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150406P - MEDICAL PRACTICE AND MEDICAL ERRORS

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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 negligence: classification, elements, forms, and examples.
·        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


[i] Bukhari K46 H11
[ii] Bukhari K2 B32