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Saturday, 23 August 2014

DOCTORS LIABILITY: WHEN AND TO WHAT EXTENT??? INFORMED CONSENT


Doctors Liability: When and to what extent?

When I read about the doctors Liability and its extent I come across this sentence “consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment.” The fact that the authorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from the pain and suffering in future are no grounds for defense here. In case it was to save life only then it’s an exception.
A common consent maybe taken where such an issue or doubt rises. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery
It is a well-accepted and established principle in Law that, every patient has a right to be adequately informed of his medical condition, and the same has been encoded in all rules guiding to medical ethics and medical practice. In moral philosophy this principle is commonly grounded in the principle of autonomy, whereas in law the patient's right to be adequately informed is asserted through requirements of informed consent.
 York Hospital[1], Respondent  it was held that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.”


A second case of NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
NEW DELHI
ORIGINAL PETITION NO. 171 OF 1997

1.      Smt. Narangiben Subodhchandra Shah
          Through her LRs/Complainants No. 2 to 4

2.      Vipul Subodhchandra Shah

3.      Bhavik Subodhchandra Shah

4.      Manish Subodhchandra Shah
          All residing at 4, Rang Varsha Society
          Opp. Bhagat Baug
          New Sharda Mandir Road, Paldi
          Ahmedabad-380007                                … Complainants

Versus

1.      Gujarat Research and Medical Institute
          Popularly known as Rajasthan Hospital
          Camp Road, Shahi Baug
          Ahmedabad-380004

2.      Dr. Tushar J. Shah
          405, Shefali Centre, Paldi
          Ahmedabad-380006

3.      Dr. Sharad H. Dave
          Having office at ‘Mahakant”
          Opp. V.S. Hospital, Elisbridge
          Ahmedabad-380006

4.      Dr. Kirit C. Shah  
          Residing at Dasaporward Society, Paldi
          Ahmedabad-380006                                … Opposite Parties

Case summary : This complaint, alleging adoption of totally unethical practice to convert a reference for angiography to coronary by-pass surgery which was not so indicated without any diagnostic support and that too without obtaining any written consent of either the deceased Subodhchandra Shah or any of his family member, has been filed by the legal representatives of the deceased against the Gujarat Research & Medical Institute, popularly known as ‘Rajasthan Hospital’ (to be referred as such hereafter) and three doctors
The say of the complainants is that their 58 years old father Subodhchandra Shah, a businessman, who was otherwise quite hale and hearty, was under the care and supervision of opposite parties no. 3 and 4 in Prerna Hospital when on the 6th of August, 1996 the doctors advised to have an angiography done.  There being no cath lab in Prerna Hospital, they advised the transfer of the patient to Rajasthan Hospital, where he was admitted the same evening at about 9.00 p.m.  Learned counsel for the complainants has emphatically argued that the transfer of the patient was for the purpose of undergoing angiography but rather than confining themselves to the conduct of angiography and apprising the complainants with the outcome of the angiogram, in a pre-meditated manner they conducted a CABG i.e. by-pass surgery on the patient, for which no consent either of the patient or his relatives was obtained.  Contending that the whole operation was conducted in a hush hush manner, it has been argued that neither they nor anyone of their relatives were ever given any information with regard to the progress of the operation.
Only after an expert opinion this case was closed
The expert opinion of Professor K.K. Talwar, an eminent Cardiologist of AIIMS, who, after scrutiny of the entire medical records of the case, has opined that on the basis of the angiographic finding the CABG was indicated in the case.  His opinion being relevant is extracted as under:-
“The angiography reel of pt Subodhbhari P. Shah and his records were examined.

1.   The angiography reel provided mentions the patients name as S.P. Shah dated 7.8.96 and performed by Dr. S.H. Dave at GRMI, Abad.  The patient has triple vessel disease with significant obstructive coronary artery disease (involving the left anterior descending artery, left circumflex and right coronary artery and their branches) along with mild left ventricular dysfunction.

2.   As per records the patient had unstable angina and subsequently was advised coronary angiography.  The angiogram revealed triple vessel disease with left ventricular dysfunction.  As per records patient has angina during the angiogram and was subsequently taken up for emergency coronary artery bypass surgery.  As for the angiographic finding the CABG is indicated in such a case.”

The criteria for determining the adequacy of information disclosed to a patient has long been the subject of intense legal debate. In recent case law, the adequacy of disclosure has been judged increasingly by the degree to which it meets the informational needs of the so-called reasonable person. To bring a successful suit against a doctor, you must prove not only that he failed to disclose some pertinent information, but also that you suffered some injury as a consequence of that failure. 
  • If your doctor does not tell you of some serious risk of a surgery, but you undergo the procedure without complications, you cannot sue the doctor because you have not suffered any harm. 
  • If you undergo the surgery and suffer from a harm you were not informed of, you probably can sue, unless there is evidence that you would have gone through with the surgery even if you had known the risk.  If you would have gone through with the surgery even with the disclosure, you cannot claim that the doctor's failure to disclose caused your harm. 

 What is Medical Malpractice?
Professional negligence is defined as the breach of a duty caused by the omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do or doing something which a prudent and reasonable man would not do. Further malpractice is defined as lack of reasonable care and skill or willful negligence on the part of a doctor in the treatment of a patient whereby the health or life of a patient is endangered. 
Today is the world of information  the gadgets hold everything no medical term will sound crazy in case it’s a literate patient, thus medical malpractice has become more and more evident and coming out in the media as well as newspapers and various other means. It’s very difficult for doctors to practice these days under the pretext of experience and age and fancy degrees ,a proper explanation and perfect information is demanded everywhere. There have been instances where the doctor have been assaulted or harmed and hospital property damaged by the family members of the patient because of a death of a family member, improper care or hospital incompetence unavailibity or simple death of the patient has invoked such reactions from the public in the recent years.
A very famous case of Medical negligence which was brought to light recently where a compensation of 5.96Cr was awarded is a benchmark for Indian system of medicine to learn and incorporate discretion.
Anuradha Saha died painfully in May 1998 at the age of 36, her skin sloughed off all over her body, except for her skull. She was encased in bandages meant to prevent infections that had already lodged in her system. Her immunity had been compromised after receiving a high dosage of steroids from some of the top doctors in Kolkata.
For the past 15 years, her husband, Dr. Kunal Saha, has pushed Indian courts to hold at least five doctors and the hospital responsible. Though the lower courts rejected his cases, Dr. Saha persisted, appealing all the way to the Supreme Court, which found the doctors and AMRI Hospital (Advanced Medicare & Research Institute Ltd.) in Kolkata guilty of negligence in 2009.
It took another four years for the Supreme Court to award Dr. Saha an unprecedented amount in a medical negligence case in India — 60.8 million rupees ($1 million), plus 6 percent annual interest for each of the 15 years that Dr. Saha has been fighting his legal battle.
The landmark ruling is supposed to remind doctors, hospitals, and nursing homes that they will be dealt with strictly if they do not maintain their standard of care, the Supreme Court said in its judgment on Oct. 24.
“The patients, irrespective of their social, cultural and economic background, are entitled to be treated with dignity, which not only forms their fundamental right but also their human right,” wrote Justices Chandramauli K.R. Prasad and V. Gopala Gowda.
In short medical negligence will not go undetected and should be brought to light, as a physician it’s my duty towards my patient and also a valid responsibility as a human being,
A classic case of medical negligence Dr.Asha vs. Mohd.Quasim NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
NEW DELHI REVISION PETITION NO. 4336 OF 2012
(Against the order dated 02.08.2012 in Appeal No. 323 of 2009 of the Jharkhand State Consumer Disputes Redressal Commission, Ranchi)
Medical negligence – complaint arose out of a surgery (hysterectomy) performed by the surgeon on the wife of the complainant and her death in another hospital resulting from an alleged post-surgery complications – a case of medical negligence was held and awarded compensation. The claim of the surgeon that it was done under the demand and pressure of the relatives of the patient in itself carries a certificate of her unprofessional conduct.

Medical malpractice with uninformed consent is also an important area to be studied
D.H. Kumari v. Director, Nizam’s Institute of Medical Services, 2003 (5) CLD 805 (AP SCDRC)
 The case goes as follows : the complaint filed against the treating doctors of the NIMS who negligently and wrongly diagnosed the problem of Kumari as breast carcinoma and subjected the patient to to unnecessary mastectomy- whether the surgical oncologist followed the standard medical protocol and displayed reasonable skill and care in diagnosing that the lump was cancerous?--- whether. According to standard medical protocol any prior or further diagnostic tests were indicated for confirmation of the disease before deciding to undertake modified radical mastectomy?
Whether the consent for surgery obtained can be considered a valid consent? No – No evidence produced on record to show that a second FNA sample was taken as a measure of ample precaution—neither the surgical oncologist himself nor the senior resident explain to kumari before obtaining her consent, hence, the “consent” was neither “real” nor “valid” ----- the commission held the NIMS as guilty of medical negligence and deficiency of service on part of main doctors.

We understand the medical profession is considered a noble profession because it helps in preserving life. We believe life is God given. Thus, a doctor figures in the scheme of God as he stands to carry out His command. A patient generally approaches a doctor/hospital based on his/its reputation. Expectations of a patient are two-fold: doctors and hospitals are expected to provide medical treatment with all the knowledge and skill at their command and secondly they will not do anything to harm the patient in any manner either because of their negligence, carelessness, or reckless attitude of their staff. Though a doctor may not be in a position to save his patient's life at all times, he is expected to use his special knowledge and skill in the most appropriate manner keeping in mind the interest of the patient who has entrusted his life to him. Therefore, it is expected that a doctor carry out his duty with utmost care.
Disclosure of Malpractice: Mandatory or not?
Generally, if there has been any kind of Malpractice, it is often wise to disclose the same to the patient. If the patient was injured by a doctor, then the doctor has a duty to inform the patient about the condition such that the patient can make a decision to receive adequate care. The doctor does, however, have an obligation to inform the patient that a surgical procedure went astray. Such information can help the patient immensely. The medical practitioner has a positive duty to inform the patient about his condition, the nature of the treatment proposed, the risks of the treatment, and other options that the patient might have.  This is so done because a patient is not likely to have consent unless the doctor gives him full and complete information. Howsoever when a doctor tells the patient the risks of a treatment, they don’t have to explain all the possible risks just those that a reasonable patient would want to know before deciding about treatment. If a doctor doesn’t give all such information, the failure could be medical malpractice, and a legal suit can arise out of such conduct. Even if a doctor doesn’t give the patient all the information, he won’t be liable if a reasonable person in the same position would have agreed to the treatment anyway.
In the case of Poonam Verma Vs. Ashwin Patel the court laid down 3 important criteria which needs to be proved by the patient in the court to prove medical malpractice against a doctor. The same are as follows:
·         Legal Duty
·         Breach of Legal Duty
·         Damages : Cause and Remoteness Test

Practices and procedures which were once in vogue have been held as bad in law by the courts. Cross-pathy practice is rampant even today, in spite of the trend-setting judgment which bars doctors trained in one school of medicine from practicing another pathy. In Poonam Verma- Appellant versus Ashwin Patel and others-Respondents 1986-1996 Consumer 2250 (NS) Supreme Court (SC) of India, the Apex Court settled the law in this regard. Dr Ashwin Patel registered as a medical practitioner with the Gujarat Homoeopathic Medical Council as he had studied Homoeopathy. He treated Pramod Verma with allopathic drugs. The patient finally died. The SC held that since the law under which Dr Patel was registered as a medical practitioner, required him to practice in homoeopathy only, he was under a statutory duty not to enter the field of any other system of medicine. He practiced Allopathy, without being qualified in that system hence was guilty of negligence and therefore the appeal against him was allowed in consonance with the maxim 'Sic Utere tuo ut alienum non loedas' (a person is held liable at law for the consequences of his negligence). A compensation of Rs 3 lakh was ordered to be paid to the dependents of the deceased.
Negligence per se and liability of Doctors:
While deliberating on the absence of basic qualifications of a homeopathic
Doctor to practice allopathy in Poonam Verma vs. Ashwin Patel[2] and Ors.
, the
Supreme Court held that a person who does not have knowledge of a particular
system of medicine but practices in that system is a quack. Where a person is guilty of
Negligence per se, no further proof is needed.

Doctor’s liability when the Patient doesn’t want to know her Medical Status?
In the last few years, some patients have begun asking not to know about their conditions. These patients often feel they are not prepared to make the necessary choices such knowledge would force the patients to make. However, these conditions are often fatal and the patients would likely perish without treatment.
For doctors, this is a difficult dilemma. The doctors have the expertise and skills to treat the patient, yet the doctors cannot treat the patient without the patient’s consent. From a legal standpoint, though, it is possible to create a waiver removing all liable from the doctor if the patient wishes not to be informed of the medical condition which afflicts the patient. This situation is less straightforward and it is more difficult to justify a breach for these reasons. Further in cases of AIDS or HIV there are situations involving a patient who is incapable of making their own decisions. If a doctor believes a patient to be incapable of making decisions, temporarily or permanently, the law allows doctors to do whatever necessary to promote the patient’s welfare.
Disclosure of Medical Information to Third Parties?
Another important question that arises quiet often is, if doctors have any obligation to disclose a patient’s medical information to third parties. This is largely seen in many recent cases where it has been said that despite the privileged communication between doctor and patient, in certain given specific circumstances, the liability of doctor to disclose information to third party like Court, Insurance Co. are mandatory. Under the Code of Ethics Regulations, 2002, it is said that registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his / her profession except[3]
  1. in a court of law under orders of the Presiding Judge;
  2. in circumstances where there is a serious and identified risk to a specific person and / or community; and
  3. Notifiable diseases.
 Some of these situations include, but are not limited to:
  • Heath Insurance
  • Criminal Liability
  • Lawsuits
  • Harmful Action on the part of the patient
  • Public Interest
Doctors can also disclose confidential information about a patient if he believes it to be in the patient’s best interests.
Public Interest:
When the law compels the disclosure of confidential information, there may be cases where the law accepts that the public interest justifies the disclosure. Finally, a doctor can breach confidentiality of a patient, without consent, if he believes it to be in the interest of the public. This is possibly the most controversial exception to the doctor’s duty of confidentiality. Even in case of Criminal Liability a doctor is not compelled by law to volunteer information to the police about criminal conduct in the part of any of his patients but may be compelled by specific statutes to do so if asked. When deciding whether to disclose information about his patient a doctor must balance the public interest in knowing the confidential details against his patient’s interest in them being kept confidential. Are the public at significant risk if he does not disclose the information? However in case of communicable / notifiable diseases, concerned public health authorities should be informed immediately.
Lawsuits:
There has been no doubt that no privilege whereby a doctor called to  court can refuse to give evidence on the grounds that it would involve the disclosure  of confidential information received by him  in the course of his professional relationship with his patient. On the other hand, the courts do have a wide discretion, and will not order the breach of a confidence unless it is absolutely necessary. Equally there is no privilege enabling a doctor to keep a professional confidence by refusing to answer questions put to him in the witness-box. The defense legal team are also only entitled to have access to confidential material that is relevant to the matters in issue in the criminal trial. They are not entitled to trawl through a patient/victim’s entire medical and/or psychiatric history seeking material for cross-examination.


Deception:
Research involving deception is controversial given the requirement for informed consent. Deception typically arises
in social psychology, when researching a particular psychological process requires that investigators deceive
Subjects. For example, in the Milgram experiment, researchers wanted to determine the willingness of participants to
obey authority figures despite their personal conscientious objections. They had authority figures demand that
participants deliver what they thought was an electric shock to another researcher. For the study to be successful, it
was necessary to deceive the participants so they believed that the subject was a peer and that their electric shocks
caused the peer actual pain.
Nonetheless, research involving deception prevents the subject/patient from exercising his/her basic right of
autonomous informed decision-making and conflicts with the ethical principle of Respect for persons.
It is stated in the Ethical Principles of Psychologists and Code of Conduct set by the American Psychological
Association, that psychologists may not conduct research that includes a deceptive compartment unless the act is
justified by the value and the importance of the results of such study, provided that this could not be obtained in an
alternative way. Moreover, the research should bear no potential harm to the subject as an outcome of deception, be
it physical pain or emotional distress. Finally, a debriefing session is required in which the experimenter discloses to
the subject the use of deception in the research he/she was part of and provides the subject with the option of
withdrawing his/her data.
Children
As children often lack the decision making ability or legal power (competence) to provide true informed consent for
medical decisions, it often falls on parents or legal guardians to provide informed permission for medical decisions.
This "consent by proxy" usually works reasonably well, but can lead to ethical dilemmas when the judgment of the
parents or guardians and the medical professional differ with regard to what constitutes appropriate decisions "in the
best interest of the child". Children who are legally emancipated, and certain situations such as decisions regarding
sexually transmitted diseases or pregnancy, or for unemancipated minors who are deemed to have medical decision
making capacity, may be able to provide consent without the need for parental permission depending on the laws of
the jurisdiction the child lives in. The American Academy of Paediatrics encourages medical professionals also to
seek the assent of older children and adolescents by providing age appropriate information to these children to help
empower them in the decision making process.
Research on children has benefited society in many ways. The only effective way to establish normal patterns of
growth and metabolism is to do research on infants and young children. When addressing the issue of informed
consent with children, the primary response is parental consent. This is valid, although only legal guardians are able
to consent for a child, not adult siblings. Additionally, parents may not order the termination of a treatment that is
required to keep a child alive, even if they feel it is in the best interest. Guardians are typically involved in the consent of children, however a number of doctrines have developed that allow children to receive health treatments
without parental consent. For example, emancipated minors may consent to medical treatment, and minors can also
consent in an emergency.

Vaccines
Except for during clinical trials, there is no Federal requirement in the United States for providing informed consent
regarding the administration of vaccines.


Exceptions to Informed Consent:
The few exception to the doctrine of Informed Consent are as follows. Liabilities for not taking informed Consent in these cases are not incurred.
1.     Extreme Emergency- insufficient time to obtain patient’s consent, patient physically incapacitated from giving consent.
2.     Right of Waiver by Patient
3.     Incompetency of the patient- where the patient does not possess the ability to understand the situation and make a rational decision (unsoundness of mind, intoxicated, minors etc.)
4.     Therapeutic Privilege – out of all other exceptions to informed consent, this has been largely grabbed all the attention. Withholding of information, by the doctor, which would upset the patient and prompt the patient to unreasonably refuse the treatment? Therapeutic privilege constitutes one of the situations where the doctor's duty of disclosure in terms of the doctrine of informed consent is restricted and allows the doctor to withhold information if disclosure would be 'harmful' to a particular patient.
4.
In Castell v De Greef [4], in which the existence of therapeutic-privilege defence was expressly acknowledged.

A patient is entitled to provide or refuse consent to treatment. This is regarded as patient autonomy or self-determination in South African medical law.
It is imperative that the correct and accurate diagnosis being provided by the treating doctor to the patient;
Alternative methods of treatment should be discussed with the patient;
The effects of treatment should be discussed with the patient;
The patient should have knowledge and appreciation as to provide informed consent.
A patient should be informed and advised of inherent risks involved with the proposed treatment:
According to the Castell v de Greef 1994 (4) SA 408 (C) decision a doctor is obliged to warn a patient of relevant and inherent risks of any proposed treatment and or surgery. "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, if warned of the risk, would be likely to attach significance to it" http://www.medicallaw.co.za/news-informed-consent.html

The therapeutic privilege is open to abuse. The most fundamental objection to the therapeutic privilege is that it is paternalistic and undermines the patient's right to self-determination, which is the cornerstone of the informed-consent doctrine. Underlying the idea of a therapeutic privilege, is the classical Hippocratic ethic in terms of which doctors should do what in their judgment would lead to the greatest good or least harm to their patents. The court in Canterbury v Spenceli[5] expressed its concern that the therapeutic privilege must be carefully circumscribed, for otherwise it might devour the disclosure rule itself. Withholding information from patients has the potential to undermine the trust placed in doctors.
Canterbury v Spenceli
Brief Fact Summary. Plaintiff experienced back pain. Defendant told Plaintiff that he needed surgery, but did not inform of the risks of the surgery. Plaintiff sued Defendant for negligently withholding the risk of the surgery.

Synopsis of Rule of Law. A doctor has a duty to disclose all reasonable information about a proposed treatment to his patients.
Facts. Plaintiff consulted Defendant, a doctor, after experiencing severe back pain. Defendant had the Plaintiff undergo a myelogram, which revealed that the Plaintiff suffered from a filling defect in the region of his fourth thoracic vertabra. Defendant told Plaintiff that he needed to undergo a laminectomy to correct what he suspected was a ruptured disc. Defendant did not tell Plaintiff the details of the proposed operation nor did Plaintiff inquire about them. Defendant told Plaintiff’s mom that the operation was a serious one, but not any more serious than any other operation. Defendant performed the operation and discovered Plaintiff’s swollen spinal cord to be in very poor condition. Defendant did what he could to relieve the pressure and left Plaintiff in bed to recuperate. Plaintiff was recuperating, when he slipped off the side of the bed and suffered near-complete paralysis. There was no one there to assist him and no side rail to break his fall. Defendant performed an em
ergency operation and Plaintiff’s condition improved. Plaintiff sued Defendant for negligence in the performance of the laminectomy and for failure to inform him of the risk involved. Plaintiff introduced no evidence to show medical and hospital practices customarily pursued in regard to the critical aspects of the case. Defendant testified that even without trauma, paralysis can be anticipated somewhere in the nature of one percent. Defendant felt that communication of the risk to Plaintiff was not good medical practice because it might deter him from undergoing needed surgery and might produce adverse physiological reactions, which could preclude the success of the operation. The trial court held that Plaintiff failed to produce any medical evidence indicating negligence. Plaintiff appealed.

Issue. Does Defendant have a duty to disclose the risk associated with surgery?
Held. Yes. Judgment reversed. Plaintiff’s evidence was of such caliber as to require a submission to the jury.
* Defendant did not reveal the risk of paralysis from the laminectomy. Every human being of sound mind has a right to determine what shall be done with his own body. It is a physician’s duty to warn of the dangers lurking in the proposed treatment. There is also a duty to impart information, which the Plaintiff has every right to expect. In this case, Defendant had a duty to make adequate disclosure to Plaintiff.
* Defendant’s noncompliance with the professional custom to reveal, like any other departure from prevailing medical practice, may give rise to liability to Plaintiff. However, Plaintiff’s cause of action is not dependant upon the existence and nonperformance of irrelevant, professional tradition. The standard measuring performance of the duty to disclose by doctors, as by others, is conduct, which is reasonable under the circumstances.
* It is unrealistic to expect doctors to discuss with their patients every risk of proposed treatment, no matter how small or remote and generally unnecessary from the patient’s viewpoint. A risk is material when a reasonable person, in what the doctors knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy.
* A doctor bears no responsibility for the discussion of hazards the patient has already discovered.
* When a genuine emergency arises, the impracticality of conferring with the patient dispenses a need for it. Also, a doctor does not have to disclose the risk of treatment if the disclosure would make the patient become ill or emotionally distraught.
* The privilege to withhold information does not include the paternalistic notion that the doctor may remain silent simply because divulgence might prompt the patient to forgo therapy the doctor feels the patient really needs.
Discussion. In this case, the court was concerned with Defendant’s attempt to sensor from the Plaintiff the risk of surgery.

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