UK: Public Policy Is In Favour Of Speaking Easy About Medical Practitioners Without Fear Of Prohibition

The recent decision of Mr Justice Males in Noordeen v Hill and the Health Research Authority highlights the need for people to be allowed to express their concerns about medical practitioners to responsible people without fear of litigation.

Summary

This was an application by Mr Noordeen, a Consultant Orthopaedic and Spinal Surgeon, for a Norwich Pharmacal order against Mrs Hill, chair of the London Stanmore Research Ethics Committee (REC) and the Health Research Agency (HRA), as the body responsible for Research Ethics Committees. Mr Noordeen alleged that he had been defamed by unknown clinicians who had told Mrs Hill that he was using magnetic rods and that children who were given these rods needed more x-rays than children who had been given a previous type of rod.

The facts

Mr Noordeen was a pioneer of a new magnetic ‘growth rod’ in children with scoliosis. Such rods were inserted into the spine to assist the child’s spine to grow straight rather than curved. The new rod could be extended without surgery by means of an external magnet. The rods received a CE mark in Germany after testing on pigs. Mr Noordeen obtained the appropriate clinical governance approval to use these rods at Great Ormond Street Hospital (GOSH).

When Mr Noordeen gave up his position at GOSH in 2010, he was keen to use the new magnetic rods in his position at the Royal National Orthopaedic Hospital (RNOH) and to carry out a research project on their use. In January 2010, he applied to the REC for permission to carry out a patient study.

In Mrs Hill’s absence, the REC rejected the application and told him, inter alia, that he may not need ethics approval if his study used the device for the purpose for which it already had CE marking. In fact, this was a mistake and Mr Noordeen did need ethics committee approval. However, the CE marking allowed him to implant the rods in patients so long as he did not do so as part of a patient study into the use of the rods.

Mrs Hill subsequently wrote to Mr Noordeen on 5 May 2010 informing him that the research must always have ethical approval from a REC. Mr Noordeen responded on 10 May 2010 making it clear that he understood the need for ethical approval and that the proposed study was not going ahead.

In June or July 2010, Mrs Hill was told by more than one clinician at RNOH that Mr Noordeen was using magnetic rods and that children who were given these rods needed more x-rays than children who had been given the previous kind of rod.

Mrs Hill was under the misapprehension that Mr Noordeen was not entitled to implant magnetic rods in patients at all and so discussed the matter with REC colleagues. Since the REC had no power to take action, Mrs Hill informed Sheila Oliver at the National Research Ethics Service (NRES), the body which was then responsible for issuing guidance about how RECs should operate, of her concern that a study which had been refused ethical approval was being carried out at RNOH. This was then passed to Dr Wisely, director of NRES, who investigated and found no reason for concern about the safety of the magnetic rods.

Dr Wisely therefore wrote to the joint medical directors of RNOH on 16 July 2010 and informed them of the concern that the study into the rods was progressing resulting in poor clinical outcomes for children although she stressed that she did not have evidence to support this statement.

Mr Noordeen was asked by the director of RNOH to confirm in writing that he would not carry out any more surgical procedures with the magnetic rods until they had been investigated, which Mr Noordeen duly did. The outcome of RNOH’s investigation was that Mr Noordeen’s proposed research study had not proceeded and clinical governance approval was subsequently given for the use of the rods at RNOH.

Mr Noordeen then wrote to Mrs Hill asking for the source of the information to be revealed to him, which Mrs Hill declined to do. Therefore, Mr Noordeen made an application for a for a Norwich Pharmacal order on the basis that he had been defamed by the clinicians who spoke to Mrs Hill in June/July 2010 resulting in the statement in Dr Wisely’s letter dated 16 July 2010 that the study was progressing resulting in poor clinical outcomes for children.

The law

In the case of Norwich Pharmacal Co v Customs & Excise Commissioners (1974), the House of Lords held that where an action could not be brought against a wrongdoer without disclosure of the information sought or where the person against whom the disclosure is sought has become involved, albeit innocently, he comes under a duty to assist anyone injured by those acts by giving full information by way of disclosure and disclosing the identity of the wrongdoers.

Mr Justice Males in the Noordeen case summarised that to obtain such an order the applicant must show that:

Even if the three conditions are fulfilled, it is a matter for the court’s discretion as to whether to grant the order.

The decision

Mr Justice Males refused to grant the order. He concluded that Mrs Hill’s evidence had explained clearly the information which she had received and from what sources, without naming names. The crux of the application was the identity of the clinicians. However, as pointed out by Mr Justice Males, there was no possibility of a successful action for defamation against those persons who spoke to Mrs Hill based on a statement that Mr Noordeen was going ahead with the study as Mrs Hill was merely told that Mr Noordeen was using magnetic rods on his patients and it was her conclusion that he was going ahead with the study.

He was also doubtful any statement that children fitted with magnetic rods needed more x-rays than children with fixed rods could on its own be defamatory and, even if it could be, it would likely fall under qualified privilege.

Importantly, Mr Justice Males also refused to exercise his discretion to grant the order for the following reasons:

Further, if Mrs Hill were required to reveal her sources, this could have serious repercussions on the work of the HRA and REC. Mr Justice Males supposed that it might also discourage clinicians from volunteering to act on RECs if they thought they would be drawn into legal proceedings because people raised concerns with them.

Learning points

The NHS Constitution pledges that staff will be supported to raise concerns regarding safety, malpractice or wrongdoing. Patient interests also demand that where there are genuinely held, but erroneous, concerns regarding the ethical basis for treatment, then these should be investigated in a timely and fair manner.

The Noordeen case would appear to be, at its core, a reiteration of those principles. It continues to offer whistleblowers the reassurance that concerns regarding the ethical or clinical underpinnings of any course of treatment can be properly brought to light without the fear that they will be subject to later defamation actions.

Each case where disclosure of information is sought, based on the Norwich Pharmacal principles, will have to be judged on its own merits. The court will not easily be persuaded to make such an order and Trusts and individuals would be encouraged to consider carefully whether they can produce sufficient evidence to trigger the exercise of judicial discretion.

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