childbirth and involves the mother’s feet being above or at the same level as the hips with the perineum (i.e. the surface region between the pubic symphysis and the coccyx) at the edge of the examination table. Lithonomy stirrups are stirrups which assisting in keeping the mother’s legs in the lithonomy position. [Back] Note 21 Neville Barnes forceps are forceps which do not involve rotating the baby’s head into a more favourable position. [Back] Note 22 A method of assessing a newborn baby’s wellbeing, by reference to five parameters each of which is capable of scoring up to two points. A score of 5 at 1 minute suggests that the Claimant was not in bad condition at birth. [Back] Note 23 No tone in the musculature of the limb. [Back] Note 24 The Apgar score is a method of assessing a baby’s neonatal condition and wellbeing by observing five parameters, namely colour, tone, respirations, heart rate and reflex response (viz. the acronym Appearance, Pulse, Grimace, Activity, Respiration) and allocating a maximum score of two points to eachcriteria. A normal Apgar score is 9. [Back] Note 25 Fundal pressure is pressure applied to the higher part of the mother’s abdomen (and is to be contrasted with suprapubic pressure which is pressure applied lower down above thepubis). [Back] Note 26 “Intrapartum Sonography and Persistent Occiput Posterior Position: A Study of 408 Deliveries” by Gardberg, Laakkonen and Salevaara published on 1st May 1998 (see further below). [Back] Note 27 “Fatal shoulder dystocia: a review of 56 cases reported to the Confidential Enquiry into Stillbirths and Deaths in Infancy” (British Journal of Obstetrics and Gyanecology, Vol. 105, December 1998) [Back] Note 28 The word “fetus” derives from the Latin meaning literally “the bearing”, “bringing forth” or“hatching of young”. The British, Irish and Commonwealth spelling of “foetus” in use since at least 1594 (selon the Oxford English Dictionary) is etymologically incorrect. Medics and medical literature use the authentic spelling “fetus”. [Back] Note 29 The symphysis pubis (or maternal symphysis) is the midline cartilaginous joint that unites the right and left anterior pubic bones; and is “OP”posite the sacral promontory. [Back] Note 30 The sacral promontory is the bony promontory on the posterior side of the pelvis (opposite thesymphysis pubic). [Back] Note 31 Interpartum Sonography and Persistent Occiput Posterior Position: a Study of 408 Deliveries by Gardbert, Laakkonen and Salvaara (Finland) (Obstetrics & Gynecology, Vol. 81, No. 5, Part 1, May 1998). [Back] Note 32 McRoberts is a position used for delivery in cases of suspected or diagnosed shoulderdystocia. The mother is laid flat and her legs are hyperflexed onto her abdomen. This has the effect of rotating the angle of the symphysis pubis superiorly, assisting the anterior shoulder to be released. It also flattens the sacral promontory and allows the posterior shoulder to move forwards.
[Back] Note 33 I.e. the occiput (the back of the baby’s head) rotated approximately 45o clockwise from “LOP” to “OP”, viz. from a position of about 4.30 o’clock ( 6 o’clock (assuming mother on her back and symphysis pubis at 12 o’clock and sacral promontory at 6 o’clock), meaning the (injured) right shoulder would have passed neither the symphysis pubis nor the sacral promontory. [Back] Note 34 I.e. the occiput (the back of the baby’s head) rotated approximately 135o anti-clockwise from “ROA” to “OP”, viz. from a position of about 10.30 o’clock ( 6 o’clock (assuming mother on her back and symphysis pubis at 12 o’clock and sacral promontory at 6 o’clock), causing the (injured) right shoulder to impact against thesacral promontory.
[Back] Note 35 A Pinard stethoscope is an old-fashioned, but effective device, for listening to a baby’s heartbeat and looks like a small trumpet. [Back] Note 36 Intrapartum Sonography and Persistent Occiput Posterior Position: A Study of 408 Deliveries – Gardberg, Laakkonen and Salevaara – 1st May 1998 [Back] Note 37 “Risk Factors for Shoulder Dystocia: An Engineering Study for Clinican-Applied Forces” (Obstetrics and Gynaecology, Vol.77, No.3, March 1991). [Back] Note 38 “Obstetrics: Comparing Clinician-Applied Loads for Routine, Difficult, and Shoulder Dystocia Deliveries” (The Americal Journal of Obstetrics and Gynaecology, Vol.171(6), December 1994). [Back] Note 39 Newton, a SI (le Système International d'Unités, or International System of Units) unit of force equivalent to the amount of force needed to accelerate 1 kg of mass at the rate of 1 m/sec2. [Back] Note 40 “Mathematic modelling of forces associated with shoulder dystocia: A comparison of endogenous and exogenous sources” (The Americal Journal of Obstetrics and Gynaecology, Vol. 182(3), March 2000). [Back] Note 41 Kilo Pascal (i.e. 1,000Pa). A Pa is a SI unit of pressure = 6,894.757 Psi and equivalent to 1 N acting on an area of 1 m2.
[Back] Note 42 "Litigation concerning obstetric brachial plexus palsy: an alternative view" (The Obstetrician & Gyaecologist, 2006, 8:45-49) [Back] Note 43 “Mechanisms of obstetric brachial plexus palsy: a critical analysis” (Clinical Risk 2002, 8: 218-222) [Back] Note 44 “Controversies surrounding the cause of brachial plexus injury” (International Journal of Gynaecology and Obstetrics (International Journal of Gynaecology and Obstetrics, Vol.104, 2008). [Back] Note 45 “A template for reviewing the strength of evidence for obstetric brachial plexus injury in clinical negligence claims” (Clinical Risk, 2008; 14: 96-100) [Back]