A Coronial inquiry into the death of Sheila Drysdale following a stem cell procedure concluded that there was no scientific evidence that the procedure would have eased her symptoms of dementia, and that Mrs Drysdale was not properly prepared for the procedure, nor properly cared for following the procedure.
Mrs Sheila Drysdale was a 75 year old married woman with three children who had been diagnosed with Frontal Lobe Dementia, altering her personality and requiring her to reside in a nursing home. Mrs Drysdale’s husband contacted Dr Bright (a practitioner at Macquarie Stem Cells) and arranged for his wife to undergo stem cell therapy after reading online that it may assist to treat dementia patients. The procedure involved removing fat from Mrs Drysdale’s thighs and buttocks, extracting stem cells and then re-infusing the cells into her body through an intravenous drip.
On 20 December 2013 at about 9:40am, Dr Bright performed the procedure. Mrs Drysdale was slow to wake up and her post-operative notes state she fainted whilst standing. During recovery, her heart rate was as slow as 42 beats per minute. Dr Bright administered one litre of Hartman’s solution (replacing lost body fluids and mineral salts) and fitted Mrs Drysdale with compression stockings. At 2:30pm that afternoon, Mrs Drysdale’s blood pressure was 126/78 and her heart rate 52 BPM. To combat the effects of her sedation, Dr Bright administered 500mg of Anexate, after which Mrs Drysdale became more alert. She was discharged between 5:00pm - 5:30pm. Dr Bright called the nursing home and spoke with a Registered Nurse (RN) informing her that Mrs Drysdale should go straight to bed. Her vital signs were not recorded by Dr Bright on discharge.
Whilst driving Mrs Drysdale back to the nursing home, Mr Drysdale spoke with the RN to ask if he should take Mrs Drysdale to the hospital. He was informed that she should travel to the nursing home first. Mrs Drysdale arrived at around 6:30pm. The RN observed that the pads over the liposuction incision were wet, but not soaked through. Mrs Drysdale’s blood pressure was 96/59 and her heart rate 86 beats per minute. At about 7:15pm, the RN again took Mrs Drysdale’s vitals - her blood pressure was 106/60 and her heart rate had risen to 90. Dr Bright was consulted and asked whether Mrs Drysdale ought to go to hospital. Dr Bright indicated it was unnecessary as her blood pressure had improved. Half an hour later, Mrs Drysdale was discovered unconscious and without a pulse. The post mortem examination revealed that Mrs Drysdale had extensive bruising on her buttocks and a subcutaneous haemorrhage.
The Coroner noted a number of errors before, during and after the procedure which led to Mrs Drysdale’s death.
The Coroner found that Mrs Drysdale was not properly prepared for the procedure. Dr Bright stated he told Mr Drysdale that Mrs Drysdale should not take aspirin for four days prior to the procedure but Dr Bright failed to inquire as to whether or not this had occurred. The nursing home records showed that in the lead up to the procedure, Mrs Drysdale took all medications, including aspirin, as usual. The views of an expert who reviewed Mrs Drysdale’s death for the Coroner were that Mrs Drysdale should not have taken blood thinning medication, including aspirin, for 7-10 days before the procedure.
Dr Bright assumed that Mrs Drysdale’s low blood pressure during recovery was a normal reaction to the procedure and would gradually rise. Expert evidence suggested that a high pulse rate with decreased blood pressure was indicative of blood loss. Dr Bright also failed to observe that the pads over the wound were blood soaked, as were the sheets under her body, which were indicative of a haemorrhage. In the expert’s view, by 2:30pm Mrs Drysdale’s vitals should have indicated that she was unstable and by 5:30pm it should have been absolutely clear that she needed hospitalisation.
The Coroner was also critical of the fact that the nursing home’s RN had been trained to escalate a situation if a patient’s systolic blood pressure was below 100, commenting that this was an arbitrary line that does not necessarily relate closely to the individual patient’s normal baseline blood pressure. Both the RN and Mr Drysdale relied upon Dr Bright’s advice. Dr Bright gave insufficient weight to their concerns, given that they knew Mrs Drysdale and her pre-operative condition and he did not.
The Coroner also found that the risks of the procedure, including a fatal haemorrhage, had not been fully disclosed to Mr Drysdale who had given consent on behalf of his wife. The Coroner further commented that Dr Bright failed to conduct an assessment of what benefit Mrs Drysdale would get from the procedure. The Coroner was critical of the stem cell procedure more generally, noting it was unproven scientifically, had not been the subject of clinical trials in humans and had the hallmarks of “quack medicine.” The Coroner considered that the procedure “was unlikely to have been significantly beneficial to Sheila even if she had lived.”
This case raises important issues relating to informed consent for experimental treatments and the Coroner made a number of recommendations around this issue, including that:
• the issue of informed consent in relation to “experimental” surgical procedures or therapies be closely considered by the relevant authorities; and
• guidelines as to the proper content and warnings be issued by the Cosmetic Physicians College of Australasia.
It is also apparent that where multiple people are charged with a patient’s pre-operative care, procedures are necessary to manage the risk that information will not be passed on to relevant parties.
The Coroner recommended that Dr Bright’s clinic, Macquarie Stem Cells, develop a pre-operative preparation checklist to be given to patients, their carers and healthcare professionals before any procedures are carried out, along with an internal checklist to ensure that the appropriate preparations have been made. This included a check that blood thinning medications have been stopped for a minimum of 7-10 days pre-operatively, and for invasive procedures not to be carried out until the internal checklist is satisfied. These types of checklists help practitioners better manage a patient’s pre-operative care.
Finally, the Coroner recommended that that the bodies representing peak nursing homes consult with the Royal Australian College of Physicians to develop an appropriate patient observation chart that considers patients’ normal baselines. In this way, significant relative changes can be observed on an observation chart.