Informed consent & innovation: New hip replacement devices

Nigel Poole has drawn attention to a recent UK decision on informed consent and potentially innovative treatments. Amongst the allegations made was that the surgeon failed to inform the patient of the limited evidence of the success and failure rates for the new devices used in her hip replacement surgery: Grimstone v Epsom and St Helier University Hospitals NHS Trust [2015] EWHC 3756 (QB).

Mr Poole commented:

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.
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.