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Presentation at a training program ‘Applying
the Principles of Ethics to Clinical Practice’ held at Aramco
Dhahran April 6, 2015 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH
(Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical
City.
Abstract
·
This paper starts by defining the various types
of error in medical practice.
·
It then describes the various types of liability
for errors as well as the legal basis for liability.
·
Discussion of assessment of damages and
disclosure of errors.
·
The paper uses the term physician but all other
health care givers are included.
Definition of Medical Error 1
·
This presentation takes a wide view of errors.
·
Medical error is an omnibus term for anything
that goes wrong in patient management and related circumstances. It includes
failure to perform according to professional standards, honest mistakes
(mistakes without negligence), avoidable mistakes, and unavoidable mistakes).
·
An error is recognized even if no patient injury
occurred.
Definition of Medical Error 2
·
Expected adverse or side effects medication or
procedures are not considered errors if the physician is aware of them and
takes them into consideration in planning therapy and takes the responsibility
of forewarning the patient.
·
The media high-light the dramatic professional
errors such as operating on the wrong patient or the wrong organ. These are
however the tip of the iceberg.
·
There are many other underlying forms of errors
that actually lead to the dramatic ones.
Definition of Malpractice
·
Malpractice is a form of medical error.
·
It is violation of the physician oath and
failure to fulfill the duties of the physician to carry the trust, adau al
manta
·
It is failure to carry out responsibilities of
the physician, masuliyat al tabiib
·
It is violation of the patient’s rights (e.g.
autonomy, privacy, confidentiality, disclosure, personal dignity, etc.).
Definition of Negligence
·
Negligence is a special type of malpractice that
is accompanied by patient injury.
·
It is defined in law as failure to perform
according to expected professional standards resulting in patient injury.
Contributory negligence
·
In contributory negligence the patient is
contributory to the negligence. The physician can plead that the patient
contributed to the injury by unreasonable conduct or behavior. Thus both the
physician and the patient end up being apportioned part of the blame.
·
The physician could still be found liable for
negligence in cases of contributory negligence if he had a chance in the course
of therapeutic relation to intervene and stop the injury by advising the
patient to change behavior.
·
The physician is relieved of the obligation of
due care when the patient deliberately exposes himself to unreasonable risk.
Comparative negligence
·
In comparative negligence the negligence is
apportioned among several physicians
·
Each physician is apportioned blame according to
the quantum of his/her contribution to the negligence.
Intentional negligence
·
In intentional negligence there is personal
injury that is intentionally inflicted by the physician.
·
This type of negligence borders on the criminal.
The 4 elements of negligence 1
·
There are 4 elements in medical negligence: (a)
existence of a duty, (b) breach of the duty, (c) injury resulting from breach
of duty, and (d) burden of proof of the causal connection between breach of
duty and injury.
·
Duty: A physician who had no duty to the
patient cannot be found negligent. The physician’s conduct must have been
careless or negligent according to generally accepted standards.
The 4 elements of negligence 2
·
Injury: The conduct must have caused injury to
be classified as negligence.
·
Causality: The connection between
injury and negligence of the physician must be proved beyond doubt. The burden
of proof is on the patient who accuses the physician of negligence. The
physician then will have to disprove the connection. If the physician fails to
disprove the connection he will pay compensation for injuries or losses
suffered as a result of the negligence.
Clarifications
·
Action for negligence may not be brought if the
actions were covered by a specific law.
·
Consent by the patient may remove the element of
crime but does not remove the professional and ethical elements of negligence.
·
The law does not recognize consent to infliction
of grievous bodily harm even if the patient is competent to give such consent
because a physician is bound to protect life.
·
The concept of negligence can be extended to
cover failure to aid a person in an accident or any other threatening
condition. In this situation even non-professionals are expected to render
assistance commensurate with their ability.
·
In some jurisdictions such as the state of
Arizona there is a Good Samaritan law that obliges a physician to stop at a
site of an accident and render any assistance that he can.
Examples
of negligence in medicine 1
·
Medical negligence may be breach of duty
resulting in causation of injury which calls for damages.
·
A tort is a civil wrong in which liability is based on unreasonable conduct.
The intentional torts are assault, battery, treatment without informed
consent, false imprisonment or confinement, intentional infliction of emotional
distress, and defamation (slander if verbal and libel if written).
·
Violation of patient rights such as abandonment of
a patient or breach of confidentiality.
·
Liability for negligent use of drugs and
devices.
Examples
of negligence in medicine 2
·
Vicarious liability arises when a physician
fails to supervise a junior or a trainee working under him or her.
·
Negligent referrals occur when a physician
fails to refer a patient to the right specialist.
·
Failure to warn about risks.
·
Failure to report a notifiable disease.
·
Professional errors that may be ordinary or
extraordinary. harmful or non-harmful.
Examples of negligence in obstetrics and
gynecology 1
·
Injuries at birth to both mother and fetus:
congenital deformities, wrongful life, stillbirth, psychiatric injury,
·
inappropriate care due to lack of current
knowledge,
·
Errors of skill or judgment,
·
Wrongful termination of pregnancy due to failure
to do a pregnancy test before gynecological surgery, Failed abortion when an
abortion is attempted but is not completed,
Examples of negligence in obstetrics and
gynecology 2
·
Negligence in fetal screening in which an
anomaly is seen at amniocentesis,
maternal blood sampling, or fetal blood sampling but it is not followed
up,
·
Negligence in prescribing for a pregnant woman,
·
False diagnosis of maternal disease that affects
the fetus,
·
Mistakes in obstetric analgesia and anesthesia,
·
Negligence in labor and delivery by failure to
detect fetal distress resulting in brain damage.
Examples of negligence in psychiatry 1
·
Sexual misconduct,
·
Failure to prevent suicide or attempted suicide,
·
Failure to prevent patient violence,
·
Wrong medication,
·
Negligent diagnosis,
·
Abandoning a patient,
Examples of negligence in psychiatry 2
·
Breach of confidentiality,
·
Early discharge,
·
Failure to hospitalize leading to suicide,
·
Failure to commit leading to murder,
·
Failure to control symptoms leading to suicide
or injury to a 3rd party,
·
Negligent certification of mental status.
Physician liability
·
Battery for lack of informed consent: Battery, assault, or
false imprisonment charges can be brought against a physician who touches a
patient without consent
·
Errors: Professional errors may be ordinary or
extra ordinary. They may be harmful or non-harmful. Informed consent or express
instruction of the patient does not relieve the physician of liability.
·
Neglect of duty: The doctor-patient
contract establishes a continuous obligation until resolution of the disease.
Work is assessed by its conclusion, al ‘amal bi al khawatiim[i].
The best of work is one that is continuous and lasting, khayr al ‘amal
adwamuha[ii].
A physician is justified in discontinuing treatment if he finds that another
practitioner is in attendance, or that the patient is refusing using his remedies
or when he is convinced that the patient is a malingerer.
Vicarious liability
·
Vicarious liability is when someone is made
liable for a negligence they did not personally perform for example the
employer.
·
Vicarious liability arises when clinical responsibility
is given to another person who is supposed to work under supervision such as
medical student performing some procedures.
Liability of hospitals
·
Employer’s vicarious liability
·
Direct breach of duty
·
Joint liability with the physician.
Manufacturer’s liability
·
Defects may be in drugs or medical devices.
·
The manufacturer is liable for harm caused by
defective products. The liability is based on negligence and breach of warranty
of quality of the product.
·
There are two approaches to recovering damages:
(a) the supplier can be found to have breached the contract of supplying a safe
product (b) under the tort of the product causing injury and harm.
·
Defectiveness can be defined as: manufacturing
defects, design defects, or marketing defects. The matter is more serious when
the supplier of the drug or device fails to provide adequate warning or may
fail to warn at all about potential problems.
Special issues of causation: situations that
give rise to litigations
·
Research;
·
Therapeutic and non-therapeutic;
·
Embryo research;
·
Transplantation;
·
Omission to warn about consequences of
sterilization.
The basis of liability
·
Breach of contract
·
Tort of negligence
·
Breach of confidence
Breach of contract 1
·
When a physician agrees to treat a patient, he
enters into an implied contract under which the patient expects reasonable care
in addition to other expressed or implied guarantees.
·
The physician-patient relation establishes a
contractual relation that if breached by the physician results in liability.
·
On the other patient breach of the contract is
accompanied by virtually no legal liability in most cases.
·
Physicians have to be careful not to enter into
a contract they cannot fulfill. The following can result in a physician being
found liable: A telephone consultation, giving a second opinion, acting as a
locum, and wrong clinical teaching.
Breach
of contract 2
·
The following normally do not lead to liability:
a side walk consultation, general medical advice at a dinner, medical advice on
the mass media, examining a person for employment purposes etc.
·
Telephone malpractice is increasing because of
increasing use of tele-medicine. The telephone is both a curse and a blessing
in medical care. Medical advice can be given by phone but there is no
documentation.
Case
scenario 1: The Boolam case: legal test of negligence a
·
In a famous case tried in 1957, important legal
principles were pronounced by the judge and they have subsequently become part
of the law.
·
The background to the case was that Boolam, a
mentally ill patient, suffered fractures during electroconvulsive treatment.
This type of treatment was accepted as a normal treatment for mental disorders
at that time. The patient had consented to the procedure.
Case
scenario 1: The Boolam case: legal test of negligence b
·
When he suffered a fracture he sued in court.
Two problems arose. He was not given full information when he was making his
consent because he was not told about the risk of fracture associated with
electroconvulsive therapy which was estimated at 1 in 10,000.
·
He was also not given a muscle relaxant that
decreases the risk of fracture during the procedure.
Case
scenario 1: The Boolam case: legal test of negligence c
·
At that time there existed differences in
professional opinions.
·
Some physicians considered informing the patient
about the risk of fracture and using a muscle relaxant as necessary whereas
others did not think so.
·
There was therefore no single standard of care
against which the actions of the attending physician could be judge to find him
negligent or not negligent.
Case
scenario 1: The Boolam case: legal test of negligence d
·
The judge ruled that doctors could not be found
negligent if they acted according to a professional opinion accepted by a
reasonable body of medical opinion even if there could exist a contrary opinion
by another responsible body of medical opinion.
Case
scenario 2: The Bolitho case:legal test of negligence
·
A patient suffered brain damage because the
doctor failed to intubate in a home setting.
·
The court ruled that doctors are expected to
follow responsible medical opinion but would not be found negligent in cases in
which that opinion did not stand up to logical analysis.
·
The court thus set a principle that the court
could over-rule medical opinion that was not logical in a specific case.
·
The implication of this was that medical opinion
was not the final arbiter of the standard of care to be used in defining
negligence.
Damages and compensation
·
Damages for personal injury
·
Damages for death
·
Damages for wrongful birth or wrongful life
·
Other forms of damage
Disclosure
of errors
·
The physician involved in treating a patient is
required to inform the patient of any error.
·
The disclosure must be immediate and complete.
·
All members of the healthcare team are obliged
to make the disclosure to the hospital authorities if the treating physician
refuses to do so.
·
Disclosure can be made to the family if the
patient is incompetent or nor ready to handle the stress of the disclosure.
Notes