Thursday, 29 January 2015

The Medical Innovation Register

The new selling point for the Saatchi Bill is that it will lead to the creation of a new and important data base of innovative treatments. As seems often to be the case with the Bill, it pays to look behind the claims and check the reality.

At its Third Reading in the House of Lords, an amendment was made to the Medical Innovation Bill. The amendment was proposed by Lord Hunt of Kings Heath, Shadow Health Spokesman in conjunction with Lord Saatchi and others.

Lord Hunt hailed the amendment on twitter on 2.1.15: "Delighted the Lords accepted today my amendment to Lord Saatchi's medical innovation bill for a mandatory register to record innovation."

The amendment is now at section 1(3)(e) of the Bill. It requires the treating doctor to,

"comply with any professional requirements as to registration of the treatment under the provisions of this Act with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatment and patients' experiences)."

I asked Lord Hunt who has agreed to operate the register. On 24 January he replied on twitter: "No body as yet. The Bill specifies principle of mandatory registration. @DHgovuk Department of Health has been discussing with GMC."

I am grateful to Lord Hunt for his openness. He is right that the amendment establishes a principle of mandatory registration. But, as he notes, there is work to be done to convert this principle into a practical reality and there remain many questions about the usefulness of the register.

First, there has to be a professional requirement with which the doctor has to comply under the bill. The bill does not require registration, it requires compliance with a professional requirement to register. There is no existing professional requirement because the Bill is not enacted and this is a new amendment. A new professional requirement has to be created. I cannot think of any body other than the GMC that would have authority to impose such a professional requirement on doctors.

I contacted the GMC and David Buckle, Head of Public Affairs, wrote to me to say that there had been contact between the GMC and the Dept of Health prior to the 3rd Reading:

"Our contact was focused upon whether professional standards set by the GMC might be a suitable route to enforce the sharing of learning from innovation. As Earl Howe stated in response to the amendment, we informed the Department that we would be very happy to consider anything that might be helpful but advised that this may not be an effective route.

"We have statutory powers to provide advice and doctors must be prepared to justify their decisions and actions against the standards set out in our guidance. Serious or persistent failure to follow the guidance will put a doctor’s registration at risk. We confirmed to the Department that our initial view was that fitness to practise proceedings being brought against a doctor for not having recording information on an online database designed to foster the sharing of learning from innovation does not seem to be a proportionate response."

So, there has been no agreement from the GMC to create a professional requirement on doctors to register treatment under the Bill, and some expression of doubt as to whether they should do so. 

Without the GMC making registration a professional requirement there will be no mandatory register. A vote for the bill on the basis that it will create a mandatory register would be a vote for a chimera.

The Saatchi Bill website announced the new amendment with customary hyperbole:

"The open access Medical Innovation Register will record all treatments and their outcomes, both positive and negative which are received under the Medical Innovation Bill ... we are thrilled... the recording of this data is essential ... Lord Saatchi and the MIB team have been pushing for a means of data collection to be included on the face of the bill for two years.

Pushed whom? They drafted the bill. In another part of the Bill's website it is claimed that the register will be for innovative treatments, providing an essential data base for researchers and doctors alike.

The amendment does nothing of the kind. The Bill provides doctors with a defence to a claim for compensation. The defence applies when a doctor has "departed from the existing range of accepted treatments." Innovative treatment is not defined in the Bill. There is no register of accepted treatments and so identifying what is a departure from the existing range of accepted treatments will be a difficult task for anyone, let alone the individual doctor. 

Treatment under the bill is not necessarily innovative, and innovative treatment is not necessarily provided under the Bill.

Negligently deciding not to operate on a patient showing clear signs of a perforated bowel and peritonitis is a departure from the existing range of accepted treatments but it is not innovative. Using new technology developed to carry out surgery for a brain tumour is innovative, but it is not treatment under the Saatchi Bill.

Two doctors may provide the same innovative treatment. One may "choose" not to do so under the bill but be confident that he is not Bolam negligent. The other may seek protection under the Bill. Only the doctor who treats "under the bill" would have to register it. 

Let's not pretend that this will be a comprehensive register of innovative treatments. At best it would be a partial register of some treatments where doctors thought they were departing from accepted treatment. At worst it would be a register of doctors who had attempted to use the bill to avoid a negligence claim.

And what is treatment provided "under the bill"? First you have to identify whether the treatment was a departure from the existing range of accepted treatments. Remember that treatment under the bill includes inaction. Then, you have to determine whether the doctor met the requirements of section 1(3). Does every doctor who asks for a second opinion thereby provide treatment under the bill? And what if the court later determines, or the doctor later admits that he did not in fact comply with the requirements of the bill. Does the treatment then become de-registered? 

The Bill team says that Oxford University has offered to host the register. I asked the GMC about what would be included on the register, how many treatments would be expected to be registered in a year, who would pay for it, who would have access to it and how patient confidentiality would be secured. Mr Buckle answered:

"These are all important matters that would need consideration if the Bill was to become law with this new amendment included. We have not as of yet however been in discussion with the Department of Health or others with regard to who would operate such a register or how it would operate."

Since it would be the GMC that would have to make it mandatory for doctors to use the register, it would need to know the answers to these questions.

The Bill team has made great play of its partnership with the Dept of Health, but in the Lords, Earl Howe, for the government opposed this amendment. Will the government oppose it in the Commons? Is there time for the details of a register to be finalised and for a professional requirement to use it to be created?

To my mind the bill is fundamentally flawed and this amendment is a side issue. Nevertheless it is being treated as an important selling point, perhaps in particular to the medical community and to MPs. I very much hope they will examine the goods before buying.

Monday, 12 January 2015

Help for Bereaved Families at Inquests

It is time to change the law to entitle bereaved families at Coroner's Inquests into the deaths of NHS and private healthcare patients to public funding for legal representation.

There can be few events more devastating than the sudden, unexpected death of someone whom you love. If the death occurs when your loved one was under the care of others, bereavement can be particularly hard to bear. Feelings of anger, loss of trust and sometimes guilt can complicate grief.

In England and Wales, a coroner has a duty under the Coroners and Justice Act 2009 to investigate a death if:
1) the coroner is made aware that the body is within that coroner's area, and 
2) the coroner has reason to suspect that:
a) the deceased died a violent or unnatural death; 
b) the cause of the death is unknown; or 
c) the deceased died while in custody or state detention.

The coroner must then establish who has died and how, when, and where they died.

Each year a number of Inquests are held which concern what might be called healthcare deaths, where at the time of death the deceased was in the care of the NHS or a private healthcare provider and the death was unexpected or unnatural. A person may have committed suicide when under psychiatric care or died due to inadvertent damage caused during surgery. Parents may have lost a child due to unrecognised meningitis, a failure to treat for the toxic effects of a prescribed drug or a failure to recognise a severe brain injury. Those are all examples of cases in which I have represented bereaved families at healthcare inquests.

Such families want the inquest to establish how and why their loved-one died, what, if anything, could have been done to avoid the death and whether similar deaths might be preventable in the future. They may want the inquest to establish facts which will allow responsible parties to be held to account for the death.

For the families of patients whose deaths are subject to inquests, the experience can be very challenging. Inquests are often much more emotionally charged than civil trials, both for the family and the witnesses. They tend to take place much closer in time to the death. The pathologist's evidence can be so upsetting that family members are advised that they might want to leave the hearing when such evidence is given. It is not uncommon for the Coroner to have to take breaks in proceedings whilst family members or other participants gather themselves, having been distressed by evidence they have heard. Often in healthcare inquests, the evidence can be quite technical and difficult to follow. There may be many professional witnesses. Sometimes the Coroner will have commissioned independent expert evidence as well as evidence from a pathologist. Sometimes the Coroner will allow interested parties to call their own expert witnesses.

I can well understand that in these cases NHS Trusts and individual doctors and nurses who may be directly involved in the circumstances leading to the death, will wish to be represented by a solicitor and/or a barrister. The case may have implications for them in terms of liability or professional regulation. Individual doctors will often obtain representation trough their professional defence organisation such as the MPS or the MDU. The taxpayer pays for representation for NHS Trusts. According to the NHSLA's annual report for 2013/14, it arranged support under the Clinical Negligence Scheme for Trusts (CNST) at over  500 inquests. The Report says:

On 1 April 2013, we extended the cover we provide under CNST to include the cost of representation at inquests where there is likely to be a claim for negligent care. This means that we can support our members much earlier in fatal cases and that claims for negligence can be resolved more quickly, including the giving of an apology, explanation and, where appropriate, admission of liability prior to the inquest taking place."

What of the family of the deceased? When I have represented families at healthcare inquests, legal work has included liaison with the coroner as to which witnesses ought to be called; help with the preparation of statements by the family; obtaining and reviewing medical and nursing records, pressing for further disclosure including serious untoward incident reports, where appropriate; obtaining expert opinion to assist in analysing the evidence and to explain what issues arise; conferring with experts and the family to consider the issues raised and how those might be explored at the inquest; advising the family as to what to expect at the inquest, what questions they might be asked, what questions they want to be asked of others; assistance with dealing with the press and media; liaison with other interested parties; legal research and advice in relation to coronial procedure, the need for a jury, whether the inquest should be an article 2 inquest and the appropriate range of verdicts; and advocacy at pre-inquest hearings and at the inquest itself, which includes questioning the healthcare professionals and any expert witnesses and making submissions as to the law. Very often further evidence emerges at the inquest and has to be assimilated and dealt with immediately.
The Ministry of Justice expects bereaved families to do all that for themselves. There is no entitlement to public funding for legal representation for bereaved families at inquests. Applications for exceptional funding can be made. The Lord Chancellor's Guidance to legal aid caseworkers on when exceptional funding for inquests should be granted, includes the following statement:

"Funding for representation at an inquest is not generally available because an inquest is a relatively informal inquisitorial process, rather than an adversarial one. The role of the coroner is to question witnesses and to actively elicit explanations as to how the deceased came by his death. An inquest is not a trial. There are no defendants, only interested persons, and witnesses are not expected to present legal arguments. An inquest cannot determine civil rights or obligations or criminal liability, so Article 6 ECHR is not engaged."

The Guidance sets out two reasons for granting exceptional funding. The first is that it is required by article 2 of the European Convention on Human Rights. The second is that there is a wider public interest.

As to the second possible criterion, the wider public interest must be significant and must relate not to the inquest itself, but the need for representation for the family at the inquest. It is clear that this criterion is intended to apply in very very few cases. I am unsure if it has yet been triggered.

In relation to the first criterion, pursuant to section 10(3) of the Legal Aid, Sentencing and Punishment of Offenders Act 2012 (LASPO), Article 2 of the ECHR may require legal aid to be granted for representation before the Coroners' Court where,

"The procedural obligation under Article 2 ECHR arises and, in the particular circumstances of the case, representation for the family of the deceased is required to discharge it."

So, a legal aid caseworker will have to be satisfied firstly that the procedural obligation has arisen in a case. In R (Humberstone) v Legal Services Commission [2010] EWCA Civ 1479 the Court held that: 
“...article 2 will be engaged in the much narrower range of cases where there is at least an arguable case that the state has been in breach of its substantive duty to protect life; in such cases the obligation is proactively to initiate a thorough investigation into the circumstances of the death.”(para 67)

In respect of "healthcare inquests" the guidance provides: 

"In the context of allegations against hospital authorities Humberstone  makes clear that there will not be a breach of the substantive obligation where a case involves only allegations of ordinary medical negligence as opposed to where the allegations of negligence are of a systemic nature. The judgment also emphasises the necessity for care to be taken to ensure that allegations of individual negligence are not dressed up as systemic failures."

This reflects the European Court's ruling in Powell-v-UK. I do not intend to question the substance of the Guidance in this post. It is sufficient to note that in the great majority of healthcare inquest cases, where the deceased was not a detained patient, the Chancellor's guidance will cause a caseworker to conclude that the procedural obligation does not arise. And even if the caseworker concludes that the obligation does arise, the Guidance provides that the caseworker should then additionally consider whether it is necessary for the family to have representation. The Guidance gives a definite steer. Whilst the dicta in the ECtHR of Jordan-v-UK are cited, the Guidance says:

"In most cases the coroner can conduct an effective investigation, with the family‟s participation, without the family of the deceased needing to be legally represented. In the case of Khan, the court found that:

“...the function of an inquest is inquisitorial, and in the overwhelming majority of cases the coroner can conduct an effective judicial investigation himself without there being any need for the family of the deceased to be represented...” (para 74., Khan v Secretary of State for Health [2003] EWCA Civ 1129)."

In fact, in Khan, the court having held the Inquest should be regarded as an article 2 Inquest, it held as follows in relation to the need for representation:
  1. If the public judicial investigation required by Article 2 is to be an effective one – and by "effective" we mean an investigation that satisfies the purposes described in paragraphs 40 to 43 of this judgment, reinforced as they are by the third principle we have derived from Lord Woolf's judgment in Amin (see para 67 above) – the inquest will not be an effective one unless Naazish's family can play an effective part in it. The evidence shows (see para 24 above) that they are in no fit state to play that part themselves. Although the function of an inquest is inquisitorial, and in the overwhelming majority of cases the coroner can conduct an effective judicial investigation himself without there being any need for the family of the deceased to be represented, every rule has its exceptions, and this, in our judgment, is an exceptional case. We note that the authors of the recent Report of a Fundamental Review into Death Certification and Investigation in England, Wales and Northern Ireland (Cm 5631) share our view, in Chapter 9 of their report, that in an exceptional case something more is needed.

  2. In particular, the evidence is so complex that the coroner has enlisted the services of an independent medical expert to assist him. The Trust and its doctors and nurses will have the benefit of legal representation at public expense, and the family are likely to wish to explore the prospects of a verdict of neglect and/or a report by the coroner pursuant to Rule 43 of the Coroners Rules. Mr Khan clearly could not manage this on his own.

  3. In the recent case of Sacker v HM Coroner for West Yorkshire [2003] EWCA 217 at [24] – [25]; [2003] Lloyds Med LR 326 Pill LJ expressed some scepticism about the suitability of a coroner's inquest, in its present form, as a vehicle for carrying out a state's obligations under Article 2. Those considerations may accentuate the need for an overdue improvement in the arrangements for inquests: it cannot in our judgment serve as a valid excuse for effectively excluding a family from participating in them in a case of this seriousness.

In my experience the relevant NHS Trust, or private healthcare provider will nearly always be represented at a healthcare inquest. Individual healthcare practitioners may also be separately represented. Even if there is no independent expert evidence, there is medical evidence from the pathologist and witnesses will be doctors, nurses and other healthcare professionals. There will nearly always be files of medical records. Thus, several of the concerns expressed in Khan about the unsuitability of families having no representation commonly apply.

Recently a spokesman explained the MOJ's reasoning for why bereaved families do not need representation at a medical Inquest:

"Lawyers are not usually required as the hearings are specifically designed so people without legal knowledge can easily participate and understand what is happening."

If so, why does the state provide legal representation for NHS Trusts? Why do the MDU and MPS provide legal representation for individual healthcare professionals? 

I have not found inquests to be informal.  The procedures and formality are not dissimilar to those in a civil court. An unrepresented family member has to manage their own emotions and deal with the emotions and distress of other family members. To expect them at the same time to master medical records, statements and reports about their loved-one's final hours and then to conduct questioning of medical or nursing witnesses on matters within those witnesses' professional expertise, in a courtroom setting, seems to me wholly unreasonable. In many cases it is a cruelty.

Coroners will of course ask questions themselves, and seek to guide the investigation. Many Coroners are very able and will go out of their way to assist bereaved families. But even the best may miss key issues if legal representatives are not available to scrutinise and challenge the evidence. In the case of Rabone-v-Pennine, the deceased was negligently allowed to leave hospital when it ought to have been know that her risk of suicide was too high. She took her own life the following day. The NHS Trust admitted negligence in later litigation but at the time of the inquest it had made no such admission and the only witness from the Trust the Coroner heard was the negligent psychiatrist who had made the decision to allow leave. The inquest lasted less than a day. The deceased's parents were unrepresented. Wider issues about the decision to allow leave were not explored. In later litigation which reached the Supreme Court, those issues were explored at length.

As the NHSLA recognises in its report for 2013/14, professional representation at an inquest can lead to an early resolution of litigation with considerable savings for the 

In my own experience there are now more healthcare inquests held than there were say fifteen years ago, and Coroners are more likely now to carry out a wider investigation into how the deceased died. Hence, as a generality, healthcare inquests have become more common and more complex than was once the case.

Yet, very few bereaved families are given public assistance at these important and difficult hearings.

In the most recent full year's statistics it is revealed that 200 applications were made for exceptional funding for Inquests and in 53 cases the application was granted.  These will include inquests concerning deaths of prisoners and others in custody. Indeed I expect that most of them will have been for prison deaths. I cannot find a statistic for the number of cases of exceptional funding granted for what I have referred to as healthcare inquests. I would be surprised to learn that it was for more than ten. Compare that with the NHSLA's support at over 500 Inquests in the last year.

I suspect that many taxpayers would wish their taxes to be spent more equally and equitably, affording bereaved families to have legal representation at healthcare inquests, at least in those cases where the NHS, or individual practitioners are represented. The inquest is at least as important to the family as it is to the healthcare provider or professional.

Under the present arrangements, bereaved families without public funding can pay for representation from their own funds (if any), or with the benefit of the charity of others or, in some cases, a lawyer will agree to act with a view to claiming the costs of their representation in a subsequent civil claim for compensation for death arising out of alleged clinical negligence. The civil claim will be funded on a 'no win no fee' basis. So if the Inquest reveals that there is no evidence to support a negligence claim, the lawyer will not be remunerated for their services at the inquest. If there is a subsequent successful civil claim then (some of) the costs of representation at the inquest may be recoverable as part of the costs of the civil claim.

However, there are several problems with reliance on this form of funding for representation at Inquests:

-  It is no guarantee of recovery of all costs of representation at the Inquest, even if those costs are reasonably incurred in terms of the the ambit of the Inquest. As the recent costs decision in Lynch shows.
-  It is not available for Inquests for which there is unlikely to be subsequent civil claim. This might be because there is no family member entitled to bring the claim, because the claim would be of no or little value and so the costs of representation would be disproportionate, or because there is unlikely ever to be sufficient evidence of both negligence and causation. I would argue that these are in fact the very cases where the Inquest may be particularly important, because it will be the only forum in which the circumstances of the unexpected death can be investigated.
-  If the potential defendant to the civil claim admits liability prior to the inquest then it is difficult to justify representation at the inquest as part of the conduct of the civil claim. Unfortunately it is not unknown for the NHSLA to make an admission of liability shortly before an inquest. Thus, at the eleventh hour, the family find that the representation they thought they would have is no longer available.
-  Why should lawyers provide their services on the "off chance" of a subsequent civil claim? Before the Inquest there may be considerable uncertainty as to how the evidence will emerge. Many lawyers are understandably not prepared to risk spending days or even weeks doing unpaid work when there may be alternative paid work avaialable. 
-  Perversely the system of "piggy-backing" the costs of inquest representation on subsequent civil claims encourages litigation, rather than promoting the resolution of claims without litigation.

I fully realise that as a lawyer who represents families at inquests this post could be interpreted as a plea out of self-interest. However it seems evident to me that there is injustice in an important aspect of our legal system and I choose to say so. 

Bereaved families should have available to them publicly funded legal representation at healthcare inquests. Other forms of funding are unsuitable for a non-adversarial state investigation. Inquests are very important proceedings for bereaved families whose loved-ones have died unexpectedly when under the care of healthcare providers. It is unreasonable, even cruel, to expect bereaved families to marshall evidence and conduct questioning about their loved- one's death in a court setting. The evidence at healthcare inquests is often detailed and technical. Other interested parties such as NHS trusts and individual doctors and nurses are very often professionally represented. In the case of NHS Trusts the state pays for legal representation. When that occurs, the state should also pay for representation of bereaved families.  To do so would be fair, merciful, and would likely serve to reduce costs of later litigation.