|Year : 2015 | Volume
| Issue : 1 | Page : 1-4
Safe clinical practice: Medico-legal issues
Rashmi Teresa Mathai K
Department of General Medicine, Father Muller Medical College, Mangalore, Kartnataka, India
|Date of Web Publication||8-Dec-2014|
Rashmi Teresa Mathai K
Department of General Medicine, Father Muller Medical College, Kankanady, Mangalore - 575 002, Kartnataka
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Mathai K RT. Safe clinical practice: Medico-legal issues. Muller J Med Sci Res 2015;6:1-4
Safe clinical practice: Medico-legal issues
Every doctor must expect to become embroiled in complaints and claims from time to time and be prepared to justify why they managed a particular case in the way that they did. The complete eradication of error may be an unattainable goal, but attention to a few basic principles reduces the risk of litigation, and in the event of a claim renders a successful defense more likely.
Good medical practice  involves the following:
- Defensible practice, which depends upon staying within the limits of your own expertise
- Keeping up-to-date and conducting audits
- Ensuring effective administration
- Communicating effectively with patients and their bystanders.
- Communicating effectively with colleagues
- Medical records recalling all salient facts relating to the patient
A few important aspects of medical practice are dealt with subsequently.
| Consent|| |
Consent is an essential element of the validity of any act that involves two persons. Two persons are said to have consented, when they agree upon the same thing in the same sense.
For consent to be legally valid, the following must be true:
- The patient must be legally competent (adult, with sound mind and understanding).
- Consent must be freely given.
- The person consenting must be suitably informed.
- What the patient has been told must be recorded in the notes.
- Consent is patient-specific and depends on the individual's circumstances.
- A competent adult's refusal of treatment must be respected.
Sidaway Versus Governors of Bethlehem Royal Hospital (1985) 
Mrs. Sidaway complained that she had undergone elective surgery to relieve pain in the neck, shoulder, and arms. After the surgery, which was carried out with all due care, the patient was left in a worsened state. She had not been informed of the risk that this might happen. Had she been so informed, she said, she would not have had the surgery. So she alleged that the doctor was in breach of his duty for not informing her of the risks, which would have enabled her to make an informed choice. So the doctor must disclose all material risks as determined by the "prudent patient test" - what a reasonable patient in the position of the plaintiff would need to make a decision based on the treatment advice given.
Therefore B, a surgeon knowing that a particular surgery is likely to cause the death of Z, who suffers from a painful condition, but not intending to cause Z's death, and intending in good faith, Z's benefit, performs the surgery on Z, with Z's consent, B has not committed any offense even if Z dies following the surgery e.g., surgery in a case of colorectal malignancy. The surgeon is legally protected as per Sec. 88 of the Indian Penal Code, (IPC) ("Act not intended to cause death, done by consent in good faith for person's benefit. - Nothing which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harm").
In the following exceptional situations, the doctor has a right to withhold information:
- The patient is not competent to make a reasoned decision.
- The information may cause serious psychological harm to the patient.
- Disclosure would adversely affect the recovery of the patient.
- An emergency situation, for example, a patient is brought into the emergency room with a major crushing injury to one of the lower limbs following a road traffic accident, necessitating immediate surgery of the extremity to control ongoing bleeding. In this situation the patient's condition is too critical to obtain consent from him/her or the guardian/spouse, hence the surgeon will be saved from liability if he/she operates, as the act was done in good faith for the benefit of the patient (Sec. 92 IPC- "Act done in good faith for benefit of a person without consent - Nothing is an offence by reason of any harm which it may cause to a person for whose benefit it is done in good faith, even without that person's consent, if the circumstances are such that it is impossible for that person to signify consent, or if that person is incapable of giving consent, and has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time for the thing to be done with benefit").
There are two major types of consent:
- Express consent: Consent is valid if it is expressly given, for example, a patient admitted to a hospital for surgery gives his express consent by signing a consent form authorizing the surgery.
- Implied consent: Consent is not explicitly expressed by the patient, but is signified through his conduct, e.g., when a health professional wants to take blood pressure and a patient offers his arm. In emergency cases, it may be presumed that consent is implied.
Samira Kohli Versus Prabha Manchanda (2008)
Samira, an unmarried woman of 44, visited Dr. Manchanda's clinic with a complaint of prolonged menstrual bleeding. After consultation and discussion, it was decided that she would undergo a diagnostic laparoscopy under general anesthesia (GA). So the patient signed on the consent form for hospital admission and medical treatment as well as surgery. The patient was then subjected to GA, and laparoscopy was performed. While still under GA, Dr. Manchanda's assistant surgeon arrived outside the operating room and took Samira's mother's consent for performing total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO). The patient left the hospital without settling the bills. Dr. Manchanda lodged a police complaint alleging that Samira had abused and threatened her and that she had left against medical advice (LAMA) without clearing the bills.
Samira lodged a complaint against Dr. Manchanda alleging negligence and unauthorized removal of reproductive organs. The case escalated up to the National Commission, which dismissed the complaint, saying that Samira had voluntarily visited the clinic for treatment and consented to surgery and that TAH/BSO had been necessitated as she was suffering from grade IV endometriosis and if not operated there was a likelihood of the disease extending to the intestines and bladder and damaging them.
On appeal to the Supreme Court (SC) by Samira, it was held that there had been no consent for TAH/BSO and so such a radical surgery amounted to "deficiency in service." Since it was not a life-threatening emergency, consent should have been taken from the patient before proceeding with the surgery. Unauthorized invasion and interference with the patient's body amounts to a torturous act of assault and battery. So the SC directed Dr. Manchanda to pay compensation of Rs. 25000/- for unauthorized surgery. 
Consent need not be obtained in the following circumstances:
- The examination or treatment of a person with a notifiable disease (as listed by the local health authorities).
- Routine examination of an immigrant (at a port/airport) or a member of Armed Forces.
- Personnel handling food and dairy milk.
- A medical emergency.
- If court orders examination/treatment.
| Confidentiality|| |
The concept of patient confidentiality arose in the 5 th century BC and is highlighted in the following excerpt from the Hippocratic Oath. 
"And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my intercourse with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets."
This concept has been borrowed and promoted in the Code of Medical Ethics as well as in the Declaration of Geneva.
Confidentiality is crucial for the following:
- Retaining the bond of trust between the doctor and the patient, and ensuring that the patient feels safe in divulging information about his/her illness to the doctor, thus helping the doctor make a diagnosis.
- Promoting the patient's medical autonomy.
- Sheltering patients from outside criticism or interference with decisions regarding medical care.
Since India has several issues of greater immediate urgency like malnutrition, poverty, and illiteracy, the protection of medical data and doctor-patient confidentiality may not assume the significance it has in the West. But in the global context, citizens do take the breach of their civil liberties as a serious offense.
Velazquez Versus St. Clare's Hospital (S.C. New York 1994)
Nydia Velazquez was admitted to St. Clare's Hospital in 1991 after attempting suicide, treated, and discharged. In 1992 she was running for election to the U.S. House of Representatives. Her medical records were faxed anonymously to several newspapers, which ran them in front-page stories. It was never determined whether hospital personnel were responsible for this disclosure, but Velazquez sued the hospital for breach of contractual and fiduciary duties of confidentiality, wrongful disclosure, and negligence in maintenance of the security of her medical records. Needless to say, she won the case. 
However, there are certain situations where disclosure of personal health information is permitted, such as the following:
- During referral.
- When demanded by the court or by the police on a written requisition.
- When demanded by insurance companies as provided by the Insurance Act, when the patient has relinquished his rights on taking the insurance.
- When required for specific provisions of workmen's compensation cases and consumer protection cases
- For disease registration.
- During investigations of communicable disease.
- The reporting of drug adverse events.
Case: Mr. T. is 35 years old and is married. He has had unprotected sex with prostitutes on two occasions. He is asymptomatic but becomes anxious about the possibility of having contracted a venereal disease, and consults his physician. The physician orders a number of tests and the HIV blood test comes back positive. The physician offers to meet with Mr. T. and his wife to assist with the disclosure of this information, but Mr. T. states that he does not want his wife to know about his condition.
Even though patient confidentiality is part of medical ethics and incorporated in the Medical Council Act, the patient's right to confidentiality is not enforceable if the patient is HIV-positive and stands a risk of spreading it to his spouse. So the right to privacy is not absolute in this situation and is thus restricted.  The doctor has the full responsibility to inform the spouse, and the failure to inform her would make him an accomplice. India's matrimonial law also cites venereal disease as a ground for divorce.
| Record Maintenance|| |
A good medical record should have the following characteristics:
- It is legible, clear, concise, and accurate.
- It is dated and timed.
- Details are recorded in the format "Patient Name/Unique ID/Date/Your name/Your signature."
- The context of your assessment/involvement in accordance with protocol is given.
- Findings, investigations, results, and planned further interventions are recorded.
- Ward round updates and management plans are given.
- Patient consent to any proposed treatment or investigation is usually implied consent, and if not, express consent must be obtained.
- Drug treatment/administration of medications or blood products is recorded in detail.
| Medical Negligence|| |
To ascertain whether medical negligence exists in a certain scenario, the following constituents should exist:
- A legal duty to exercise due care on the part of the party complained of, toward the party complaining the former's conduct within the scope of duty.
- Breach of said duty.
- Causal link between breach of duty and harm.
- Consequential damage that was not too remote.
"Breach of a duty" may be defined as that caused by the omission to do something a reasonable person guided by those considerations that ordinarily regulate the conduct of human affairs would do, or doing something a prudent and reasonable person would not do. Therefore, the understanding of negligence hinges on the "reasonable man." Ordinarily, it is said that you judge the presence of negligence by the action of "the man on the street" - he is the ordinary man, that is, "on top of a Clapham Omnibus." In 1957, when the Bolam judgment was pronounced, Clapham was a nondescript South London suburb, which represented "ordinary London." "Omnibus" was the term used at that time for the public bus. Thus "the man on top of a Clapham Omnibus" was a hypothetical person who was reasonably educated and intelligent but was a nonspecialist.
A professional may be described as a person doing or practicing something as a full-time occupation or for payment or to make a living, and that person knows the special conventions associated with his/her profession. The standard to be applied for judging whether the person charged has been negligent or not would be that of an ordinary competent person exceeding ordinary skill in that profession. A simple lack of care, an error of judgment, or an accident is not proof of negligence on the part of the medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he/she cannot be held liable for negligence merely because a better alternative treatment was also available or because a more skilled doctor would not have chosen to follow that practice that the accused followed.
Bolam Test (1957)
Mr. Bolam was a patient at a mental health institution run by the Friern Hospital Management Committee. He agreed to undergo electroconvulsive therapy (ECT) and signed a consent form. But he was not warned of the risk involved, that of fracture. There was evidence that the risk of fracture was very low (1: 10,000). On the second occasion, when the plaintiff was being administered the ECT, he sustained fractures. No relaxant drug or manual restraint was used. The use of relaxant drugs would have admittedly excluded the risk of fractures. Among those skilled in the profession and experienced in ECT, there were two bodies of opinion: One that favored the use of relaxant drugs, and the other that opined that the use of relaxant drugs was attended by mortality risks and that, therefore, the use of muscle relaxants should be confined to those cases where they were absolutely indicated. Since the plaintiff's case was not such a case, the jury returned a verdict for the defendant and held that the doctor was not negligent if he was acting in accordance with a practice accepted as proper by a responsible body of medical professionals skilled in that particular profession. Merely because there is a body holding the contrary opinion, the defendant cannot be held liable.  But a doctor cannot obstinately carry on with an old technique, if it has been proved to be contrary to what is substantially followed by majority of the medical fraternity.
Suresh Gupta v. Govt. of Delhi (1994)
The appellant is a plastic surgeon who was accused of a charge under Sec. 304A IPC ("Causing death by negligence- Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both") for causing the death of his patient in 1994. The surgeon operated on the patient to correct his nasal deformity. The anesthesiologist assisting the surgeon in the operation was made the coaccused. The postmortem report had categorically mentioned that the death was due to a complication arising from the procedure. The patient was a 38-year old man, without any cardiac illness, who was given an incision in the wrong part, and in consequence blood had seeped into the respiratory passage, resulting in asphyxia.  The court has clearly held that whenever a patient dies due to alleged medical negligence, the doctor can be tried under civil law to pay the compensation. Only when the negligence was is so gross and his/her action is so reckless as to endanger the life of the patient will criminal law under Sec. 304A of IPC, 1860 apply.
| Conclusion|| |
Though it may seem like the doctor is in a "Catch-22" situation between the insurance companies and his conscience, the following few guidelines may reduce the risk of possible litigation:
- First and foremost, as the patient's physician, do the right thing and do no harm.
- Keep the patient's rights and interests foremost.
- Treat your patient as you would want your family treated.
- Remember that you, the doctor, are the clinically responsible party and that you will be held accountable for your clinical decisions.
| References|| |
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Raveendran RV. Samira Kohli vs. Dr. Prabha Manchanda & Anr on 16 January, 2008. A.I.R. 2008 Supreme Court 1949.
Helidonis ES, Prokopakis EP. The contribution of hippocratic oath in third millennium medical practice. Am J Otolaryngol 2001;22:303-5.
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Mr. 'X' v. Hospital 'Z', A.I.R. 1999, Supreme Court 498.
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Dharmadhikari DM. Dr. Suresh Gupta vs. Government of N.C.T of Delhi & Anr on 4 August, 2004. A.I.R. 2004, Supreme Court 4091.