Legal Aspects of Caring for PreEclamptic Women

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Legal Aspects of Caring for Pre-Eclamptic Women

• Samantha Critchley
• Partner
• Field Fisher Waterhouse

Date 8 May 2009
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Points to be covered today

• Clinical negligence claims generally
• Breach of Duty
• Causation
• Quantum
• Limitation
• Human Rights Act 1998
• Compensation culture?
• Case Studies

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1. Clinical Negligence Claims Generally

• 1.1 Burden of proof
• 1.2 Identity of the Defendant
• Private treatment/GP
• NHS Trust employees
• NHS Trust safe system of work

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Bill v Devon Health Authority 1993 4 Med LR 117

• Hospital on two sites
• Consultant obstetrician took 68 minutes to attend
  to deliver the second twin resulting in brain
  damage. the system should have been set up
  so as to produce a Registrar or Consultant on
  the spot within twenty minutes, subject to some
  unforeseeable contingency there was an interval
  of about an hour this interval was much too
  long. Either there was a failure in the
  operation of the system, or it was too sensitive
  to hitches which fell short of the kind of major
  breakdown against which no system could be
  invulnerable.

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2. Components of Negligence

• 2.1 Breach of duty
• 2.2 Causation

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3. Breach of Duty

• Bolam Test
• Different schools of medical practice
• NB. Bolitho v City and Hackney Health Authority

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4. Causation

• Significant injury
• Which was avoidable
• But for test
• Balance of probability
• E.g. Barnet v Chelsea Kensington Hospital
  Management Committee

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5. Quantum

• General Damages
• Special Damages
• Future losses
• Reasonably forseeability

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6. Limitation

• The basic rule is that proceedings must be issued
  within three years of
• the date of the injury. It can be longer,
  however, if-
• the Claimant is a child, in which case the three
  year limitation period only starts to run from
  his/her 18th birthday
• if the Claimant is a patient within the meaning
  of the Mental Health Act 1983, in which case the
  three year period is suspended
• later date of knowledge that the Claimant
  suffered a significant injury related to his/her
  treatment
• a Court is persuaded that it would be fair to
  allow a longer period.

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7. Human Rights Act 1998

• Article 2 The right to life
• Article 3 The right to be protected from
  inhuman and degrading treatment
• Article 8 The right to respect for private and
  family life.
• Just satisfaction v full compensation

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8. Compensation Culture?

• In 20062007 5,426 claims of clinical negligence
  were brought against NHS bodies.
• This compares with 5,697 claims in the preceding
  year, 2005-2006.
• 96 of the NHSLAs cases are settled out of
  Court. Fewer than 50 clinical negligence cases a
  year are contested in Court.
• As at 31 March 2007 the NHSLA had 18,493 live
  claims. This can be broken down by speciality.
  8,532 of these claims relate to obstetrics and
  gynaecology.

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Total number of reported CNST claims by
speciality at 31 March 2007
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Total value of reported CNST claims by specialty
at 31/03/07
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Remit of NHSLA

• The remit of the NHSLA is to maximise resources
  available for patient
• care. The framework document states that one of
  the aims of the NHSLA
• is to-
• Minimise the overall costs of clinical
  negligence, to the NHS and thus maximise the
  resources available for patient care, by
  defending unjustified actions robustly, settling
  justified actions efficiently, and contributing
  to the incentives for reducing the number of
  negligent or preventable incidents.

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9. Case Studies

• W F v Hospitals NHS Trust
• K v A

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W F v Bromley Hospitals NHS TrustSequence of
Events

• Prior to admission on 29.06.03 the Defendant knew
  history
• of
• (a) essential hypertension
• (b) familial hypertension and
• (c) pregnancy induced hypertension.

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• On admission the Defendant knew or ought to have
  known
• (a) ambulance crew had recorded that the First
  Claimant had suffered a severe headache earlier
  that day vaginal bleeding for 30 minutes lower
  back pain
• (b) a history of pain at 2330 on 28.06.03 of 30
  minutes duration
• (c) a history of haemorrhaging at 0030 that
  morning
• (d) hypertension (176/104 and 165/101 in contrast
  to 110/80 on booking)
• (e) proteinuria.

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• Thereafter there were serial signs and symptoms
  of hypertension which threatened both maternal
  and fetal well-being see chronology.
• The failure by the Defendant to diagnose that
  the First Claimant was hypertensive resulted in
• (a) a hypertensive crisis
• (b) placental abruption
• (c) the intra-uterine death of the baby
• (d) life-threatening haemorrhaging and acute
  disseminated intravascular coagulation (and
  associated complications) and
• (e) both Claimants suffering psychiatric injury.

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Preliminary Internal Review (January 2004)

• poor record keeping.
• all CTG traces should be dated and timed.
• the consultant on call should be kept advised of
  any adverse or complicated cases.
• doctors hand over notes should be recorded in
  the Delivery Suite book with all relevant
  information noted.
• patients consultant to be informed of any
  adverse outcomes immediately.
• emergency caesarean sections to be clinically
  prioritised on all occasions.

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Informal Meeting (April 2004)

• Couple advised to either
• Pursue formal complaint
• Take legal advice
• No admission but verbal apology for loss of baby.

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Risk Review Meeting (October 2004)

• A meeting was convened to review the actions
  taken
• following the clinical risk review of the case.
• Formal report prepared by the medical
  director/consultant
• obstetrician gynaecologist and the acting head of
  midwifery.
• Neither of the review team members were involved
  directly in
• the Claimants care.

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Issues highlighted

• Failure to recognise maternal and fetal risk
  factors
• Failure to diagnose pre-eclampsia
• Failure to adhere to local guidelines
• Management of Antepartum Haemorrhage
• Documentation
• Failure to follow-up blood results in timely
  manner
• Interpretation of electronic fetal monitoring
  (CTG)
• Incident reporting and risk review

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Recommendations following review

• 1. The Consultants need to address the problem of
  continuity of care where
• many different professionals are involved and
  care is handed over between teams and shifts.
  Clarity needs to be established in terms of who
  is in overall charge of any patients care in any
  given situation, and that on-going care and
  management instructions and decisions are
  documented fully and clearly.
• 2. Improvement in the standards of documentation
  to meet professional guidance to Clinical
  Negligence Scheme for Trusts (CNST) standards.
  These include
• Every entry needs to be identifiable.
• Each entry must be supported by the date and time
  of entry, a clear signature supported by printed
  surname and status.
• Writing needs to be legible, and in line with
  relevant professional guidance.
• There needs to be a clear management plan of care.

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• There needs to be an improvement in standards of
  interpretation and documentation of electronic
  fetal heart rate monitoring in context with the
  overall clinical picture. It is understood that
  the Directorate has implemented training session
  in Electronic Fetal Monitoring (CTG) and this
  needs to be multidisciplinary.
• It is understood that the Directorate is
  currently reviewing its procedures for incident
  reporting and risk management. As part of this,
  the Directorate will need to ensure, via
  subsequent audit and documented evidence, that
  the revised procedures and processes are fully
  understood and implemented by all staff members.
• The review team recommends that the
  multi-disciplinary team, especially those
  directly involved, revisit this case as a case
  study to facilitate learning.
• 6. With regard to Supervision, particularly Locum
  staff, there needs to be systems, validations and
  assurances in place that Locum Medical staff and
  Agency Midwives are supervised adequately, and
  are made familiar with local guidelines.

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• 7. There needs to be an improvement in statement
  writing, and the review team suggests that
  guidance notes for statement writing is reviewed
  and that the Trust guidance on statement writing
  be adhered to.
• 8. It is understood that the Directorate has
  arranged multi-disciplinary case presentations of
  high risk obstetric women. It is recommended
  that the treatment of woman with hypertension and
  Antepartum Haemorrhage are presented as case
  studies for teaching purposes.
• 9. The maternity unit needs to consider if
  sublingual Nifedipine should be available on the
  maternity unit.
• 10.The Maternity Unit need to consider processes
  and systems.

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Breach of Duty Causation of Injury

• The Claimants relied upon an admission of
  liability by the NHS Litigation
• Authority for and on behalf of its member Trust
• , it is admitted that there was a delay in the
  diagnosis of pre-eclampsia and a failure to
  appreciate its severity. Furthermore, there was
  a failure to consider that placental abruption
  maybe associated with hypertension and this
  amounts to a breach of duty on the part of the
  Trust.
• Further, it is admitted that but for the breach
  of duty, on the balance of
• probabilities, the baby would have survived and
  your client would not
• have suffered a haemorrhage.

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Progress of the claim

• October 2005 - FFW instructed.
• December 2005 - Letter of Claim sent in
  accordance with Pre-Action Protocol.
• May 2006 - Partial Admission received from NHS
  Litigation Authority
• May 2006 - Formal apology received from Trust.
• June 2006 - Claim Form issued.
• October 2006 - Claim Form served. Time extended
  for service of Particulars
• of Claim and supporting evidence until
  February 2007.
• March 2007 - Agreement between the parties that
  the claim be stayed
• whilst ADR explored.
• 29 May 2007 - Claimants Part 36 offer of
  40,000. Rejected. NHSLA value
• claim at no more than 15,000. NHSLA want
  disclosure of
• medical evidence before agreeing to settle.

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K v ASequence of Events

• 1. EDD at booking estimated as 01.07.06. BP
  120/60 mmHg
• 2. 32 weeks and two days gestation mild oedema.
  BP 100/65, urine NAD
• 3. 34 weeks gestation - BP 120/70
• 4. 36 weeks and five days gestation - BP 140/90
  protein in her urine, oedema of her face,
  trunk and legs was noted. Seen at the Maternity
  Day Assessment Unit and then admitted.
• 5. Assessment on admission on 08.06.2006 family
  history of severe PET noted.
• BP 165/110, urine protein
• oedema of feet, face.
• No headaches or visual disturbances.
• MSU v . PET Bloods v LFTs v
• 6. 17.00 BP 165-155/100-105
• Plan IOL today
• Placed on moderate PET protocol i.e BP 4-hourly
  and urine daily

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• 7. 21.15 No show. OS closed.
• IOL
• 8. 09.06.2006 04.50 06.15 suspicious trace
• 9. From 0615 two non-reassuring abnormalities
  present
• (a) decelerations and
• (b) a period of reduced variability from 0605.
  
• From 0645 no responsible midwife/obstetrician
  would have failed to diagnose the CTG trace as
  pathological.
• 10.06.59 CTG removed for the Claimants mother
  when she went to the toilet.
• 11. CTG then discontinued again by registrar.

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• 12 08.53 CTG reconnected. FH below 100 bpm for
  3 minutes Emergency bell pulled.
• 13. 09.05 Plan for EMCS
• 14. 09.30 Plan for EMCS reversed as some
  recovery on trace
• 15. 09.45 ARM
• 16. 10.00-11.00 The CTG trace shows a baseline
  of 140 bpm and variability of less than 5 bpm,
  and no accelerations. Frequent decelerations.
  The trace should have been classified as
  pathological.
• 17. 12.00 The CTG has a baseline of 150 bpm.
  Variability is less than 5 bpm. There are no
  accelerations. There is a loss of recording
  between 1206 to 1217 a deceleration at 1222
  frequent shallow decelerations from 1232 until
  1250. The trace is properly classified as
  pathological.

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• 13.00 14.00 The CTG has a baseline of 135 bpm,
  variability less than 5 bpm and no
  accelerations. Shallow decelerations around 1300.
  The trace is properly classified as
  pathological. Syntocinon ?
• 15.00 16.00 CTG shows a baseline of 135 bpm
  falling to 120 bpm by 1538. Variability is less
  than 5 bpm. There are no accelerations. There
  are shallow decelerations.
• 18.00 19.05 Decision made for LSCS.
• 19.11 Knife to skin
• 19.19 Delivery

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Summary of Delivery

• Apgar scores as one at one minute, three at five
  minutes and
• seven at 10 minutes.
• The arterial cord pH value and the venous cord pH
  value were recorded,
• respectively, as 6.89 and 6.97 respectively.
• The arterial and venous base excess were
  recorded, respectively, as
• minus 20.2 and minus 17.6.
• A diagnosis was made of
• Grade 3 HIE
• Microcephaly
• Spastic quadriplegia

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Internal Enquiry

• The report includes criticism of
• The persistent misinterpretation of the CTG
  traces and the failure to interpret the traces as
  a whole.
• The introduction of prostaglandin at 0530 on
  09.06.06 with a non-reassuring CTG trace from
  0450.
• The failure to proceed to deliver the Claimant by
  caesarean section when the Claimants mother was
  first taken to the operating theatre at about
  0900 on 09.06.06.

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Admission

• Letter in response from the Defendants
  solicitors
• It is accepted that the Trust were in breach of
  duty and that delivery should have taken place by
  0730 on the 8 June 2006.

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Breach of Duty

• Failed to attach sufficient importance to the
  severity of the Second Claimants pre-eclampsia
  on admission to hospital and the risks to the
  Claimant which this condition exposed him to.
• Persistently mis-interpreted the CTG from 0450
  onwards. From 0450 it was suspicious in
  appearance and from 0645 it should have been
  interpreted as pathological.
• Administered Prostin when it should not have been
  used to induce labour, given the fact that the
  appearance of the CTG trace.

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Breach of Duty cont.

• (d) Failed at 0650 on 09.06.06, in accordance
  with the RCOGs and the Defendants own
  guidelines and in the presence of a pathological
  CTG trace and in the absence of reassurance as to
  fetal well being, to expedite delivery and to
  do so, in accordance with those guidelines,
  within 30 minutes that is by 0730 on 09.06.06.
• (e) Despite the matters set out above and despite
  the pathological appearance of the CTG trace,
  thereafter permitted the labour to continue and
  to do so without evidence of fetal well-being for
  12 further hours until 1919 on 09.06.06.
• (f) Despite the pathological appearance of the
  CTG trace, thereafter discontinued the CTG trace
  at various times

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Breach of duty cont.

• Despite the pathological appearance of the CTG
  trace, thereafter augmented the labour with
  Syntocinon
• (h) Thereafter continued to administer Syntocinon
  and did so in increasing doses when the CTG
  remained pathological. Syntocinon should not
  have been administered.

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Causation

• Claimant suffered severe injury resulting in
  spastic quadriplegic cerebral palsy.

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Legal Aspects of Pre-Eclampsia

• Samantha Critchley
• Partner
• Field Fisher Waterhouse

Date 8 May 2009