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4 June, 2018
Mesh debate judgment clarifies the scope of Montgomery ruling
On 1 June 2018, Lord Boyd of Duncansby issued his Opinion in the mesh litigation, having heard a two-week debate in December. A range of issues were canvassed during that debate. All are important for the future of that litigation. But one may prove to be of more general application and importance: the proper application of the Montgomery test.
Montgomery and what is a “reasonable treatment option”
In Montgomery v Lanarkshire Health Board  UKSC 11, the Supreme Court held that in obtaining a patient’s informed consent, a doctor had a legal duty to discuss the reasonable treatment options and the material risks associated with those treatment options. In the present litigation, the clinicians argued that what was a reasonable treatment option remained a matter of professional judgment and thus regulated by the Hunter v Hanley test for professional negligence. In other words, to make out a case based on a failure to present a particular treatment option, a patient would need to show that no ordinarily competent clinician, exercising ordinary skill and care, would have failed to offer that option. Such an allegation must be underpinned by an expert opinion to that effect (D v Lothian Health Board  CSIH 27 at para.73). On the other hand, the pursuers argued that what was reasonable was to be determined by reference to what a patient might find reasonable after a full discussion of all the treatments, whether or not those were available. In other words, the pursuers argued that a doctor was under a legal duty to present treatment options which she herself was unable to perform (whether by lack of training or availability in that particular hospital) and, if necessary, arrange referral to an appropriate hospital.
Lord Boyd preferred the argument for the clinicians (paras.38-45) and concluded that decision in Montgomery represented “a limited, albeit important, innovation on the rule in [Hunter v Hanley]” that was restricted to the question of risks associated with treatment options. Lord Boyd cited the submission presented to the Supreme Court by counsel for Mrs Montgomery: “Decisions about diagnosis and treatment must necessarily, and by definition, be made by the medical practitioner by reference to his special skill, learning and experience in an expert field which is not shared by the patient. By contrast decisions by the patient as to whether to submit to proposed treatment are his to make as of right, and his to make by giving whatever weight he thinks it right to put upon the risks and benefits which the options available bring.” (para.44). That, Lord Boyd held, emphasised the limited extend of the decision in Montgomery. Decisions about treatment “by definition” being matters of clinical skill, learning and experience, it remains appropriate for them to be assessed by reference to the test for reviewing any other exerciser of professional skill and judgment, namely that in Hunter v Hanley.
Lord Boyd’s decision represents the first (Scottish) judicial recognition of the more limited change made by Montgomery to the law on informed consent. Thus, to plead a relevant case based upon treatment options, a pursuer must still engage with the Hunter v Hanley test (and thus hold a supportive expert opinion). Furthermore, a pursuer must also plead what she would have done (i.e. which alternative she would have selected) had she been presented with the options she claims to have been entitled to (paras.46-50). Those conclusions are likely to have general application to claims based upon informed consent.
In the current cases, the outcome of Lord Boyd’s judgment is that the pursuers have not been allowed proof on any of the alternatives they claim should have been presented and thus are left with a simple case: the operation they had and now complain of or no operation at all.
Other points taken on behalf of the clinicians
In addition to the “treatment options” point, those representing the clinicians asked Lord Boyd to consider several other issues. First, in relation to causation, it was argued that, following the approach of the High Court of Australia in Wallace v Kam  HCA 19, the only risks that were relevant were those that were not warned of and which materialised (as opposed to risks which were warned of and accepted or risks for which there was no duty to warn)(see para.76 onwards). In other words, the clinicians argued that damages could not be awarded for a risk that the patient was willing to accept. That was said to be consistent with the “information”/“advice” distinction drawn by Lord Sumption in Hughes-Holland v BPE solicitors  UKSC 21 but was a narrower view than that taken by Lord Caplan in Moyes v Lothian Health Board 1990 SLT 444. This was not a point that Lord Boyd was prepared to decide without hearing evidence (as had been done in both Wallace and Moyes). He also doubted the application of Hughes-Holland to the medical setting, concluding: “I doubt that [the patient] would then see the doctor’s discussion of proposed treatments and reasonable alternatives as anything other than advice.” On the “risks” question, Lord Boyd accepted that the key question was whether the pursuer would have been prepared to accept the risk which led to her loss. If she was, her case cannot succeed. The real issue, he concluded, was whether risks are seen as cumulative (as in Moyes) or distinct (as in Wallace). That was held to be a matter for proof (see paras.89-93). So, for now, an answer to the causation consequences of Montgomery will have to await proof in this, or another, litigation.
Secondly, Lord Boyd was invited to approve the English decisions of Shaw v Kovac  EWCA Civ 1028 and Diamond v RDE NHS Foundation Trust  EWHC 1495, which had each held that a patient does not have a claim for breach of personal autonomy where informed consent was not obtained (i.e. a patient must still show loss in the normal way). However, during the course of the debate, the pursuers withdrew that part of their claim and those averments have been deleted by Lord Boyd. Unsurprisingly, he then refused to offer his opinion on a point that had been rendered academic in the cases before him.
First, the manufacturers of the products argued that the actions against them should be dismissed as irrelevant. During the debate, the common law case against the manufacturer was withdrawn (para.165). That left a case based on the Consumer Protection Act 1989 and whether the products were defective within the meaning of that Act. That case has been allowed to proceed to proof. Whilst Lord Boyd expressed reservations about how the case against the manufacturers had been framed, the level of pleading required of the pursuers took account of the knowledge the manufacturers would have about their own products and given the issue of defect required a holistic approach to be taken, what was and was not relevant, and the particular weight to be placed on any one factor, was something that could only be assessed after proof. Given similar product liability cases in England and Wales have been resolved after trial (for example, and most recently, Gee and others v Depuy International Limited  EWHC 1208) and, in Scotland, the Vioxx litigation has recently been allowed to proof by the Inner House (Richards v Pharmacia Ltd  CSIH 31), it is perhaps unsurprising that the cases against the manufactures were allowed to proceed.
Secondly, Lord Boyd reiterated the approach to pleadings and the necessity to provide fair notice. Those rules did not change when the court was presented (as here) with a large number of cases which had a number of common features (para.30). Two particular points are worthy of note. First, he held that the Ch.42A case management powers does not convert litigation into an inquisitorial process and it remains for the pursuer to plead a relevant case. It is not for the court, through case management orders, to take a lead in identifying the issues (para.27). Secondly, in a slight innovation on the traditional approach, Lord Boyd was prepared to look at the content of the defences when considering the question of fair notice. That, he held, was consistent with the spirit of Ch.42A where parties are encouraged to make early disclose. In those circumstances, it would be wrong to ignore the content of the defences (para.31).
Finally, in each of the four lead cases limitation pleas were taken by all of the defenders. Two of those cases were held to be barred by limitation so far as the clinicians were concerned on the strength of what has been pled. The other two cases, in relation to the clinicians, require proof to determine the question of limitation. In relation to the manufactures, proof was held to be necessary in each of the cases to allow limitation to be determined. For the cases that have been held to be barred by limitation, the application of s.19A (the power to relieve a pursuer of the consequences of limitation) has yet to be determined. But perhaps the most significant aspect of the limitation discussion is Lord Boyd’s insistence that the issue turns on the particular circumstances of the particular case. In a litigation such as this (where limitation pleas have been taken in the majority of the 500 or so claims), that suggests it will be hard to resolve the cases on anything other than an individual basis.
Ampersand’s Graham Primrose, QC, Simon Bowie, QC and Paul Reid were instructed by the NHS Central Legal Office and David Stephenson, QC and Jamie Dawson were instructed by the MDDUS for the debates. Vinit Khurana is also instructed in behalf of the NHS.