Tuesday, 17 March 2015

Shoulder Dystocia - New Findings

Obstetric Brachial Plexus Injury (OBPI), including Erb's Palsy, has been claimed to be caused by obstetricians or midwives applying excessive traction to the baby's head when trying to overcome a stuck shoulder (shoulder dystocia). Drills for overcoming shoulder dystocia without applying excessive traction forces to the head have been developed.

In Sardar-v-NHS Commissioning Board [2014] EWHC 38 (QB) Haddon-Cave J held that the severe (group 4) and permanent brachial plexus injury suffered by my client had been caused  not by traction forces but, prior to delivery of the head, by natural forces of labour. He identified those as being the large size of the baby and/or impact of the posterior shoulder on the sacral promontory and/or maternal contractions.

Initially the Defendant had accepted that the injured shoulder was anterior at birth but its case changed. There was a medical record which, if it was accurate, as the Court found it to be, allowed the Court to find that the injured shoulder was posterior at delivery. That was a crucial finding of fact and one which was fatal to our claim. The Judge was not persuaded by our argument that the severity of the injury was probative of it having been caused by traction rather than propulsion. We sought unsuccessfully to persuade the judge that there was little to no scientific or medical evidence that propulsive forces can cause such severe OBPI.

The Judge rejected the Claimant's argument that the severity of the OBPI (grade 4) was not consistent with a propulsive force, finding that "contractions can themselves be very powerful." [paragraph 80(8)].

In submissions I put to the Judge that there was very little evidence that severe, permanent OBPI can be caused by forces of propulsion. We called expert evidence that it was far more likely to be due to forces of traction and that the records of "difficulty delivering shoulder" and "shoulder dystocia" were also consistent with a traction injury. It appeared that there was only one recorded case of a severe and permanent brachial plexus injury having been caused by "natural forces of propulsion" and that case was not from any medical or scientific literature, but was a finding by Jack J in the case of Rashid-v-Essex Rivers NHS Healthcare Trust [2004] EWHC 1338 (QB). Following Sardar, there are now two such cases.

It does not follow from the mere fact that brachial plexus damage is caused by traction applied by an obstetrician or midwife at delivery, that there has been negligence. The recent case on consent - Montgomery-v-Lanarkshire (see my previous blog) is a reminder of the terrible consequences that can occur if delivery is not achieved promptly following shoulder dystocia. In that case the obstetrician the baby suffered from cerebral palsy having endured 12 minutes of hypoxia when shoulder dystocia prevented early delivery of the shoulders after delivery of the head. The accoucheur tried various techniques to deliver the baby and ultimately applied a lot of force to deliver the stuck shoulder. The baby did suffer from Erb's Palsy. Applying force sufficient to cause a brachial plexus injury may be the cost of delivering a child promptly  -  alive and, it would be hoped, without brain damage. However, the drills are designed to overcome shoulder without causing brachial plexus injury. They include the application of suprapubic pressure.

A new study published online on 17 February 2015 by the Royal College of Obstetricians and Gynaecologists by Crofts and others (the link is to an abstract only I am afraid), demonstrates the huge success of the adoption of an obstetric emergencies training programme - training in drills designed to avoid the application of excessive traction. In a study of births in Bristol where such training had been established, it was found that in a ten year period none of the 17,039 babies suffered permanent OBPI. Nor was the avoidance of permanent OBPI at the cost of an increased incidence of hypoxia or other birth injuries.

The following are my own thoughts about the implications of this study. I am sure that the experts will form their own views and, I hope, set them down in writing.

  • Most obviously the study shows that the use of proper obstetric emergency training is very effective in reducing the frequency and severity of OBPI. Indeed, as the authors conclude, the study "challenges the commonly held view that permanent injury is largely unavoidable. Permanent brachial plexus injuries must no longer be viewed as an inevitable complication of shoulder dystocia."

  • It seems to me that training to avoid excessive traction would not have any impact on the occurrence of severe, permanent OBPIs due to propulsive forces. Note then that during the ten years of the study there were no cases of severe OBPI at all, i.e. none due to propulsion or traction. Doesn't this study suggest that the occurrence of permanent OBPI due to propulsive forces (over which the accoucheur has no control) is extremely rare?

  • In Bennion-v-NE Wales NHS Trust (24 February 2009) HHJ Halbert concluded at para 7.7: "I am not satisfied on the evidence before me that any conclusion can be drawn as to whether the majority of [obstetric brachial plexus injuries] are probably caused by traction, probably caused by propulsion or probably caused by a combination of both." The new study would surely prevent another court from adopting the same position.

  • In Sardar, Haddon-Cave J concluded at [79], that "there is no longer any presumption that BPI is caused by excessive exogenous or iatrogenic (i.e. clinician applied) traction rather than excessive endogenous (i.e. uterine contraction and maternal expulsive forces) combined with impact with the sacral promontory. Accordingly the Claimant's argument ... that injury could only have been caused by the application of excessive force to deliver the baby's torso during delivery is untenable." This study might not establish that permanent OBPI due to natural forces of propulsion is impossible, but it may go some way to supporting the argument that propulsion is highly unlikely to cause permanent OBPI. 

In this post I have intended to focus on the causation of severe, permanent OBPI. The arguments may be different from temporary OBPI.

The courts have understood the science to be that permanent OBPI may be attributable either to the application of traction or to the natural forces of propulsion and that the fact of a permanent OBPI is not in itself probative of traction having been the causative force. I wonder whether the medical community will continue to support that understanding.

Perhaps the widespread dissemination of training in how to avoid excessive traction will be so successful in eliminating serious OBPI that it will avoid the need for the courts to consider such cases too many times in the future. That is something everyone can wish for.

Wednesday, 11 March 2015

Patient Autonomy Triumphs over Medical Paternalism

The Supreme Court has made a clear statement that the Bolam test is not applicable to issues of consent to medical treatment. A seven member decision in Montgomery-v-Lanarkshire Health Board [2015] UKSC 11 displaces previous authorities and is the new leading case on consent.

Perhaps the importance of the decision explains the length of time between the hearings (July 2014) and the judgment (11 March 2015) but there may be other reasons of which I am unaware.

Mrs Montgomery was of small stature and suffered from insulin dependent diabetes mellitus. Women suffering from diabetes are likely to have larger than normal babies. She underwent intensive monitoring during her pregnancy and was under the care of a Dr McLennan.

A particular risk was of shoulder dystocia which, should it occur, is a real obstetric emergency. Not only does it give rise to a risk of brachial plexus injury, but if the baby cannot be delivered promptly there is risk of serious oxygen deprivation, brain damage and even death of the child. The Supreme Court proceeded on evidence that there was about a 10% risk of shoulder dystocia occurring during the delivery of the child. Mrs Montgomery was not warned of that risk.

The leading judgment was given by Lord Kerr and Lord Reed, with whom four other Justice agreed, Lady Hale giving an additional but fully supportive judgment. Lord Kerr and Lord Reed noted at [13] :

"Unsurprisingly, Dr McLellan accepted that this was a high risk. But, despite the risk, she said that her practice was not to spend a lot of time, or indeed any time at all, discussing potential risks of shoulder dystocia. She explained that this was because, in her estimation, the risk of a grave problem for the baby resulting from shoulder dystocia was very small. She considered, therefore, that if the condition was mentioned, “most women will actually say, ‘I’d rather have a caesarean section’”. She went on to say that “if you were to mention shoulder dystocia to every [diabetic] patient, if you were to mention to any mother who faces labour that there is a very small risk of the baby dying in labour, then everyone would ask for a caesarean section, and it’s not in the maternal interests for women to have caesarean sections”."

Dr MacLennan accepted that Mrs Montgomery was concerned about the size of her baby but stated that she had never specifically asked about shoulder dystocia. The court noted that the risk of brachial plexus injury was 0.2% and the risk of prolonged hypoxia causing cerebral palsy or death was as low as 0.1%. There were also risks to the mother, including increased risk of post partum haemorrhage.

At delivery shoulder dystocia occurred and delivery took 12 minutes to accomplish (vividly described in the judgment) during which time the umbilical cord was wrapped around the baby's neck causing hypoxia and severe brain damage.

At first instance, and at first appeal, the courts rejected the claimant's claim on the basis - which was accepted by the Supreme Court - that a reasonable body of medical opinion would not have advised Mrs Montgomery of the risk of dystocia (and that it was not irrational to fail to do so). The lower courts considered that the case of Sidaway-v-Board of Governers ... [1985] AC 891 remained good law and that it determined that the Bolam test applied to the issue of consent - was Dr MacLennan's conduct in accordance with a reasonable or responsible body of medical opinion.

Lord Kerr and Lord Reed noted and analysed the range of opinion stated by their Lordships in Sidaway. There was no unanimity as to whether the Bolam test should apply, unqualified or at all, to the question of consent. The application of Bolam to consent was further questioned in Pearce-v-United Bristol Healthcare NHS Trust 1999 PIQR P53 and Chester-v-Afshar. 

In Pearce, a Court of Appeal decision, Lord Woolf MR said this:

“In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law, as indicated in the cases to which I have just referred, that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.”

This then appeared to displace the reasonable doctor test with a prudent patient test. But Sidaway was a House of Lords decision.

Any lack of clarity has now been resolved. Lord Kerr and Lord Reed noted comparative jurisprudence including the Australian case of Rogers in which the court had noted that a doctor should be alert to the particular concerns of a patient about certain risks, which might be different from the concerns of a hypothetical reasonable patient. Lord Kerr and Lord Reed observed that there had been many social or societal developments and changes even since Sidaway. He said at [81] that what social and legal developments

"... point towards is an approach to the law which, instead of treating patients as placing themselves in the hands of their doctors (and then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices."

And at [82] and [83]:

"82. In the law of negligence, this approach entails a duty on the part of doctors to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment. This can be understood, within the traditional framework of negligence, as a duty of care to avoid exposing a
person to a risk of injury which she would otherwise have avoided, but it is also the counterpart of the patient’s entitlement to decide whether or not to incur that risk. The existence of that entitlement, and the fact that its exercise does not depend exclusively on medical considerations, are important. They point to a fundamental distinction between, on the one hand, the doctor’s role when considering possible investigatory or treatment options and, on the other, her role in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury which may be involved.

"83. The former role is an exercise of professional skill and judgment: what risks of injury are involved in an operation, for example, is a matter falling within the expertise of members of the medical profession. But it is a non sequitur to conclude that the question whether a risk of injury, or the availability of an alternative form of treatment, ought to be discussed with the patient is also a matter of purely professional judgment. The doctor’s advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient’s entitlement to decide on the risks to her health which she is willing to run (a decision which may be influenced by non-medical considerations). Responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical professions."

And so at [87] Lord Kerr and Lord Reed set out the authoritative position on consent to medical treatment:

"The correct position, in relation to the risks of injury involved in treatment, can now be seen to be substantially that adopted in Sidaway by Lord Scarman, and by Lord Woolf MR in Pearce,  subject to the refinement made by the High Court of Australia in Rogers-v-Whitaker  which we have discussed at paras 77-73. An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it."

There is the therapeutic exception to this rule, namely that a doctor may withhold information from a patient if he considered it would be seriously detrimental to their health. Clearly that was not thought to apply in the present case (even though Dr MacLennan's view was that imparting information about risk of shoulder dystocia, and the possible complications from it, would lead all diabetic mothers to have Caesarean sections). Indeed Lord Kerr and Lord Reed warned that the therapeutic exception must not be abused.

They also noted that the assessment of risk could not be reduced to a question of percentages and, further, that the consent process involved a dialogue between doctor and patient.

The second part of the lead judgment concerns the issue of causation - an important issue but it was decided on its facts in the particular case. Of note, the Supreme Court were concerned to stress that the issue was not the risk of the complications of shoulder dystocia, but the risk of shoulder dystocia (about 10%) and of the various complications and procedures that SD might entail. 

The Supreme Court does seem to have regarded elective Caesarean section as having virtually no risk at all [91]. Perhaps this decision will lead, as Dr MacLennan thought likely, to Caesarean sections becoming the norm for diabetic mothers. If we live in a risk averse age - or at a time when we are still on the learner slopes when it comes to how best to weigh competing risks - then the removal of medical paternalism will be likely to affect the treatment choices patients make, perhaps leading to greater demand on NHS resources.

In reality, of course, it remains true that the manner in which a doctor gives information about risk can strongly influence what decision a patient makes. Many patients are content to be guided by their doctors. Other patients will have strong opinions about their treatment and will make decisions that their doctor thinks unwise. So be it - that is their right. Patient autonomy has to respected and that is now, unequivocally, the view of the Supreme Court.

On the other hand a patient does not have a right to demand that a doctor gives them whatever treatment they ask for. There are funding restrictions within the NHS and, in some cases, doctors may refuse to give treatment because they they believe that to do so would cause harm and would not be in the patient's best interests. Patient autonomy is not the same as a right to treatment on demand. Doctors have professional obligations.

The ramifications of this decision will require more reflection and consideration, but there can be no doubt that it is an important judgment that will affect clinical negligence litigation for years to come.

Monday, 2 March 2015

Court Fees Hike

Court fees are due to rise dramatically and, it seems, very soon.

There can be no doubt that this will make it much more difficult for people who have suffered avoidable serious injury due to clinical negligence to obtain access to justice.

Obviously claimants seeking compensation for injury, loss and damage, are more likely to be struggling financially. They may be unable to work. They may face bills for care and equipment. To find an additional £10,000 to exercise the "right"to bring a claim for compensation will be difficult. In some cases it will not be possible - justice denied.

If claimants are represented, should their lawyers pay the fees? I am not sure why that should be expected. Would your builder to pay all your planning and building regulations application fees himself? And what about the small and medium sized businesses so beloved of politicians. Suppose a law firm has 50 cases worth £200,000 or more in damages - where are they meant to obtain £0.5 million in court fees? How will they possibly manage their cash flow?

The idea may be that litigants or their lawyers should enter into complex financial/insurance arrangements to borrow money up front simply to pay fees for the court system to process their claims. But those arrangements do not come cost free nor risk free.

And what will you get for your £10,000? The court staff work very hard but many of them would be the first to admit that they are unable due to constraints to provide a Rolls Royce service. Stories are legion of papers not being put before the Judge, forms going missing, courts being double-booked. Litigants might start to demand more for their money. Or perhaps people will start to by-pass the court system altogether. It would be odd for the Ministry of Justice to want people to give up on the justice system.

Bringing a claim for substantial compensation is not really a choice in many cases. It is a necessity. I wonder what proportion of clinical negligence claims conclude with an award of compensation less than the amount offered to the claimant before proceedings were commenced? Very few I would have thought. In every case where a greater sum is recovered after issuing proceedings than was previously offered, it was reasonable and necessary to bring the proceedings and to incur the court fees.

If a claimant succeeds in the claim then they will recover the issue fee from the defendant. So the NHS will end up paying £millions more in costs. The NHS will be subsidising the Ministry of Justice. And we know who will get the blame for the rising cost to the NHS of litigation - yes, those greedy lawyers.