Tuesday, 25 February 2014

The Saatchi Bill - Why?

Lord Saatchi's Medical Innovation Bill should be of great interest to all medical practitioners and all who practise in clinical negligence. The Bill is now open for public consultation. Click on this link for a copy of the Bill.  It is very helpful to have had the publication of guidance to the Bill including a detailed advice given by Christopher Gibson QC, although that guidance appears to address a previous draft of the Bill. It begins: "How can an Act of Parliament Cure Cancer?" which gives you some idea of the claims Lord Saatchi has made about his proposed legislation.

A patient can sue a doctor in negligence where he or she has suffered harm as a result of conduct of the doctor which would not have been supported by any responsible body of practitioners in the same field, at the relevant time.

The Bill proposes a change to the law on clinical negligence, providing that it shall not be negligent for a doctor to depart from accepted practice, even in circumstances where no responsible body of medical opinion would support that departure, provided he takes that decision responsibly. Whilst this is intended to promote departures from accepted practice which are positive for innovation, there is no definition of innovation and so the Bill seems to apply to all treatment which departs from "the pre-existing range of accepted treatments" whether it adds to progress or not. Doctors' conduct is of course not only governed by the law of negligence, but more directly by professional obligations, employment contracts and regulations. The Bill has nothing to say about those restrictions on doctors' innovative treatments.

The conceit driving the Bill is that the common law of clinical negligence is impeding medical innovation.

The proposed solution is to protect doctors from being held accountable in law when they cause harm to patients by giving them treatment which no responsible body of their peers would condone. Surely there are better ways of promoting medical innovation.

For those who counter by saying that the Bill only allows non-negligent treatment, the obvious response is to ask why the Bill is needed: a patient cannot now recover compensation for non-negligent treatment, whether innovative or otherwise.

Whilst I have serious reservations about the Bill, I recognise that it is an important issue and you can read about the proponents' views here . For a powerfully expressed view in the Health Service Journal opposing the Bill see here.

You can respond to the consultation on the government's website here

As the Bill progresses through the Parliamentary process it is important that its contents and potential consequences are recognised. I have set out key elements of the draft Bill below.

I have previously posted on interviews Lord Saatchi had given in support of his Bill, suggesting that some of the claims he made about clinical negligence law were incorrect. In fact the Bill seems to take as its starting point that innovative treatment is that which departs from "the existing range of accepted treatments for a condition".

However, the Bill provides that decisions to depart from accepted treatments will not be negligent if they are taken responsibly. Thus the test of what is  responsibly taken decision becomes crucial. Is this a substantive requirement that the decision itself should be a responsible one, or merely a requirement that a responsible process is undertaken when reaching the decision? It appears to be the latter. If it were the former then the Bill would be circular. Hence, under the Bill, provided the doctor can establish that he or she believes that there are plausible reasons why the proposed treatment will be beneficial and has considered factors set out at 1(5) of the Bill and has gone through the processes at 1(6) and (7) of the Bill, then he or she will not have been negligent (subject to clause 1(8)). The decision made and treatment given are not, at this part of the Bill, scrutinised, only whether certain considerations and processes were taken into account in reaching the decision.

One of the general protections at clause 1(8) is that nothing in the Bill permits treatment which is other than for the purpose of the best interests of the patient. Thus a doctor who departs from accepted practice but does so responsibly may nevertheless be negligent if he does not act for the purpose of the patient's best interests. This cannot be intended to be an objective test of what in fact was in the best interests of the patient - that would defeat the purpose of the Bill which is to protect doctors who might face a negligence claim when the patient is harmed by their actions (without harm there could be no negligence claim). It appears to be a subjective test - was the rationale and intention of the treatment for the best interests of the patient, whatever the outcome or the actual likelihood of the outcome? Thus this is very little protection at all.

The other general protection is that the doctor must provide treatment with such consent from the patient as is required by law. In other words, the doctor must act in accordance with the current law.

My primary objection to the Bill is that it is unnecessary. Firstly, I am not aware of any evidence, other than anecdotal, that medical innovation by doctors is impeded by the existing common law rules of medical negligence. Yes, doctors might be intimidated by the threat of litigation generally. But when considering truly innovative treatment, I doubt very much whether the law of negligence is relevant to decision making, as opposed to the requirements of the GMC, ethics committees and other regulations. Secondly, if the Bill merely seeks to codify the common law position in relation to negligence, then it will make no substantive change. When analysed many of the provisions simply require doctors to abide by the law. Chirstopher Gibson QC advised that :

 "I have considered this formulation [of the Bill]  with care. It seems to me that there is nothing in this draft that effects a substantive change in the law. By definition the Bill is not concerned with standard treatment that conforms to standard practice: I have considered how a Court would consider treatment that was intended to be innovative and which departed from standard procedure, and it seems to me that this is an effective definition of how the task would be approached. I believe that it succeeds in the aim of setting out a framework and defining an approach that does not change the existing law."

Why then is it needed if it does not change the law? Surely it is not the purpose of legislation merely to provide reassurance to a group of individuals, here doctors, because they do not appreciate fully the current law. That is a problem for other policies to address, but not one requiring a change in the law. In any event the Medical Defence Union has now said that it sees no need for the Bill and has no evidence that fear of litigation discourages doctors from innovating.

My secondary concern is that if it does produce any change in substance, it will be a change for the worse from the patient's point of view. I once had a case where a patient with a malignant melanoma with a poor prognosis was given treatment with high dose interferon. The doctor departed from standard practice (which was governed by a clinical trial at the time) and the patient died because of that departure. We obtained expert evidence that no reasonable body of practitioners would have acted as the doctor acted and that the departure from the protocol caused the premature death of the patient. This Bill, if passed, would give doctors like that a potential defence.

         The Bill, if enacted, could provide a possible defence to negligence claims where none was intended. One man's "innovation" is another's eccentric experimentation. A doctor whose actions were not supported by any reasonable body of his or her peers, could defeat a claim in negligence by pleading the innovation defence even where the weight he/she gave to the listed considerations was unreasonable and the decision he/she came to was also unreasonable. Provided the doctor can persuasively contend that he or she took into account the considerations set out in the Bill, made a decision through an open process, obtained consent and that the purpose of the treatment was to further the patient's best interests, then he/she has a defence to what would otherwise be considered unacceptable practice by all reasonable bodies of doctors (negligent). I don't believe that changing the law to provide that defence is desirable in the interests of patients or innovation.

Tuesday, 18 February 2014

Duties of Care

In many negligence claims the existence of a duty of care is not in issue - it is well established that certain relationships give rise to a duty,  for example doctor/patient, employer/employee or driver/pedestrian. In other cases the court may have to determine whether a relevant duty existed from first principles. Last year I posted on a case in which I was involved which concerned a catastrophic injury to the driver of a motorised go-kart. She brought a claim against, amongst others, the owner of the kart. They had been two of a group of friends who had gone out karting at an empty car park on a Sunday afternoon. It was a social setting. No money exchanged hands. The claimant had been free to choose whether to drive the kart or not.  Mrs Justice Swift found that no duty of care was owed.

In Yates-v-National Trust [2014] EWHC 222 (QB) Mr Justice Nicol, as did Mrs Justice Swift, considered Caparo-v-Dickman and Tomlinson-v-Congleton [2003] UKHL 47. in order to determine whether a duty of care was owed by the defendant to the claimant. The claim concerned an accident at Morden Hall Park, Surrey, an estate owned by the National Trust. Following a visual tree assessment the warden of the estate engaged an arborist claled Jackson to fell a diseased Horse Chestnut Tree close to Morden Lodge. Mr Jackson arrived with a team, including the claimant, to do the job. The claimant had been working from the tree for about 1 to 1.5 hours and was 50 ft from the ground when he fell.

The Judge noted that it was not contended that the NT owed to the claimant a duty to ensure that the claimant was covered by adequate insurance (although, as was noted, in some cases the absence of employers' liability insurance might be evidence of incompetence -  Gwilliam-v-West Hertfordshire Hospital NHS Trust [2002] EWCA (Civ) 1041. In some cases the He had found that the NT did not owe to the claimant a duty of care to ensure that it had chosen a competent or reputable arborist (Mr Jackson). It would not be fair and reasonable to impose on the NT a duty to the claimant to ensure that his own "boss" was competent.

"It is right that a failure to exercise reasonable care in the choice of an independent contractor might lead the NT being liable to an ordinary visitor since it could not then rely on s.2(4)(b) of the Occupiers Liability Act 1957 but it would place a very much more onerous obligation on occupiers to extend that duty to the contractor's employees or sub-contractors. That is because, as the present case illustrates, there is very much more scope for an employee to be injured than for an ordinary visitor. Therefore the range of matters which the occupier would have to take into account in order to discharge that wider duty would be considerably greater and the imposition of such a duty would not, in my view, be fair or reasonable." [52]

A further question arose as to whether the NT owed a duty directly to the claimant to supervise him in the conduct of his work. The Judge dismissed that proposition relying on an extract from the judgment of Lord Keith in Ferguson-v-Welsh [1987] 1WLR 1553:

"It would not ordinarily be reasonable to expect an occupier of premises having engaged a contractor whom he has reasonable grounds for regarding as competent, to supervise the contractor's activities in order to ensure that he was discharging his duty to his employees to observe a safe system of work. In special circumstances, on the other hand, where the occupier knows or has reason to suspect that the contractor is using an unsafe system of work, it might well be reasonable for the occupier to see that the system was made safe. The crux of the present case, therefore, is whether the council knew or had reason to suspect that Mr Spence, in contravention of the terms of his contract was bringing in cowboy operators who would proceed to demolish the building in thoroughly unsafe way."

Pushing the boundaries of the tort of negligence is a strenuous task.

Tuesday, 11 February 2014

Top Ten Fictional Advocates

The courtroom can sometimes be a theatre, sometimes a morgue. I was inspired by Crown Court and Rumpole to become a barrister. Here is my personal top ten list of inspirational fictional trial advocates - an eclectic bunch just like in real life. I am not sure I would want all of them to represent me. One finctional character I would certainly wish to represent me would be"Davis",  Henry Fonda's character in Twelve Angry Men; but whilst he would have made a great trial lawyer, he was playing a jury member. Sorry Paul Newman (the Verdict), William Shatner (Boston Legal) and Calista Flockhart (Ally McBeal) but you did not quite make it.

1. Horace Rumpole: fearless, independent, hilarious and just.

2. Atticus Finch: humane, unstinting and right.

3. Crown Court (this is Richard Wilson playing Jeremy Parsons QC) - no particular barrister but what a series! Intelligent, realistic and gripping.

4. Edward Marshall-Hall (I know he was real!) as played by Jonathan Hyde - courageous, charismatic and fabulous.

5. Alan Shore (Boston Legal) - ridiculous, flawed, genius.

6. Phyllida Trant (Rumpole) - smooth, sophisticated, astute - the real deal.

7. Perry Mason: you cannot take your eyes of him in court. A great cross-examiner.

8. William Garrow (I also know he was real) as played by Andrew Buchan - a canny advocate, pioneering, and inspiring.

 9. Martha Costello (Silk) - modern, committed, brave.

10. Vincent Laguardia Gambini - irreverent, course and triumphant.

Monday, 3 February 2014

Losing Streak

Recently, reading a newly reported trial judgment in a clinical negligence case, it crossed my mind that it had been a while since I had read of a decision in favour of a claimant. I did a quick search and the result was striking.

Fourteen judgments in High Court clinical negligence liability trials have been reported on Lawtel in the past 12 months. In thirteen of them, the claim failed. In one the claimant recovered only minor damages having lost on the key causation issue.

Of course the next fourteen High Court trials might all result in success for the claimants. Further, I cannot claim that this list is comprehensive: not all High Court trial judgments necessarily appear on Lawtel and these are High Court cases only (many clinical  negligence claims are heard in the County Court). All I did was use the search term "clinical negligence" so I may have missed some trials which were not brought up by that search. Some of these fourteen might yet be successfully appealed. Nevertheless, with all those caveats, it is quite a losing streak. I thought it was of interest and might give pause for thought for those who think the courts help foster a compensation culture amongst NHS patients.

What does this losing streak tell us? That the NHS, MDU and MPS have been astute in judging which cases to settle and which to contest at trial? That our High Court Judges are sceptical about clinical negligence claims? That claimants and their representatives are overly optimistic about their chances at trial? I do not have the answer. Perhaps it is just a statistical anomaly.

Here (most recent case listed first) are links to case reports where available, alternatively case summaries on Lawtel, together with a brief comment on each.

1) C-v-North Cumbria University Hospitals NHS Trust [2014] EWHC 61 (QB)

Midwife administered second dose of Prostin to induce labour. Placental abruption resulted. Mother died. Child suffered permanent cerebral injury. The Judge found that the midwife had

"acted within the bounds of reasonable judgment. I of course accept that she might, equally reasonably, have adopted a very cautious approach and had she done so this tragedy would not have occurred. But this reflects the fact that there are a range of possible reasonable actions that might have been taken in this case and [the midwife's] decision was within that range."

2) Jones-v-Portsmouth [2014] EWHC 42 (QB) 

Claimant failed to prove negligent delay in proceedeing to surgery when she had necrotising myositis; failed to prove that remedial surgery was inadequate and failed to prove that she had been given negligent advice as to the available reconstruction options leading to an unnecessary amputation.

3) Sardar-v-NHS Commissioning Board  [2014] EWHC 38 (QB)

Group 4 Erb's palsy suffered after shoulder dystocia noted at birth. Court found that injured shoulder was posterior at birth and was injured by forces of propulsion not traction,

4) Chappell-v-Newcastle-upon-Tyne  [2013] EWHC 4023 (QB)

Severe brain damage to child was not attributable to any negligent management of mother's labour or delivery. In any event the claim on causation would probably have failed since the damage resulted from meningitis caused by maternal infection during labour and not hypoxia.

5) Shah-v-North West London Hospitals NHS Trust [2013] EWHC 4088 (QB)

 GP was not negligent in failing to palpate the peripheral pulses of the legs of the deceased who had collapsed having recently had a child.

6) Nyang-v-G4S Care [2013] EWHC 3946 (QB)

Negligent failure to carry out an adequate mental health assessment of detainee at an immigration removal centre. Claimant injured spine running into a wall. Negligence not causative since it was found that his act of self-harm would have happened in any event.

7) Weeks-v-Wright 14.11.2013, Judge Forster (QB)

Rectal damage caused by use of monopolar diathermy was due to inadvertent heat spread from the instrument, a recognised complication, rather than negligent direct application of the instrument to the rectal wall.

8) Appleton-v-Medway 7.11.2013, Judge Hampton (QB)

NHS Trust in breach of duty of care in delaying treatment for foot infection but below knee amputation was due to diabetes and not infection and so delay had not caused injury.

9) Orwell-v-Salford Royal NHS Foundation Trust [2013] EWHC  3245 (QB)

NHS Trust in breach of duty in failing timeously to diagnose and treat compartment syndrome but delay not causative of injury since patient's leg muscles were already damaged by the time treatment ought to have been carried out.

10) Beech-v-Timney [2013] EWHC 2345 (QB)

GP's note of blood pressure was accurate and GP not liable.

11) Ecclestone-v-Medway [2013] EWHC 790 QB

Consultant Orthopaedic Surgeon not negligent when operating on knee by using percutaneous rather than arthroscopic technique. Both were recognised and acceptable surgical techniques logically supported by a
responsible body of relevant opinion.

12) Meiklejohn-v-St George's Healthcare NHS Trust [2013] EWHC 409 (QB)

No negligence in failing to suspect and therefore treat patient for rare genetic disorder.

13) Oliver-v-Williams [2013] EWHC 600 (QB) 

GP negligent in failing to tell a patient that he was urgently referring her for investigation. As a result ovarian cancer and surgery for it were delayed by five and a half months. However claimant failed to establish that the breach had caused a material or measurable difference to her life expectancy. Perhaps it is unfair to include this as a losing case for the claimant. Damages were recovered for some injury, but less than £10,000 and the key issue of loss of life expectancy was lost.

14) Dove-v-Jarvis [2013] Med LR 284 

Orthopaedic surgeon not negligent in performing hip replacement. An assurance that the surgery would be "well done" was not a material representation that the surgery would be successful and did not indicate that the surgeon was assuming a higher than usual standard of care.