Investigation 09HDC01932 – Crippled with Intent

https://www.hdc.org.nz/decisions/search-decisions/2013/09hdc01932/

This investigation explores the mind-set of a laparoscopic surgeon preying on patients and considers whether there is a tendency, by the surgeon, to inflict harm without any remorse or responsibility for their diagnosis and treatment. The results of this investigation should be compulsory reading for any patient prescribed treatment for epilepsy; this includes epilepsy sufferers undergoing ‘private practice’ treatments to manage the side effects of this condition. Also, this includes any patient to undergo weight loss surgery. Patients should seek to understand the ‘why’ and ‘how’ of their situation.

Take the simple fraud test: – It is possible to confirm a patient’s safety is at risk, and the surgeons are lying incessantly about the likely post-complication side effect risks from treatments received for laparoscopic cholecystectomy. This investigation shows this is one of surgeons’ favourite ‘bread and butter’, money spinning weight loss surgeries.

Walk into any New Zealand health store and discuss with a registered nutritionist or naturopath about their experiences of patients affected by Postcholecystectomy complications. Also, ask the same question of patients undergoing weight loss surgery.

You will find that patients have been left to their own devices, many suffering from health complications that are not disclosed, or accepted, by the surgeons during the consent process. Furthermore, no support or post-operative care is provided. It is possible to take this one step further and obtain patient hand out consent forms and post procedure information to verify this as being true.

 (See ‘$100K reward ‘for evidence backing a laparoscopic cholecystectomy that surgeons claims)

This case discusses the failure of health care services provided by a young woman’s doctors and laparoscopic surgeon, and the lack of accountability for these failures by the HDC. Once again, the HDC are implicated for protecting unethical behaviour that is arguably criminal, resulting in harm to patients.

Timeline summary:

  • At age 10, the patient was diagnosed with epilepsy and placed on the medication Epilim. Side effects of which include: confusion or problems with memory or attention, aggression, agitation, anxiety, depression and suicidal thoughts, weight gain, liver and kidney issues and nutritional depletion.
  • At age 20, a private psychiatrist diagnosed her with the psychiatric condition Bi-Polar Affective Disorder (BPAD), commonly known as manic depression. She was put on psychiatric drug medication, which also lists weight gain as a side effect.
  • Over the next five-month period the patient experienced weight gain of 40kg.
  • Without consultation with the private psychiatrist, a laparoscopic surgeon obtained consent for Fobi Pouch gastric bypass and cholecystectomy (gallbladder removal). The side effects of both procedures include anxiety, depression and suicidal thoughts, as well as nutritional depletion.
  • Four months post-surgery, after a protracted period of issues, the patient is finally diagnosed with thiamine deficiency (vitamin b1), which then caused permanent harm caused by Wernicke’s encephalopathy, as a direct adverse effect of bariatric (gastric bypass) surgery. The result was permanent blindness in both eyes, with peripheral neuropathy, affecting most of the patient’s peripheral muscle strength.
  • The patient continues to have limited mobility and requires the aid of a walker, and she needs constant support in her daily activities. She has very poor vision, memory loss and oscillopsia (a condition where objects appear to oscillate).
  • These issues have occurred on top of the side effects for epilepsy and Bi-Polar.

2. Take Home Points

  • Once again, the HDC’s application of the legally enforceable Code of Rights is extremely questionable. The HDC invoke their unwritten policy of ‘learning not lynching’ of medical practitioners and protect them rather than holding them accountable. This equates to legalised fraud by the HDC, ensuring the Code is never legally enforced. As a result, doctors have ‘clinical freedom’ and protection to do what they like, how they like. The likelihood of these medical practitioners seeing the inside of a courtroom to face malpractice charges in New Zealand is slim to none.
  • Exposing the consequence of protection: New Zealand surgeons have gone on the record and stated, ‘when a patient signs their consent forms, (absent of any disclosed long term side-effects and complications), the patient has accepted a surgeon’s opinion’. As a result, surgeons believe they cannot be held liable for any subsequent damages to health resulting from long-term side effects of surgery, or for not disclosing alternative treatment options.
  • Malpractice lawsuits have effectively been blocked by the fact that the HDC continues to issue no breach rulings, based solely on surgeons’ opinions.

3. What Happened?

A young woman was diagnosed with epilepsy in 1998, and at age ten was prescribed the medication Epilim (sodium valproate). The side effects of this medication include weight gain and a number of mood disorders, including confusion, or problems with memory or attention, aggression, agitation, anxiety, depression and suicidal thoughts [3, 4].

Ten years later, the woman was diagnosed with the psychiatric condition Bi-Polar Affective Disorder (BPAD) under the care of a private psychiatrist, who prescribed several psychiatric drug medications, which also included weight gain as a side effect.  The patient noted gaining more than 40kg in 5-month period (107kg to 150kg). Meanwhile, her medication had been doubled.

The woman’s GP then referred her to a surgeon at a private clinic for consideration for gastric bypass surgery, after she had been declined for gastric band surgery.

It should be noted that the hospital at one point also expressed a desire to transfer the patient to Inpatient Mental Health Service for psychiatric review in a response to the patient’s pain experienced post cholecystectomy.

Key concerns:

The 1991 National Institute of Health (NIH) and American Society for Metabolic and Bariatric Surgery guidelines for assessing a patient’s suitability for gastric bypass surgery state that the patient must:

  1. Have a BMI of 40 or more without significant co-morbidities or 35 or more with significant co-morbidity;
  2. Have demonstrated a genuine exercise and dieting programme in the past; and
  3. Be psychologically suitable for surgery.

Of concern in this case is that the surgeon has failed to adequately assess the patient’s suitability for surgery in regards to points 2 and 3, and this equates to unethical conduct, or neglect of professional duty (improper professional conduct).

Medical Notes:

 Thiamine Deficiency:“ Thiamine (B1) Severe thiamine deficiency can cause seizures in both alcoholic and non-alcoholic patients; these seizures are reversible with thiamine supplementation” [5] and also a side effect of some epilepsy medications [6,7]

4. The HDC investigation outcome

The Commissioner found that the surgeon did not adequately assess the patient’s suitability for surgery – He failed to obtain a formal psychiatric or psychological assessment, or consult her psychiatrist. This is a breach of the Code, Right 4(1) – Failed to provide services with reasonable care and skill. 

5. Breaches of patient rights not investigated (unanswered questions)

Is the HDC providing protection for the behaviour of surgeons? Is there a conspiracy to obstruct justice and a failure to identify the patient’s Code of Rights breaches?

According to the HDC’s detailed investigation, the only breach found was that that surgeon did not “adequately assess patient’s suitability for surgery” – He failed to obtain a formal psychiatric or psychological assessment, or consult her psychiatrist. Breach: Right 4(1) of the Code. Failed to provide services with reasonable care and skill. 

Yet, based on similar, previous investigations breaches were identified. Strangely, the HDC failed to find the following breaches in this case:

  • There is no evidence alternative treatment management options were recorded as being discussed with the patient in order to make an informed choice.
  • The HDC failed to review informed consent information, patient information handouts or the DVD and booklet about gastric bypass surgery provided by the surgeon. This was needed to confirm the patient was advised of all the risks and side effects (including chronic and lifelong side effects) and the possible effect on the patient’s quality of life for treatments (gastric bypass and cholecystectomy).
  • The HDC failed to review Informed consent documentation to appraise if confirmed consent was legally obtained for gastric bypass and cholecystectomy.

The only option presented to the patient was surgery for weight again. As confirmed by the absence of medical notes found in the investigation. As such, the HDC failed to identify the proper consent of the patient. Instead, it was obtained illegally by deception and concealment. At no time was the patient advised that:

  1. The likely cause of her 40Kg weight gain over 5-month period was a direct result of psychiatric drug medication for a newly diagnosed condition Bi-Polar Affective Disorder (manic depression).
  2. The likely understanding of the side effects of epilepsy medication (sodium valproate) such as weight gain, liver and kidney issues and nutritional depletion, confusion or problems with memory or attention, aggression, agitation, anxiety, depression and suicidal thoughts.

The laparoscopic surgeon had full knowledge the young 20-year-old patient suffered from psychiatric disorders and was undergoing treatment by a psychologist.

The surgeon stating they had an attempt to contact the treating Psychiatrist is only hearsay, there was no phone system record presented, or any attempt made to confirm voice mail messages left. As such, based on the HDC’s previous rulings (not detailed in clinical notes), the surgeon failed to undertake appropriate investigations to elucidate the root cause of the highly unusual, rapid 40kg weight gain in the 5 months since starting medication. 

The HDC’s own experts found that a formal psychiatric assessment of Ms B should have been obtained before surgery. This would have ensured the patient was competent enough to provide consent. By reviewing the investigation notes, much of the patient’s actions reflected that the patient was not in a position to give consent.

The HDC somehow strangely failed take on board the advice from the DHB that the surgeon failed to meet acceptable standards practices, in order to proceed with treatment. Furthermore, the surgeon rejected these standards reflecting that all patients, new and old, are at risk.

Here are the 1991 National Institute of Health (NIH) and American Society for Metabolic and Bariatric Surgery guidelines for assessing a patient’s suitability for gastric bypass surgery:

These include that the patient must:

1.       Have a BMI of 40 or more without significant co-morbidities or 35 or more with significant co-morbidity;         

2.       Have demonstrated a genuine exercise and dieting programme in the past;

3.       Be psychologically suitable for surgery.

 Answer

YES

NO

NO

 Furthermore, there is this information form Professor Tania Markovic in Bariatric Surgery Work Up, Patient Selection and Follow Up. Metabolism & Obesity Services, RPAH Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders. Sydney University:

Psychological profile:

1.       Undergone comprehensive psychosocial evaluation, and free of acute psychiatric issues, or drug dependency problems

2.       Proven to be able to comply with and adhere to the behavioural changes required after surgery

3.       Capacity to understand the associated risks and commitment

4.       Well-informed and motivated

Bariatric surgery exclusion criteria:

1.       Uncontrolled, severe psychiatric illness

 Answer

NO

.

Not confirmed

Apparently Not

Apparently Not

YES

 Simply, the HDC failed take the above advice on board when considering the fundamental question of whether the decision to proceed with both surgeries was appropriate and should have gone ahead? An honest answer of no would require more specific investigation and substantial findings.

What should have happened is that the HDC refer this case to the Director of Proceedings to decide whether to take the case to the Health Practitioners Disciplinary Tribunal (HPDT), or forward it on to the appropriate authority, such as the police, to determine whether there was any liability or culpability, or if a criminal office has occurred?

The HDC, glaringly, failed to pick up the fact that there was a complete absence of any recorded documented evidence, detailing the justification for the removal of the patient’s gallbladder, or, whether consent was provided in the first place. Was there gallstone/ gallbladder related pain, or symptoms, experienced by the patient? 

Furthermore, was consent ever lawfully obtained for cholecystectomy? With the understating of the side effects of her medication and the likely cause of rapid weight gain, which can cause damage to the liver and kidneys, the surgeon managed to obtain consent for a Fobi Pouch gastric bypass and cholecystectomy at the same time.

Here is a summary of breach of the Code of Rights took place, as identified in similar, previous investigations:

Right to freedom from exploitation:

Right 2, right to freedom from discrimination, coercion, harassment, and exploitation. Every consumer has the right to be free from discrimination, coercion, harassment, and sexual, financial or other exploitation

Right 4 (4) every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of, that consumer.

Right to make 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. Failing to disclose risks during the informed consent process breached Right 6(1)(b) of the Code of Health and Disability Services Consumers’ Rights (the Code).

Right 7(1) –Informed consent was obtained illegally, by fraud deception, concealment of risks, including the likely true root of the cause behind weight gain, as well as an exploitation of the patient’s psychiatric condition / medication.

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.

Right to life:

Right 4 (4) every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of the consumer.

Right 4 (1) Surgeon failed to undertake appropriate investigations to elucidate the cause for rapid weight gain (40Kg over 5 months)

5.  Unanswered questions:

Question 1a: Was there a breach of common law, was consent illegally obtained and did a criminal offence take place?

 If so, why was the matter not referred to the police or the Director of Proceedings or even the Professional Conduct Committee / Medical Council of New Zealand for review, in accordance with section 45(2)(f) of the Health and Disability Commissioner Act 1994?

Question 1b: If Question 1a is true, did the HDC conspire to prevent the course of natural justice by blocking a thorough investigation, deliberately omitting breaches previously identified in similar investigations?

Furthermore, why was the HDC not forwarding information on to the appropriate authority for a more detailed and qualified investigation?

The HDC accepted, on face value, the surgeon’s statement that the patient’s rights were met because they “discussed all aspects in detail, including complications and uncertainties”, without reviewing the clinical notes to confirm what was ever discussed in consultation. Conversely, in the HDC investigation # 2HDC00779, the HDC ruled:

“In the absences of any record documented evidence detailing ….  Risks of surgery that were specific, 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 … and breached Right 7(1) of the Code.

Question 1c: Did the surgeon knowingly put the patient’s life and health at risk with their understanding that nutrient deficiencies are a side effect for all four treatments that the patient was to receive?

The combined side effects of each treatment, added to existing medications that the patient was taking, meant that the surgeon was potentially granting the patient a death sentence:

  • The surgeon knew there is a horrendously long list of side effects, including nutritional deficiencies and weight gain, for anti-epileptic and psychiatric drug medications.
  • The surgeon knew that there are side effects, including nutritional deficiencies and malnutrition, for cholecystectomy complications.
  • The surgeon knew that there are side effects, including nutritional deficiencies, for gastric bypass surgery.

And also;

  • Vitamin supplements such as folic acid, vitamin B6, vitamin E, biotin, vitamin D, may be needed to prevent or treat deficiencies, resulting from the use of anticonvulsant drugs.
  • Patients diagnosed with thiamine deficiency are at risk of epilepsy. Thiamin (vitamin B1) should be prescribed to help reduce epileptic manifestations [11].

Question 1d: Were these risks ever clearly disclosed and understood by a 22-year old suffering from manic depression, in order to legally obtain consent?

 As such, did she agree to take potentially lifesaving nutria supplements for life, as sadly confirmed to be the case in this situation?

Key notes on the term “understands risk”:

Here is an extract from on the current Code of Ethics of the New Zealand Medical Association records:

“Doctors should ensure that patients are involved within the limits of their capacities, in understanding the nature of their problems, the range of possible solutions, as well as the likely benefits, risks, and costs, and shall assist them in making informed choices”.

The approach taken by the High Court of Australia was eerily similar to the standards, which the New Zealand Medical Council had enunciated.

“….that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment: a risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, warned of the risk, would be likely to attach significance to it.”

The High Court of New Zealand B v The Medical Council of New Zealand

More information about the law can be found here: xxxxx

Question 2: Was informed consent lawfully obtained for the two surgery procedures?

Question 3:  Did the HDC cause harm, or suffering, to other past patients potentially at risk under the same circumstances, by ensuring that further investigations never took place by the appropriate authorities?

How many other patients have been injured, or have died, as the result of practices considered as being “treatment provided according to reasonable standards”.

Surgeons categorically rejected any criticisms based on the American Society of Metabolic and Bariatric Surgery and had no willingness to see any wrongdoing and held steadfast that “treatment provided according to reasonable standards”. Effectively, surgeons are saying there is no requirement to advise the patient of the truth of her weight gain. Why would the HDC not take steps to ensure that all past patients have not been harmed in a similar manner?

External opinion – Some 40% of my gastric bypass patients admit to previous psychiatric disorder, in particular depression, and a number have had BPAD.

Compare that to the surgeon’s opinion in this case: “I do not consider these to be a contraindication to surgery, and indeed the psychiatric status of the patient” And; “Medication (for BPAD) was on-going and in my experience such weight gain is seldom, if ever, completely reversible following cessation of such medication.”

Furthermore, the surgeon in this particular case was of the opinion that:

  • It is acceptable for an experienced clinician and team such as himself and his staff to make a judgement about psychological suitability for bariatric surgery.
  • The surgeon considers that the recommendation of the American Society of Metabolic and Bariatric Surgery referred to by the HDC’s independent expert, Dr Flint, is supported by only weak evidence.
  • Formal mental health evaluations involve additional costs to patients and programmes without good evidence to support them.
  • And there was ‘treatment provided according to reasonable standards, legal, professional, ethical, consistent with her needs, minimises the potential harm to, and optimises the quality of life ”, right 4

Question 4: Why was the psychiatrist treating the patient not contacted by the HDC for input, or held accountable for diagnosing and prescribing (and doubling the quantity) of psychiatric drug medications?

All of this occurred on top of existing anti-epileptic drug medications given to the patient, without due care for side effects.

There was a failure to provide a duty of care to the patient, by causing injury to the patient through ‘rapid weight gain’ as a side effect of medication. This was not investigated, constituting negligence. This is a breach of the Code: Right 4 (4) every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of the consumer.

6. References

  1. https://www.theage.com.au/national/thousands-of-back-pain-sufferers-given-harmful-treatments-20180321-p4z5h0.html
  2. https://www.globalresearch.ca/ex-pharmaceutical-sales-representative-comes-clean-reveals-horrors-of-western-medicine/5438950
  3. http://www.netdoctor.co.uk/medicines/brain-and-nervous-system/a6665/epilim-sodium-valproate/
  4. Prescribing issues associated with anticonvulsant medications for epilepsy https://bpac.org.nz/bpj/2009/november/anticonvulsants.aspx
  5. Ali A. Asadi-Pooya, Scott Mintzer, and Michael R. Sperling. Nutritional supplements, foods, and epilepsy: Is there a relationship? https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1528-1167.2008.01678.x
  6. Asif, Mohammad. (2013). Role of Various Vitamins in the Patients with Epilepsy. International Journal of Pharmacological Research. 3. 10.7439/ijpr.v3i1.34. https://www.researchgate.net/publication/307678604_Role_of_Various_Vitamins_in_the_Patients_with_Epilepsy
  7. Nutritional Depletion as a Side Effect of Anticonvulsant Medications. http://www.angelfire.com/journal/ldps/SideEffectsofAnticonvulsantMedications.htm
  8. Keyser A. · De Bruijn S.F.T.M. Epileptic Manifestations and Vitamin B1Deficiency. https://www.karger.com/?DOI=10.1159/000116660
  9. Roizblatt A, Roizblatt D, Soto-Aguilar B F. Suicide risk after bariatric surgery https://doi.org/10.4067/S0034-98872016000900011
  10. Keyser, A & Bruijn, Sebastiaan F. (1991). Epileptic manifestations and vitamin B1 deficiency. European 31. 121-5. https://www.researchgate.net/publication/21110637_Epileptic_manifestations_and_vitamin_B1_deficiency