Do Patients Need New Law For Life Saving Treatments? - PowerPoint Presentation

1. Do Patients Need New Law For Life Saving Treatments?Dr. Joanne BeswickStaffordshire Universityj.l.beswick@staffs.ac.uk

2. The Perceived Need for New Law The perceived need for a new law was at least partly driven by the concern that Bolitho v City and Hackney HA [1998] AC 232 and the ‘new Bolam’ approach might stifle innovation. That doctors would be reluctant to offer innovative treatment (either drugs or techniques) even when such treatment may offer the last chance of a cure for a patient.

3. The Perceived Need for New Law Lord Saatchi (whose wife had died from untreated cancer) was so concerned that he introduced his Medical Innovation Bill. The Bill was vetoed, but a similar Bill the Medical Treatments (Innovation) Bill was introduced by Chris Heaton-Harris in 2015.

4. Outline Responsei) Bolam is not and never has been a ‘defence’ to an accusation of clinical negligence. ii)There is no firm proof that defensive medicine exists, nor whether it would necessarily be a bad thing if it did.iii) Innovative treatment subject to appropriate oversight by the courts via Bolam is perfectly able to function without the so called Saatchi Bill.

5. Bolam is not a defence (but is fit for facilitating risk/benefit analysis)As Brazier and Miola contended when peers disagree, and the disagreement illustrates well-founded (therefore reasonable) debate within the profession, the professional should not be penalised. However, this should not license any profession to decide what the appropriate legal standard should be, nor place themselves beyond the law’s remit.

6. Bolam is not a defence (but is fit for facilitating risk/benefit analysis)Mulheron blamed Bolam for the special treatment afforded to the medical profession and contended that the courts were being dictated to rather than exercising their own judgment. She used the phrase ‘Bolam evidence’ to describe a view of an expert witness introduced to the court, and appeared to elevate the importance of this to a quasi-defence. She acknowledged the existence of the view, that judicial scrutiny of medical expert opinion was no different from the legal analysis a judge must make

7. Bolam is not a defence (but is fit for facilitating risk/benefit analysis)in respect of other professional evidence, and how McNair J did not intend the doctor’s expert evidence to be conclusive, yet she felt no compunction in blaming Bolam for the period when the courts went awry in their deference. It is contended Bolitho could go awry in the same way Bolam did. The adjective ‘logical’ does not prevent, prescriptive and descriptive standards becoming confused. Mulheron acknowledged it has already been judicially recognised it will be difficult to

8. Bolam is not a defence (but is fit for facilitating risk/benefit analysis)apply Bolitho where a distinguished expert in the field considered the accused doctor’s treatment or diagnosis to be a reasonable one. Mulheron’s other preferred Bolitho adjective ‘irrational’ raises particular concern, especially if she is intending the meaning given to this in the opinion of Dillion LJ in the Court of Appeal consideration of Bolitho where he applied the public law test of Wednesbury unreasonableness

9. Bolam is not a defence (but is fit for facilitating risk/benefit analysisIt is argued Marriott v West Midlands HA [1999] Lloyd's LR Med 23 signified the court utilising a less deferential approach. The patient had been admitted to hospital following an injury to his head, after X-rays and neurological observations he was discharged the following day. He continued with head aches, lethargy and loss of appetite, his GP visited and advised the claimant’s wife to telephone him if the claimant deteriorated and suggested analgesics for the headaches. Four days later the claimant’s condition deteriorated, and following emergency surgery to repair a skull fracture he was left paralysed with a speech disorder.Judge Alton found:

10. : …a court must clearly be reluctant to depart from the view of an apparently careful and prudent general practitioner, I have concluded that, if there was a body of professional opinion which supports the course of leaving the patient who has some seven days previously sustained a head injury at home in circumstances where he continues to complain of headaches, drowsiness, etc., and where there continues to be a risk of the existence of an intracranial lesion which could cause a sudden and disastrous collapse, then such a view is not reasonably prudent. Although the risk was slight in probability, this had to be balanced against the most grave of consequences.

11. Samanta et al explained although ‘a wealth of expert opinion’ supported the notion a referral to hospital for neurological assessment was not indicated at an earlier point, in the light of the plaintiff’s symptoms a weighing of the risks suggested otherwise. The Court of Appeal dismissed the appeal on the basis the judge was entitled to find that it could not be a reasonable exercise of a GP's discretion to leave the patient at home rather than readmit to hospital.

12. Defensive Medicine?The fear of defensive medicine has certainly been a cause for concern among elements of the judiciary notwithstanding a lack of evidence for such a phenomenon. This has been part of a wider fear over the last twenty years, most evident in the medical literature and popular press that the UK is in the grip of a malpractice crisis. They feared that the increased likelihood of litigation would lead to defensive medical practices. Lawton LJ in Whitehouse v Jordan [1980] 1 All ER 650 said “defensive medicine consists of adopting procedures which are not for the benefit of the patient but safeguards against the possibility of a patient making a claim in negligence”.

13. Defensive MedicineJones and Lyons discuss the lack of agreement about the meaning of the term ‘defensive medicine’ and how some doctors use the term defensive simply to mean treating the patient conservatively or even “more carefully” and how what to one doctor may seem defensive may to another appear good practice

14. Defensive MedicineHowever, it cannot be stated that the whole of the judiciary has fallen prey to the fear of defensive medicine and the potential consequences of such practice. Some judgments have actually acknowledged that making special allowances for the medical profession in order to avoid such fears may lead to more negative consequences. For example: Rougier J in Barker v Nugent (Unreported) I can only think of one thing more disastrous than the escalation of defensive medicine and that is the engendering of a belief in the medical profession that certain acts or omissions which would otherwise be classed as negligence can, in a sense, be exonerated

15. Defensive MedicineAt least one senior member of the judiciary has noted, extra judicially:“It is unwise to place any profession or other public body providing services to the public on a pedestal where their activities cannot be subject to close scrutiny. The greater the power the body has, the more important the need”. Lord Woolf ‘Are the Courts Excessively Deferential to the Medical Profession’ (2001) 9 Medical Law Review 1.

16. In Gregg v Scott [2005] UKHL 2 [2005] 2 AC 176 : Lord Bingham noted:“To describe awareness of a legal duty as having an ‘insidious effect’ on the mind of a potential defendant is to undermine the foundation of the law of professional negligence”.

17. No offence, but…No group in society should be beyond the oversight of the law. Whilst it is acknowledged that the incidents below are the exceptions they also show no profession should be beyond the law. Renegades can inhabit all walks of life. Additionally there have also been a number of well publicised medical scandals: the Bristol heart surgery; the retention of organs at Alder Hey; the conviction for murder of Harold Shipman; the disgraced gynecologists Dr. Ledward and Dr. Neale and finally the se of Dr. Robertson who stole an elderly patients’ savings.

18. Bill is not even wantedMiola 2015 (Bye Bye Bolitho? The Curious Case of the Medical Innovation Bill, University of Leicester School of Law Research Paper No. 15-24) points out that neither The Medical Defence Union nor the the Medical Protection Society report being aware of any evidence that fear of litigation prevents innovation. With the MPS actually stating that there is evidence that doctors are not deterred from innovating.

19. Court as the arbiter of InnovationThe standard of care in clinical negligence is of course, an objective standard of reasonable care as determined by the law. The advantage of the current common law system is that judicial oversight is maintained as the court is the ultimate arbiter of the standard of care under Bolam more so than under Bolitho.

20. Cases which Prove Innovation Possible under Bolam/ Bolitho De Freitas v O’Brien [1995] 6 Med LR 108 Expert evidence established only a small minority of neurosurgeons endorsed the defendants’ practice. Khan and Robson were concerned it would license a small fringe group practising experimental techniques as a responsible body of medical opinion. Defreitas need not necessarily have worrying consequences, it might only illustrate that a robust interpretation of Bolam where the courts are the ultimate arbiters need not risk stifling the innovation of the medical profession. It confirmed the requirement is reasonable on the courts assessment,

21. Cases which Prove Innovation Possible under Bolam/ Bolitho that numbers alone do not count.Ratty v Haringey HA [1994] 5 Med LR 413 showed that the courts utilization of standard practice guidance need not stifle all individual clinical discretion, the claimant relied on ‘Marnham's rule' a medical rule of thumb that asserted there should be no resection without histological proof of cancer. In this instance the claimant had a lesion of the colon with no histological evidence it was malignant.

22. Cases which Prove Innovation Possible under Bolam/ Bolitho Notwithstanding ‘Marnham's rule’ the defendant surgeon performed a resection which later histology proved to be non-malignant. The Court of Appeal held although Marnham's rule was a useful guideline it was no more than this, there was evidence the surgeon had deviated from it for sensible clinical reasons, he was not negligent. This highlighted how practice need not be overly constrained, although it illustrated how a careful balance needed to be struck

23. Cases which Prove Innovation Possible under Bolam/ Bolitho The standard practice laid down in guidelines was departed from yet the deviation endorsed by the court as reasonable care in law in Vernon v Bloomsbury Health Authority. (1995) 6 Med LR 297. The plaintiff received doses of a drug higher than those recommended by the Product Datasheet, the British National Formulary, the Monthly Index of Medical Specialties, and Martingale’s Extra Pharmacopoeia. The periods of administration also exceeded that recommended in MIMS and Martingale’s.

24. She suffered bilateral vestibular damage and loss of balance as a result. Judge Tucker heard the evidence of several expert witnesses, all but one agreeing that they would have prescribed at the same dose as the defendant. It was held:

25. Cases which Prove Innovation Possible under Bolam/ Bolitho “...the dosage was a proper one. The doctors were not negligent in prescribing it. I agree with the defendant’s experts that the guidelines laid down by the manufacturers and, for example, MIMS, are too conservative and that they err on the side of caution. I accept the views expressed by Dr. Sowton, Dr. Reeves, and Dr. Cooke, all of whom have had great practical experience of prescribing this drug. In particular, I rely on the views of Dr. Reeves. He has consistently prescribed higher doses than those recommended by the manufacturers and has advised others to do the same”.

26. Cases which Prove Innovation Possible under Bolam/ Bolitho Simms v Simms (a child) [2002] EWHC 2734 The case concerned patients suffering from probable variant Creutzfeldt-Jakob disease, who lacked capacity to make their own decisions. No firmly established effective treatment existed, but a potential treatment never tried in the United Kingdom had been identified. The patients’ parents wished this treatment to be administered to them. The court was asked to issue a declaration that the treatment would be in their best interests.Professor Miola contended “The case has been used by the Bill team as an example of the unsatisfactory nature of Bolam

27. Cases which Prove Innovation Possible under Bolam/ Bolitho in assessing genuinely innovative treatment. In particular, this particular passage from Simms has been quoted by the Bill team: The “Bolam test” ought not to be allowed to inhibit medical progress. And it is clear that if one waited for the “Bolam test” to be complied with to its fullest extent, no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted”.Miola further contends

28. Cases which Prove Innovation Possible under Bolam/ Bolitho “what supporters of the Bill do not then acknowledge is that Butler-Sloss LJ held that because there was a body of medical evidence in support of the treatment, and in view of the fact that the alternative was the inevitable death of the patients, the treatment would indeed be in the patients’ best interests”. It should be remembered that not a single case has so far been produced as an example of a doctor being sued for providing innovative treatment.

29. Dangers of BillIf it became law it could return the law of clinical negligence to the days where providing an expert, any expert could be found who would ‘agree’ with the defendant’s course of action, that the court would feel constrained in acting as the ultimate arbiter of the appropriate standard of care- thus effectively placing the medical profession beyond the reach of the courts and allowing the medical profession to

30. Dangers to set the legal standard which would be owed. This could effectively lower the standard to the lowest common denominator

31. References Jones Michael with Lyons Muiris, Medical Negligence (4th edition Sweet and Maxwell 2008)

32. References Mulheron Rachel, ‘Trumping Bolam: A Critical Legal Analysis of “Bolitho’s Gloss” (2010) 69(3) Cambridge Law Journal 609.Samanta Ash, Mello Michelle, Foster Charles, Tingle John and Samanta Jo,‘The Role of Clinical Guidelines in Medical Negligence Litigation: A Shift from the Bolam Standard?’ (2006) 14 Medical Law Review 321.