Investigation 09HDC01505 – Consent Fraud Twice?

http://www.hdc.org.nz/decisions/search-decisions/2011/09hdc01505/

This tragic story perpetuates the inhumane treatment carried out on a patient, by a cholecystectomy surgeon. The patient suffered for many years from recurrent epigastric pain health issues, without any diagnosis. She was not provided with any genuine treatment, at any time, to deal with her underlying health problems, or to increase the quality of her life. Instead, the opposite occurred.

The patient was misled twice, in order to obtain consent for the same procedure, by the same surgeon. As a result, she was left with chronic health complaints, which most likely caused side effects resulting in reduced quality of life.

In effect, the treatment of the patient can arguably be considered as dehumanising. The following is a summary of breaches by the doctor, which they ignored their duty of care and were negligent.

  1. Consent obtained for laparoscopic cholecystectomy, on both occasions, appears to be unjustified and obtained illegally.
  2. The patient’s health problems were neglected for many years as doctors and surgeons strangely failed to appropriately investigate and manage.
  3. The best efforts for diagnosing and treating health issues, most likely Postcholecystectomy complications, resulted in a second laparoscopic cholecystectomy surgery to remove a non-existent gallbladder.
  4. The patient was left seriously harmed and her quality of life was significantly affected even further.

2. Take Home Points

  • This case provides yet more evidence that every informed consent for Laparoscopic Cholecystectomy in New Zealand is obtained illegally by deception. Obtaining consent illegally is a criminal offence and is obtained through coercion, deception and concealment, a misrepresentation of risks, side effects affecting quality of life and alternative non-surgical treatment options. This deception occurs under the direct protection of the HDC and is in breach of the Code of Health and Disability Services Consumers’ Rights (the Code).
  • The HDC covered up the surgeon’s failure to provide a duty of care to the patient, causing serious injury to the patient and it is highly possible that both surgeries conducted on this woman constitute informed consent fraud.
  • This case provides more evidence that the HDC are giving protection rulings, resulting in harming health consumers. There has been no improvement in health services for patients undergoing treatment for gallstones.
  • New Zealand surgeons continue to provide false information about the side effects and alternate treatment options. In this particular case going as far as removing a gallbladder for the treatment of ‘non biliary colic, stomach pain problems’.

3. What Happened?

The patient’s gallbladder was removed in 1996 to resolve ‘epigastric pain not entirely typical of biliary colic’. This has been called ‘non-ulcer dyspepsia’ and the procedure was carried out to get her off all medication, including H2 antagonists and proton inhibitors used to address stomach issues .

  • Waikato Hospital advised, “A consented to the surgery and signed the appropriate consent forms”
    • Her doctor wrote to the surgeon, “she has been on H2 antagonists and proton inhibitors and I hope that when we get her gall bladder out we will be able to get her off all medication”
  • Fast forward 13 years, the patient was then aged 61, and she presented herself to the Hospital Emergency Department with sudden severe right upper abdominal colic-like pain, and chest pain radiating to the shoulders, associated with sweating, pallor, nausea and vomiting.
  • She meets with a surgeon and discussed the symptoms she was experiencing, and explained the ultrasound results – there were no sign of gallstones or gallbladder due to it being possibly ‘contracted’. He explained laparoscopic surgery and its general risks.
  • Despite the surgeon ordering a preliminary CT scan, the surgeon fails to review the results before conducting a cholecystectomy, blaming a lack of computer printing skills. The CT scan report clearly stated that the gallbladder had been previously removed, “Cholecystectomy clips are seen”.
  • During the surgery, the surgeon ‘initially’ believed that he had removed a shrunken gallbladder, but then found that a major duct injury had occurred.

NOTE: Although never disclosed, as transparency and honesty was lacking, the bile duct injury was most likely the most serious possible after removing a portion of the common bile duct.

Medical Notes:

Epigastric pain: Pain or discomfort right below your ribs in the area of your upper abdomen. It often happens alongside other common symptoms of your digestive system. These symptoms can include heartburn, bloating, and gas.

4. The HDC Investigation Outcome

The surgeon breached the following provisions of the Code of Health and Disability Services Consumers’ Rights (the Code):

  • Dr C operated on Mrs A in these circumstances, he did not exercise an appropriate degree of care by reviewing all the information available to him, and therefore did not minimise the potential harm to Mrs A. Accordingly, in my opinion, Dr C breached Rights 4(1) and 4(4) of the Code.
  • Failing to review CT scan report, review patient records detailing previous cholecystectomy; and
  • There was 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. Accordingly, in my view, Dr C breached Rights 6(2) and 7(1) of the Code.
  • Advisor: consented and planned for a laparoscopic cholecystectomy before all the results had been viewed and this coupled with not picking up the relevant history or examination findings ….  A departure from the normal standard of care in the preoperative work up of this patient which I would regard as a severe departure from good practice.” And,
  • It is clear that the care provided to Mrs A was detrimentally affected by the DHB’s failure to take reasonable steps to alert her treating clinician to relevant clinical information in May/June 2009. Therefore, in my opinion, Waikato DHB breached Right 4(1) of the Code

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

There appears to be no apparent justification for the original diagnosis and treatment of removing the gallbladder. The HDC glaringly failed to pick that fact there was a complete absence of any record, documenting evidence detailing the patient was diagnosed as having gallbladder related symptoms and the justification for removing the gallbladder originally in 1996.

 This was subsequently confirmed also by the fact that health issues continued after treatment and for many years.

Medical Notes detailed:

The diagnosis for removing the gallbladder mentioned in the records was: “epigastric pain not entirely typical of biliary colic and non-ulcer dyspepsia” with no presence of gallstones mentioned.

And;

“She has been on H2 antagonists and proton inhibitors and I hope that when we get her gall bladder out we will be able to get her off all medication”

Gallstone Symptoms include:

  • Sudden and rapidly intensifying pain in the upper right portion of your abdomen
  • Sudden and rapidly intensifying pain in the centre of your abdomen, just below your breastbone
  • Back pain between your shoulder blades
  • Pain in your right shoulder
  • Nausea or vomiting

Information from the HDC advisor prior to this investigation, (Case # not published):

“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

There was no disclosure of the side effects of surgery, or alternative treatment options available. There is no evidence that the risk of the side effects on the quality of life of the patient were ever disclosed during the informed consent process. This is also confirmed when reviewing the DHB informed consent form documentation, which has a complete absence of an explanation of the treatment options available and expected side effect risks (see link Waikato DHB IC Forum).

Medical notes advise the one main justification for removing the gallbladder was for the treatment of acid reflux issues. However, one recognised Postcholecystectomy side effect risk of removing the gallbladder function is gastro-oesophageal reflux. This is recognised by evidence-based medical studies but not accepted by the New Zealand surgeon’s testimony, to the HDC or patients, during the informed consent process. 

Question 1: Why would a patient, having received disclosure of side effect risks, which included acid reflux, undergo a cholecystectomy to treat acid reflux?

Were side effect risks concealed or misrepresented by New Zealand surgeons and patient information forms, resulting in obtaining informed consent fraudulently? “No likely side effect, can return to a normal life, digestion returns to normal, once the gallbladder is removed’.

Remembering her doctor wrote to the surgeon “she has been on H2 antagonists and proton inhibitors and I hope that when we get her gall bladder out we will be able to get her off all medication”

Recap on Post Cholecystectomy syndrome (PCS) – ‘gastro-oesophageal reflux’: PCS refers to a variety of persisting or new symptoms after the surgery that usually required further investigation to establish the cause, and specific treatment. Therefore diarrhoea could be termed a symptom of PCS, as could gastro-oesophageal reflux, but these will require different treatments and may have different causes, although many symptoms can be related to changes in bile flow following removal of the gallbladder.

Dr David Maplesden, Medical Advisor, Health and Disability Commissioner

Bile (duodenogastric) reflux occurring in 20%-30% of patients [3,4,5]. Likely damage attributable to chronic bile exposure post-cholecystectomy includes:

  • cellular damage to esophagogastric junction
  • bile induced Gastroesophageal Mucosal Injury (Protective barrier that constrains the acidic reflux)
  • increase the incidence of gastric and esophageal cancer

Glaringly, the  HDC’s own words also elude to the fact consent was not legally obtained and a criminal offence occurred, as doctors have an obligation to abide by the Code of Health and Disability Services Consumers’ Rights (the Code). Under the Code, every patient has the right to make an informed choice and to give informed consent. This is also a breach of common law .

“There was insufficient information available to assess the suitability of the (Original Cholecystectomy) procedure for Mrs A, including the risks and benefits. Consequently, he did not provide her with an adequate explanation of her condition (“epigastric pain not entirely typical of biliary colic and non-ulcer dyspepsia” with no presence of gallstones mentioned) This was information she needed before making an informed choice or giving informed consent. Accordingly, in my view, Dr C breached Rights 6(2) and 7(1) of the Code.

The HDC strangely forgot to mention this section of the Code that states patients are required to be advised of ‘alternative treatment options and side effects’:

“An explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option”

More importantly, had the Postcholecystectomy side effects risks been disclosed on both occasions by the surgeon, who also carried out the original procedure, the patient would most likely understand the underlining cause of  the problems that she was experiencing for the 13-year period after the original treatment for ‘gallstones / gallbladder problems’ . As such, secondary procedures and the resulting major injury would never have occurred.

Question 2: Did the surgeon mislead the HDC?    

The surgeon is able to review blood results, received electronically. Yet, when receiving and reading the CT scan with the patient’s details, he was unable to connect the dots between that and the patient’s report because he could not print out the relevant information. Apparently, this occurred because he sent this to a remote printer, behind a locked door, he did not know how to re-print to an alternative, closer printer.

Although the surgeon advised the patient a CT scan was necessary before making a decision about surgery, there was a completed and signed CT request form. The HDC was advised he did “not expecting the procedure to have been carried out at all”. “He claimed that the administration staff took it upon themselves to remove the form from the file and action it, without reference to him”, claiming, “ (bad) administration staff departed from the usual process.”

This is another example of the hospital’s gross culpability in providing information necessary to determine there was no gallbladder in place. In addition, the cholecystectomy clips were seen and surgery was unnecessary. Displaying complete negligence to investigate and treat other root causes of the issue.

When the patient “asked him about the result of a scan on the morning of her surgery” the surgeon believed that she was referring to the April ultrasound scan” two month prior, and so he “repeated the information he had already provided”.

Investigation notes:

  • The result of the CT scan was sent electronically to Dr C on the 29th of May. The report stated: “Cholecystectomy clips are seen. …IMPRESSION: Post-cholecystectomy status with mild prominence to the common hepatic duct and left hepatic duct. Correlation with liver functions is recommended. Incidental non-obstructive left renal calculus.”
  • Dr C advised the HDC he received number of reports sent to him that day.  When opening the report for the patient “he noted Mrs A’s name at the top of the report. Dr C said, “I acknowledged the CT report without recognising it as [Mrs A’s] particular case.”. He displayed no concern that the results were ignored because they were sent to printer in a locked room. He failed to call after hours IT support to learn how to select another printer, on an IT system that had been in operation for three months. Again it was deemed as the Hospital’s fault.

More about side effects not disclosed:

Post Cholecystectomy side effect complications, also known as Postcholecystectomy Syndrome (PCS) include:

Cholecystectomy is associated with several physiological changes in the upper gastrointestinal tract, which may account for the persistence of symptoms or the development of new symptoms after gallbladder removal. The cholecyst sphincter of Oddi reflex, cholecyst-antral reflex, and cholecyst-oesophagal reflexes are all disrupted and some local upper gastrointestinal hormonal changes also occur after cholecystectomy. Thus, there is an increased incidence of gastritis, alkaline duodene gastric reflux and gastro-oesophageal reflux after cholecystectomy, all of which may be the basis for postcholecystectomy symptoms.

Symptoms occur in about 5 to 40 per cent of patients who undergo cholecystectomy, and can be transient, persistent or lifelong. The chronic condition is diagnosed in approximately 10% of postcholecystectomy cases

(See appendices section for full details of side effects affecting quality of life)

See link for more details http://lifewithnogallbladder.com/faq/postcholecystectomy-syndrome-pcs/

Question 3: Under well-established HDC protection, was this patient blocked from receiving diagnosis and treatment of Postcholecystectomy side effect complications for a 13-year period?

HDC past rulings Investigation HDC6446 , Investigation 2HDC00779, Investigation 11HDC00531,  support the New Zealand Surgeons’ opinions that Postcholecystectomy Syndrome and the risk of developing side effects, chronic or life lasting, is at most, only – simply – controversial.

HDC supporting ruling statements on Right to be fully informed, Right to make an informed decision:

  • “Removal of the gallbladder is generally considered to have no lasting consequences, although some people experience more frequent and less formed stools or diarrhoea”
  • “When NZ surgeon who has explained the (see 100K reward) general and specific complications of the procedure (The types of complications discussed are those arising interpretatively, or well recognised post-operative complications (such as bleeding, infection). ” I do not consider that further medical advice is necessary.

By not providing genuine treatment, the patient was left to suffer these known side effect complications for years. Withholding treatment support is arguably equal to medical torture. The fact that the surgeon, doctor or the DHB maintain the opinion that Postcholecystectomy Syndrome is merely controversial, and that the cholecystectomy and removal of the gallbladder and its function has “no likely health complications“, is a misguided, cruel opinion. Even using these opinions to prevent post-care treatment support could be described as degrading, and is a torturous infliction of physical, or mental, pain and suffering on victims’ having to watch their health fail while blocked from post-care support or proper diagnosis. Furthermore, this behaviour is likely in breach of The Convention on the Elimination of All Forms of Discrimination against Women (1979).

There remains the possibility of breaches being identified if the protection is removed and complaints are investigated:

Breach of the code by the doctor / surgeon:

A breach of Right 4(1) – the right to have services provided in a manner that minimised the potential harm and optimised her quality of life (Right 4(4)). A Failure to appropriately investigate and manage well-recognised Postcholecystectomy health complications breaches the patient’s rights under the Code, in particular her right to have services provided with reasonable care and skill.

  • Cholecystectomy patients are entitled to receive services of an appropriate standard from the DHB’s surgeons and doctors. They are also entitled to have symptoms investigated appropriately, to find and confirm the underlying cause of problems, and a proper diagnosis in order to provide correct treatment for symptoms.
  • Patient safety is compromised through the failing to get the basic assessments right and a failure to carry out an investigation into the underlying cause of symptoms needed to mitigate and treat side effect risks, also known as Postcholecystectomy Syndrome.

The doctor / surgeon fail to disclose the risk of harm from post side effects of cholecystectomy. In doing so, they breached the following rights:

Right (1)(a) of the Code provides that patients have the right to be treated with respect. Failure to disclose inadvertent harm from side effects involves tacit deception – respect for patient autonomy supports a truthful and sensitive discussion about what can go wrong once the gallbladder and its function is removed,  side-effects disabling a patient health and why

Right 5(2) of the Code every patient has the right to an environment that enables both patient and doctor to communicate openly, honestly, and effectively. Open and honest communication requires surgeons to disclose the truth about harm and injury to the body’s ability to function normally and side effects once the gallbladder function is removed on the part of the doctor;

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 cholecystectomy side-effects occurs, the patient is entitled to open, truthful, and timely information about the post complications, its effect and its significance of quality of life

Question 4: Why did the Surgeon and/or the DHB not provide an honest and transparent description of the true nature and extend of injury to the patient. Was this ever disclosed to the patient?

According the HDC investigation notes, the surgeon causes in injury to an ‘extrahepatic bile duct’.  A more honest and direct disclosure would have been, the surgeon in fact ‘removed a section of the common bile duct’. A significant and serious outcome that is most likely to affect the patient for life.

More about: extrahepatic bile duct’

  • Extrahepatic bile ducts – Are small tubes that carry bile outside of the liver. They are made up of the common hepatic duct (hilum region) and the (common bile duct).
  • Bile duct injury and its effect on a patient – “The incidence of Bile Duct Injury (BDI) during laparoscopic cholecystectomy has decreased but remains as high as 1.4%. Despite the excellent functional outcome after repair, the occurrence of a BDI has a great impact on the patient’s physical and mental quality of life, even at long-term follow-up”.  [3]

6. Summary

The sad, inhumane treatment carried out on this woman would never have happened if New Zealand surgeons would come clean about the well-known likely side effect risks of Postcholecystectomy Syndrome (PCS). It is a heterogeneous group of diseases and symptoms presenting following gallbladder removal. Symptoms occur in up to 40% of patients overall, and up to 43% in women who undergo a cholecystectomy. These symptoms can be transient, persistent or lifelong.

Although the HDC forwarded the case to the Director of Proceedings, the Director decided not to take disciplinary proceedings against the surgeon in this case, or bring a claim for damages before the HRRT, because the consumer is eligible for ACC cover for the treatment injury that would preclude an award of compensatory damages.

The consequences for criminal negligence conducted on this woman, including informed consent fraud, are non-existent and remain under the protection of the HDC. No doctor will ever see the inside of a court room in New Zealand for their culpability in ruining this woman’s later years of life, in an entirely preventable act.

7. References

  1. Dr. Alwyn Wong, DC.  December 1, 2015. Top 10 Causes of Epigastric Pain in the Upper Abdomen. https://www.doctorshealthpress.com/general-health-articles/causes-of-epigastric-pain-in-upper-abdomen/
  2. Health Navigator New Zealand. Proton pump inhibitors. https://www.healthnavigator.org.nz/medicines/p/proton-pump-inhibitors/
  3. Nudo R, Pasta V, Monti M, Vergine M, Picardi N.Correlation between post-cholecystectomy syndrome and biliary reflux gastritis. Endoscopic study. https://www.ncbi.nlm.nih.gov/pubmed/2699712
  4. Lorusso D1, Pezzolla F, Montesani C, Giorgio P, Caruso ML, Cavallini A, Guerra V, Misciagna G. Duodenogastric reflux and gastric histology after cholecystectomy with or without sphincteroplasty https://www.ncbi.nlm.nih.gov/pubmed/2253017
  5. Shah Gilani SN1, Bass GA1, Kharytaniuk N2, Downes MR3, Caffrey EF3, Tobbia I3, Walsh TN4. Gastroesophageal Mucosal Injury after Cholecystectomy: An Indication for Surveillance? https://doi.org/10.1016/j.jamcollsurg.2016.12.003
  6. S.S.JaunooS MohandasL.M.Almond. Postcholecystectomy syndrome (PCS) https://www.sciencedirect.com/science/article/pii/S1743919109001538
  7. Boerma, D., Rauws, E. A. J., Keulemans, Y. C. A., Bergman, J. J. G. H. M., Obertop, H., Huibregtse, K., & Gouma, D. J. (2001). Impaired Quality of Life 5 Years After Bile Duct Injury During Laparoscopic Cholecystectomy: A Prospective Analysis. Annals of Surgery, 234(6), 750–757. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1422134/
  8. NEW ZEALAND Herald.  Surgeon’s trouble for op double-up.  Nov, 2011 http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10763045