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Lecture
for 4th year medical students on January 4, 2012 at King Fahad Medical City Riyadh by Dr Omar Hasan Kasule
Sr.
ABSTRACT
This
paper starts by defining the various types of error in medical practice. It
then describes negligence: classification, elements, forms, and examples. It
then describes the various types of liability for errors as well as the legal
basis for liability. The court procedure
of malpractice suits is described in detail followed by discussion of
assessment of damages and disclosure of errors. The paper uses the term
physician but all other health care givers are included.
1.0 DEFINITIONS
1.1
Definition of Medical Error
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. 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. This paper will take a wide view of errors.
1.2 Definition
of Malpractice
Malpractice
is a form or 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, failure
to and to carry out responsibilities of the physician, masuliyat al tabiib,
or violation of the patient’s rights (eg autonomy, privacy, confidentiality,
disclosure, personal dignity, etc).
1.3
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.
2.0
NEGLIGENCE
2.1
Overview of negligence
Negligence
in medical practice is breach of duty owed by the physician to the patient
resulting in damage or injury. It is defined according to the customary
standards of care that are established by the profession. All human activity is
error-prone and even if professional
standards are followed some harm can occur. Ordinary medical practice does not
prescribe to the doctrine of strict liability (physician found negligent for
any mistake even if reasonable). The concept of negligence is therefore relative.
No medical procedure is error-free and no practitioner however careful and
meticulous can eliminate all errors. There is a threshold beyond which patient
risk is considered unreasonable. Negligence is found only when performance is
below what would be expected from a reasonable professional with average skill
and knowledge. Negligence is therefore
relates to unreasonable error.
2.2
Classification of negligence
2.2.1 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.
2.2.2
Comparative negligence
In comparative negligence the negligence is
apportioned among several physicians each according to the quantum of his/her
contribution to the negligence.
2.2.3
Intentional negligence
In intentional
negligence there is personal injury that is intentionally inflicted by the
physician. This type of negligence borders on the criminal.
2.3 Elements
of negligence
2.3.1
The 4 elements of negligence
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. 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
conduct must have caused injury to be classified as negligence. 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.
2.3.2
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. It should be noted that 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.
2.4 Forms of negligence
1. Medical negligence may be
breach of duty resulting in causation of injury which calls for damages. 2. 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). 3. Violation of patient rights such as abandonment
of a patient or breach of confidentiality. 4. Liability for negligent use of
drugs and devices. 5. Vicarious liability arises when a physician fails to
supervise a junior or a trainee working under him or her. 6. Negligent
referrals occurs when a physician fails to refer a patient to the right
specialist. 7. Failure to warn about risks. 8. Failure to report a
notifiable disease . 9. Professional
errors that may be ordinary or extraordinary. harmful or non-harmful.
2.5 Examples
of negligence in obstetrics and gynecology
1. Injuries at birth to both mother and fetus, 2.
congenital deformities, 3. wrongful life, 4. stillbirth, 5. psychiatric injury, 6. inappropriate care
due to lack of current knowledge, 7. errors of skill or judgment, 8. wrongful
termination of pregnancy due to failure to do a pregnancy test before
gynecological surgery, 9. failed abortion when an abortion is attempted but is
not completed, 10. 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, 11. negligence in
prescribing for a pregnant woman, 12. false diagnosis of maternal disease that
affects the fetus, 13. mistakes in
obstetric analgesia and anesthesia, 14. negligence in labor and delivery by
failure to detect fetal distress resulting in brain damage.
2.6 Examples
of negligence in psychiatry
1. Sexual
misconduct, 2. failure to prevent suicide or attempted suicide, 3. failure to
prevent patient violence, 4. wrong medication, 5. negligent diagnosis, 6. abandoning
a patient, 7. breach of confidentiality, 8. early discharge, 9. failure to
hospitalize leading to suicide, 10. failure to commit leading to murder, 11. failure
to control symptoms leading to suicide or injury to a 3rd party, and
12. negligent certification of mental status.
3.0
Types of liability
3.1 Physician
liability
3.1.1 Battery
for lack of informed consent: Battery, assault, or false imprisonment
charges can be brought against a physician who touches a patient without
consent
3.1.2 Errors:
Professional errors may be ordinary or extra ordinary. They may be harmful or
non-harmful. Informed consent or express instruction of the patient do not
relieve the physician of liability.
3.1.3 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.
3.1.4 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.
3.1.5 Liability
of hospitals:
Hospitals
can be found liable in three ways: (a) employer’s vicarious liability (b)
direct breach of duty (c) joint liability with the physician.
3.1.6 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.
3.1.7 Special
issues of causation
The
following situations could give rise to litigations: Research; therapeutic and
non-therapeutic; Embryo research; transplantation; and omission to warn about consequences of
sterilization.
4.0 THE
BASIS OF LIABILITY
4.1 Breach
of contract
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. 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.
4.2 Tort
of negligence
Tort
refers to acts that cause harm and associated with award of damages to the
injured party. Tort is confined to civil and not criminal cases. It is about
injuries to individuals and not the community or the public interest. Tort laws
serve the purposes of punishment, deterrence, and compensation for hurt and
injury. Action is brought for harm to life, health, economic earnings, honor,
reputation, and privacy. Specific laws dealing with injuries have replaced tort
law in many instances. The tort of
negligence is invoked when there is breach of duty that leads to injury of either
the patient or a third party (such as an unborn child).
4.3 Breach
of confidence
The
physician may also be liable for breach of confidence. The physician-patient
relation is based on that confidence.
5.0 MALPRACTICE
SUITS: COURT PROCEDURE
5.1 Purposes
of malpractice suits are to (a) to ensure quality control by forcing
physicians to perform according to expected standards (b) compensation for
injury (c) Personal satisfaction for the patient that justice has been
done
5.2 Statute
of limitations
Court
action must be instituted within a reasonable period. The statute of
limitations states that there is a fixed period after the breach during which
tort action can be brought. The reason for this is that if the suit is delayed
too long witnesses or medical records may no longer be available.
5.3 Filing
the complaint
The
legal process follows several steps. The patient files a complaint with the
court. A sermon is then served on the physician. The physician has to plead,
the plea may be guilty or non-guilty otherwise a default judgment is made in favor
of the plaintiff. This is followed by various motions to dismiss or amend the
complaint. Motions may also be made to add other parties to the suit. Normally
the hospital is included as part of the defence.
5.4 Process
of discovery
The
process of discovery then starts in which lawyers for both sides collect more
information by interviews, examinations, and collection of documents. The
results of discovery are deposited with the court. Access to health records is
pivotal for prosecution of medical malpractice. Documentation can be the
physician’s best friend or worst enemy.
5.5 The
trial proper
5.5.1 The
trial proper then starts. Opening statements are made. The patient’s witnesses
are then examined by the patent’s lawyers followed by cross examination by the physician’s
lawyers. The physician’s witnesses are
examined by the physician’s lawyers followed by cross-examination by the patient’s
lawyers. Witnesses called to court are of two types: fact witnesses and expert
witnesses. Physician may be called as an expert witness or a court appointed
expert. Closing arguments are then made and judgment is delivered.
5.5.2 The
burden of proof of breach of standard of care lies with the patient. The
standard of proof used is a balance of probabilities. Proof of breach may be
based on ‘but-for’ test. Proof of breach may be based on proof of causation of
damage or risk
5.5.3 Physician
defense against malpractice suits rests on consideration of the 4 elements of
negligence: absence of duty, no breach of duty, lack of causation, and lack of
damage. Additional defenses that could be presented are: comparative
negligence, statute of limitations which states the maximum period within which
a tort can be prosecuted, and any agreement between the physician and the patient
that absolves the physician of liability
5.5.4 Instead
of a trial, alternative dispute resolution procedures may be used: arbitration,
mediation using an expert facilitator, fact finding and investigation of the
case by an expert.
6.0 LEGAL TESTS FOR NEGLIGENCE: Bolam as
modified by Bolitho
6.1 The
Boolam case
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 Bolam, 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.
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.
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.
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.
6.2 The
Bolitho case
In a
subsequent case of Bolitho, a patient who 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.
7.0 MALPRACTICE SUITS: THE SAUDI PERSPECTIVE
8.0 DAMAGES AND COMPENSATION
8.1 Definition
The principles for damages for medical errors are generally
the same as those of injury causation in other areas of life with some
exceptions. Compensation, dhamaan,
for doctor errors arises when the doctor is found negligent. In order to
protect the public interest there is still liabaility in erring while acting
with good intentions, diyat al khataa.
8.2 Damages
for personal injury
Pecuniary
damages involve full compensation of losses in personal injury which include
medical expenses and loss of earnings including prospective ones, and loss of
earning capacity. Non-pecuniary damages in personal injury involve fair or
reasonable compensation for pain, suffering, and loss of faculty which leads to
loss of amenity. Aggravated damages cover pain and suffering. Exemplary damages
are punitive. Provisional damages are paid if further deterioration is
expected. Provisional payments may be made while waiting to ascertain full
damage.
8.3 Damages
for death
Court
actions for the benefit of the deceased continue after death. The survivors are
entitled to compensation of financial support in case of fatal accidents. They
also get payment for bereavement and loss of dependency.
8.4 Damages
for wrongful birth or wrongful life
A woman
can bring charges against a physician for wrongful birth due to failure of
contraception. Damages for wrongful birth include mother’s lost earnings and
the cost of child maintenance. A child can bring action claiming damages for
wrongful life due being born with severe congenital anomalies. The child can
claim a legal right to be dead rather be alive with such severe disability.
8.5
Other forms of damage
Action
for damage can be brought for emotional distress, economic loss, and breach of
confidence. The physician must be careful in answering queries about a patient
from the police, employers, and child protection agencies. A physician cannot
volunteer to give evidence about a patient in a court of law. He can go to
court only on subpoena.
9.0
DAMAGES FOR INJURY AND DEATH: THE SHARI’AT PERSPECTIVE
9.1
Overview
The
shari’at has very advanced concepts for assessing damage that need to be
studied and to be applied to modern forms of injury. My belief is that the conceptual
basis of the shari’at guidelines on damages is far superior to the conventional
standards that are used today.
9.2 Intentional causation of death
9.2.1
Overview
Purely
intentional homicide, qatl 'amd, is
deliberate pre-planned and pre-meditated murder. The perpetrator of the crime
sets out with a clear intention to terminate the life of an individual for a
specific motive. It can be conceived in three forms: criminal homicide,
judicial homicide, and medical procedures involving deliberate termination of
life. The hospital shares in the liability and pays a portion of the diyat
because it is responsible for background checks not to allow criminal persons
as hospital employees.
9.2.1 Criminal
homicide for personal reasons is rare in a medical situation and if it occurs
should be handled according to the normal rules of retribution, qisas. The
punishment could be execution or payment of blood money, diyat. The
family of the deceased could forgive the killer because the shari’at treats
homicide as a civil case.
9.2.2 Judicial
homicide occurs when a physician is ordered by governmental authorities to take
part in execution of a criminal such as giving a lethal injection or operating
an electrocution apparatus. This does not lead to any liability for the physician
but physicians are advised not to participate if they can because the role of
executioner is contrary to the primary role of the physician to preserve and
protect life and health, hifdh al nafs.
9.2.3 Medical
procedures that have a non-criminal intention to terminate life include:
euthanasia both active and passive, withholding or withdrawal of life support,
physician-assisted suicide, do not resuscitate orders, termination of
pregnancy, separation of siamese twins involving letting one die so the other
can survive, selective killing of fetuses in multiple pregnancy so that some
can survive, craniotomy or any procedure that involves killing a fetus who
cannot be delivered otherwise in order save the mother’s life. Some of these procedures
have been allowed by the jurists while others have been prohibited. If a
physician commits a forbidden procedure he will be liable for destruction of
life but the punishment cannot be the same as that of criminal homicide but
this matter is better left to the jurists to determine.
9.3
Un-intended causation of death, qatl
khata
Purely
accidental homicide is defined as death ensuing due to an honest mistake[iii].
This occurs in iatrogenic death due to wrong medication or wrong surgical
procedures. For example diyat is due if an ignorant or incompetent
physician makes a mistake leading to death[iv].
Expiation is carried out by fasting 2 consecutive months in addition to the diyat. The diyat is reduced and is called ghurrat (about 10% of the full diyat) if the victim was a fetus.
9.4 Intentional causation of injury
9.4.1
Overview
Purely
intentional injury is one in which the criminal had malicious intent to cause
injury. Purely accidental injury or negligence resulting in harm has no
pre-meditated intention to harm. Unintended injury accidental injury occurs in
the course of medical treatment.
9.4.2
Criminal intentional injury is rare in a medical environment. If it occurs it
is punished by the usual rules of retribution, qisas.
9.4.3
Unintentional injury occurs in medical practice. Diyat is imposed on the
physician and the hospital. Full diyat (equivalent to the diyat
of homicide) is imposed for destruction or loss of function of single organs:
the nose, the eye, the tongue, the lips, the penis, and the testicles[v].
Half of the full diyat is imposed for destruction or loss of function of
paired organs like the hand, the eye, the ear, the foot[vi].
Ijtihad is made for injuries to other organs.
9.5
Computation of diyat
The
computation of the diyat involved is complicated and requires new ijtihad.
The classical Law manuals various amounts of diyat in terms of camels or
other objects for different types of injury. Not all possible injuries were
covered. Modern medical knowledge enables us to describe injuries in a more
precise way. We are also better able to describe and assess functional
disability resulting from the injuries. A study is also needed to clarify the
distinction between punitive and compensatory awards for body injuries.
10.0 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.
REFERENCES