Wednesday, 30 July 2014

Case Closed

The government has published its response to the public consultation on Lord Saatchi's Medical Innovation Bill. The bill seeks to change the law on clinical negligence which Lord Saatchi regards as a barrier to medical innovation. This response establishes beyond reasonable doubt, that the fundamental premise of the bill is flawed and that the bill is unnecessary and unwelcome. And yet, for some unexplained and inexplicable reason, the government will continue to work with Lord Saatchi to allow the bill to progress. Amending the bill, as the government proposes, will create a host of unwanted and unavoidable problems for medics, patients, researchers and lawyers.

"Laws are like sausages. It is better not to see them being made."


Lord Saatchi himself was not prepared to await the results of the consultation. Between the close of the consultation and the government's response, he has introduced a new version of his bill into the House of Lords where it has already had its second reading and will now go to the committee stage.

As troubling are claims that were made about the consultation process. In The Telegraph on 1 May 2014 Lord Saatchi wrote:

"Last week, the Department of Health closed the public consultation into the Medical Innovation Bill ... And thanks to the Secretary of State, and his legislation team at the Department of Health, it has been a model of a Government listening.

"We now have the results. A staggering 18,655 people - including doctors and patients, relatives of the bereaved and soon-to-be-bereaved, scientists, lawyers, legislators and the man and woman in the street - have responded wholeheartedly in support of this Bill. Fewer than 100 were against it..."

In contrast the Government's official response states:

"By the end of April 2014, comments from 70 people had been published online and a further 100 responses to the consultation had been sent directly to DH" (the Department of Health).


Lord Saatchi's additional 18,500 people comprised about 16,000 who signed an online petition created by the Saatchi Bill Team, and another 2000 who were channelled through a Saatchi Bill website. His claim that "fewer than 100" respondents were against the bill is not established by the government's response. Of course if over 85 opposed the bill, then a majority of the 170 respondents opposed it. To the consultation question of whether the bill should become law the government states, "There was support for the bill in some responses..." [emphasis added] but goes on to state the reasons given by others for not supporting the bill. If the government has not said how many of the 170 responses it received supported the bill, how can Lord Saatchi know?

The fundamental premise underlying the bill is that current clinical negligence law impedes medical innovation. The bill seeks to promote innovation by protecting doctors against being found negligent. If that premise is wrong, the bill is unnecessary and fundamentally flawed.

The government asked respondents "Do you have experience or evidence to suggest that the possibility of litigation sometimes deters doctors from innovation?" The government reports that some individuals said they did have such evidence, as did the British Association of Surgical Oncologists. However,

"many of the respondents who said "no" were medical bodies, including the Academy of Medical Royal Colleges and the Royal Colleges of Pathologists, of Physicians and Surgeons of Glasgow, of Radiologists, and of Surgeons of Edinburgh. It has been argued that "top doctors" are least likely, and the "rank and file" most likely, to be deterred from innovating by the fear of litigation, so it is worth noting that the British Medical Association and the two medical defence organisations that replied to the consultation also answered "no" to this question.... 
"Other respondents also answered no to this question. These included:
- medical research charities (including Cancer Research UK, Leukaemia & Lymphoma research, the Motor Neurone Disease Association, the Muscular Dystrophy Campaign, Parkinson's UK, Prostate Cancer UK and Target Ovarian Cancer);

- other bodies active in research and science (including the Academy of Medical Science, the Medical Research Council, the Wellcome Trust and the British Pharmacological Society);
- bodies primarily concerned with patients (including Action against Medical Accidents, Genetic Alliance UK and the Teenage Cancer trust);
- NHS England, the NHS Litigation Authority and the National Institute for Health and Care Excellence."

The evidence was therefore overwhelming - fear of litigation does not deter medical innovation. In an eye-opening article Dr Prentice, President of the Royal College of Pathologists, describes the overwhelmingly negative response of the royal medical colleges at a consultation meeting concerning the Saatchi Bill at which Lord Saatchi spoke.

"Meetings of the Association of Royal Medical Colleges can be tedious and divisive but this one was remarkable for the colleges' unanimous, professional rebuttal of Lord Saatchi's assertions... Lord Saatchi's PR team have not produced any examples of inhibition of research and development for this reason [fear of litigation]. But "No rational argument will have a rational effect on a man who does not want to adopt a rational attittude" (Popper) so there has been no let-up in the propaganda pumped into the media."

Proponents of the bill seem to think that it is sufficient to say that many people could benefit from new treatments and therefore a bill called the Medical Innovation Bill which seeks to encourage doctors to provide new treatments must be "a good thing". What a Bill is intended to do is not the same as what it will do. The bill makes one fundamental change to the law and one only - it allows doctors who would currently be found negligent to avoid being found negligent by following certain procedural requirements. Doctors who are not negligent are not protected by the bill, only negligent doctors. The bill protects them against being sued by their own patients who are harmed when the doctor gives them treatment which no responsible body of doctors supports.

As Lord Saatchi said in his Telegraph article in May, "In democratic politics, perception is reality." By working with Lord Saatchi to progress this bill the government has decided to listen to PR rather than evidence and reason.





Thursday, 3 July 2014

Heroes and Villains


Mr Grayling, Secretary of State for Justice and Lord Chancellor is introducing proposed legislation which he believes will "finally slay much of the "elf and safety" and jobsworth culture that holds back so much of our society."  The Social Action, Responsibility and Heroism Bill was born of a meeting of minds of Mr Grayling and Oliver Letwin .  These Georges have identified their dragon: the law of negligence and civil claims for breach of statutory duty. Heroic stuff.




I leave it to others to judge whether the dragon is reality or myth but legislation this important deserves careful examination. How will SARAH slay the dragon?

The bill provides that in determining claims for negligence and breach of statutory duty the court must have to take into account the following matters:

Clause 2 - "whether the alleged negligence or breach of statutory duty occurred when the person was acting for the benefit of society or any of its members."

Clause 3 - "whether the person, in carrying out the activity in the course of which the alleged negligence or breach of statutory duty occurred, demonstrated a generally responsible approach towards protecting the safety or other interests of others."

Clause 4 - "whether the alleged negligence or breach of statutory duty occurred when the person was acting heroically by intervening in an emergency to assist an individual in danger and without regard to the person's own safety or other interests."

Quite deliberately the Bill does not dictate how the court must take into account these matters when determining a claim in negligence or breach of statutory duty, only that it "must" have regard to them. The explanatory notes to the bill do not assist in interpreting the provisions of the bill. Are these matters to be taken into account when considering liability or quantum? Presumably liability. "The person" in each case is the person who is alleged to have been negligent or in breach of duty (clause 1).

To those of us working in the civil justice system it may come as a surprise to learn that the government believes that these matters are not presently being taken into account by the courts. In fact Mr Grayling accepts in his article on Conservative Home cited above that the courts apply "common sense", and  the government says that "the bill has been developed in response to concerns that people may be put off from taking part in voluntary activities, helping others or intervening in emergencies due to worries about risk and liability." It believes that the bill will "send a strong message to reassure people" that the court will consider the wider context of activities being considered in a negligence claim. So, the government is not saying that the bill will change what the courts decide in negligence cases, only that it will reassure people who are worried about how the courts deal with such cases. The Lord Chancellor is proposing an Act of Parliament which is not intended to change the law.






He is surely right not to claim that the bill will change the way the courts actually deal with negligence and statutory duty claims as an examination of the three main clauses demonstrates.

Clause 2 - Social Action

When might clause 2 apply? What is "society" (didn't someone once say there was no such thing?) and does it include groups of people who live or come from abroad? Surely a "member of society" is, in short, everyone. When I drive my son to a cricket match I am acting for the benefit of a member of society, i.e. my son. In fact when I drive to work alone I am acting to the benefit of my clients that day (arguably). An employer who operates a factory is benefiting members of society. A doctor who treats a patient is acting for the benefit of a member of society. The Home Office is trying to help everyone. So this provision applies in almost every conceivable situation.

Is the degree of benefit to others from the activity relevant to the determination of the claim? Perhaps the fact that I am driving to work would not cut much ice with the judge if when doing so I ran someone over. But would a different standard of care apply to a school bus driver? He is doing a more socially useful act than I am when driving on the road. Should a different standard of care apply to his driving? Often if more people are likely to be affected by the activity, the degree of care required to be taken actually increases. An airline might be expected to take more care over the maintenance of its aircraft than a cyclist over the care of his bicycle.

The work of doctors and other healthcare professionals is for the benefit of members of society. Would this bill lower the standard of care they are expected to meet? Will the Bolam test be modified? Will the standard of care expected of those who work in other  jobs be affected by this bill: dentists, physiotherapists, paramedics, traffic police, highways inspectors, lawyers? Of course not, because the standard of care is set by reference to all the circumstances of a particular case.

Will clause 2 cause any judge to make a different determination of a negligence claim than he would now make? I doubt it.

Clause 3: Responsibility

Clause 3 requires the court to take into account the general approach to the safety or other interests of others of the person carrying out the activity in which the alleged negligence occurred. "Other interests"? So, presumably a surgeon who has a good patient safety record should have that taken into account if he amputates the wrong limb. A driver with an unblemished record over 40 years should have that taken into account when he runs a red light and kills a child? It reminds me of this Steve Coogan character in the mockumentary The Swiming Pool on The Day Today.

A judge hearing a negligence case now would, I believe, take into account that the allegedly negligent individual had no record of negligence or had generally taken care. In certain cases that might lead a judge to conclude that it was unlikely that they were negligent on the particular occasion because it would have been out of character. The unblemished record of the surgeon might lead the court to be reluctant to find that he was negligent on a particular occasion, but if the negligence was obvious, such as amputating the wrong leg, his record will be of little assistance to him. If, however, on the facts, a defendant fell below an acceptable level of care for a driver, employer or doctor, for example, then they would be found liable whether it was the first or the umpteenth time they had been negligent. Will clause 3 make any different to any judgment? I doubt it.

Clause 4: Heroism

Clause 4 would have quite narrow application. The person acting heroically is the person alleged to have been negligent, not the person injured. Presumably this is intended to protect fire or police officers from being found negligent when they inadvertently injure someone when trying to rescue or protect them or others. Is a police officer running a red light to attend an incident acting "heroically"? Is the paramedic who misses an obvious spinal injury a hero? The provision will certainly not protect employers of rescuers from being sued if the rescuer is injured due to negligence of the employer. I can see the logic behind this provision, but I wonder how many judges have found a heroic rescuer to be negligent? I would be interested in learning of any examples. Even if the courts have made such findings they would undoubtedly have taken into account the circumstances including that the defendant was acting "heroically".


Perception 

The villain of the piece, the law of negligence, is designed to provide compensation for avoidable injury not to punish the negligent. Negligence claims are determined on the evidence in each case, taking into account all the relevant circumstances. The courts do take into account factors such as those set out in SARAH when they are relevant but do not when they are not relevant. Decisions whether an act or omission was negligent are made after the evidence is heard and arguments made. For that reason there is a degree of uncertainty involved. You cannot accurately predict the outcome of every claim.

The determination of negligence claims is in the hands of judges. You would not mistake a room full of county court and high court judges for a gathering of socialist radicals. They come in all sorts of political shapes and sizes but they are generally conservative (small 'c'). As a group they are neither pro-claimant nor pro-defendant. They are truly independent. That is one of the greatest assets of our system of law.

If this bill is enacted I do not believe it will make a jot of difference to the way the courts determine cases involving negligence or breach of statutory duty. It will serve only to require judges to include in their judgments that they have taken into account the matters set out in the SARAH Act. They will then come to the same decisions they would have come to had the Act never existed, not because they will ignore the Act, but because they already take into account all the matters set out in it.

Is that of reassurance to people? Does that justify this proposed Act of Parliament? Surely, by the government's own admission this bill is pure PR. It has the hallmarks of a Something Must be Done Act. which leaves nothing unchanged. This is not a party political point - the last Labour government came up with section 1 of the Compensation Act.

There are plenty of ways in which the civil laws of compensation could be changed and there are sound reasons to be concerned about the way the law of negligence operates. But it doesn't say much for "the people" if we are satisfied by an Act of Parliament which is designed merely to reassure us and which will not actually make any substantial change to the way negligence cases are determined.