Sunday, 27 December 2015

Trial and Grimstone

As if to draw together my two blogging pre-occupations in 2015 - the Access to Medical Treatments (Innovation) Bill and consent to treatment following Montogmery - Christmas brought the judgment of McGowan J in Grimstone v Epsom & St. Helier University Hospitals NHS Trust [2015] 3756 (QB).

The Claimant, a keen sportswoman in her mid-fifties, sought out expert treatment for her problem hips. She found Professor Field who recommended hip replacement surgery using bone conserving implants, Mitch PER devices which were relatively new devices, for which there was limited evidence of longer term success and failure rates.

The Claimant signed a consent form for bilateral hip replacements, which were performed in 2008. Unfortuantely, although the operations were competently performed, they went poorly for the Claimant who had to undergo several follow- up procedures. There was no allegation of negligent surgery, but rather that the Claimant's informed consent was not obtained. Amongst the allegations made was that the surgeon failed to inform the Claimant of the limited evidence of the success and failure rates for the new devices used in her hip replacement surgery.

The Judge recorded:

It appears that the Claimant does not say she asked about alternative methods of hip replacement, rather she argues that the Professor should have made her aware of the lack of data for the newer alternatives. The Professor's evidence is that there was no such request for that information and it would not be his usual practice to provide such material if not sought, he would if asked have done what he could to explain the design and performance of the devices available.

The Judge referred to and quoted a long passage from Montgomery v Lanarkshire. A key part of that passage was the conclusion that:

"The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. "

The Judge found that the surgeon had proposed surgery (using the bone conserving implants) specifically to suit the Claimant's stated needs. He found that there was ample research into the use of the implants which were "new" but not "experimental". He found that the Claimant was motivated to have the new, bone-conserving implants in preference to older Charnley implants.

In relation to the need to provide information to the Claimant of the limited evidence of success and failure rates, the Judge's conclusion at paragraph 12 (iv) was:

"Was he obliged to tell her about the limited data available on the device used?
There was a great deal of evidence about the status and volume of data available on the new device that was used in this surgery. It is not necessary to assess the scientific worth of that material. The agreed fact in this case is that the Professor did not tell Mrs Grimstone anything about the success rates. It is not therefore of any value to analyse what would amount to good data if there were an obligation, at the time, to impart it to a prospective patient. The "concern" expressed by the Claimant's expert, Mr Charnley, that the data or lack of it was not explained to the patient cannot outweigh the view of the equally expert witness called by the Defendant, Mr Hamer, that a reasonable body of doctors in the same position would not have given such information to a patient. It is not accurate to refer to the device as "experimental", it was new. All the clinicians accepted it was an appropriate device to have used in this case."

Arguably therefore the Judge did not apply the materiality test from Montgomery, even though he had referred to it in his short judgment. Instead he applied the Bolam test as to what a reasonable surgeon would have advised. It seems to me that information about the success and failure rates for the new implants was information about risk, and therefore that the Montgomery test applied and the Bolam test did not apply. However, given other findings in the judgment it is very possible that even if the Montgomery test had been applied, the Judge would have found that even it was not satisfied in this case, the Claimant would still have opted to have the bone-conserving implants.

Use of bone-conserving implants was clearly within the existing range of accepted treatments in 2008 (to adopt the test in the Access to Medical Treatments (Innovation) Bill, at least on the findings made by the Judge in Grimstone. What of the time when they were "experimental" rather than "new"? The Judge ought to have applied the same test as to the advice that a doctor should give a patient - the materiality test from Montgomery set out above. Would a reasonable patient attach significance to the fact that the devices were in a trial period with little evidence as to their effectiveness? Or should the doctor be reasonably aware that the particular patient would attach significance to that information?

In many cases new devices or treatments are subject to a controlled trial when they are at the "experimental" rather than "new" stage. Patients are carefully consented when partaking in the trial and the trial is designed to produce useful information about the effectiveness of the treatment. If doctors propose such treatments in good faith and for patients for whom they are suitable, doctors stick to well-designed trial protocols and patients give proper consent, there is no prospect of a negligence action if complications arise. I am not aware of the courts ever having had to decid such a claim.

The Access to Medical Treatments (Innovation) Bill is designed to address a very different kind of "experimental" treatment - that which is outwith a well-designed, controlled trial. Under the current law, and under the AMTIB, a doctor would have to obtain the patient's informed consent to the proposed treatment. As I think is clear, the courts will require doctors to inform patients of the fact that there is no evidence as to the effectiveness of such treatment, or to inform them of the basis on which it is thought that the treatment might be of benefit. However, under the current common law a doctor might still be found negligent for providing such treatment if no responsible body of doctors would have condoned its use on the patient, even if the patient had given her informed consent. You might think this is paternalistic, or you might think it is a reasonable protection of patients who are not in an equal relationship with doctors.

The Bill is designed to allow doctors to proceed in those circumstances without fear of litigation. The protection is removed and replaced with a series of steps which, if the doctor takes them, will prevent the courts from finding the doctor negligent for deciding on an experimental treatment, even if no responsible doctor would have supported the decision.

So, an interesting judgment with which to end 2015.

I wish all my readers a good 2016.






4 comments:

  1. Rosalyn Grimstone4 January 2016 at 15:36

    Not all bone-conserving implants are the same- indeed it was stated that the Mitch PER implants used were a 'modification' of the gold standard of the time, the Birmingham implant. The Birmingham hip had been in use for about five years in 2008 whereas the Mitch PER had been in use for less than one year and only approximately one hundred had been fitted hence the lack of evidence as to the effectiveness of this new design. It would seem eminently material that the relative merits or otherwise of these two alternative methods were NOT discussed prior to consent and the patient could not have been aware even of the existence of these new 'modified' implants and hence was not in a position to ask for information about them. Also interestingly these Mitch PER implants are no longer in use. Therefore I cannot see how this constitutes informed consent.

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  2. Rosalyn,
    Thank you for commenting on my blog. Assuming you were the Claimant in the case, I can sympathise with the frustration a party can feel that a judgment does not always contain all the details and nuances of the evidence you would wish. It is very helpful to have your thoughts on the materiality of the lack of evidence of the effectiveness of the Mitch PER implants. Best wishes.

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  3. Mrs Grimstone - I agree with you entirely. In fact, the Birmimgham resurfacing had been in use since 1997 and had a good stock of performance data by 2008.
    It seems the judge applied quite the wrong test on consent. What a reasonable body of surgeons would regard as acceptable is outdated and incorrect. I note that she also placed a great deal of weight on your refusal to answer her question as to what you would have done if you had been told that the PER was the best there would have been no evidential basis on which Professor Field could have made such claims. Had he secured your consent by making such claims, he would probably have been negligent in that regard too.
    I do hope you will appeal.
    Richard Starkie,
    Pryers Solicitors.

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  4. Apologies, a few of my words seem to have disappeared there.
    I intended to say "...if you had been told that the PER was the best thing for you and the longest lasting device available, there would have been no evidential basis..."

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