Ethically it is a breach of duty by failing to warn of true likely risks associated with removing gallbladder and its function by a junior less experienced surgeons, training or otherwise.
Informed Consent
The legal doctrine of informed consent can be traced back to the post-World War II Nuremburg Code, a set of guidelines drafted to ensure that unethical “medical” experiments were no longer carried out in the name of science. The doctrine is founded on the general principle that a person of the age of majority and sound mind has a legal right to determine what may be done to his or her body. Thus, when a patient is subjected to a procedure he or she has not agreed to, the physician performing that procedure is violating the patient’s legal rights and may be subject to medical malpractice litigation
The following raises the ethical violations hospital surgeons a are carrying out on patients when not discloses a surgeons experience and added risk of inoperative complications when conduction Laparoscopic Cholecystectomy (LC) .
LEGAL – Violations
No one has the right to even touch, let alone treat another person. Any such act, done without permission (as a result of making informed consent), is classified as “battery” – physical assault and is punishable.
ETHICAL – Violations
The concept of consent arises from the ethical principle of patient autonomy and basic human rights. Patient’s has all the freedom to decide what should or should not happen to his/her body and to gather information before undergoing a test/procedure/surgery. No one else has the right to coerce the patient to act in a particular way.
What the law says
UK ” The legal position regarding the provision of information needed to make an informed consent derives from the 1985 case of Sidaway v Board of Governors Bethlem Royal Hospital (Sidaway v Board of Governors Bethlem Royal and the Maudsley Hospital [1985] 2 WLR 480), where the House of Lords held that the legal standard to be used in deciding whether adequate information had been given to a patient would be the same as that in judging whether a doctor had been negligent in their care”
US ” What constitutes a material risk is at the heart of the controversy surrounding the informed consent doctrine. Generally, the patient should be informed of all serious risks, even if unusual or rare. In one court case, a 1% risk of hearing loss required disclosure (Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965])
In Canterbury, a young man was advised by his physician to undergo a laminectomy in an effort to alleviate back pain. The physician, aware that 1 percent of laminectomies resulted in paralysis, did not advise the patient of the risk because he believed this might cause the patient to reject the useful treatment. Following the procedure, the patient fell from his hospital bed and was paralyzed. It remained uncertain whether the laminectomy procedure or the patient’s fall caused the paralysis.
The patient sued, alleging that the physician failed to inform him of the risks associated with the procedure. The court held that “the standard measuring [physician] performance…is conduct which is reasonable under the circumstances” [3]. In other words, the court held that, instead of adhering to the community disclosure standard, physicians are now required to disclose information if it is reasonable to do so. Essentially, to establish true informed consent, a physician is now required to disclose all risks that might affect a patient’s treatment decisions.
In Canterbury, the decision outlined key pieces of information that a physician must disclose:
(1) condition being treated; (2) nature and character of the proposed treatment or surgical procedure; (3) anticipated results; (4) recognized possible alternative forms of treatment; and (5) recognized serious possible risks, complications, and anticipated benefits involved in the treatment or surgical procedure, as well as the recognized possible alternative forms of treatment, including non-treatment [4, 5].
Medical Studies confirming informed consent fraud of risks when surgery conducted by junior or less experienced surgeons
Submission A :
“The laparoscopic “learning curve” of the surgeon is a key-factor contributing to the high rates of bile duct injury. However, in comparison with air plane pilots, this surgical concept of learning curve is by some aspects ethically unacceptable.”
“The southern Surgeons Club series reported bile duct injury rate in the first 13 patients operated on was 2.2%, compared to 0.1% subsequent patients . Later, the same group reported 90% of BDI in a series of 8,8829 LC occurred before 30 cases of experience”
“In the Connecticut state audit reported by Orlando et al, 53% of the reported BDI occurred during the surgeon’s first ten cases, 33% between case 11-50 and only two cases (13%) after 50.”
Submission B:
“This study confirms a higher incidence of Bile Duct Injury (BDI) during LC. It highlights the relevance of the number of previously performed LCs and of the correct surgical technique to avoid BDI. The need for correct procedures, adequate expertise of the repairing surgeon in BDI repairs, and a multidisciplinary approach in the management of BDI is emphasized”
Submission C:
“Several reports have tried to address the learning curve. For open cholecystectomy a large Swedish survey showed that most biliary injuries were made between the 25th-100th operations per surgeon . The Southern Surgeons Club reported an initial high rate of bile duct injury (2.2%) during the first 13 laparoscopic cholecystectomies performed by a surgeon. This rate fell to 0.1% for subsequent operations. The West of Scotland group conducted a prospective audit on biliary injuries between 1990-1995 and reported an injury rate of 0.8% in the first year, which decreased to 0.4% in the final year of the audit. Although experience is important in the reduction of bile duct injuries, it is clear that in the laparoscopic era there is no norm and that the learning curve is surgeon-related. Thus bile duct injuries sustained during LC occur over a larger spectrum of experience by individual surgeons”
References:
- A – Gigot, J.-Fr. Bile Duct Injury during Laparoscopic Cholecystectomy: Risk Factors, Mechanisms, Type, Severity and Immediate Detection. https://doi.org/10.1080/00015458.2003.11679400
- B – Nuzzo G, Giuliante F, Giovannini I, Ardito F, D’Acapito F, Vellone M, Murazio M, Capelli G. Bile Duct Injury During Laparoscopic CholecystectomyResults of an Italian National Survey on 56 591 Cholecystectomies. Arch Surg. 2005;140(10):986–992. doi:10.1001/archsurg.140.10.986 https://jamanetwork.com/journals/jamasurgery/fullarticle/509003
- C – G.E.I.ShallalyA.Cuschieri(Prof). Nature, aetiology and outcome of bile duct injuries after laparoscopic cholecystectomy
- https://doi.org/10.1016/S1365-182X(17)30693-7
- DSteven D. SchwaitzbergEmail authorDaniel J. ScottDaniel B. JonesSophia K. McKinleyJohanna CastrillionTina D. HunterL. Michael Brunt. Threefold increased bile duct injury rate is associated with less surgeon experience in an insurance claims . https://doi.org/10.1007/s00464-014-3580-0
- Bryan Murray. American Medical Association Journal of Ethics. July 2012, Volume 14, Number 7: 563-566.
- HEALTH LAW – Informed Consent: What Must a Physician Disclose to a Patient? http://journalofethics.ama-assn.org/2012/07/hlaw1-1207.html
- Satyanarayana Rao, K. H. (2008). Informed Consent: An Ethical Obligation or Legal Compulsion? Journal of Cutaneous and Aesthetic Surgery, 1(1), 33–35. http://doi.org/10.4103/0974-2077.41159
