Dr KK Aggarwal
Recipient of Padma Shri
Vice President CMAAO
The practice of medicine has evolved from ‘paternalism’ to ‘patient-centered care’ typified by shared decision making.
Two recent judgements, the Montgomery case and Dr Bawa-Garba case, both in the UK, reflect this changing trend in the doctor-patient relationship. These cases, which have become landmark cases, will shape the practice of medicine in UK, but their repercussions will be felt in Asian countries too including India.
Montgomery v Lanarkshire Health Board 2015
Nadine Montgomery, a molecular biologist at Glasgow University, gave birth to a baby boy in October 1999 at Lanarkshire. Hers was a high risk pregnancy that required intensive monitoring owing to the fact that she was small statured and had insulin dependent diabetes mellitus. A baby born to a mother with diabetes is likely to be large for gestational age. Shoulder dystocia is a major concern in such cases as it increases dangers not only to the mother, but also to the baby.
Despite her concern about the size of the baby, she was not told about the risks of her experiencing mechanical problems during labour, particularly about the risk of shoulder dystocia or that an elective caesarean section was a possible alternative to vaginal delivery.
It took about 12 minutes for the baby to be delivered from the time the baby’s head appeared. As a result of complications during the delivery, her baby was born with severe disabilities. After his birth, he was diagnosed as suffering from cerebral palsy due to hypoxic damage to the brain due to umbilical cord occlusion. All four of his limbs were affected by the cerebral palsy. He also suffered a brachial plexus injury resulting in Erb’s palsy.
She claimed damages on behalf of her son for the injuries which he sustained alleging negligence on the part of her obstetrician and gynaecologist responsible for her care during her pregnancy and labour, who also delivered the baby.
In its final judgement, the UK Supreme Court said, “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.”
On the issue of disclosure of risks, the Court ruled that “there can be no doubt that it was incumbent on Dr McLellan to advise Mrs Montgomery of the risk of shoulder dystocia if she were to have her baby by vaginal delivery, and to discuss with her the alternative of delivery by caesarean section. The risk of shoulder dystocia was substantial around 9-10%. Applying the approach which we have described, the exercise of reasonable care undoubtedly required that it should be disclosed. Shoulder dystocia is itself a major obstetric emergency, requiring procedures which may be traumatic for the mother, and involving significant risks to her health.”
It was argued on behalf of the doctor that her decision to withhold information about the risk of shoulder dystocia from her patients was because they would otherwise request caesarean sections. And the risk of serious injury in this case was small; 0.2% risk of a brachial plexus injury and less than 0.1% risk of cord occlusion.
But, the Supreme Court ruled that Mrs Montgomery should have been informed of the risk of shoulder dystocia and given the option of a caesarean section The question to be addressed, according to the Supreme Court, was Mrs Montgomery’s likely reaction if told of the risk of shoulder dystocia.
And, it was the unequivocal view that Mrs Montgomery would have elected to have a caesarean section if she had been told of the risk of shoulder dystocia. Mrs Montgomery was awarded £5.25 million in damages.
The case of Montgomery v Lanarkshire Health Board from Scotland in 2015 was a landmark judgement of the UK Supreme Court on informed consent reflecting the changing nature of the doctor- patient relationship. This judgement negated ‘paternalism’, even though well-intentioned, and made the patient an active partner in decision making regarding treatment. Subsequent to this judgement, in a marked change from the past practice, ‘Bolam test’ will not be applicable to the issue of ‘consent’ or ‘provision of information to the patient’ in any case of alleged negligence in UK. Although the complainant must still prove causation, that the injury was a direct result of breach of duty.
Bolam test has been used to assess the standard of care when deciding cases of medical negligence for the past several decades following the judgement in Bolam v Friern Hospital Management Committee in 1957. It is the “standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill, it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising' that art (a health care professional), is not guilty of negligence if he has 'acted in accordance with a practice accepted as proper by a responsible body of medical man skilled in the particular act”.
In Bolam test, the adequacy of information disclosed to the patient for a valid consent must be in accordance with the practice accepted at that time as considered proper by a responsible body of medical opinion. Bolam v Friern Hospital Management Committee upheld the doctor’s right to withhold information about the dangers or risks, if he believes that the particular treatment is the only hope for a cure for the patient.
In the Montgomery case, the Supreme Court ruled that the doctor has a duty “to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments”.
Material risk is defined as a risk which a reasonable person would consider significant or a risk which a doctor knows (or should reasonably know) that the patient would consider it to be significant.
This judgement also has implications for the therapeutic privilege exercised by the doctor, where the doctor is privileged to use his/her judgement to decide if the patient would be hurt by the disclosure and if so, to then withhold the information.
On the duty of doctors for disclosure of information in order to get consent for the treatment, the Supreme Court in Montgomery v Lanarkshire Health Board ruled that “the “therapeutic exception” is not intended to enable doctors to prevent their patients from taking an informed decision. Rather, it is the doctor’s responsibility to explain to her patient why she considers that one of the available treatment options is medically preferable to the others, having taken care to ensure that her patient is aware of the considerations for and against each of them.”
Dr Bawa Garba v GMC
Another recent judgement in the case of Dr Hadiza Bawa-Garba, which convicted her of manslaughter by gross negligence and gave a two-year suspended sentence for mistakes which led to the death of a six-year-old boy with Down’s syndrome. Her name was erased from the medical register and she was debarred from practicing medicine for life for system failures on an appeal from the GMC, who did this to protect public trust.
Apparently the time has come to practice totally defensive practice. Always write on case sheets about system deficiencies.
Were the mistakes in famous Dr Bawa Garba Case real enough to be called as manslaughter? Here is a rundown of the mistakes alleged to have been made by her in handling this case.
Wrong working diagnosis: Missing diagnosis of sepsis
At 10:30 am, Dr Bawa-Garba assessed Jack Adcock, a 6-year old boy with Down syndrome who was referred by the general practitioner (GP) for nausea, vomiting, and diarrhea and low BP. It is not wrong to treat on the lines of hypovolemia.
She made a presumptive diagnosis of fluid depletion from gastroenteritis and administered an intravenous fluid bolus immediately and started him on maintenance fluids. She requested a chest radiograph; sent off bloods for blood count, renal function, and inflammatory markers; and drew blood gases, which showed that Jack was acidotic with a pH of 7 and a lactate
The metabolic profile confirmed her working diagnosis of shock from gastroenteritis; but, judging from the tests she ordered, pneumonia was in her differential. After the initial fluid bolus, Jack seemed to be trending in the right direction, metabolically. The repeat blood gas showed he was less acidotic, with a pH of 7.24, heading towards a normal pH of 7.4.
Most of us would do the same.
Delay in getting and reading chest x-ray
Fact: At 3 pm, she looked at the chest x-ray, which showed Jack had pneumonia. She prescribed antibiotics, which were given at 4 pm. The radiograph had been exposed at 12:30 pm.
Radiographs are not routinely interpreted by radiologists; there aren't enough radiologists in the NHS.
In most busy hospitals this would be a routine.
Delay in starting antibiotic
Argument: Had Jack received antibiotics within 30 minutes, rather than 6 hours, his chances of survival would have increased dramatically.
Fact: Antibiotic was given the time pneumonia was confirmed.
Won’t starting antibiotics in every case presenting in such situation may amount to misusing the antibiotics?
Also missing sepsis cannot be called manslaughter; at the most it can be an error.
Not calling her senior
Fact: At 4:30 pm, she met Dr O'Riordan, her boss, in the hospital corridor. She showed him Jack's blood gas results and explained her plan of action. Her boss did not see Jack.
When asked why he did not see Jack, Dr O'Riordan said that Dr Bawa-Garba had not asked him to; she had not impressed upon him Jack's clinical urgency.
Was the onus not on the consultant to sniff out trouble?
Was it not the fault of the seniors?
Guilty of homicide for mistaking normalizing pH after a fluid bolus for hypovolemic rather than septic shock
Facts: The jury heard about Jack's delayed treatment. But they did not hear about the other patients who were receiving care in the same hospital from Dr Bawa-Garba.
Jack's blood gases were deemed characteristic of sepsis. If they were so characteristic, why did Dr O'Riordan, the peripatetic consultant of the day and Dr Bawa-Garba's supervisor, not instantly diagnose sepsis when he saw the blood gases?
If a resident, who was doing the work of three registrars, can be found guilty of homicide for not understanding acid-base physiology, what does it say about the competence of her supervisor?
Failing to prevent enalapril being given
In the ward, Jack received enalapril. Dr Bawa-Garba had not prescribed enalapril, and she clearly stated in her plan that enalapril must be stopped. Nor was enalapril given by the nursing staff—they stick to the doctor's orders. An hour after receiving enalapril, Jack had a cardiac arrest.
Fact: The drug was given by the mother and the allegation was that the team did not tell the family not to give any drug outside the hospital practice. Is it not the law?
If UK practices differently and allows the parents to give the medicine because of short staff, can this be a blunder on the part of the doctor.
After vigorous attempts at resuscitation, interrupted for a minute by Dr Bawa-Garba mistaking Jack for another child who was not for resuscitation, Jack was pronounced dead.
Fact: The interruption for only for less than a minute and could not have been the cause of failed CPR.
Writing honestly in e-process log
She was honest and wrote her feelings in the e-process log which was later used against her as evidence.
After Jack's death, Dr Bawa-Garba was distraught, and her consultant encouraged her to record her failings in her electronic portfolio. Trainees are encouraged to record their mistakes. She could have, if she wanted, written about the system failures of that day. But that would have been making excuses, and you don't stick around in a field like pediatrics if you're the sort who points fingers at others. But was this not her mistake?
The most merciless expert witness was none other than Dr Bawa-Garba herself. Her electronic portfolio became her confession. She erred because she had confessed to erring.
Was it a doctor’s failure?
The trust led an internal inquiry that identified several system issues that contributed to Jack's death. Medical errors can be caused by system issues and physician factors. The American patient safety movement has taken the high road and placed the blame for medical errors on systems. The Tort system targets both individuals and systems. The truth is that both can contribute.
Not raising an alarm on inadequate staff and system failures
Dr Bawa-Garba's supervisor, Dr O'Riordan, was not in the hospital but teaching in a nearby city.
Dr Bawa-Garba's colleagues (i.e., other registrars) were also away on educational leave. Normally, a registrar each is assigned to cover the wards, the emergency department, and the Children's Assessment Unit (CAU).
On that day, Dr Bawa-Garba covered all three. She was new to the hospital but with no formal induction (i.e., no explanation where things are and how stuff gets done in the hospital). She was expected to get along with the call and find her way around the hospital.
Registrars are the principle decision-makers in hospitals; they function as both a senior resident and an attending.
Shouldn’t she have raised an alarm and wrote about the deficiencies in the system? Will the seniors and the management have allowed that?
Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA