CLINICAL NEGLIGENCE

1. CLINICAL NEGLIGENCE Professor Vivienne Harpwood

2. OUTLINE • Brief summary of the basic law • Focus on problem areas • Analysis of the recent developments • Case study – Bolam and Bolitho cases • The impact of NHS changes • Analysis of case scenarios

3. THE LEGAL FRAMEWORK • CLAIMANT MUST PROVE: Duty of care owed Breach of duty Damage caused by that breach

4. Is there a duty of care? • In most healthcare situations this has been established by precedent. • If no precedent exists the court must decide

5. THE TEST FOR ESTABLISHING A NEW DUTY • Foresight • Proximity • Is it fair just and reasonable to impose a duty?

6. JUDICIAL POLICY “The use of the word “policy” indicates that the court must decide not simply whether there is or is not a duty, but whether there should or should not be one, taking into account both the established framework of the law and also the implications that a decision one way or the other may have for the operation of the law in our society”. Winfield

7. POLICY CONSIDERATIONS • Economic considerations • Justice – moral and ethical issues • Practical implications • Insurance • Loss allocation • “Floodgates” fear of too rapid an expansion • Protection of classes of individuals

8. THE HUMAN RIGHTS ACT 1998 • It is unlawful for public bodies to act in a way which is incompatible with a Convention right.

9. THE HUMAN RIGHTS ACT “Public Authorities” must act in accordance with Convention rights • Courts • The Government • The GMC • NHS Trusts • NICE and Healthcare Commission

10. CONVENTION RIGHTS AND MEDICAL LAW • The right to life (Article 2) • The prohibition of inhuman and degrading treatment and torture (Article 3) • The right to liberty and security (Article 5) • The right to a fair trial (Article 6)

11. CONVENTION RIGHTS (continued) • The right to respect for privacy and family life (Article 8) • The right to receive and impart information (Article 10) • The right to marry and found a family (Article 12) • The right not to be discriminated against (Article 14)

12. IMPACT OF HRA ON CLINICAL NEGLIGENCE • An end to blanket immunities for public authorities • New routes for claiming damages – Savage and Rabone cases

13. Article 6 of the Convention • “In determination of his civil rights and obligations, or of any criminal charge against him, everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal”

14. DUTY OF CARE: GREY AREAS • Good Samaritan acts • Members of an indeterminate class • Wrongful life • Police, ambulance and other emergency services • Psychiatric injury – secondary victims

15. GOOD SAMARITAN ACTS “Doctors are increasingly reluctant to give medical assistance on aircraft for fear of being sued if things go wrong. 1000 incidents a week. There is a steady fall in the percentage of occasions when a doctor or healthcare professional responds to a crew announcement seeking a volunteer". (BMJ Report 2004)

16. BREACH OF DUTY 1 • General law of negligence – the standard of care is that of the reasonable person • Clinical negligence – the standard of care is that of the reasonable healthcare professional at the same level and with the same qualifications

17. BREACH OF DUTY 2 • The Bolam Test/Defence • “A doctor is not guilty of negligence if he acted in accordance with a practice accepted as proper by a responsible body of medical opinion….A doctor is not negligent if he is acting in accordance with such a practice merely because there is a body of opinion that takes a contrary view”

18. Later applications • Whitehouse v Jordan 1980 • Maynard v West Midlands RHA 1984 “I have to say that a judge’s preference for one body of distinguished opinion over another also professionally distinguished is not sufficient to establish negligence”

19. Criticisms of Bolam Test • Too protective of doctors • Judges not permitted to choose between competing expert views • “Responsible body” not defined • A sociological rather then a normative framework

20. CAUSATION • The claimant must prove that the breach of duty caused or substantially contributed to the damage suffered.

21. Science and Law • Scientific proof = 95% probability • Legal proof = 51% probability – “a balance of probabilities”

22. Causation in clinical negligence • Patients often already sick • Several different possible causes of illness • Recollections of staff and patients seldom coincide • Staff may be in conflict • Medical records often incomplete • Dependence on medical experts

23. Tests to establish causation • “But for” test • The chain of causation test • Was there a novusactusinterveniens? • The material contribution test

24. Complex Cases • Omissions • Multiple defendants • Consent • Loss of a chance

25. Remoteness of damage • The defendant is only liable for damage that is of a type which is reasonably foreseeable • The courts define the extent of damage • The thin skull rule

26. SOME QUESTIONS ABOUT BOLITHO • What were the facts of the case? • What were the issues for the court to decide? • Whose evidence as to the facts (what had happened) did the trial judge prefer and why? • Was there a breach of duty in this case? • If so, what form would it have taken? • What was the main issue on causation for the judge to decide?

27. Bolitho questions continued • Could anything have been done short of intubation to avoid the injury to the child? • How many expert witnesses were there and what were their fields of expertise? • Which experts did the judge prefer and why? • What was the claimant’s theory about what had happened? • What was the defendant’s theory?

28. Bolitho continued • What test had the trial judge applied to determine the standard of care? • Did the Court of Appeal agree with the trial judge? • Does the Bolam test or something like it apply to causation? • What cases support the view that there might be negligence even if a body of opinion exists to support the defendant?

29. Bolitho continued • What was the new/modified test laid down by the House of Lords? • Has this new test made a difference in practice?

30. THE BOLITHO TEST The judge is permitted to choose between two conflicting expert opinions and can reject one of those opinions if it is not “logically defensible”.

31. BOLITHO: CLINICAL GOVERNANCE • Bleeps • “Systems” • Record keeping • Medical back-up • Court recognition of risks and benefits • Application to law on consent – Pearce v Bristol United HC Trust 1998

32. SOLUTIONS TO CLINICAL NEGLIGENCE PROBLEM • The development of the Bolitho principle • The use of guidelines to define standards • Legal reforms • Contributory negligence defence • More radical solutions

33. The Compensation Act 2006 1 Deterrent effect of potential liability A court considering a claim in negligence or breach of statutory duty may, in determining whether the defendant should have taken particular steps to meet a standard of care (whether by taking precautions against a risk or otherwise), have regard to whether a requirement to take those steps might— (a)prevent a desirable activity from being undertaken at all, to a particular extent or in a particular way, or (b)discourage persons from undertaking functions in connection with a desirable activity.

34. (Continued) 2 Apologies, offers of treatment or other redress An apology, an offer of treatment or other redress, shall not of itself amount to an admission of negligence or breach of statutory duty.

35. Can Guidelines set the standard? • Definitional problems • Too many guidelines • Conflicting guidance • Difficult to establish place in hierarchy • Objections from medical profession • Difficult to enforce

36. CLINICAL GOVERNANCE • “A framework through which NHS bodies are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which excellence in clinical care will flourish” “A first class service: Quality in the New NHS”

37. MAIN REQUIREMENTS • Clear lines of accountability • Implementation of comprehensive programmes to improve quality using evidence-based guidelines, compulsory audit and monitoring • Establishing risk management policies to identify and remedy poor performance

38. THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE THREE MAIN FUNCTIONS: • Appraises and develops new and existing technologies • Commissions and disseminates clinical guidelines • Promotes clinical audit and Confidential Inquiries

39. NICE Guidelines • Official status close to the top of the hierarchy • Disseminated throughout the NHS • Must be implemented • Will be monitored regularly by the Healthcare Commission • Will provide a normative basis to measure the standard of care in negligence cases

40. Expert’s views “If guidelines have been produced by a respected body and have been accepted by a large part of the profession, a doctor would have to have strong reasons for not following that guidance” Dr Graham Burt of the MDU 1993

41. Scottish Office Advice “With the increasing use of guidelines in clinical practice, they will probably be used to an increasing extent to resolve questions of liability. Those who draft, use and monitor guidelines should be aware of these legal implications”. (1995)

42. OFFICIAL VIEW • “Nice guidelines are likely to constitute a responsible body of medical opinion for the purposes of litigation” • “Doctors are advised to record their reasons for deviating from guidelines”- Sir Michael Rawlins • A deviation may not be regarded as “logically defensible”

43. Sir Michael Rawlins 2003 • “I always urge doctors when they depart from a NICE guideline to record in the patient’s notes at the time why they did so, because there is a general legal view that NICE guidelines will replace the Bolam test in medical negligence” • MedEconomics 2003

44. A FINAL THOUGHT • “There are very few professional men who will assert that they have never fallen below the high standards rightly expected of them. That they have never been negligent…..What distinguishes Mr Jordan from his professional colleagues is not that on one isolated occasion his knowledge and skill deserted him, but that damage resulted” Lord Donaldson in Whitehouse v Jordan.