Investigation 2HDC00779 – First HDC Accountable Death

https://www.hdc.org.nz/media/288924/12hdc00779casenote.pdf  OR found here:   12hdc00779

This case is the first HDC published cholecystectomy patient death investigation, where the HDC can be held accountable as an accessory to the fact for medical malpractice, resulting in a patient’s death. It is arguable that the HDC is vicariously liable for manslaughter.

There is a bizarre, confusing and even conflicting HDC timeline of rulings leading up to this death:

Recap : Previously, in an unpublished ruling, just prior to this death, the HDC took extraordinary steps to whitewash consumer complaints about the method that New Zealand surgeons obtained consent for cholecystectomies. The complaints made the point that consent was obtained illegally through deceptive and fraudulent means. The HDC was strongly advised it would breach the Code of Health and Disability Services Consumers’ Rights and would be held accountable for personal damages such as loss of income and loss of life expectancy for every cholecystectomy carried out in New Zealand, if they failed to investigate informed consent fraud as mandated by the HDC Act. The outcome was as follows, the HDC chose to ignore its own independent internal advisor  opinions that confirmed that New Zealand surgeons were deliberately lying to Health Consumers and the HDC about chronic side effect outcomes of cholecystectomies and alternative non-surgical treatment options.

More shocking, the HDC went on to rule, (if a patient experiencing pain that continued after the removing the gallbladder, without ever having a gallbladder attack, with only gallstone present and despite providing a health directive no side effects to occur, ) a surgeon has clinical freedom to do withhold treatment options or disclosure of side effect  in order to obtain consent.

This patients death could have been avoided if not for the HDC’s prevention of patient right to be advised of alternative treatment options or advised side effect risk which influences health consumers informed choice consent process. 

Recap The HDC actually sanction New Zealand surgeons’ practice of withholding informed consent. Instead of identifying breaches of the code Right 6(2), the HDC review and sign-off on misleading and untruthful informed consent documentation, absent of major risks, side effects affecting quality of life and alternative non-surgical treatment options. (See ruling: HDC6446, 2009)

  1. Here, when this surgeon uses the HDC signed off ‘misleading informed consent documentation’ in this investigation, the patient dies. Here we see the HDC does a 180-degree turn and confirms an actual breach of Right 6(2), and Right 7(1) the right to make an informed consent (choice). (See ruling HDC6446, 2009 where no breach found?)
  2. Then the HDC ensures this ruling and its outcome never sees the light of day by removing it from the HDC website. Most likely because it would be used as evidence in a breach of Human Rights in complaints made against the HDC for blocking patients rights to receive informed consent.
  3. Subsequently, after removing the published investigation, the HDC does another 180-degree turn, once again giving surgeons a ‘free pass’ by finding no breach of the Code for all surgeons, who continue practicing by withholding informed consent. The concealment of the risks of side effects and alternative non-surgical treatment options continue under exactly the same circumstances.  (See further resulting patients death HDC 00531, HDC 01488 and all other rulings published on this website . Sadly, breaches of patients’ rights and preventable death followed, and will continue to occur, under the direct protection of surgeons, by the HDC. Victims and their families will never know that the HDC was strongly advised it would be accountable for patient harm by protecting cholecystectomy treatment fraud committed by New Zealand surgeons.

Note: This complaint investigation (2HDC00779) was removed from the HDC website at the same time, in exactly the same circumstances, as similar cholecystectomy deaths were being investigated resulting in no breach being found. Also, about the same time, a formal Human Rights complaint was made to the Human Rights Commissioner (included reference links to this HDC publication) against the HDC for blocking patients’ rights to informed consent,  post-care treatment support and patients’ rights to live.

1. Take Home Points

  • The HDC can be held accountable as an accessory to the fact for patient deaths, by knowingly blocking patients’ right to make an informed choice free from coercion and deception, whilst also concealing the risks of side effects of surgery and alternative non-surgical treatment options. (See link to the $100K reward for more information)
  • This case provides more strong evidence that every consent for a cholecystectomy is obtained illegally through coercion and deception, whilst also concealing and misrepresenting the risks and side effects of surgery and alternative non-surgical treatment options. This amounts to a criminal offence and directly impacts patients’ quality of life. Surgeons continue to remain under the direct protection of the HDC and remain consistently in breach of the Code of Health and Disability Services Consumers’ Rights (the Code).

2. What Happened?

  • A patient with a history of significant medical co-morbidities is presented to ED.  An ultrasound identified multiple gallstones. The patient is discharged with no treatment provided but is referred to the surgeon for an assessment.
  • Three months later, having been provided with no non-surgical treatment options over this period, the patient is assessed by a surgeon who recommended he undergo an open cholecystectomy and incisional hernia for previous procedure.
  • Unfortunately the patient dies several days after surgery due to complications.

3. Outcome of the HDC Investigation

In what could be described as a landmark ruling and the setting of a new precedent for every consent obtained for cholecystectomies treating and managing gallstones, the HDC actually found the surgeon failed to properly inform a patient with an extensive medical history of problems about the risks involved with the cholecystectomy procedure. Also, it was found that there were other alternatives treatment options that should have been presented. This occurred despite the surgeon claiming the HDC reviewed and signed off on the gold standard consent information brochure being used.

  • “In the absences of any record documented evidence detailing whether the gallstone related pain he was experiencing, if any, was significant enough for him to undergo surgery in light of alternative management options, or the risks of surgery that were specific to him, including his increased risk of death”
  • The surgeon failed to provide information that a reasonable consumer in his position would have needed to make an informed choice about treatment, breaching Right 6(2) of the Code of Health and Disability Services Consumers’ Rights (the Code).
  • The surgeon did not obtain informed consent for surgery from Mr A, and breached Right 7(1) of the Code.
  • The surgeon demonstrated a lack of reasonable care and skill in deciding to perform surgery and approach to condition postoperatively was insufficiently cautionary, breaching Right 4(1) of the Code.
  • The surgeon’s documentation fell below professional standards and, accordingly, the surgeon breached Right 4(2) of the Code.
  • There was a lack of discernible leadership, coordination and critical thinking in the clinical team treating the patient post-operatively, and a lack of support offered by senior doctors to junior staff. This demonstrated a service level failure by Tairawhiti DHB to provide services with reasonable care and skill, and was a breach of Right 4(1) of the Code.
  • There was a pattern of suboptimal documentation by clinical staff treating the patient post-operatively. The Commissioner found that the Tairawhiti DHB failed to ensure that its staff met expected standards of documentation, and breached Right 4(2) of the Code.

In an ironic twist, the HDC instructed Tairawhiti DHB to provide training to staff on the legal requirements of informed consent, and provide evidence of that training.

The Informed consent documentation used currently today, and the very same documentation signed off by the HDC as being acceptable, is directly responsible for this patient’s death – No alternative treatment options were presented by the surgeon, nor were the significant risks or side effects of surgery detailed. This is the very same documentation that would later go on to play apart in killing more patients. See here Royal Australasian College of Surgeons (RACS) Brochure of Laparoscopic Gallbladder Surgery  

4.  Breaches of Patient Rights Not Investigated (Unanswered Questions)

Question 1: Did a breach of common law take place? Was consent not legally obtained? And did a criminal offence occur?

Why was the matter not referred to the police or the Director of Proceedings in accordance with section 45(2)(f) of the Health and Disability Commissioner Act 1994?

  • The HDC: ‘Despite the consent form the patient signed, which includes a standard section stating that the risks, benefits and alternatives to surgery have been explained to the patient, I am concerned that the patient may not have been given sufficient information about the risks, benefits, and alternatives to surgery that were specific to him’

Note: Nowhere in the Royal Australasian College of Surgeons (RACS) Brochure of Laparoscopic Gallbladder OR surgery patient handout presented to the patient is the word ‘death’ mentioned, nor were the risks of side effects of surgery affecting quality of life or alternative treatment options mentioned.

Note: The Royal Australasian College of Surgeons (RACS) Broch Also states:  ‘Laparoscopic surgery may not be suitable with patients with previous surgery scar tissues’ such as this patient’

  • The Patient’s wife, who was present in a meeting told the HDC that she recalls: “there wasn’t really anything discussed … there was very little said, nothing about complications or alternatives or anything’
  • The HDC: ‘Dr D did not record any discussion had with Mr A about whether the pain was gallstone related., significant enough to justify undergoing surgery  ., or the risks of surgery that were specific to him, (including his increased risk of death’) or alternative management options ever  discussed due  to absence of any documented evidence
  • Independent advisor:  ‘Alternative causes for pain were not considered despite his atypical presentation especially as he was later diagnosed with renal calculi.  Surgeon was the first to document that [the patient] had an incisional hernia, there is no evidence that this was a problem for him or that it needed repair. It was known that the operation could be difficult and as [the patient] had a very significant history of vascular disease..’
  • The HDC: There is a section on the consent form titled “Confirmation of Health Care Procedure (to be completed immediately prior to procedure)”, which is unsigned. There is also a separate “Reconfirmation of Consent” section, which states that it is required to be signed only if there are significant changes to the patient’s health status or the planned procedure, or if there is undue delay in undertaking the procedure. This section of the form is also unsigned.

Question 2a: Did Tairawhiti DHB have reasonably practicable safe guards in place to prevent the act or omission of employees that breached the Code?

Failing to do so would result in a justification for police criminal prosecution under the Health and Disability Commissioner Act 1994, where employers are vicariously liable under Section 72(2)- Steps as were reasonably practicable to prevent the act or omission of employees that breached the Code.

Question 2b: Why did the HDC not consider whether the surgeon, or its employer, Tairawhiti DHB failed to provide treatment options to Mr A in a manner that would minimise risks and harm and, accordingly, breached Right 4(4) of the Code?

Was it because if the HDC referred this case to the appropriate authority, a police investigation into the death could use evidence to determine whether there was any “liability or culpability” directed towards the surgeon and the HDC?

References:

  1. Man dies after possibly unnecessary operation.  https://www.radionz.co.nz/news/regional/279822/man-dies-after-possibly-unnecessary-operation 
  2. Tairawhiti DHB criticised by Health and Disability Commissioner after man’s death https://www.stuff.co.nz/national/health/70587441/tairawhiti-dhb-criticised-by-health-and-disability-commissioner-after-mans-death