Blog
For anyone out there googling “misoprostol”, here are some interesting pieces of the evidence in the case which came to court recently. That case involved the use of Misoprostol to induce labour in a stillbirth. As a result, the claimant suffered catastrophic brain damage. The hospital, through the NHS Litigation Authority, admitted that the injury was caused by their negligence, but only at the very last minute, about three weeks before the case was due to come to court.
According to the obstetrician who was selected as the expert for the negligent hospital:
Question: Was it reasonable for NC to be given misoprostol?
Answer (given on the 5th November 2010): It was the practice in a number of units to use misoprostol when there was an intrauterlne death. My own unit used it then and still does now. It is more reliable at leading to birth of the baby within 24 hours of first administration than either gemeprost or prostin in my experience. Drugs are commonly used without licence in obstetrics, sometimes because they are cheaper, sometimes because they are more effective and misoprostol is both of these. In my view it was reasonable to use this drug”.
That defence expert appeared to approve the dosages used in this case, by saying: “The first dose of 800mcg is larger than commonly used but 400mcg is commonly used and 2 protocols of similar doses have been provided. …. Sadly this was a situation with a dead baby and the main concern is to encourage timely birth. Misoprostol is more effective in that regard than the other agents and it was a dose used by other units.”
Our expert, on the other hand, said:
“I repeat what I have said in my report, that the use of misoprostol to induce labour in Mrs C's case was unacceptable since there was an effective and safe licensed alternative available (Prostin), there was known to be an increase in the risk of uterine hyperstimulation, and associated adverse events including amniotic fluid embolism which had been highlighted by the manufacturing drug company, the Cochrane Collaboration had concluded that there were doubts about the safety of Misoprostol, and the national Guidelines formulated by NICE and the RCOG clearly stated that the use of Misoprostol should be restricted to randomised controlled trials.”
As to dosage:
“The first dose in this protocol is 16 to 32 times greater than would normally be used for induction of labour with misoprostol in protocols from clinical trials”.
Letter from manufacturers of the drug, 23rd August 2000
“Important drug warning concerning unapproved use of intra-vaginal or oral misoprostol in pregnant women for induction of labor or abortion
Dear Health Care Provider:
The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion. …. The uterotonic effect of Cytotec is an inherent property of prostaglandin El (PGE1), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.
Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.
Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established
Searle promotes the use of Cytotec only for its approved indication.
Michnel Cullen, MD
Medical Director, U.S.
Searle”
Manufacturers Guide 12th October 2004
“CYTOTEC (Misoprostol) may endanger pregnancy, and its effect on a developing human foetus is not known. Therefore, CYTOTEC should not be used in pregnant women. Women should be instructed not to become pregnant while taking CYTOTEC If a woman becomes pregnant while taking CYTOTEC, use of the product should be discontinued.”
National Institute for Clinical Excellence (NICE) Induction of Labour Clinical Guideline D, review January 2004:
“6. Future research recommendations
The following further research is recommended. ….
Evaluate the risks and benefits of vaginal/oral misoprostol for induction of labour using commercially produced tablets of appropriate dose.”
Royal College of Obstetricians and Gynaecologists, Induction of Labour, Evidence-based Clinical Guideline Number 9, June 2001:
“7 Vaginal or oral misoprostol (PGE1): research to date
7.1 Background
Misoprostol has been widely investigated as an agent for induction of labour. There are two current systematic reviews that focus on the use of both oral and vaginal misoprostol. According to the evidence currently available, misoprostol appears to be more effective than vaginal prostaglandins and oxytocin in the presence of ruptured membranes (either spontaneous or artificial) for induction of labour.
There are safety aspects of misoprostol that have not been fully evaluated and it is not currently licensed for obstetric use. Its use must therefore be restricted to RCTs (randomised control trials).”
National Collaborating Centre for Women’s and Children’s Health, Clinical Guideline, July 2008:
“At the time of publication (July 2008), misoprostol was not licensed for labour induction in fetal death in utero in the UK. Informed consent should therefore be obtained and documented.”
Seeing patients in hospital shortly after a catastrophic injury is always difficult, but usually worthwhile. There are so many stresses and strains on the patient and the family, and sometimes input from knowledgeable specialists can be helpful. If liability is straightforward, and insurers are prepared to be sensible and co-operative, there are many ways in which we can help the wider rehabilitation process. Getting out of hospital, getting home, getting back on track, are all important in the wider process, and delays and frustrations can be positively damaging.
A word of warning to anyone involved in the use of Misoprostol for the induction of labour. it is not licensed for that use in the UK, nor in America, because it may lead to catastrophic injury. Patients should, in my opinion, be given the choice to make an informed decision about whether to consent to its use. To obtain informed consent, the hospital would have to spell out the risk of catastrophic injury, coupled with the availability of a safe, but more expensive, alternative.
I finished a liability case last week which was one of the worst defended I have seen for years. It was listed for trial at the end of this month, and we had a settlement meeting in November. The defence team tried to persuade us that they genuinely thought that they were likely to win the liability issue (it was all or nothing, win or lose), and they offered 25%. We felt that we were highly likely to win, and offered to accept 95%. They responded with 35%, telling us that that was the limit of their authority. It’s unusual for grown up litigators in catastrophic personal injury claims to be so different in their assessments of risk, which alerted us to the possibility that we were just being tested.
That was the end of the settlement meeting, and following a consultation with our expert we decided that this was a case we would like to fight. Two months later, the defence solicitor wrote: “We are disappointed that efforts made on our part to resolve this matter on a basis which in our view accurately reflects the risks to both parties in continuing with the litigation has been rejected. We note that no offer has been put forward by your side with regard to the split in liability. We feel that this is a true 50% risk case for both parties. In a further attempt to settle this matter short of trial we are now instructed to put forward a Part 36 offer to settle in a gross sum of £1,500,000. This represents a serious and realistic attempt to resolve this matter and we trust it will be given serious consideration.”
Note the tone of righteous indignation, coupled with the suggestion that we were to blame. We rejected that offer, and made no counter offers, because we believed that we were bound to win the trial. About six weeks later, the defendant offered 85%, followed by 95%, both rejected, leading to 100%, three weeks before trial.
Some observers may think what jolly good fun that is, but there is a catastrophically brain damaged woman lying at home, looked after by her husband and children, in poor conditions. There was huge pressure on the husband, who had to rely on our assurance that we would win the case – remembering that it was all or nothing, and that nothing would doom his wife to a very limited life.
The defendant was a government department, the one which shouts loudest about how they’re being screwed by claimants. I cannot conceive of any responsible explanation for that pattern of negotiation. How can they have thought that they were likely to win, and then decided that they were bound to lose? It’s not only that it wastes money, but far more importantly it is not, in my opinion, reputable for this type of defendant to play negotiating games in the hope of bullying the claimant into submission. I think they should all be ashamed of themselves.
A friend asked me recently whether judges ever express disapproval of the levels of damages for pain, suffering and loss of amenity. My impression is that they never do, in the type of work I do (catastrophic brain and spine); for example, Mrs Justice Swift gave an excellent and detailed judgment in Whiten recently, and decided on a figure for pain and suffering, but did not comment on its inadequacy.
Because we are “guided” by the JSB (why should we be, I wonder), I see no realistic prospect of general damages for pain, suffering and loss of amenity increasing dramatically.
However, the question made me think of an article I wrote over 10 years ago, pointing out that, if we applied the multiplier and multiplicand system, the annual figure for catastrophic injuries would look ridiculous.
It still does. I’ve taken a few of the recent cases on my site, and one example is £1,500 a year for a severe brain injury which has prevented a young woman from working for life, and made her dependent on lifetime support.
Maybe if we all made a point of doing that calculation it would highlight just how mean our system is.
This is a quick plea for those involved in claimant personal injury litigation to consider paper management. Over the years I’ve been in silk (20), the volume of paper has increased enormously. I’ve been paperless for about five years, and I find it very easy to manage the paperwork that way. The plea here is for solicitors, particularly, to consider saving the paperwork electronically, and then providing it to all those who need it by storing it on a secure site, and allowing access to relevant people. I know a couple of solicitors who do it, and I think it’s great!
I've just finished reading several articles on the Legal Services Act, and the impact and opportunities for UK lawyers (the opportunities for outside investment and management). I agree that we need to run our businesses efficiently, and my own Chambers have been managed progressively, in a corporate way, for at least 20 years.
I do feel strongly though that, in the claimant personal injury world, we need to keep a firm hold on the reasoning behind what we do. We’re here to serve our clients to the best of our ability; to make sure that our ability is up to the job; and to make quite sure that our business interests, or our own profit, do not get in the way.
Our Chambers approach is that, although we are running an efficient and effective business, it a business with the sole aim of providing professional services, professionally, and with the client’s best interests at the heart.
Since a recent case (Kotula), provisional damages for syringomyelia have been on our minds rather more, and I think that we’re pursuing them rather more than previously.
That raised a question for me recently; what happens if a syrinx does develop in a way which has a financially significant, adverse, effect on the claimant? On the face of it, if the syringomyelia causes, for example, an increased need for care, the claimant is entitled to apply for further damages to reflect the extra cost. So far, so good.
But what if the syringomyelia reduces the claimant’s life expectancy, so that, if his damages were re-assessed in the light of the syrinx, they would be reduced?
I think the answer is that the wording of section 32A of the Supreme Court Act 1981 allows the court to award further damages if it thinks fit. In other words, it has discretion whether to increase the existing figure, but not to reduce it.
So often, I wish I had been called in earlier. It seems to me that the first year following catastrophic injury is the time when patients and families need as much support as is possible, and as little intrusion and upset from the court case as is achievable.
To achieve the support, and reduce the intrusion, usually depends on a combination of skills, and the smooth operation of a knowledgeable team. I think that the team should be created early on, possibly whilst the patient is still in hospital. After all, one of the most upsetting problems must be the move from hospital to home; particularly because many pre-accident homes are not suitable for the injured person.
Another area of concern to me is that, sometimes, insurance companies seem to take advantage of the injured person, for example by not dealing with the question of blame for the accident (liability), or by delaying rehabilitation. Usually, the core of the problem is that they will not provide interim payments (ie payments early on, before the case is finalised) unless forced to by the court. That can and does create untold distress for those affected by a catastrophic injury.
I had a discussion recently which emphasised, to me, the fact that it is easier and cheaper to look after a catastrophically injured person if they don’t do much. The young man who sits at home, watching TV and playing computer games in his bedroom, is far easier for the support workers than the person who wants to go out, but can be difficult to manage in the community.
Not surprisingly, perhaps, it can be tempting for support workers to allow or encourage the patient to stay at home, and to paint a rosy picture of how well life is going.
In addition, there is a bit of a debate about the injured person’s right to make his or her own decisions about what they want to do with life. If you ask the person does he or she want to go out, you may well be met with a refusal; either because of lack of motivation, or for any one of a number of other reasons caused by brain injury. It can be argued, though, that the individual has the right to make that decision. If so, it can lead to a desolate life of no real quality.
Of course every injured person is different, as are their families, so there is no rule to cover all. I would say, though, that most of the people I see would or do benefit from community activity, and enjoy it when it is well managed, and arranged so that they can see and feel the benefits. That could involve making decisions for them, so that they don’t just vegetate at home.
I had an experience recently which reminded me of the importance of selecting experts. I’ve been lecturing and writing on this topic for nearly 20 years, and the theme is always that careful selection of good experts (including barristers) wins cases. There is nothing more confidence-inspiring than attending a mediation or settlement meeting, knowing that you have got the best, and the other side are struggling with their experts. A judge described a barrister’s submissions as “wholly unrealistic” recently, and another judge said about an expert that “her primary strength …. was that she spoke clearly and extremely loudly.”
All good personal injury lawyers keep records of experts, but the real question is always, in my opinion, track record. Of course I would say that, having done what I do for 20 years, but I really do think it’s what marks the best out from the rest. If an expert has been around for some time, there should have been opportunities to see his or her reports, to see him or her in consultation, and ideally (though less so nowadays) giving evidence at trial.
Basically, we really do (or should) want to know whether our expert is right. I had a consultation some time ago, with an expert I haven’t used for ten years, in which it was clear that the expert had no confidence in the report which had been written.
If your expert has a proven, good track record, you are well on the way to success.
I wrote an article (see Publications, Articles) for the British Association of Brain Injury Case Managers last year, to celebrate their 15th anniversary. I said that “good case managers can and do have the ability to resolve all sorts of problems”.
Last week, I enjoyed hearing the claimant’s mother telling me that the case manager is very good, and is indeed sorting out all the problems. It was obvious that the case management input had been, and was continuing to be, really valuable, and also supportive to the parents.
In almost all catastrophic injury claims I think that one of the most important steps is to find a good case manager. It doesn’t always work first time round, because the family need to find someone they can get to like, and trust, and they need to see real value. Usually, though, they do eventually find a suitable person, and the patient’s quality of life is improved.
A colleague asked me a question the other day which made me think about the use of a claimant’s medical records.
I have always taken the view that we should not let outsiders, including defendants, trawl through a claimant’s medical records willy nilly. They sometimes include private matters which can have no bearing on the claim, and these should not be disclosed.
However, this colleague’s question raised a different issue. The claimant and the defendant both had satisfactory medical reports from the same medical specialty, but the defendant decided that it would like to instruct an expert from an alternative area of medical expertise. The claimant refused permission, but the defendant instructed a fresh expert to do a desk top report (for which the medical records were presumably necessary).
As a general rule, in major personal injury claims, each side tends to agree that they will instruct their own experts, and that they can do so in whatever reasonable specialty seems appropriate. As a claimant adviser, I always say that we should do so, provided we are being reasonable, whatever the defendant or the court may think.
Here, the defendant has done precisely that, and in the ordinary course of events I would not complain. However, it could be argued that permission to disclose the medical records was refused, by the refusal to agree to a new specialty.
Claimants might want to make sure that their medical records are not disclosed without clear permission. That could make life difficult for defendants to have desk top reports prepared without permission.
The Lord Chancellor is currently reviewing the “discount rate” which is used for the calculation of future loss and expense in England and Wales. We are all waiting eagerly for the result of his consultation process, but there has been another development running at the same time.
Jonathan Sumption QC, now Lord Sumption a judge of the Supreme Court, decided in Guernsey that the discount rate should not be 2.5%, but instead that the correct discount rate to apply was MINUS 1.5 per cent for earnings-related losses, and 0.5 per cent for the non-earnings-related elements of his future losses. That was a potential revolution, because the argument in England and Wales is that, if you look carefully at the financial climate, as was done by Lord Sumption, you would decide that the current statutory discount rate should not be 2.5%, but should be significantly less.
The Defendant appealed to the Privy Council, and the appeal was rejected last week. That does not mean that the English discount rate will automatically come under attack, nor does it mean that the Lord Chancellor will have to reduce the rate. It does mean though, that a Supreme Court judge has grasped the issue, and come to the conclusion that, in Guernsey, the rate is not appropriate at the present time.
Monday 5, March 2012
I cannot remember ever having heard such a stupid point from a defendant
We hear much nowadays about co-operation and respect between claimants and defendants, and how each side should respect the other; we have been hearing that message since Lord Woolf’s reforms in 1999. I have always been sceptical, because my experience has shown that insurers frequently do not engage in a genuine fashion with such dialogue. Over the past few years, I think that there has been some genuine change of attitude (on both sides?), but I heard a story today, in relation to one of my cases, that made my hair curl!
The Claimant was an innocent pillion passenger on a motor bike which collided with a bus. The rider was convicted of careless driving. The Claimant’s solicitor asked the solicitors of the motorcycle rider to admit liability, so that they could enter judgment. That request was refused. An application was made for summary judgment, citing the careless driving conviction as support for the allegation of negligence. The defence solicitor responded by arguing that, because the Defendant had pleaded guilty, there was no “conviction”, and therefore there was no support for the allegation of negligence.
I really cannot remember ever having heard such a stupid point being taken. It is worth remembering that the Claimant sustained very severe brain damage, so that this is a major claim. Defendants really shouldn’t be allowed to take ridiculous points like this, and not be punished for their stupidity and lack of understanding.
Sunday 4, March 2012
Credit to excellent defence QC
I had a settlement meeting last week which was particularly enjoyable. Part of the reason was that the defence QC is very good, which makes our lives easier. It is so much better if you can have a sensible and realistic discussion about the strengths and weaknesses of each side; by doing that you can evaluate risks, and balance them against the benefits. Also, the case was well prepared, so that we had a good idea of the claimant’s need. The end result is another case finalised, and another judge avoided!
Thursday 1, March 2012
Problem with periodical payments in public liability insurance cases?
I was told today, by Ian Gunn of PFP, the financial advisers, that there may be a problem with the security of periodical payments in public liability insurance cases. The answer to this problem isn’t clear yet, but we need to keep our eyes wide open until it is.
Thursday 23, February 2012
Mental capacity cases and why they are getting more difficult
I’ve seen hundreds of traumatic brain injury cases where mental capacity is a relevant issue, spread over 20 years, but my impression is that they are getting potentially more difficult.
Where there is a real dispute about whether a patient has capacity, the starting point is the Mental Capacity Act of 2005. Although it did not really change the law in this area, it did emphasise various fundamental principles which should guide claimants’ lawyers.
We represent the claimant, and we have a duty to pursue that person’s instructions and best interests, and to do so against the fundamentally important background that he or she has the right to manage his or her own affairs unless and until there is good, reliable evidence that this right should be taken away.
More and more over the last few years, I have had the feeling that we (lawyers and doctors) should explore the patient’s thought processes in more detail than we do. Careful and thorough questioning is likely to be useful, but not if it is conducted as some sort of general knowledge question eg “what is inflation” (a question I have seen relied on by a doctor).
In addition, the evidence needs to be scrutinised for reliability; sometimes it is not as straightforward as it seems. This is an area where lawyers may have to inform doctors, because the latter may not be quite as restrictive about what amounts to reliable evidence.
If you’re interested in the legal detail of the capacity issue, and the Mental Capacity Act, it’s all set out in my book.
Thursday 16, February 2012
£4.2 million settlement today - a good example of mediation working well
I did another mediation today – me representing the claimant, not being the mediator. I'm very keen on the development of mediation in personal injury litigation, and this case was a good example of it working well. It finished in four hours, not that anyone felt in any way hurried, and both sides felt that they had been able to put their points forward in a way which was palatable to the other. The end result was a combined lump sum and periodical payments agreement, capitalised at about £4.2 million.
It has been very difficult for the claimant’s mother to manage the effects of the injury on him. He sustained a very severe brain injury, which has made his management during the time he has been growing up, to be problematic. With help from family and friends, and with the support of her solicitor, mother managed to survive, and will hopefully now find that life will settle to some extent. She will be able to buy a house for her son, in an area where he will not be too vulnerable, and the periodical payments will give him a very satisfactory support package.
I wish them all the very best.
Tuesday 14, February 2012
Getting patients home
Getting patients home from hospital or an institution such as a care home is often a major aspect of what good personal injury lawyers do. It is not always easy, because the case of Eeles in 2009 restricted the court’s ability to order a defendant to make a large interim payment for the purpose of buying suitable accommodation. That case has not made it impossible, but it certainly has encouraged claimant lawyers to try to solve the problem in other ways.
Renting a suitable house is a real possibility. A suitable one can sometimes be identified, and it may need only limited adaptation. It might prove to be an expensive solution for the insurer, in the sense that, when the case is finalised, it may be costed on the basis that the claimant will buy his or her own house as soon as possible, restoring the rented one to its pre-adapted state (at a significant cost).
As always, claimants should look for a genuine, fair, reasonable solution, but it must be one that suits them and helps the claimant to achieve good quality of life.
Monday 6, February 2012
Case has left me with warm glow of satisfaction
I’ve just finalised a case which has left me with a warm glow of satisfaction!
I first met the claimant nearly four years ago, when he had been paralysed for a year. He was still going through the recovery and adaptation process, and had not re-engaged with life. The defendant, perfectly sensibly from their point of view, wanted an early settlement meeting, which we had, but because the future was uncertain we did not reach an agreement.
We encouraged the claimant to try to do whatever he felt was suitable in order to create a good quality of life in his new circumstances, and he gradually did just that. He bought a bungalow, started to arrange a good support package, and got out more. All of that gradually created a completely different state of mind, and a different approach to life, so that, when we had our second settlement meeting, we knew moderately well where he wanted to go with the future.
That meant that we could present his case with more confidence at that second meeting, and present it in such a way that the very sympathetic and sensible defence team could see that it was reasonable. We accordingly settled the claim at a figure which both sides felt was compromised but sensible.
It really is essential for claimants’ lawyers to do more than just prepare the case. We should always have a view about when and how we want to finalise the claim, and we need a good route map to take us there.
Incidentally, we did it all without any useful input from the court.
Monday 6, February 2012
Settlement meetings and the true needs of the claimant
Another enjoyable week!
The highlights have been two settlement meetings, one in the south, the other in the north.
They both highlighted how important it is to have a clear, reasoned view, preferably before the meeting, of the true needs of the claimant. The reason it is so important is that, for a settlement meeting to be successful, each side has to compromise. Before we advise the claimant to do so, we need to have good reasons to move away from our expert evidence, if that is what we are suggesting when discussing compromise.
Of course the easy way to explore experts’ views is to arrange a consultation with all the major ones present, so that views can be discussed and explored. That has a number of difficulties, though. First, it is a nightmare to arrange. Secondly, it may send the wrong message to the claimant, who almost certainly needs to be present, if everyone talks about how to reduce the claim, at the same time as they are supposed to be preparing it.
As a general guide, I think that we should gradually learn from the claimant and his or her family what the life plan is, during the preparation phase of the case, and then, when the settlement meeting is arranged, make sure that we have a suitable consultation with claimant and experts beforehand.
I know it sounds obvious, but it is not always done.
Monday 30, January 2012
Consultations - genuine co-operation still not universal
I've had four consultations this week, seeing patients who have suffered extremely severe brain injury. They raise an area of real interest to me, apart from all the important detail of the individual patient, which is the scope for genuine co-operation with the defence. Of the four cases, one seems to be heading towards genuine co-operation, one seems to be well-established in the traditional adversarial system, and the other two are somewhere in the middle.
I think it will take a long time before we reach a situation in catastrophic claims where both sides are sufficiently confident to discuss all issues of treatment and rehabilitation together, secure in the knowledge that, if co-operation doesn't work, no harm has been done, and they can revert to the old fashioned system.
I know I would say this, but advocates who have seen scores or hundreds of catastrophic cases are, perhaps, more likely to be comfortable in this area of innovation and progression.
Monday 23, January 2012
An apparently respectable expert’s opinion fails to withstand the scrutiny of a true expert in a specialised field
I had a good example today of an apparently respectable expert’s opinion failing to withstand the scrutiny of a true expert in a specialised field. The expert is one I come across moderately frequently, always instructed by the defence (I never advise his instruction for claimants). He asserted that the disabling condition suffered by the claimant was not caused by the accident, but was completely coincidental. It may not sound a very impressive suggestion but, when put forward by a senior clinician, it might well un-nerve claimant lawyers to the extent of reducing the value of the claim in order to take account of the risk that the expert might just be right. Of course, the best course is to find a true expert, which is what we did. He rubbished the defence doctor’s opinion, using phrases such as “In my opinion this statement is untenable, and flies in the face of all the clinical and imaging evidence.”
Interestingly, in the same case, one of our lead clinicians commented that the defence care report seems to be “rather cursory - There seems to be a gross underestimation of his disabilities and handicap.”
