Martin John Stevens v University of Birmingham
| Jurisdiction | England & Wales |
| Judge | Mrs Justice Andrews |
| Judgment Date | 31 July 2015 |
| Neutral Citation | [2015] EWHC 2300 (QB) |
| Docket Number | Case No: HQ15X02256 |
| Court | Queen's Bench Division |
| Date | 31 July 2015 |
[2015] EWHC 2300 (QB)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISIONF
Royal Courts of Justice
Strand, London, WC2A 2LL
The Honourable Mrs Justice Andrews DBE
Case No: HQ15X02256
Jeremy Hyam (instructed by RadcliffesLeBrasseur) for the Claimant
Mark Sutton QC (instructed by Mills & Reeve LLP) for the Defendant
Hearing dates: 21–22 July 2015
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
The Claimant, Professor Stevens, is a highly distinguished clinical academic. In 2004 he was appointed to the Chair of Medicine (Diabetes and Metabolism) at Birmingham University. His contract of employment as one of the University's 241 clinical academic staff is expressly dependent upon his having and retaining an honorary appointment contract with the Heart of England NHS Foundation Trust ("HEFT") under which he undertakes clinical duties as a consultant. 120 other clinical academic staff are employed at consultant level by the University, out of a total of 6320 academic staff. Professor Stevens receives no remuneration from HEFT under his contract with them, but HEFT provides the University with the funds from which to pay his salary.
Professor Stevens has a job plan which sets out his main academic duties and responsibilities and his main clinical duties and responsibilities, and gives an indicative split of his time between them, which is stated to be "flexible". One of his listed academic duties and responsibilities is to "lead and co-ordinate a programme of research into the aetiology and management of diabetic neuropathy, foot complications and heart disease complicating diabetes." His listed clinical duties include leading the multidisciplinary diabetic foot service and multidisciplinary diabetic neuropathy service across HEFT.
As part of his research activities, Professor Stevens has been the Chief Investigator ("CI") responsible for the scientific and overall conduct of five randomised controlled clinical trials of investigational medical products ("the trials"). All the patients taking part in the trials were already receiving NHS treatment at Heartlands Hospital. Such trials are experiments undertaken to compare alternative interventions on patients with a defined medical condition — in this case, diabetes. They involve screening for suitable patients, confirming their eligibility, randomly allocating them to one or other intervention, following them through a defined timeframe, and assessing and comparing their outcomes. Since the allocation of a drug to a particular patient is made on a random basis, any observed differences in outcomes can be confidently attributed to the difference in interventions, rather than to pre-existing differences between the groups. For this reason, trials of this type are regarded as the "gold standard" method of evaluating the impact of interventions on patient health.
Professor Stevens has given a description of each of the five trials in paragraphs 23–34 of his first witness statement, which it is unnecessary for me to reproduce in this judgment. The University does not accept that his description is comprehensive or entirely accurate, but it agrees that it conveys a sufficient impression of the background facts for present purposes. All but one of the trials are jointly sponsored by HEFT and the University; the remaining trial is sponsored by the University alone. It is the sponsor's responsibility to be satisfied that the study meets the standards set out in the regulations and that arrangements are put in place and maintained throughout for management, monitoring and reporting on the trial. Where there are co-sponsors, they may agree to divide certain defined sponsor responsibilities between them, and that is what HEFT and the University did.
The roles of the University and HEFT differed in relation to each of the trials. For example, in respect of two of the five trials, HEFT was responsible for provision of the CI, for the study protocol, and for ensuring compliance with Good Clinical Practice ("GCP"); in the third trial those responsibilities all fell to the University. The evidence before me in respect of the remaining two trials is unclear as to where those responsibilities lay. In all of the trials the University was responsible for the registration and administration of the study. The University was generally responsible for pharmacovigilence (the process of monitoring the safety of all medicinal products used as part of a clinical trial), while HEFT was generally responsible for provision of a pharmacy service for, and the sourcing and supply of, the study drugs.
The Medicines and Healthcare Products Regulatory Agency ("MHRA"), an executive agency of the Department of Health, is responsible for ensuring that clinical trials are carried out in accordance with accepted standards, and for safeguarding patient interests. The MHRA is entitled to carry out inspections, including visits to the premises at which a trial is being carried out, and reviews of documentation, including records held at the site of the trial or at the sponsor's premises.
In December 2013 concerns that there had been breaches of GCP were initially raised by Professor Stevens himself and drawn to HEFT's and the University's attention in the course of preparing for an MHRA inspection of HEFT as sponsor involving a review of Trial E (one of the trials in which HEFT was responsible for ensuring compliance with GCP). This prompted the University to offer support and advice. Professor Stevens liaised with Ms Wilma van Riel, an employee of the University from the College of Medical and Dental Sciences, in preparation for the inspection, and with a view to addressing the problems that had been identified and ensuring that they did not recur.
Following the MHRA inspection of trial E and two of the other trials, Trials P and V, in which various breaches of GCP were found and reported, the University suspended Professor Stevens from any duties associated with research with effect from 20 December 2013, whilst it carried out an internal disciplinary investigation into allegations of misconduct. At that stage, the suspension was partial and Professor Stevens was still able to engage in clinical activities and to carry out his teaching responsibilities.
At around the same time, the Pro-Vice Chancellor of the University and Head of the College of Medical and Dental Sciences, Professor Jenkinson, commissioned an internal "Management Review" by a Professor Deeks (a Professor of Bio-Statistics) in respect of the research activities of the team working under Professor Stevens in all five trials, in order to determine whether there appeared to be prima facie evidence of any breach of the University's Code of Practice for Research ("the Code") sufficient to warrant any disciplinary action against them, or what was mischaracterised in Professor Deeks' report as an "extension of the existing disciplinary action" against Professor Stevens. There is, as yet, no such disciplinary action. The whole purpose of a disciplinary investigation is to determine whether or not any disciplinary action should be taken, and if so, at what level.
In February 2014, an email was sent to the General Medical Council ("GMC") by Professor David Adams which, on its face, purported to be from both the University and HEFT, informing the GMC that they had each decided to suspend Professor Stevens from his research activities and that the matters were currently the subject of internal investigation by both the University and HEFT. In fact, it is the University that has been responsible for any investigation from a disciplinary perspective.
Professor Deeks' report, completed in June 2014, did lead to further allegations of misconduct being added to those that had already been made against Professor Stevens, in consequence of which he was suspended from all his duties at the University on 11 July 2014.
There are 28 separate alleged breaches of the Code listed in total under the five trials. Professor Deeks has very fairly stated in the introduction to his report that unlike trials E, P and V, where there have been MHRA inspections, the judgments for trials R and T are those of only one assessor, and should be treated with a greater degree of caution until others have confirmed the assessments. At the time when these proceedings commenced, Professor Stevens had not seen copies of the MHRA reports, and therefore he did not know what they said about the conduct of the three trials to which they related.
For present purposes it is unnecessary to go into any detail about the nature of the allegations of misconduct, but they largely relate to an alleged lack of oversight of the team, inappropriate delegation, a failure to keep proper records or samples of tests, and other matters pertaining to the way in which the trials were conducted or documented. I have seen no allegations that patients were put at risk or inappropriately treated, though one allegation is that Professor Stevens "failed to ensure that medication was prescribed following proper checks and assessments by health professionals and in accordance with HEFT policies for prescribing".
The University had no choice but to take these matters seriously. As Mrs Carolyn Pike, the University's Director of Legal Services, explains in her witness statement, findings (and consequential reports to the MHRA) of widespread serious breaches of the Code could have significant ramifications for the University, including restrictions being placed on existing clinical trials, and current (or...
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