CLINICAL NEGLIGENCE

1. CLINICAL NEGLIGENCE An illustration of the operation of negligence

2. 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

3. 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”

4. 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”

5. 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

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

7. Factual issues “Cause in fact” is a question of fact to establish a causal link between the incident and the injury

8. Remoteness of damage “Cause in law” The extent of the defendant’s liability is determined by the boundaries set by the judges

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

10. Marcia Angell “We can rarely absolutely prove a hypothesis although we can gather enough evidence from scientific studies to make the hypothesis so probable that we can say it is true for all practical purposes” Science on Trial

11. Causation issues in clinical negligence claims • 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

12. Tests to establish causation • “But for” test • The chain of causation test • Was there a novus actus interveniens? • The material contribution test • Bolitho test for omissions • Fairchild

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

14. Omissions Bolitho v City and Hackney Health Authority Failure to attend and intubate child with respiratory difficulties

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

16. 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?

17. 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?

18. 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?

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

20. 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”.

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

22. POSSIBLE SOLUTIONS TO CLINICAL NEGLIGENCE PROBLEM • The development of the Bolitho principle • The use of guidelines • Clinical Governance • National Patient Safety Agency • The Human Rights Act 1998 • Civil Procedure Rules • Radical Reform

23. GUIDELINES The problems to date - • Definitional problems • Too many guidelines • Conflicting guidance • Difficult to establish place in hierarchy • Objections from medical profession • Difficult to enforce

24. 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”

25. 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

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

27. THE HEALTHCARE COMMISSION • Provides national leadership, and develops principles of clinical governance • Provides advice and information on monitoring arrangements and reviews the implementation of NICE guidance. • Investigates, advises and reports on specific matters and conducts national reviews (section 20) - wide-ranging powers in section 23 • Note recent developments - CHIA

28. INNOVATIVE AGENDA IN THE HEALTH ACT 1999 • “Rationing” of resources. • Controlling the drug budget. • Dealing with the clinical negligence problem. • Ensuring co-ordination of care between health and social services.

29. RATIONING Relenza. Viagra. Beta interferon. Gender reassignment cases. “It is no good recommending a therapy if there is not the money available.” Sir Michael Rawlins NICE considers both cost effectiveness and clinical effectiveness Can guidelines provide a solution by defining the standard of care?

30. Is There A Hierarchy Of Guidelines? • NICE Guidelines? • Guidelines issued by the Courts - Re MB (Adult)(Refusal of Caesarean Section)? • DOH guidelines – Thomson v James? • BMA Guidelines – Kent v Griffiths and London Ambulance Service? • Employers’ guidelines? • Royal Colleges’ Guidelines?

31. 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

32. 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

33. 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)

34. 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”

35. 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

36. Concerted Action – Legal Reforms • The Civil Procedure Rules 1998 • The Protocol for the Resolution of Clinical Negligence Disputes • Use of the NHS Complaints System • Use of mediation

37. The Pre-action Protocol • Directs claims managers to clinical governance as a means of controlling claims • Recommends that healthcare providers develop an approach to clinical governance which ensures that clinical practice is delivered to commonly accepted standards and is routinely monitored

38. Additional Measures • National Patient Safety Agency • National Clinical Assessment Authority • Mandatory National Reporting System • Confidential Inquiries • Annual appraisal of all doctors • Changes to GMC and other professional organisations • Care Standards Commission for private health care • Public Interest Disclosure Act 1998 • “Supporting Doctors, Protecting Patients”

39. Mandatory Reporting System • Compulsory reporting of near misses and adverse events • Introduction of a single national database • Analysis of complaints, litigation adverse incidents and near misses • New culture of naming without blaming

40. CONCLUSIONS * Human Rights considerations could expand the scope of liability * Nice Guidelines will define the standard of care * Further NHS structural changes may improve quality of care • Fruitful analysis and action on complaints, litigation and reported incidents • Fewer mistakes therefore less litigation • Successful Clinical governance • More Cases will be settled out of court

41. CONCLUSION Healthcare workers and care workers could be the casualties of the legal system: they have rights too!

42. 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.