Return of the Saatchi BIll

Introduction

Enough has been said about whether the bill is required (it is to me wholly clear that it is not). However for now let us imagine that the bill is in fact necessary.I want to provide some comment on the effect the bill would have on the law. 

I avoided doing so previously because it had been indicated that the bill would be amended. The updated version of the bill has now been published (and is available at the back of the briefing note here.)

The aim of the bill is now very helpfully set out in the Briefing Note:

The Bill for Session 2014-15 is set out in Annex A: it is the shortest of all the versions

of the Bill so far, and it reduces the Bill to its essential message – innovate by

following a responsible process with the support of a responsible body of medical

opinion, and you can be confident that the law will support you; innovate in a

reckless manner without the support of your colleagues, and the law will not protect

you.

(The eagle-eyed reader will notice that this passage has a hidden message: “follow… a responsible process with the support of a responsible body of medical opinion… and the law will support you.” That is, to all intents and purposes, an explanation of the Bolam test. All that has been added is the phrase ‘innovate by…’ This is why many lawyers agree that the bill is unnecessary; the Bolam test already supports innovative treatment, provided that it is supported by a responsible body of opinion.)

The Aim of the Bill

I digress. To return to the ‘aim’ of the bill. It is (according to the briefing note) that the law will support innovation which is ‘responsible’ and which is carried out ‘with the support of a responsible body of medical opinion’, but not to protect innovation which is reckless and ‘not supported by colleagues’.  That is an entirely appropriate limitation on the type of treatment which the law should support (and is the present law).

The real question is whether the bill in fact does this.

The answer is short: it does not.

The Content of the Bill

Section 1(2) says that it is not negligent to depart from the existing range of accepted treatments if the decision is taken in accordance with a process which is accountable, transparent, and allows full consideration of all relevant matters.

Section 1(3) says what that process must include:

(a) consultation with appropriately qualified colleagues, including any

relevant multi-disciplinary team;

(b) notification in advance to the doctor’s responsible officer;

(c) consideration of any opinions or requests expressed by or on behalf

of the patient;

(d) obtaining any consents required by law; and

(e) consideration of all matters that appear to the doctor to be

reasonably necessary to be considered in order to reach a clinical

judgment, including assessment and comparison of the actual or

probable risks and consequences of different treatments.

Section 1(4) provides:

Nothing in this section  

(a)   Permits a doctor to administer any treatment for the purposes of research or for any purpose other than the best interest of the patient, or

(b)   Abolishes any rule of the common law in accordance with which a decision to innovate is not negligent if supported by a responsible body of medical opinion.

The Effect of the Bill: What is Negligent?

Section 1(2) provides that treatment caught by Section 1(3) will not be negligent. That is of course applicable to any treatment because there is no definition of innovation. It provides an circumstances in which treatment will not be negligent (i.e. additional to the Bolam test.) It therefore diminishes and weakens the Bolam test.

This may appear contradictory to the later section 4(b) which states that it retains the Bolam test. But what Section 4(b) in fact does is retain the Bolam test in respect of what is not negligent.

It is already the case that treatment is not negligent if supported by a responsible body of medical opinion (the Bolam test). By virtue of Section 1(2) treatment which might not fall within the Bolam test (and would therefore be negligent) could still avoid being negligent if it falls within Section 1(3).   

The Effect of the Bill: Section 4(a)

Section 4(a) rightly prevents research taking place, though in my view if a treatment is entirely unsupported by evidence and is properly to be considered ‘innovative’ then it is likely also to be what one might consider research.

It also prevents treatment for any purpose other than the patent’s best interests. This seems to provide some protection to patients, but in fact is likely to be interpreted as a subjective test (in line with the remainder of the bill).

The ‘purpose’ of a doctor’s treatment will almost always be the best interest of the patient: a doctor who has as his purpose the best interests of the patient can still provide negligent treatment.

Doctors who make mistakes act with the purpose of the patient’s best interests.

Those who believe in unverified alternative therapies believe that they are acting with the patients best interests.

For this section to provide any adequate protection the ‘best interests’ of the patient would have to be assessed on an objective basis, by expert evidence. That would effectively be a return to the Bolam test.   

The Effect of the Bill: Section 1(3)

All of those matters listed must be included in the process in order for it to be ‘caught’ by section 1(2).

But where, in that section, is the “support of a responsible body of medical opinion” required? It is not. The closest that section comes to requiring this is Section 1(3)(a), requiring ‘consultation with’ colleagues, including the MDT.

Does consultation require the gaining of support? No.

The Legal advice on the bill (from Parliamentary Counsel who drafted it, and available here), says that the ‘duty to consult sets a high threshold’, referencing a number of cases. Those cases are all public law cases on the duty of public bodies to consult. They are not authority on the meaning of the word in statute, and certainly not in the context of this Act.

A standard interpretation of consultation is a process of listening. In this context, listening to colleagues. Courts are unlikely to interpret that to include the gaining of explicit support. The argument will be that if parliament had intended to require the gaining of support it would have included that in the Act, rather than explicitly requiring only consultation.

So does the Bill provide that the law will not protect innovation which is ‘not supported by colleagues’? For the same reasons, no.

Conclusions

The reality is that, under the Bill, a doctor could comply with all of the procedural requirements in Section 1(2) and 1(3), consult with colleagues, ignore their views and press ahead, and s/he would not be negligent.

So the bill provides very limited protection to patients. The protections are inadequate because to provide appropriate safeguards would be to return to the Bolam test (as hidden in the ‘aims’ of the bill set out in the briefing note). That is itself an indication of why the bill is not required.

The Bolam test is the right test to provide the balance between protecting patients and promoting innovation. If there is a perception that doctors cannot innovate then more education is required. 

  

Bailey and Cumulative Causes Considered Again: Aspinall

*****
Update: 
Bailey v MOD has been considered again (albeit obiter) in two cases:

In Coakley v Rosie, (at 101-120) where HHJ Oliver-Jones QC found that, had he been unable to find for the Claimant on primary causation, he would have found for the Claimant on the basis of a material contribution, following Bailey.  

Coakley referred to another recent case in which Bailey was considered (but not relied upon by the judge): Pringle v Nestor (on Lawtel: [2014] EWHC 1308 (QB))
*****


The High Court has considered the judgment in Bailey v MOD [2008] EWCA Civ 883 (Bailii) on cumulative causes in clinical negligence, in the case of Aspinall v Secretary of State for Health [2014] EWHC 1217 (not available on Bailii as yet).

The Background: Bonnington and Bailey

The well-known principle in Bonnington Castings v Wardlaw [1956] AC 613 is that where a number of ‘agents’ can be shown to have materially contributed to an indivisible injury, a Defendant will be liable if one of those agents is the result of his negligence. Of course, if an injury is divisible, the Defendant is liable to the extent to which it contributed.

The application of the rule in Clinical Negligence cases was considered by the Court of Appeal in Bailey. The question was whether, following Bonnington, a contribution which was more than de minimis was sufficient.

The answer to the question was yes - the ‘but for’ test is modified in some cases. The Court set out the position explicitly (with emphasis added) (at [46]):

[…] If the evidence demonstrates that 'but for' the contribution of the tortious cause the injury would probably not have occurred, the claimant will (obviously) have discharged the burden. In a case where medical science cannot establish the probability that 'but for' an act of negligence the injury would not have happened but can establish that the contribution of the negligent cause was more than negligible, the 'but for' test is modified, and the claimant will succeed.

Interestingly in Clinical Negligence cases the issue is often not contribution directly to an ‘injury’ (like in Bonnington) but contribution to a condition or event. In Bailey the Claimant aspirated her vomit and thus suffered brain damage. The issue was why she had been so weak as to aspirate her vomit, and therefore the causation question was effectively ‘what contributed to her weakness?’ The court upheld the Judge’s decision that the negligence had made a material contribution.

Aspinall

In this case the claimant suffered an IVH shortly after birth. The remaining allegation at the end of trial was that the doctor had failed to detect and rectify a problem in the Claimant’s ventilation for a 45 minute period.

The allegation of negligence was dismissed, but the court went on to consider whether that period had contributed to the injury.

The court found on the basis of the expert evidence that the Claimant would have suffered the IVH regardless of the 45 minute period.

However, there was expert evidence that the 45-minute period would have contributed to the bleed the Claimant suffered. It would have “encouraged its onset” ([52]), and was “likely to have contributed to [it]” ([54]).

The Claimant therefore argued that Bailey could apply because the contribution of the 45 minute period was ‘more than negligible’.

Philips J dismissed this argument (at [58]): this was not a ‘cumulative cause’ case; the experts had been able to express a view and the court had found that the injury would have occurred in any event.

Analysis

This judgment affirms the position that the application of ‘Bonnington’ is only appropriate where medical science ‘cannot establish’ but for causation.

Put simply, Bailey will apply only if:

(i)                  the injury is indivisible, and

(ii)                medical science cannot establish whether or not the injury would have             occurred notwithstanding the negligence.

Such a conclusion is entirely logical – if it can be concluded that the whole of an injury would have occurred without the Defendant’s negligence, the Defendant should not be liable.

Claimants should be very cautious of attempting to rely on the Bailey decision, unless it really cannot be said to what extent the various causes contributed to the injury / condition.

"responsible" Innovation and responsible reporting

The Department of Health consultation on what has been referred to as the "Saatchi Bill" is about to close. 

The Medical Innovation Bill (to give it its proper title) has been considered on a number of other blogs (particularly here) but I have decided to set out (briefly) my views on the bill. 

The background to the bill and its intended purpose is set out here, where you can also respond to the consultation.

There are for me three main concerns: (the primary concern) whether the bill is necessary, the campaign which surrounds it, and the protection it provides.

Necessity
The Bill is necessary, it is claimed, because the current law on Medical Negligence prevents innovation, as "currently the law dictates that patients are only offered standard treatments."

As has been noted by other commentators, that is simply not a correct statement of the law. As all practitioners know, to be negligent, a doctor has to take a course of action which "no reasonable body of medical men, skilled in that particular art, would support. The House of Lords even went to far as to put it the other way (also in Bolam): 

Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view

There is in principle no negligence in using a new or innovative treatment, provided that support can be found for it among some reasonable body of professionals. 

Let us consider an example. A patient is terminally ill with an unusual and/or complex cancer. There is no known effective treatment for the condition, and without treatment the patient will die. The doctor proposes a logical, reasonable procedure which may or may not be successful, and for which there is perhaps limited evidence. There are a number of outcomes:

i) The treatment is effective and the patient's condition improves: no claim lies in negligence (there is no loss)

ii)The treatment has no effect and the patient dies: No claim lies in negligence (there is no loss; there was no better alternative treatment)

ii)The treatment has no effect and the Claimant suffers some negative effects/harm:

• A claim being brought in such circumstances is, in reality, unlikely. 
• If the side effects were known and communicated to the patient, who properly consented, there is no claim in negligence (the treatment was not negligent)
• If the side effects would not have been known or anticipated by a responsible                 body of professionals (i.e. because of limited evidence about the procedure), there is no claim in negligence. 

Much of the publicity around this bill has focused on the issue of new pharmaceuticals (particularly for cancer). The same applies to new drugs, but there is the more complex issue of licensing. That, however, is an issue for regulation, not for the law on clinical negligence.

Even the Medical Defence Union (always staunch in its defence of doctors) says that there is 'no evidence' to suggest that innovation is being stifled, and that "medical innovation should not leave them open to an increased threat of litigation". 

It is noteworthy that the campaign has not yet been able to point to a single example of a doctor being successfully sued for what would, under the bill, be 'responsible innovation'. 

The material on the issue on the "Saatchi Bill' website, and in articles, refers to the total damages paid out by the NHS, and to a "culture of defensive medicine". 

This, in my view, is the real issue. There is nothing in the current law on negligence which prevents the innovation which the bill's proponents (quite rightly) wish to see. What is preventing that innovation (if anything) is fear of litigation. The answer to that fear is re-education, not a wholesale change to the law on medical negligence. 

The Protections in the Bill
The wording of the Bill itself is (according to Lord Saatchi in the Google Hangout on 22 April 2014) going to be subject to some amendment following the consultation. I will therefore post again on this issue once the Bill has been redrafted. 

I will say briefly that, in its current form, the bill effectively removes all protection from medical negligence. 

The decision has to be based on: "the doctor’s opinion that there are plausible reasons why the proposed treatment might be effective".

The decision must consider the risks, likely success rates, and opinions of colleagues. 

There is no objective consideration of whether the treatment is reasonable or appropriate. Provided the Doctor complies with the steps and shows that he has considered the relevant factors, the treatment is not negligent. 


The Campaign
It is perhaps not surprising that a bill supported by one of the founders of Saatchi and Saatchi should come with a very effective social media campaign.  

However, I have concerns about the way in which it has been conducted (not, I should say, by the said Saatchi and Saatchi). Specifically:

• The way in which the current law is being expressed (which is simply incorrect);
• The articles in the Telegraph (which fail to raise any of the important questions about the bill) by Dominic Nutt who fails to disclose that he is the Director of Communications for the Saatchi Cancer Initiative (the Saatchi Bill campaign). 

This campaign for greater innovation in the treatment of rare conditions is quite commendable. However it is based on a fundamental error: The change required is in education and policy, not in the law of negligence.