Origin of ‘informed consent’ and its implications
In
various relationships like marriage, Businesses, services, consumer goods,
lawyer-clients, etc. It is always understood that a duty is liable like for
example in the relationship between lawyers-clients the lawyers have a duty
towards their clients to make disclosure of any conflict of interest that has
arose and accordingly inform them and if the lawyer fails to do the same it is
said to be a breach of duty on the lawyer’s part.
The
moral of the story is that the client should not be the one who should suffer
for the mistake of the lawyer. Therefore the question here is that why should
not the same rule apply to doctors that is should it not be the duty of a
doctor to inform the patient about the necessary care and treatment.
History
"Informed
consent" is a technical term first used in a medical malpractice United
States court case in 1957.
These practices are
all part of what constitutes informed consent and their history is the history
of informed
Consent. They
combined to form the modern concept of informed consent rose in response to
particular problems
This happened in
modern research. Whereas various cultures in various places practiced informed
consent, the
Modern concept of
informed consent was developed by people who drew influence from Western
tradition.
In this context originated the role of ‘informed consent’ in
the field of medical treatment in common law jurisdictions which mainly
originated in the United States and spread to Canada although not much
influence has been made on the English legal system.
[1]. This doctrine is also well developed
in numerous civil law countries like France and Switzerland where informed
consent is directly linked to an individual’s right of self-determination.
[2]
Medical history
Medicine and History
goes hand in hand since birth of human kind there is presence of disease and
being a Homoeopath, Dr.Hahnemann follower I understand history is a very
important part to understand any topic. Everything in Medicine starts with
Hippocrates and Dr.Hahnemann, a conjunction of Modern and Old school of
medicine under every aspect of the sciences.
Historians cite a
series of medical guidelines to trace the history of informed consent in
medical practice.
The Hippocratic
Oath, a 500 B.C.E. Greek text, was the first set of Western writings giving
guidelines for the
Conduct of medical
professionals and a similar text the Hahnemannain Oath, It advises that
physicians should conceal most information from patients in order
To give the patients
the best care. The rationale is a beneficence model for care; the doctor knows
better than the
Patient and
therefore should direct the patient's care because the patient is not likely to
have ideas which would be
Better than the
doctor's.
Henri de Mondeville was a French surgeon who
in the 1300s wrote about medical practice. He traced his ideas to the
Hippocratic Oath.
Among his recommendations were that doctors "promise a cure to every
patient" in hopes
That the good
prognosis would inspire a good outcome to treatment although .Mondeville never
mentioned getting consent,
But did emphasize
the need for the patient to have confidence in the doctor. He also advised that
when deciding
Therapeutically
unimportant details the doctor should meet the patients' requests "so far
as they do not interfere with
treatment"
Benjamin Rush was an
18th-century United States physician who was influenced by the Age of
Enlightenment
Cultural movement.
Because of this, he advised that doctors ought to share as much information as
possible with patients. He recommended that doctors educate the public and
respect a patient's informed decision to accept
therapy. There is no
evidence that he supported seeking consent from patients. In a lecture titled
"On the
duties of patients
to their physicians", he stated that patients should be strictly obedient
to the physician's orders; this
was representative
of much of his writings.
John Gregory, Rush's
teacher, wrote similar views that a doctor could
best practice
beneficence by making decisions for the patients without their consent.
Thomas Percival was
a British physician who published a book called Medical Ethics in 1803.
Percival was a student
of the works of Gregory and various earlier Hippocratic physicians.
Like all previous works,
Percival's
Medical Ethics makes no mention of soliciting for the consent
of patients or respecting their decisions. Percival
said that patients
have a right to truth, but when the physician could provide better treatment by
lying or withholding
information, he
advised that the physician do as he thought best.
When the American
Medical Association was founded they in 1847 produced a work called the first
edition of the
American Medical
Association Code of Medical Ethics. Many sections of this book are verbatim copies of
Passages from
Percival's Medical Ethics. A new concept in this book was the idea that
physicians should fully
disclose all patient
details truthfully when talking to other physicians, but the text does not also
apply this idea to
disclosing
information to patients. Through this text, Percival's ideas became pervasive
guidelines throughout the
United States as
other texts were derived from them.
Worthington Hooker
was an American physician who in 1849 published Physician and Patient.
This medical
ethics book was
radical demonstrating understanding of the AMA's guidelines and Percival's
philosophy and soundly
rejecting all
directives that a doctor should lie to patients. In Hooker's view, benevolent
deception is not fair to the
patient, and he
lectured widely on this topic.Hooker's ideas were not broadly influential. Thus
we see a general idea about Ethics and Physicians duties towards patient which
later on implied towards a proper Informed Consent procedure.
History makes Doctor
like God and Law makes him more human and answerable to variety of questions.
THE
PROCESS FOR OBTAINING INFORMED CONSENT:
Informed
consent is a process for getting permission before conducting any form of
health care on a patient and such informed consent has to be given by a patient
by understanding all necessary facts, implications and consequences of the said
medical treatment or procedure, which are to be given by the doctor.
[3]. Impairments to
reasoning and judgment which may make it impossible for someone to give
informed consent include such factors as basic intellectual or emotional
immaturity, high levels of stress or a severe intellectual disability, severe
mental illness, intoxication, severe sleep deprivation, Alzheimer's disease, or
being in a coma.
Some
acts can take place because of a lack of informed consent. In cases where an
individual is considered unable to give informed consent, another person is
generally authorized to give consent on his behalf, e.g., parents or legal
guardians of a child (though in this circumstance the child may be required to
provide informed assent) and guardians for the mentally ill. [4]
The
methods of Obtaining the Consent can be summarized as follows:
Consent can be given in the following ways:
a.
Express Consent: It may be oral or in writing. Though both these
categories of consents are of equal value, written consent can be considered as
superior because of its evidential value.
b.
Implied Consent: Implied consent may be implied by patient's
conduct.
c.
Tacit Consent: Tacit consent means implied consent understood
without being stated.
d. Surrogate
consent: This consent is given by family members. Generally, courts have held
that consent of family members with the written approval of 2 physicians
sufficiently protects a patient's interest.
Advance consent, proxy consent,
and presumed consent are also used. While the term advance consent is the
consent given by patient in advance, proxy consent indicates consent given by
an authorized person. As mentioned earlier, informed consent obtained after
explaining all possible risks and side effects is superior to all other forms
of consent.
Consent does not mean mere writing YES in the
consent form. What the surgeon is going to do has to be clearly explained and
only in that case the person concerned can exercise his discretion. So
obtaining the consent is not a matter of mere formality.
The
doctrine of informed consent mostly falls within the law of tort and also has
its roots in criminal law. [5]. The idea behind
this doctrine is that a patient should be able to determine as to what should
be done with his or her body and accordingly decide to take up the necessary
treatment or not. It is here that flows the duty of the doctor to protect the
patient’s right of self-determination by disclosing all the necessary
information that includes the nature of the treatment, associated risks and any
possible alternatives, so that the patient is able to make a proper decision.
[6]. Physicians and
doctors owe their patients an honest relationship duty which requires them to
act exclusively in the interest of the patient and to disclose all the
information which is material to the interest of the patient. However when it
comes to a doctor’s duty to disclose there are a few issues. Firstly the
doctor’s duty to disclose all material facts is very relative from jurisdiction
to jurisdiction with respect to the numeric probability of an adverse medical
outcome.
The question that
arises is that does this probability refer to the average risk that can be
incurred by the large population or does the risk only extend to the smallest
group to which the patient belongs, the latter being more relevant to the
patient[7].
In this context, the Supreme Court of California in Arato v Avedon[8], considered
the victim’s claim, who was the wife of a deceased pancreatic cancer patient,
that failure to disclose information regarding the life expectancy of
pancreatic cancer patients meant breach of duty of informed consent. The
plaintiffs argued that had they known about the life expectancy[9],
then the deceased would not have been subjected to such painful therapy and
treatment and would not have incurred such economic losses. The Court held that
the rule of law required the disclosure of specific information that included
the statistical life expectancy from a given treatment.
Arato completed a routine questionnaire that asked, among
other things, whether he wanted to be “told the truth” about his pancreatic
cancer condition. Arato answered yes. The oncologists, including Dr. Melvin
Avedon (defendant), recommended a course of chemotherapy medication and
radiation treatment. Arato and his wife were never told the statistical
probability of his survival. Arato nor his wife ever asked for life expectancy
information and Arato’s operating surgeon did not disclose statistical life
expectancy data because Arato was extremely anxious about his condition. Avedon
also did not disclose the specific statistics because the direct disclosure of
extremely high mortality rates for pancreatic cancer would negatively impact
Arato’s hope for a possible cure. About eight months after his surgery, Arato’s
cancer returned and quickly spread. He died shortly thereafter. Arato’s wife
(plaintiff) filed suit against Avedon, his surgeon, and the other physicians
alleging that they had not adequately disclosed statistical mortality
information of the cancer and thus failed to obtain his informed consent to
undergo the treatment. His wife claimed that had he known the bleak truth
regarding his chance for survival he would not have sought treatment and,
instead would have chosen to die peacefully at home. At trial, all of the physicians
testified that statistical life expectancy data obtained from large groups had
little predictive value when applied to a particular patient with individual
symptoms, history, etc. The jury found in favor of Avedon. A divided court of
appeals reversed and ordered a new trial. Avedon petitioned the California
Supreme Court to review the decision.
The
second issue with respect to the doctor’s duty to disclose is with respect to
disclosing alternatives. Doctors are ordinarily required to inform their
patients about the risks of treatments as well as any reasonable[10] alternatives. Some
jurisdictions even require the doctors to disclose even those forms of
treatment that may be more hazardous than the current treatment. The third
issue is related to causation or injury. Here causation is of two types namely
injury causation and decision causation. Injury causation is the undisclosed
risk that must have caused the patient’s harm, is an element of all informed
consent claims while decision causation is if the patient were properly
informed, he would have made a different decision with respect to the treatment.
Even under the prudent patient test, it
is the doctor who retains ample discretion over the best possible way to inform
the patient about the risks involved to his patient. Also this test does not
require the doctor to make disclosure to his patient, if in his judgement; it
would be harmful to the patient’s health or in cases where the patient has made
it clear that he does not want to know. Due to the fact that the average
patient knows so little about medicine, the patient must be able to receive all
details from the doctor so that he is able to make a good decision. It is due
to the right of the patient to make an informed choice that gave rise to the
duty of the doctor to make necessary disclosures of the risks that are related
to medical diagnosis and treatment. [11]
In Wilson v Scott[12], the Texas
Court stated that in some medical procedures, the dangers are big while in
other cases, the dangers are minimal and therefore probably some disclosures
may disturb the patient which may hinder necessary treatments. It is the medical
practitioner who should consider the health of the patient, the condition of
his heart and nervous system, his mental state and accordingly assess risks[13]
involved and their possible adverse
consequences if any on the patient.
The
point being ADEQUATE INFORMATION[14]
- the treating doctor should enable the
patient to make a balanced judgement as to whether he should submit himself to
the particular treatment or not. This means the doctor[15]
should disclose
a.) Nature and procedure
of the treatment and its purpose, benefits and effect;
b.) Alternatives ,if
available
c.)
Outline the substantial risks and adverse consequences of
refusing treatment.
Yet in this I hold a point where there
needs a discretion about not frightening the patient or confuse them with
remote risks and information. A balance should be achieved by the physician
individually, as we have seen earlier in the writing about the endometrial
cancer case where the patient overlooked every risk and simply followed her
choice the doctors opinion was not considered, although this again is an
individual case, not all patients are so dogmatic about decisions and consider
their physicians word over their own.
Here’s citing one more case of Informed
consent of another manner
IN
THE SUPREME COURT OF TEXAS
AARON
FELTON, PETITIONER,
Vs.
BROCK
LOVETT, D.C., RESPONDENT
Argued
September 13, 2012
Summary
of the Case:
Health
care must be based on a patient’s informed consent. A health care provider may
be
Liable
for failing to disclose to a patient the risks inherent in proposed treatment.
The issue in this case is whether the
possibility that a patient, due to an undetectable physical condition, will
suffer
a
severe, negative reaction to a procedure is a risk that is inherent in the
procedure.
Aaron
Felton sought treatment for neck pain from Brock Lovett, a doctor of
chiropractic.
Lovett
obtained a history, x-rayed Felton’s cervical spine, and on two occasions, manipulated
his
neck.
When the treatments did not provide relief, Lovett performed a more forceful
manipulation
on
Felton's third visit. Felton immediately began experiencing blurred vision,
nausea, and dizziness.
Lovett
called an ambulance, which took Felton to the hospital, where doctors
determined that he had
suffered
a stroke resulting from a vertebral artery dissection.
Lovett
was well aware of the risk of stroke from chiropractic neck manipulation. Just
that
morning,
he had been reading an article on the subject. And, he previously had a patient
who
suffered
a vertebral dissection.
Felton
sued, alleging that Lovett had failed to disclose the risks associated with the
neck
manipulations
and was negligent in treating him.
In this case the so called physician is a
CHIROPRACTIONER and not a MEDICAL doctor,
The
respondent appealed on this Basis
Lovett
appealed. For the law governing Felton’s claim for lack of informed consent,
the
court
of appeals looked to Section 74.101 of the Medical Liability Act (“MLA”), which
states: 2
In
a suit against a physician or health care provider involving a health care
liability
claim
that is based on the failure of the physician or health care provider to
disclose
or
adequately disclose the risks and hazards involved in the medical care or
surgical
procedure
rendered by the physician or health care provider, the only theory on
which
recovery may be obtained is that of negligence in failing to disclose the risks
or
hazards that could have influenced a reasonable person in making a decision to
give
or withhold consent.3
Id. at 390-391.
2
TEX. CIV. PRAC. & REM. CODE § 74.101
(emphasis added).
3
3This
is the theory the trial court submitted to the jury at Felton’s request and
without objection. But 4
as
Lovett argues, under the MLA, while a chiropractor is a “health care provider”,
he is not a
5
physician,
and “medical care” can be provided only by physicians. Also, Lovett did not
(and 6 7
Legally
could not) perform surgery. Thus, Felton’s suit was not based on a failure to
disclose the 8
risks
of “medical care or surgical procedure” and was not covered by Section 74.101.9
But
when Section 74.101 does not apply, the common law does. It imposes on 10
“physicians
and surgeons [the] duty to make a reasonable disclosure to a patient of risks
that are.
Cases like AARON FELTON, PETITIONER,
Vs.
BROCK LOVETT, D.C., RESPONDENT
Make us aware that informed consent is a tool
for the patient’s own safety. Here in this case it’s very important to
understand the variety of alternative methods available in market today.
Informed consent in cases of Psychiatry cases,
here there are immense possibilities. Taking the modern medicine methods there
may be certain levels of ease. When it comes to more traditional methods where
does the patient draw a line when they have no control?
Methods
like Herbal home remedies where only statutory warnings are given and available
at free will, I would say such procedures are seldom useful and often
misunderstood as FIRST-AID practice which is false and should be made evident
and more understanding. As a consulting doctor I have come across many such
cases where a medical intervention was avoided and Non-medical person was
approached. Without any lawful training and adequate expertise such practitioners
only mislead common man and since there is not much imposed upon them they are
not answerable.
Hypnosis – which involves that the practitioner
just take the Consent from the Universe or ether or Cosmos or the Soul, is a
very beyond Law Books concept.
How can the soul give consent?
How can Soul consent be proved in a court of
law?
Regressions techniques etc. involve the same
methods.
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