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Legal & Ethical issues
Professor Magdy Amin RIAD
Professor of Otolaryngology. Ain shames University
Senior Lecturer in OtolaryngologyUniversity of Dundee
اليتامى رؤوس فى ألحالقة تعلموا
اليتامى رؤوس فى ألحالقة تعلموا
Law & Society
• Legal rules codify important social and cultural values .
• The origins and scope of this rule illuminate the relationship between the physician and the patient.
Informed consent
• The requirement that physicians obtain an informed consent from their patients before treatment codifies a culture that people have a basic right to control their own lives and bodies.
Informed consent
• An informed consent is a consent that results from an understanding by the patient of the risks and adverse effects of the proposed treatment.
• Obtaining an informed consent requires that the physician make an effort to educate a patient capable of learning.
• The physician who makes this effort and obtains such consent has met both the legal and ethical obligations imposed upon him by law
Informed consent
• any offensive and unconsented touching of another renders a person liable in damages.
• This law still also apply to patients under anesthesia.
Informed consent
• Patients autonomy must be respected at all times • Patients can determine what treatment that they are or are
not willing to receive • They have the right to decide not to undergo a treatment • This could adversely affect outcome or result in their death • Patients must be given sufficient information to make
these decisions • Obtaining informed consent is not an isolated event • It involves a continuing dialogue between doctor and
patient
Types of consent
• Express consent - oral or written – Needed for most investigations or treatments with risks
attached
– e.g. consent for operation
• Implied consent – Non-written consent when patient co-operates with a
particular action
– e.g. physical examination
Legal theory
• Breach of a duty, through failure to provide patients with information is negligence.
• If the underlying rationale is that patients should direct their own lives, then a patient who is not a minor or who has not been ruled incompetent by a court cannot justifiably remain uninformed.
The therapeutic privilege
• Although the law allows withholding information under special circumstances (ie, the therapeutic privilege), where a patient's family and physician agree that a patient would be harmed by the information,
• Rarely is there reason to invoke it.
Arguments against full disclosure
• Physician arguments that a given patient may refuse necessary treatment and thereby lose a chance of cure generally and rightfully have been disregarded and discarded by the courts.
• Such arguments presuppose paternalistic authority of the physician to make necessary cost-benefit analyses for the patient.
• Only the patient can understand his or her own priorities
Information required for valid consent
• When obtaining consent patients should be informed of: – Details of diagnosis and prognosis with and without treatment – Uncertainties about the diagnosis – Options available for treatment – The purpose of a proposed investigation or treatment – The likely benefits and probability of success – Any possible side effects – A reminder that the patient can change his or her mind at any stage – A reminder that the patient has the right to a second opinion
Information required for valid consent
• All questions should be answered honestly • Information should not be withheld that
might influence the decision making process
• The person who obtains consent must be: – Suitably trained and qualified – Have sufficient knowledge of the proposed
treatment and its risks
informed consent that is acceptable to a court
the following information must be provided : • Nature of the disease and the proposed treatment or
surgery • Chances of success based on medical knowledge • Risks of the proposed treatment or procedure • Adverse effects of the proposed treatment or procedure • Reasonable alternatives and their chances of success, risks,
and adverse effects • Consequences of deciding not to proceed with the
recommended course of treatment
Identifying adverse effects
• Adverse effects may be well known to physicians; however, it is not safe to assume that patients have this same knowledge.
• (eg, gustatory sweating after a parotidectomy),
What to disclose
• The initial formulations of the level of disclosure needed for an informed consent require a physician to make those disclosures that a reasonable medical practitioner would make under the same or similar circumstances.
• the level of required disclosure is largely determined by local practice.
The rationale of limited disclosure
• The courts attempt to further differentiate the risks required to be disclosed by referring to them as material risks.
• The definition of a material risk is a risk or adverse effect that is important to the patient; information that would affect the decision-making process of a reasonable person.
• Risks that may be trivial but are common and risks that may be rare but are severe must be disclosed.
The rationale of limited disclosure
• A risk that is severe but rare is the risk of death. • It seems reasonable that the risk of death be
disclosed in all cases.• Many physicians object to such disclosure, stating
that everyone knows that the risk of death is present. They emphasize that the risk may interfere with patient rapport and patient healing and recovery.
Written statement
• a written statement by the physician that "all risks were discussed, all questions answered, and an informed consent given" covers all eventualities.
• Conversely, the patient can insist that the complication was never mentioned.
• The explicit rationale in this instance is that, in such a conflict of assertions, a jury will believe the physician
The rationale of full disclosure
• First, it is not the physician's province to determine what risks or adverse effects each patient considers important.
The rationale of full disclosure
• Second, when the most complete disclosure list possible is created, only the most obscure possibilities are excluded.
• A conscientiously prepared list excludes only a few risks that are highly unlikely and occur in fewer than 1 per 100,00 cases.
• Therefore, the chances of such an event both occurring and being absent from the list is much less than 1 per 100,000 cases.
process of providing the patient with the following:
• Working or presumed diagnosis • Differential diagnoses • Purpose and risks of any planned tests • Options to treatments recommended • Prognosis • An estimate of the current level of severity of the
patient's condition
The responsibility for informed consent
• The responsibility for informed consent remains with the physician, even though physicians may delegate the duty of educating patients to auxiliary staff.
• The auxiliary staff presents the informed consent document to the patient for signature.
The responsibility for informed consent
• Informed consent is not a piece of paper with a patient's signature at the bottom.
• In a nation where a substantial number of adults have limited ability to read, further explanation and teaching must occur before the patient signs the paper.
• The piece of paper documents a process, just as a signed contract provides written evidence of a process of negotiation that has led to an agreement.
The responsibility for informed consent
• The agreement comes before the decision is made to put the agreement in writing.
• Therefore, informed consent implies patient participation in medical decision-making.
• Enough information must be provided to patients in terms that they can understand to assure that their right to self-determination can be exercised effectively
Informed consent in emergencies
• In an emergency a life-saving procedure can be performed without consent
• All actions must, however, be justifiable to ones peers
Informed consent and minors
• Generally, minors may not give consent for their own medical care.
• At age of 16 years a child can be presumed to have the capacity to decide on treatment
• Below the age of 16 years the child may have the capacity to decide depending on their ability to understand what the treatment involves
• If a competent child refuses treatment a person with parental responsibility may authorise treatment which is in the child's best interests
Informed consent and the (possibly) mentally incompetent
• No special issues arise when a court of competent jurisdiction has declared a person in need of medical treatment incompetent and appointed a guardian.
• The guardian stands in loco parentis and can give consent to the same extent as a parent could give consent for a child.
• However, problems arise when the person in need of treatment has not been declared incompetent beforehand.
• When physician and family are in agreement that a particular treatment should be provided, it generally is safe to proceed with the informed consent process with all responsible family members.
• When the physician and family do not agree, protection of a court order should be sought if time permits
Informed refusal
• In cases where consent is refused, the physician should obtain an informed refusal from the patient.
• Failure to inform the patient of the risks of declining treatment renders the physician liable to the same extent as failing to disclose the risks of performing the treatment.
• Unless the patient knows the risks of leaving the disease or condition untreated, a truly informed decision in which the patient can balance the risks and benefits within the patient's own psychological framework has not been reached
Medical malpractice
• The law of errors and omissions relating to professional liability for physicians, is not a new issue.
• More than 4000 years ago, the Babylonian king Hammurabi promulgated a law that provided that a physician whose patient lost an eye as a consequence of surgery should himself lose his hand.
Legal theory
• Under the general umbrella of medical malpractice, more than one legal theory exists under which suit can be filed.
Breach of contract
• less-than-favorable result.
• If a substitute physician is sent instead.
• Removing the wrong kidney or the wrong leg could be considered an unconsented touching.
Professional liability
• Claims alleging sexual harassment and sexual misconduct has increased
• Professional liability insurance is to provide protection from financial injury arising from liability for errors, not to provide protection from financial consequences arising from willful and wrongful acts.
Claim of negligence
• To sustain a claim of negligence against a physician, the plaintiff must prove each of the following elements:
(1) A relationship must exist between physician and patient such that a duty of due care was created.
(2) that duty must have been breached (the standard of care was not met); and
(3) the breach of the standard of care must have been the proximate cause of
(4) a compensable injury to the patient. • Each of these elements is considered essential.
Existence of duty: reasonable expectation of treatment.
• Physicians have a higher duty, which is to possess the knowledge and to exert the care and diligence that would be expected of another similarly trained physician in similar circumstances.
• This requirement usually is abbreviated to “duty to meet the standard of care.” For this duty to apply, a physician-patient relationship first must exist.
• Generally, courts look to see if contact between the physician and patient led the patient to have a reasonable expectation of treatment.
Breach of duty by failure to meet standard of care
• Expert witness report to testify both to the standard of care and to departure from the standard of care in the case at hand.
• The major exception is a situation where an error clearly was made, the incident could not have occurred in the absence of some person's error, and the physician was the person in control at the time the error was made
• A classic example of such an error is a surgical instrument left in the wound.
Abandonment
• Once a physician has contracted to provide care, the physician may not withdraw care through his absence without providing a substitute equally skilled and trained.
• Or without providing adequate notice for the patient to find alternate care without risk.
• When a physician is accused of abandonment, failure to provide proof that coverage was available leads to a finding of liability without expert testimony.
Breach of duty must have caused the patient's injury
• The legal concept of proximate cause includes a requirement that breach be both the actual and legal cause of injury.
Compensable injury must have occurred
• If a physician's negligence led to loss of wages and extra medical expense, even for a complication that resolved after a relatively brief period of time, a compensable injury clearly has occurred.
Response to suit
• Notification of a suit puts physician's finances, reputation, opportunities for professional advancement, personal relationships, and both mental and physical health at risk.
• Once a physician has been sued, damage to some or all of these important facets of a physician's personal and professional life is unavoidable.
• Maximizing success and minimizing harm requires that a physician should do certain things and avoid doing others
Providing records
• A request for records may include copies of preoperative and postoperative photographs.
• it is illegal to refuse to provide records.
• Neither fear of suit nor failure of the patient to pay outstanding charges excuses failure to provide records.
Contact with the patient or patient's attorney
• Foremost among errors that physicians make is to contact the unhappy patient or the patient's attorney.
• An angry or shocked physician easily may say things that could be regarded as evidence of fault
• Once suit has been filed, any contact with the patient should be restricted to professional contacts initiated by the patient.
Contact with the patient or patient's attorney
• Sometimes, the patient decides to continue care with the same physician he/she is suing.
• While this continued relationship may work to the physician's advantage because it makes it difficult for the patient's attorney to discount the physician's competence, it generally is a poor idea.
• A carefully documented termination of physician-patient relationship, avoiding any appearance of abandonment, is advisable.
• Contact with the patient's attorney should be made only by the physician's attorney.
Alteration of records
• Another common error is to review the patient's chart to correct errors.
• Alteration of the record usually is detected by document examiners or because the physician is unaware that the patient's attorney had a copy of the record before the suit was filed.
Discussing the case
• As difficult as it may be to avoid, physicians should be cautious about discussing misadventures with colleagues outside formal peer review requirements
What steps should be taken by the physician who has been sued?
• Notify the insurance carrier
• notify the insurance carrier as soon as an event occurs that has a clear potential to result in suit. Examples include facial paralysis following middle ear surgery, and intraoperative death.
Provide a detailed narrative
• write out as complete a narrative history of the case as possible.
• As precaution against loss, copies of all original documents that leave the office should be kept, and where geography permits, originals should be hand-carried to their destination rather than entrusted to mail or other carriers.
Avoid appearance of patient abandonment
• At times, suits may be prevented by avoiding any appearance of abandoning the patient.
• Many physicians succumb to a desire to put their unfortunate results out of mind.
minimize the risk of suit
• First and most important is to practice medicine within the scope of the physician's expertise.
• Records are clear and legible, including pertinent negatives in all notes
• Obtaining adequate informed consent.• Never altering medical records after the fact
(corrections always can be made as a separate entry with date and signature)
• Responding promptly to patient concerns, especially in the postsurgical period
Out of court offer to settle a suit
• consequences should be seriously considered when evaluating an offer to settle a suit for some minimal amount. Pressing for complete vindication may well be better
Conflicts of interest
• Conflicts of interest may arise between physicians and their insurers.
• Each physician will have to divert blame to his/her colleague.
• If the same company insures both physicians, one attorney should not represent both physicians.
Out of hours / Leave cover
• Most physicians sign out to other physicians at night and on weekends..
• The physician has a duty to assure that the covering physician is competent.
• When a physician knows, or should have known, that another physician's competence is open to question, the attending or referring physician may be held liable along with the physician who committed actual malpractice.
• Physicians also are liable for their employee-physician's errors and for their trainee's errors.
Four Most Prevalent Suits
• I. Improper Performance
• II. Error in Diagnosis
• III. Failure to Supervise or Monitor a Case
• IV. Performed When not Indicated or Contra-indicated
Improper Performance in Order of Prevalence
• Operative procedures on paranasal sinuses• Operative procedures on nose• Operative procedures on tonsils and
adenoids• Comment: Surgical and diagnostic
procedures on the paranasal sinuses and nose dominate the claims paid.
Errors in Diagnosis in Order of Prevalence
• Malignant Neoplasm of the Pharynx
• Malignant Neoplasm of Tongue
• Benign Neoplasm of the Cranial Nerves
Failure to Supervise or Monitor Case
surgery on the paranasal sinuses and middle ear and mastoid were the most expensive.
Surgery Performed When not Indicated or Contraindicated
Frivolous suits
• Suits that are based on complete lack of science.
• An example of a frivolous suit might be the well publicized suit filed a few years ago in which a person complained that MRI scans performed after a head injury had deprived her of her psychic abilities
Medical malpractice: final remarks
• Medical malpractice are suits alleging negligence by the physician.
• Once a physician-patient relationship has been established, the physician has a duty to provide the level of care of a physician in that field of practice.
• If the patient suffers compensable injury due to breach of the standard of care, suit may succeed.
• Physicians can minimize risk by instituting certain measures in their practice and by practicing good medicine within the limits of their knowledge and training.
• Once suit results, attention to proper responses may be critical in preventing a finding of liability
Referral to the coroner
• A death should be referred to the coroner if: – The cause of death is unknown
– The deceased was not seen by the certifying doctor either after death or within 14 days of death
– The death was violent, unnatural or suspicious
– The death may be due to an accident (whenever it occurred)
– The death may be due to self-neglect or neglect by others
Referral to the coroner
– The death may be due to an industrial disease or related to the deceased employment
– The death may be due to an abortion – The death occurred during an operation or
before recovery from the effects of an anaesthetic
– The death may be due to suicide – The death occurred during or shortly after
detention in police or prison custody
Breaking difficult news
• SettingCorridors are not appropriateTime and placeprivacy• UnderstandingLanguageHearingAnxiety
Breaking difficult news
• What do they knowMost people have already guessed the seriousness
Denial
• Knowing moreCheck before volunteering
Breaking difficult news
• Warn – pause – check
We found something abnormal
Pause to see response
Check if patient want to know more
Repeat with every statement
Breaking difficult news
• More help
Difficult questions have to be answered immediately
Acknowledge the importance of the question
Check why the question is being asked
Being honest about uncertainty is acceptable
Agitation
• Do not leave patient unattended.
• Ensure environment is safe.
• Do not use opioids to treat agitation.
• Hypoxia should be excluded .100% Oxygen via facemask
• Midazolam 2-10 mg IV or 5mg IM until settled
Confusion
• Memory failureDementiaCerebral tumour
• Change in alertness.DrugsHypercalcaemiaCardiacPulmonarySubdural
Confusion
Hallucinations.
Altered behaviour
The withdrawn patient
• Usual behaviour
• Refusing help
• Confusion
• Fears ,guilt or shame.
• Clinical depression.
• Organic cause
The withdrawn patient
• Usual behaviourOffer tome to establish trust
• Refusing helpTheir rightAcknowledge refusal and offer help in future
• Confusion
The withdrawn patient
• Fears ,guilt or shame.
• Clinical depression.
Persistent low mood for>4weeks , for>50% of time
4 other depressive symptoms (early morning rise, diurnal variation, hopelessness..)
Lofepramine 70 mg at night up to 140 mg
The withdrawn patient
• Organic cause
Parkinson’s
Severe fatigue
Drugs causing Parkinson’s like symptoms
The angry patient
• Appropriateness of anger.
• Escalating anger.
• Depression
• Persisting anger.
The angry patient• Appropriateness of anger.
Explore cause
Show understanding without being defensive
Apologise if it is your fault
Do not apologise for others
The angry patient
• Escalating anger
If anger is not defusing or worsening :Position yourself near exit doorSet limitsIf patient cannot accept limits = pathological angerStop interview and leave immediately
The angry patient
• Depression
Anger can be a feature
• Persisting anger.
Consider specialist help
Unexpected deterioration
• Drugs are the cause.
• Uncertainty about treatment.
• Comfort only.
Unexpected deterioration
• Drugs are the cause.
Check medicationsCheck any recent additionsReduce dose
Unexpected deterioration
• Uncertainty about treatment.
Review plans
Hour by hour deterioration review every 3 hours
Day by day deterioration review every 3 days
Further deterioration consider treatment for comfort only
Unexpected deterioration
Comfort onlyRapid deteriorationIrreversible causeVery short prognosisPatient refusing treatment
Sedation if agitatedAnalgesia if in painSupport patient and family +/-staff
End-of-life Care Just as Important as Cures
• Being able to have a peaceful death with dignity can be among the positive milestones in the cycle of life
• Studies show that up to 88 percent of people in our country want to die at home surrounded by their loved ones.
• Yet the reality is that only about one in four people have a peaceful death at home or in a hospice setting
