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England and Wales High Court (Queen's Bench Division) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Queen's Bench Division) Decisions >> Noordeen v Hill & Anor  EWHC 2847 (QB) (17 October 2012)
Cite as:  EWHC 2847 (QB)
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QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| Mr. Hilali Noordeen
|- and -
|Mrs. Joyce Rosemary Hill
Health Research Authority
Rory Dunlop (instructed by Capsticks) for the Defendant
Hearing date: 11th October 2012
Crown Copyright ©
Mr. Justice Males :
"it was also thought that Dr Noordeen may not need ethics approval if his study is indeed using the device for the purpose for which it already has CE marking."
"The type of research you are doing must always have ethical approval from a REC. The last paragraph of the letter sent to you refusing approval does not say that you 'do not' need ethical approval. The words 'may not' were used meaning it was purely a discussion and does not change the ethical opinion of the Committee."
She went on to explain that the statement in the earlier letter was an error due to the absence from the February meeting of those with experience of relevant legislation.
"1. I completely understand that this type of research must have ethical approval from an REC.
2. I understand that the study cannot be conducted without Ethical Committee approval.
3. The Company that sponsors the study, I believe, do not wish for the study to go ahead either here or at Great Ormond Street."
"I am writing to alert you to a potentially serious matter, although I must from the outset emphasise that we have no evidence to support the concerns and no powers to investigate, and as there is no current application to a REC really no available course of action at all. Given the serious nature of the concerns raised, I am forwarding them on to you for your consideration of any appropriate action. …
Unfortunately, during the discussion with Mr Noordeen, one member of the committee incorrectly claimed that as the device had a CE mark ethical approval was not required and this comment was captured in the minutes and the letter to Mr Noordeen giving the unfavourable ethical opinion. When this comment came to our attention we wrote again to Mr Noordeen to clarify that ethical approval was required for the research. We were advised by Mr Noordeen that the research study was not progressing.
However the concern that has been passed to me in confidence is that there is a belief that the study is progressing and further that it is resulting in poor clinical outcomes for children, as I said at the outset I have no evidence to support this statement but in the circumstances feel I must pass on this concern to the Trust.
In the course of our discussions with the committee we have sought clarification from the MHRA that a CE authorisation from Germany does indeed mean that no further authorisation is required by the MHRA for use in the UK. This is a correct position, although the MHRA were puzzled that the documentation submitted to the REC suggested the device was CE marked using data from pigs, as the view was that such a device would need to have clinical data to show that it works and is safe when used on humans before it can be CE marked. Of course there may be such data for the product and it was just not referenced with the REC, but if there are any concerns that this device has been CE marked without relevant clinical data then this would need reporting to the MHRA compliance section for investigation."
(1) First, it rightly made clear that if the concerns expressed proved to be valid, the matter was very serious. Particularly serious was the suggestion, if true, that the claimant was pressing ahead with a research study in the face of a refusal of ethical approval.
(2) Second, there were also concerns expressed as to the clinical effectiveness of the treatment by means of magnetic rods and the clinical data, if any, by which the safety of such devices had been ascertained.
(3) Third, however, it was made clear that the use of the magnetic rods was lawful.
(4) Finally, the letter was moderately expressed, in terms which made clear that the concerns expressed were merely matters which might need investigation, and were not allegations supported by firm evidence.
"They said that they would say to Dr Wisely that they had looked into the matter and that there was no substance to it. They had not made the letter known publicly, they said, and they wanted to put the matter to bed quietly."
"… we are writing to confirm the following outcome of the investigation into the matters raised in your letter:-
- The letter states that there 'is a belief' that the study is progressing. Our investigation has shown that this is not the case. The relevant research study did not proceed. No relevant activity has taken place in respect of the unsuccessful original request to conduct a trial that was made to ethics committee. Subsequent applications to ethics committee for a prospective trial have been made by another Consultant and are currently being considered. As part of this the relevant MHRA compliance has been confirmed. We consider it highly likely that the trial will be approved.
- The letter states that there was a belief that the study 'is resulting in poor outcomes for children' but it does recognise that there is 'no evidence to support this statement'. Given that the trial has not taken place our investigation has shown that this is not the case as no activity has taken place within the trial. Separate to the trial, the investigation noted that the technique received clinical governance approval to proceed in Great Ormond Street Hospital (GOSH) and that, given Mr Noordeen's move from his joint appointment with GOSH to full-time appointment at RNOH, there were 2 cases carried out at RNOH, independent to the clinical trial, and there remain a number of patients being monitored and followed up at RNOH. RNOH has agreed a process for achieving R&D and Clinical Governance approval before new cases are carried out at RNOH. No evidence of poor outcomes has been indicated in the course of the RNOH investigation although we have to note that there has been no review of activity that has taken place outside of the RNOH."
1) a wrong must have been carried out, or arguably carried out, by an ultimate wrongdoer;
2) there must be a need for an order to enable an action to be brought against the ultimate wrongdoer; and
3) the person against whom the order is sought must:a) be mixed up in the wrongdoing so as to have facilitated it; andb) be able, or likely to be able, to provide the information necessary to enable the ultimate wrongdoer to be sued.
(1) the strength of the claimant's prima facie case against the wrongdoer;
(2) the gravity of the allegations;
(3) whether the wrongdoer was waging a concerted campaign against the claimant;
(4) the size and extent of any readership and thus the extent of the damage of which the claimant was at risk;
(5) the fact that the wrongdoer was hiding behind the anonymity which the website allowed;
(6) whether the claimant could identify the wrong-doer by other means; and
(7) whether the defendant had a policy of confidentiality for users of the website.
While this does not purport to be an exhaustive list, and not all of these factors are present in this case, I respectfully consider that this is a helpful checklist.
"have a detrimental impact not only on the source in question, whose identity may be revealed, but also on the newspaper against which the order is directed, whose reputation may be negatively affected in the eyes of future potential sources by the disclosure, and on the members of the public, who have an interest in receiving information imparted through anonymous sources and who are also potential sources themselves..."
Is there an arguable case of defamation?
"A privileged occasion is, in reference to qualified privilege, an occasion where the person who makes the communication has an interest or a duty, legal, social or moral, to make it to the person to whom it is made, and the person to whom it is so made has a corresponding interest or duty to receive it."
"be very slow to draw the inference that a defendant was so far actuated by improper motives as to deprive him of the protection of the privilege unless they are satisfied that he did not believe that what he said or wrote was true or that he was indifferent to its truth or falsity."