Investigation 00HDC07593 – The Cartwright Inquiry Take II and Cover Up

http://www.hdc.org.nz/decisions/search-decisions/2002/00hdc07593/

The Dame Silvia Cartwright inquiry confirmed that the Code of Patients’ Rights is legally enforceable and exposes current methods and behaviours.

In this case, the HDC provide the surgeon responsible with a free pass. Once again, they are not holding New Zealand surgeons to account for non-consensual, illegal and unethical human experimentation that violates the core principles of medical ethics and patient autonomy.

The result of such continued behavioural patterns by certain medical practitioners and the HDC mean that potentially thousands of affected patients, and their issues, have never been fully exposed, and the subsequent harm has been covered up.

This is occurring, despite the very reason why the HDC was established. As a result of the Cartwright inquiry, a commission was set up to investigate unethical experimentation on patients, without proper consent or proper approval – leading to patient harm and even deaths. The office of the Health and Disability Commissioner was established and created along with the legally enforceable Code of Rights for health consumers. Furthermore, there was the establishment of regional ethics committees.

Despite the creation of these authorities and the reason for their creation, the HDC in this case, again, refused to find significant breaches of the Code and failed to forward information to the appropriate authority and/or the Police to investigate if a criminal offence has occurred under the Crimes Act 1961.

The outcome of this investigation sadly positions the HDC as a branch of Government that does not legally enforce what it was created to do, which is to ensure ‘The of the Code of Health and Disability Services Consumers’ Rights’ are followed. As a result, doctors are never likely to face the legal consequences for medical frauds including assault, illegal experimentation on patients, and assault and battery.

A medical intervention, without valid informed consent, is a criminal offence and the physician can be charged with battery. Taking, or, to be in possession of, human body parts (including tissue), during an unrelated surgical procedure for personal experimental research, without consent, is a criminal offence under the Crimes Act 1961.

The only way these incidents could ever be investigated by police or criminal charges laid, would be for the HDC or the Director of Proceedings to decide whether to take a case to Health Practitioners Disciplinary Tribunal (HPDT) or forward it to the appropriate authority, such as the Police, to investigate if a criminal office has occurred.

The fact that this never happened is most likely due to the HDC reinforcing their unofficial policy of ‘learning not lynching’ designed to protect doctors and not hold them to account for their actions.

What more is needed to be learned? From the outcome of the Nuremberg trials emerged specific legally enforceable principles, the Nuremberg Code, which is a great influence on the development of international criminal law and The Universal Declaration of Human Rights, 1948. The principles regarding medical interventions include:

• That voluntary consent is absolutely essential.
• The ability for patients to exercise freedom and power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion.
• Patients’ should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision.

Resultantly, these cases are either experimentation conducted on patients without consent – therefore illegal and a criminal offence (outcome of Cartwright Investigation). Or, they are simply a learning experience for the surgeon, regardless of how many patients are affected, or injured as a result.

It has been said, ‘The main way to reduce criminal offending is to instil a realistic fear of being caught, tried, and, if convicted, punished.’

The Honourable Dame Silvia Cartwright – Some Human Rights issues. http://www.nzlii.org/nz/journals/WkoLawRw/2001/1.html

2. Take Home Points

• Every patient’s consent for cholecystectomies in New Zealand is obtained by deception and concealment.
• To the extent that surgeons are carrying out experiments on patients illegally and strongly believe their conduct is ethical, even though they are breaching the legally enforceable Code of Rights.
• Criminal law does not apply to New Zealand laparoscopic surgeons and their practice of lying to patients:
  • Even the most serious of criminal activities is protected by the HDC.
  • Doctors are above the law; illegal practices will never see the inside of a courtroom.
  • The HDC is required to forward breaches of ethical standards to the relevant registration bodies, but fail to do so in this case.
  • Doctors obtain a ‘no breach’ ruling from the HDC, effectively receiving the ultimate protection. The likelihood of a medical malpractice case ever being won in New Zealand courts is next to nothing and no New Zealand lawyer would ever take a case under these circumstances. The HDC have even reaffirmed this stance to the New Zealand Government – that doctors are protected. See HDC Report xxxxx “xxxx” .

3. What Happened?

In this case, the laparoscopic surgeon carries out illegal experimentation on patients for 10 years. It is entirely possible that thousands of patients are affected, and some likely injured [1].

In regards to this particular health consumer, the patient is injured (see below feedback) as the possible result of carrying out an illegal liver biopsy during a laparoscopic cholecystectomy. During the surgery for the treatment of gallstones, (a side effect risk of a first surgery conducted – Silastic Ring Gastric Bypass) the surgeon took an illegal liver biopsy. 

The experimentation required a before and after illegal liver biopsy:

Both the surgeon and staff member lie incessantly about their activities throughout this procedure. The independent advisor to the HDC (a surgeon and senior academic) believes personal research actions were taken when treating the patient raising significant ethical issues.

4. The HDC Outcome

The HDC found the surgeon carried out an illegal procedure on the patient – and potentially thousands of others affected over a 10-year period because of the failure to inform patients properly of the risks of such procedures. The experiment breached the Code of Rights 6(1)(d) and 7(6)(a).

Yet, the HDC give the surgeon a free pass. There is no breach of Right 4(1) of the Code for the injury that occurred because the same surgical advisors, who believed that the actions were ‘ethical’, noted that, ‘a gall bladder bed haematoma is a recognised complication of a cholecystectomy and, on the balance of probabilities, cannot be attributed to the liver biopsy’.

The HDC did not refer this incident to the Director of Proceedings, to decide whether to take the case to Health Practitioners Disciplinary Tribunal (HPDT), or to forward it on to the appropriate authority, such as the Police to investigate if a criminal office has occurred?

If investigated by these parties, the decision could well have found professional misconduct that at the very least constitutes malpractice or negligence. The HPDT outcome may have included forwarding the investigation to the police, which could have resulted in prosecution

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

Question 1: Did the Laparoscopic Cholecystectomy surgeon really conduct liver biopsy to provide on-going clinical support to the patient?

And did the HDC cover up malpractice and fraud potentially affecting thousands of patients with potential injuries, and even possible deaths, by not holding this surgeon to account as required by the Code?

The question must be asked if the HDC has covered up fraud? Because of the reasoning they provided for his behaviour, ‘He (surgeon) has since reiterated that his intentions were to undertake the procedure as part of clinical care.’ 

Conflicting opinion and statements exists:

• Patient – Mrs A stated that surgeon’s nurse told her that he kept the data for his own personal quality assurance. However, when Mrs A requested her medical notes, the questionnaires were not included.
• The HDC – The surgeon kept detailed personal records on all of his patients since about 1990. A detailed database has been compiled of information from each patient’s detailed personal record. The surgeon used this information to publish internationally and to make improvements and modifications to his procedures. The surgeon’s nurse and a senior scientific officer assisted him in maintaining the patient database and collating the data in preparation for scientific meetings, both nationally and internationally, and for his many publications over the years.
• Surgical advice: I believe that this was performed to gather new knowledge, and not to alter management directly and hence would have required appropriate consent.

Surgical advice: The second liver biopsy was taken, not for clinical purpose, but for what is probably best termed research.

Combine this with the outlook of the surgeon:

I personally continue to believe there should be no need to advise a patient that a liver biopsy is being obtained at the time of gastric bypass (and it would seem laparoscopic cholecystectomy) because any risk associated with this is tiny.

To the contrary, medical studies conclude:

Liver biopsy complications and risk factors, “In this patient population, the overall complication rate was 6.4% and the overall death rate was 1.6%” (Figures include laparoscopic liver biopsy)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4695539/

Question 2: Did the HDC give a free pass to the surgeon and cover up potentially New Zealand’s largest ‘investigated’ informed consent malpractice fraud carried out by a single surgeon, since the Cartwright Inquiry into 948 women illegally experimented on?

The surgeon was conducting illegal liver biopsies over a 10-year period, possibly affecting thousands of patients and putting them at risk, especially with the well-documented overall complication rate of 6.4% and an overall death rate of 1.6%.

This ruling also had the effect of blocking past patients from ever being advised fraud ever took place on their person. By blocking all past patients from being advised of possible harm, the HDC breached right (1)(a) and Right 6(1) of the Code. The HDC are obstructing justice by concealing criminal offences of any deaths that have occurred as a direct result of this surgeon’s behaviour, to both victims and their family members.

Duty of care to patients full disclose harm or injury as a result of criminal activity: Right (1)(a) of the Code provides that patients have the right to be treated with respect. Failure to disclose inadvertent harm involves tacit deception – respect for patient autonomy supports a truthful and sensitive discussion about what went wrong and why;  Right 6(1) of the Code affirms every consumer’s right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive. When a surgical complication occurs (illegal experimentation conducted on them without their knowledge or consent), the patient is entitled to open, truthful information about what occurred, its effect and its significance

Question 3: Given the injuries that can occur from liver biopsies and laparoscopic cholecystectomies, which include bleeding and can initiate potentially life-threatening blood oozing, is refusing to see patients’ post-operation, or directing them to the nearest hospital, putting their lives at risk?

This is a breach of the Code of Rights. Specifically,

Right to services of an appropriate standard Right 4(1) the right to have services provided in a manner that minimised the potential harm to the patient. There was a failure to appropriately investigate and manage well-recognised Postcholecystectomy health complications; a breach of the patient’s rights under the Code, in particular her right to have services provided with reasonable care and skill.

Is contacting the patient the following day acceptable?

When Mrs A returned home on 18 February she noticed a large “dark red wine” coloured bruise on her abdomen. She tried to contact Dr B but was unable to speak to him until 19 February when he advised that “these things happen sometimes and that it would be better eventually, but might take a bit longer than initially suggested”. Mrs A continued to have severe pain and on Monday 21 February she rang Dr B, who advised that he would fax her “chemist a prescription for stronger pain relief“. Mrs A’s pain was so severe that on 23 February she was admitted to a public hospital after attending an After Hours Medical Centre.

6. Additional Questions – Which can only be Comprehensively Answered by the Patient Making the Complaint

In the absence of clinical notes and patient records presented to the HDC, the following questions, potentially breaching the Code of Rights are left unanswered:

1.    In order to legally obtain an informed consent for the first, original procedure of a ‘Silastic Ring Gastric Bypass’ was the side effect risk of developing gallstones, resulting from rapid weight loss (being high as 30%) disclosed to and signed off by the patient?

In order to legally obtain an informed consent for the second Cholecystectomy procedure, was the side effect risk of developing further nutritional deficiencies and reflux, (an original health complication), disclosed and signed off by the patient?

Failing to do so is a breach of the Code:

Informed Consent Right 6(1)(b) Every patient have the right to the information that a reasonable consumer in his circumstances would expect to receive, including an explanation of the treatment options available and an assessment of the expected risks, side effects (affecting quality of life), benefits and costs of each option. Right 7(1) very patient right to make an informed choice and give informed consent Every consumer has the right to make an informed choice and give informed consent. Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent. Without this information, patients are denied that opportunity to legally give informed consent.

2.   In order to legally provide a ‘Silastic Ring Gastric Bypass’ treatment, provided in a manner that minimised the potential harm to her, and optimised her quality of life, did the surgeon provide post-care support following the ‘Silastic Ring Gastric Bypass’?

Post-care support should be put in place to mitigate the side effect risks of developing gallstones in order to help avoid repeat surgery. Or was the patient simply left to their own devices, developing health complications? Therefore guaranteeing repeat business and another surgery for the surgeon.

Right to services of an appropriate standard Right 4(4), right to have services provided in a manner that minimised the potential harm , and optimised her quality of life.

More about cholesterol gallstones risk:  The development of cholesterol gallstones is associated with certain well-defined risk factors.^1–4 The risk for developing gallstones during active weight reduction is well accepted.^5–11 Between 10% and 25% of persons having lost weight through very low-calorie dieting (VLCD) develop gallstones.^12,13 In addition, 35–38% of patients with morbid obesity develop gallstones as they lose weight after bariatric 

Post care treatment: A daily dose of 500 mg of ursodeoxycholic acid for 6 months is effective prophylaxis for gallstone formation following gastric restrictive procedures. [1]

3.   Did the surgeon advise of the possibility of this risk, and the fact that it could further reduce the patient’s quality of life should a ‘cholecystectomy’ take place? This is due to well known Postcholecystectomy side effect symptoms, including the presence of reflux oesophagitis, an existing condition before surgeries.   

Was the condition of ‘reflux oesophagitis’ being treated or made worse following the ‘cholecystectomy’ and did the patient receive support to mitigate or treat this? Failing to receive support for a known side effect, which has the potential to reduce the quality of life is also breach of Right 4:

Investigation Notes: “8th February 1999. [Mrs A] was seen by [Dr B] in his rooms. She was noted to be overweight with a weight of 116kg and a body mass index (BMI) of 42.6 kg/m2, putting her in the ‘clinically morbidly obese’ category. Such patients are prone to many of the obesity related conditions; [Mrs A] had one such condition, reflux oesophagitis”

4.   Was consent obtained for cholecystectomy to treat gallstones obtained by deception and fraud?  In order to obtain a before and after liver biopsy, illegally, a second surgery opportunity is required – to take an after biopsy. Was the patient provided alternative treatment options for gallstones?

Right 6(1)(b) Every patient have the right to the information that a reasonable consumer in his circumstances would expect to receive, including an explanation of the alternative treatment options available and an assessment of the expected risks, side effects (affecting quality of life), benefits and costs of each option.

5.   Should the cholecystectomy even have to take place? The patient complained of “several episodes of abdominal pain”. The presence of gallstones was only seen by the surgeon’s practice ultrasound equipment. This does not justify removing the gallbladder, as exposed in past investigations.

Published Ruling 12HDC00779 outcome:  The surgeon “Did not record any discussion she had with Mr A about 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. Breaching – Right 6(2), Right 7(1)

And;

Published Ruling 09HDC01505 outcome:  There is insufficient information available to assess the suitability of the procedure for Mrs A, including the risks and benefits. Consequently, he did not provide her with an adequate explanation of her condition. This was information she needed before making an informed choice or giving informed consent.  Breaching Rights 6(2) and 7(1) of the Code.

Investigation notes: 7^th February 2000. [Mrs A] reviewed by [Dr B] in his rooms. Her weight had fallen to 79kg. She was noted to have had several episodes of abdominal pain and an ultrasound scan had demonstrated gallstones. In view of this pain, [Mrs A] was advised to undergo cholecystectomy.

Previous HDC external advice regarding diagnosis for treatment:

“The majority of patients found to have incidental gallstones will remain asymptomatic. When symptoms occur, they are usually biliary colic rather than complications of gallstone disease. The cardinal symptom of gallstones is biliary colic. Biliary colic is a moderately severe crescendo type pain in the right upper quadrant radiating to the back and right shoulder, which may be accompanied by nausea. Despite its name, the pain is usually steady and not colicky. Pain may be brought on after ingestion of fatty foods. Gallstones are sometimes implicated as the source of symptoms in patients with dyspepsia. However, such an association should be made cautiously, since gallstones may silently coexist in patients with dyspepsia, and other causes of dyspepsia are more common.”

Dr David Maplesden, Medical Advisor, Health and Disability Commissioner

6.   Why was it never explained and strangely not picked up by the HDC surgeon advisors that the patient stayed in hospital for two days? It is not normal for laparoscopic cholecystectomy patients to stay in hospital for two days, with an uneventful and straightforward surgery.  The patient was released on day two with large coloured bruising on her abdomen. What really happened to justify two-day post recovery stay in hospital?

7. References:

1. Miller, K., Hell, E., Lang, B., & Lengauer, E. (2003). Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial. Annals of Surgery, 238(5), 697–702. http://doi.org/10.1097/01.sla.0000094305.77843.cf
2. Altomare DF, Rotelli MT, Palasciano N. Diet after cholecystectomy.  https://doi.org/10.2174/0929867324666170518100053
3. Flavio Nervi MD & Marco Arrese MD.  Cholecystectomy and NAFLD: Does Gallbladder Removal Have Metabolic Consequences? The American Journal of Gastroenterology volume 108, pages 959–961 (2013) doi:  https://doi.org/10.1038/ajg.2013.84
4. Kwak, M.-S., Kim, D., Chung, G. E., Kim, W., Kim, Y. J., & Yoon, J.-H. (2015). Cholecystectomy is independently associated with nonalcoholic fatty liver disease in an Asian population. World Journal of Gastroenterology : WJG, 21(20), 6287–6295. http://doi.org/10.3748/wjg.v21.i20.6287