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[YanTing]

Complementary and alternative medicine, medical liability and the proper standard of care

Vera Lúcia Raposo
Faculty of Law, University of Macau, Macau, China

Complementary Therapies in Clinical Practice, 2019-05-01, Volume 35, Pages 183-188

Abstract

Complementary and alternative medicine raises growing interests among population. Patients have the right to reject conventional medicine and instead look for a different treatment, even if sometimes is a placebo. However, currently this risks being a reckless decision, since the way complementary and alternative medicine is being provided leaves space for fraudulent practices, misleading information, wrong diagnosis, improper treatments and thus severe patient's injuries.

This paper will discuss the standard of care to be demanded from providers of complementary and alternative medicine. The paper will sustain that it should be bound to a CAM specific standard of care, expose the reasons for this solution and describe the consequences derived therein. It will conclude that the solution to protect CAM users does not rely in the extension of conventional standard of care to CAM practitioners, but in more regulation and more control for CAM practices and CAM practitioners.

https://www.sciencedirect.com/science/article/pii/S1744388118308235


Excerpts:

"This study will use the designation complementary and alternative medicine to present it as another form of medicine. However, some jurisdictions opted for different designations, as a way to underline that it is not considered a form of medicine, conventional medicine being the only medicine accepted. For instance, in Portugal it is commonly called ‘non-conventional therapeutics’ and in France it is referred to as ‘unconventional practices with a therapeutic aim’."

"Currently patients that look for CAM might be putting themselves in a reckless situation due to the lack of regulation and the inability of courts to deal with medical malpractice of CAM practitioners. Fraudulent practices, misleading information, erroneous diagnosis and improper treatments are frequent (although some of these incidents are also frequent in conventional medicine), with the aggravating note that the standard of care for CAM providers is not clear. The definition of the proper standard of care is crucial for patients, so they can conform their expectations in what regards the type of health care to be provided by CAM practitioners. It is relevant for CAM practitioners, because they must know what is expected from them – by patients, health authorities, and courts – in what regards their services. It is also important for the ones that will assess the activity of the CAM providers, especially for courts in case of legal proceedings."

"CAM modalities are so different amongst them that it is difficult to provide a comprehensive definition. In general, all of them share two essential features: its efficiency is undemonstrated and it could hardly be scientifically demonstrated in clinical trials and other scientific studies..."

"This paper does not intend to advocate for or against the use of CAM..but to analyse the standard of care to be used in CAM and the consequent medical liability associated it."

"CAM has not, until now, been the subject of serious malpractice litigation. Several reasons explain the state of grace in which CAM has existed until now: the fact that CAM is perceived as involving minor risks to their users, the perception of CAM more as a life-style routine than a real medicine, the kind of relation build between the CAM practitioner and the patient, the pro-active role of CAM patients in their own healing process, making them also responsible for the outcome of the treatment."

"Nonetheless, the overall number of lawsuits is likely to increase."

"A clear definition of the standard of care to be expected from CAM providers is crucial for imposing accountability and protect its users."

"In what regards CAM standard of care two solutions can be adopted: either the application of the same standard of care valid for conventional medicine either a CAM specific standard of care."

"The same standard of care of conventional medicine

"According with this position the standard of care of conventional medicine should apply because the practitioner of CAM holds himself as a doctor specialised in the treatment of certain medical conditions, therefore, his/her behaviour shall be guided by exact the same rules of those who treat the same medical conditions in conventional medicine."

"However, for CAM practitioners this is a particularly demanding solution, since the mere fact that they use methods that deviate from accepted medical practices constitutes a violation of the standard of care and will held them liable.

"This position was sustained in some court cases, one of the most well-known being the decision about the Gonzalez Regimen, led by Dr. Nicholas Gonzalez...In a case involving this regimen the Supreme Court of New York said: ‘The standard for proving negligence in a malpractice case is whether the treatment deviates from accepted medical standards … it would seem then that no practitioner of alternative medicine could prevail on such a question as the reference to the term 'non-conventional' may well necessitate a finding that the doctor who practices such medicine deviates from 'accepted' medical standards. This indeed creates a problem for such physicians which perhaps can only be solved by having the patient execute a comprehensive consent containing appropriate information as to the risks involved’"

"A specific standard of care for CAM

"The thesis that CAM should follow (and thus should be evaluated in light of) a specific standard of care is based in two different arguments."

"Patients look for CAM because they reject conventional medicine...and prefer to receive a different kind of treatment, thus, that is what the patient shall receive. If in the end the patient is not satisfied with the treatment provided and/or the outcome, litigation is an option, but in court the patient cannot complain because he/she has not received a treatment in accordance with the standard of care that he/she previously rejected."

"If CAM is not conventional medicine it would be illogical, unpractical and even unfair for CAM providers to demand from them the same behaviour that is required from conventional doctors. If that was the case CAM won't be considered as that anymore, but simply considered conventional medicine.

"This thesis found acceptance in some court proceedings, namely in the Shakoor case...Mr Shakoor suffered from a benign lipoma...Mr Shakoor went to a UK based Chinese herbalist..The herbalist prescribed him a mix of herbs, including Bai Xian Pi, to be taken during several days, but after nine doses Mr Shakoor started feeling nausea, was vomiting and suffering several other discomforts. He has diagnosed with hepatic necrosis and eventually died...A strong evidence against the defendant was an article published shortly before this incident in a reputed conventional medical journal, The Lancet , alerting for the risks of the referred herb for leaver [sic] conditions...However, the Chinese herbalist did not read the Lancet, nor any other publication of conventional medicine...The Court reached two conclusions. First, that the defendant had acted in accordance with the standard of care appropriate to traditional Chinese herbal medicine. Secondly, and therefore, that he had not been in breach of his duty of care."

"Like the Court in the Shakoor case, this paper sustains that the standard of care that applies to conventional physicians should not apply to CAM practitioners, who must be judged according to the standard of care recognized within the field in which they are licensed."

"This solution applies to practitioners that are not licensed to practice conventional medicine. If that is not the case and the CAM doctor is authorized to provide conventional treatments both standards of care – the one of CAM and the one of conventional medicine – will apply. In fact, in this case the CAM doctor cannot dodge responsibility for not having provided the best care to the patient alleging his/her lack of awareness about conventional medicine...A well-known case of malpractice within CAM involved Dr. Woliner, an US conventional doctor that presented himself as a holistic doctor. The medical license of Dr. Woliner was revoked by the Florida Board of Medicine after he decided to treat a patient previously diagnosed with cancer with a ‘holistic treatment’, arguing that the symptoms revealed by the patient were not due to cancer but to allergies and based on his recommendation the patient quit all conventional treatments."

"Several consequences derive from the existence of an autonomous standard of care for CAM.

"First of all, the care provided by CAM practitioners is not deviant or unlawful just because it does not follow the canons of conventional medicine...There is no point in recognising the existence of CAM and allowing CAM services to be provided, and then holding its practitioners accountable for the simple fact that they offer CAM services.

"Secondly, different regulations should apply to these two forms of medicine."

"Furthermore, expert testimony in court proceedings involving CAM practitioners cannot be done by doctors of conventional medicine, obviously unaware of CAM's specificities, but by practitioners operating in the very same field of the defendants. The exception will be when there is an overlap of expertise between conventional medicine and CAM, that is, when the level of knowledge and expertise required from the CAM practitioner is the same that would be required from a conventional medicine practitioner."

"Finally, CAM specific standard of care has its own sources: guidelines provided by professional associations, Codes of Ethics developed by CAM practitioners, books and ancient knowledge."

"However, the recognition of a specific standard of care for CAM does not exclude CAM providers from complying with the existing laws. This means that CAM practitioners cannot prescribe substances considered illegal by the existing laws..."

"Several situations can involve the CAM practitioner in medical malpractice: lack of license, misdiagnosis, failure to monitor and report adverse effects, nondisclosure of conflicts of interest, fabrication of research data."

"CAM practitioners have been held liable for not referring the patient to a doctor of conventional medicine, thus failing to identity that the patient's condition require treatments only provided by the latter."

"Convictions based on the violation of this duty are frequent in US courts, especially with cancer patients."

"CAM doctors must recognize the limitations of their respective therapies and comply with the duty to refer the patient for a conventional physician.

"However, for that assessment the CAM doctor is only required to use the particular knowledge of his/her CAM practice. If by chance the decision to recommend conventional treatments could only be taken using knowledge specific of conventional medicine, not accessible to a regular CAM doctor (thus, excluding the cases in which the CAM doctor is also a conventional doctor) the CAM won't be required to make that assessment."

"In light of current scientific knowledge, it is fair to assume that the reasonable CAM doctor (the reasonable person criteria applied to medical practice) would conclude that only conventional medicine is able to treat cancer."

"In what regards other medical conditions might not be so easy to assess if CAM is or is not suitable. In Kerkman v. Hintz (Supreme Court of Wisconsin, 418 N.W. 2d 795 1988) the Supreme Court of Wisconsin stated that a chiropractor was not required to conclude that a cervical subluxation should be treated with conventional treatments instead of chiropractic treatments."

"...the chiropractor is held to that degree of care, diligence, judgment, and skill which is exercised by a reasonable chiropractor under like or similar circumstances'."

"Patient informed consent seems to be still in a very preliminary stage in CAM, as concluded by a study performed in 2010...One of the conclusions of the study was that few CAM doctors have written consent forms and that the amount of information provided was quite low, because most CAM doctors got the impression that patients looking for their services would not enter into litigation. Many CAM doctors even considered informed consent to be exclusive of conventional medicine..."

"On the opposite, some have argued for a more demanding standard for informed consent in what regards CAM, based on its classification as an experimental practice due to the lack of scientific validation. If that were the case, indeed, CAM's informed consent would have to be more detailed, based on the higher level of demand imposed for experimental treatments."

"In order to comply with the requisites of informed consent the CAM doctor must inform the patient about the treatment that it is going to be provided and possible alternatives, including the reference to conventional medicine...the risks involved (many CAM doctors consider their practice to be immune to risk, but that is not the case), the outcome...and the fact that CAM does not count with reliable scientific evidence, even though some anecdotal cases may reveal stories of success.

"CAM practitioners may be sued for failing to inform their patients about their conditions and the treatment proposed, in particular, failing to adequately disclose the risks of the therapies they provide."

"...for most CAM therapies we don't know if they are save [sic] and efficient enough to be regularly used in patients, what are their risks and how they work.

"So, if the CAM practitioner is only bond to a standard of care based in his/her area of practice – as sustained in this paper - chances are that this standard of care is based on undemonstrated expertise, leaving the patient unprotected.

"In order to have a specific CAM standard of care that is not detrimental for patients some measure need to be implemented.

"Such measures involve strict scrutiny of all CAM therapies to be authorized in the jurisdiction....The method to evaluate CAM might not be exactly the same used for conventional medicine. For instance, randomised controlled trials – one of the most efficient tests for conventional treatments – might have to be substituted or complemented by other methods."

"After the CAM therapy is authorized, strict control regarding each practitioner must be implemented. There should be a licensing process to prevent the exercise of the profession by con artists."

"Control cannot stop after the licensing, since practitioners must have their activity monitored at all time by health authorities. Professional associations can also be useful for controlling the exercise of the CAM practice..."