Integrated Medical Education Resources: 131009P - PRACTICE BEYOND THE GUIDELINES: ETHICO LEGAL CONSIDERATIONS

Presentation to a Medical Grand Round King Fahad Medical City on October 9, 2013 by Professor Omar Hasan Kasule Sr.

CASE #1

A six-year-old girl presented with headaches and vomiting after a recent history of chicken pox. The differential diagnosis was varicella, meningitis or encephalitis. She deteriorated neurologically 2 days later and got a lumbar puncture.
Three days later she suffered a seizure and irreversible brain damage. A CT scan performed at that point showed a brain tumor.
Her parents sued the doctor for not doing the lumbar puncture earlier before she "lost the chance" to have her brain tumor treated before she sustained permanent brain damage[1]

DEFINITIONS: MALPRACTICE and NEGLIGENCE

· Malpractice is failure to fulfill the duties of the trust put on the physician. The term malpractice includes the legal concept of medical negligence.

· Negligence is breach of duty owed by the physician to the patient resulting in damage or injury. Negligence is defined according to the customary standards of care that are established by the profession. Example the standard for diabetic care is pre-prandial blood glucose <80 mg/dl, glycated hemoglobin <70%[2].

EXAMPLES OF NEGLIGENCE

· Examples of negligence: abandonment of a patient, not mentioning all complications in the consent process[3], breach of confidentiality, negligent referrals, failure to warn about risks, and failure to report a notifiable disease, medication errors[4], bladder or ureter injury in gynecologic surgery missed because bladder cystoscopy was not done.

· Professional errors (ordinary or extraordinary; harmful or non-harmful).

BASIS OF LIABILITY IN NEGLIGENCE

The physician owed a duty of care
The physician failed in that duty / breach of standard of care
The failure resulted in damage.

DEFINING THE STANDARD OF CARE

Precise meaning of ‘standard of care’ is still elusive[5]. Standards are not unanimous and do change frequently.
Clinical practice guidelines
Gold standard
Expert witness / clinical wisdom
Statistical evidence used for standard of care[6]
Avoid hindsight bias[7]
Patient safety can be improved by deriving new guidelines from closed malpractice cases[8]

DEFINING THE STANDARD OF CARE: clinical practice guidelines

Examples of clinical practice guidelines for oncology,[9] hypertension,[10] endocrine conditions,[11] liver hepatitis,[12] instrumental delivery,[13] thrombosis associated with central venous catheters in cancer patients[14].
Guidelines are described as international[15], evidence based[16], formal systematic and consensus[17]

DEFINING THE STANDARD OF CARE: gold standard 1

Examples of gold standards: stent restenosis[18], open surgery for thoracic coarctation of the aorta in an adult[19], destination therapy for heart failure patients with left ventricular assist devices[20], surgical aortic valve replacement for aortic stenosis[21], the radial approach in cardiac catheterization [22], surgery for obstructive hypertrophic cardiomyopathy?[23]

DEFINING THE STANDARD OF CARE: gold standard 2

Examples of gold standards: simultaneous pancreas and kidney transplantation in diabetes with renal failure [24], posterior vaginal wall prolapse repair with mesh or native tissue?[25], Rives technique for incisional hernias[26], Ferguson hemorrhoidectomy [27], corticosteroids for non-infectious uveitis.[28], epidural technique for postoperative pain?[29] transforaminal endoscopic spinal surgery for discectomy?[30] Holmium laser enucleation of the prostate.[31], hypertonic saline and not mannitol for intracranial pressure,[32]

LEGAL TEST OF NEGLIGENCE: The Boolam case 1

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. 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.

LEGAL TEST OF NEGLIGENCE: The Boolam case 2

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.

LEGAL TEST OF NEGLIGENCE: The Boolam case 3

Change from Boolam to Bolitho[33] [34] [35] [36] [37] [38]
Boolam has been criticized because it gives the medical profession the right to set practice standards but Bolitho may have gone too far in the other direction[39] of giving more rights to the claimants[40]

LEGAL TESTS OF NEGLIGENCE: THE Bolitho case 1

Bolitho, a patient who suffered brain damage at home because the doctor failed to intubate, 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.

AVOIDING / PREVENTION OF MALPRACTICE SUITS

Obtaining and maintaining registration
Sticking to defined professional standards of care
Peer review
Quality assurance
Use of protocols
Defensive medicine
Politeness with patients.
The best protection against medical negligence is the conscience of all health care workers to make sure that mistakes do not occur.