The subject matter of medical negligence is extensive, changes frequently, and varies from country to country, and it is impossible to do justice to the topic in this chapter. Several good texts are available, and these are listed in the reference section.
The development of current medical negligence law is fascinating and warrants a brief tour to understand the niceties of present-day legal process. As modern surgery developed in the mid- to late 1800s, with the introduction of general anesthesia in 1846 using inhaled ether and subsequently antisepsis by Joseph Lister in 1867, so the idea of surgery for nonfatal conditions moved from being an interesting possibility into reality. Along with this massive transformation of what could be achieved surgically came the inevitable problems.
One of the early medicolegal cases in the United States involved a woman, Mary Schloendorff, who entered New York Hospital in January 1908, “suffering from some disorder of the stomach.” She agreed to an “ether examination” to aid in identifying a lump that had been detected. While the patient was under the effects of the anesthesia, the surgeon removed a fibroid tumor discovered during the examination. An infection, gangrene, and the amputation of several fingers allegedly resulted from the operation. The claim was denied, but eventually in 1914, Judge (later Supreme Court Justice) Benjamin Cardozo laid down his famous opinion in the judgment, stating: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’ s consent commits an assault for which he is liable in damages.”1
This ringing phrase is technically incorrect, but is quoted frequently in medicolegal texts in support of the rights of individual patients. However, rather than an assault, Mary Schloendorff’s injuries resulted from a battery. In US law, a civil assault is “an intentional attempt to do injury or commit a battery upon the person of another.” The assault requires intent to inflict injury or put the victim in apprehension of such injury. A battery consists of the unwanted touching, with the only intent required being the intent to make contact, not intent to do injury.2 In
British law, battery consists merely in unlawfully touching another (thus, no particular injury is necessary), although there has to be intention or recklessness for the wrongdoing of battery to exist.
In general terms, claims for medical wrongdoing cannot be for assault, as there is no intent to do harm and battery seems inappropriate. Nowadays, in the United Kingdom and in most former British Commonwealth countries, the United States, and much of Europe, medical mishaps are pursued under the mantle of “negligence,” requiring the proof of fault in the clinician’s actions, although in a minority of countries “no-fault compensation schemes” have emerged. Neither process is without its associated problems.
The definition of negligence differs from country to country. Europe has no common laws on medical malpractice.
The development of the tort, or wrongdoing, of negligence has a long history extending back into the thirteenth century, with deflections and variations forced by the agricultural revolution and then the industrial revolution, as life for employees became more dangerous. A classic early outline of negligence was given by Alderson in 1856.3 “Negligence is the omission to do something which a reasonable man, guided upon those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.”
Negligence in medicine is either the omission of an appropriate medical act or performing an action which falls below some standard of medical care and which causes harm.
In 1932, a young man made legal history by buying a bottle of ginger beer from a small shop near Glasgow. He bought this to make an ice cream soda for his girlfriend. She drank some, but as he was refilling the glass the corpse of a long dead snail seemed to fall out of the opaque bottle. The lady suffered nervous shock and a violently upset stomach.
What was the legal position at the time? If the young man had sued the shopkeeper he would have been entitled to his money back under the law of contract from the shopkeeper. But he had suffered no physical injury, and it was the girlfriend who was claiming damages from the manufacturer, not from the shopkeeper, even though the snail was never produced in evidence, if it existed at all. The House of Lords ruled that there could be liability in negligence, and Lord Atkin’s judgment became the cornerstone of the modern law of the tort negligence. He said,4 “The liability for negligence is no doubt based upon a general public sentiment of moral wrongdoing for which the offender must pay.”
However, Lord Atkin realized that there must be a limit to this, and he formulated his now famous dictum: “You must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour.”
Who are neighbors? Neighbors are “persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation when I am directing my mind to the acts or omissions which are called in question.” Thus there has to be “proximity” between the action (or the omission to act) and the adverse outcome, which must have been reasonably foreseeable.
The language of this judgment was beautifully clear, with a directness and simplicity that gave it a wide appeal. However, while the dictum states to whom the duty of care is owed, the extent of this duty is not defined except in terms of reasonableness. It was not for some years that a working definition of the reasonable person surfaced in law in a case involving Glasgow Corporation. The judgment by Lord MacMillan in 1943 laid down what was reasonable. He said,5 “The standard of foresight of the reasonable man is in one sense is an impersonal test. It eliminates the personal equation and is independent of the idiosyncrasies of the individual person whose conduct is in question.” He went on to say: “Some persons are unduly timorous and imagine every path beset with lions; others of a more robust temperament fail to foresee or nonchalantly disregard even the most obvious dangers. The reasonable man is presumed to be free from both overapprehension and from overconfidence.”
Early in the last century, medical negligence cases were rare and tended to be tried under the common law tort of trespass or assault and battery. Since then, medical mishap has become a part of the overall common law tort of negligence. However, it differs from the “run-of-the-mill” accident in that medical practice involves the application of specialized skills in an attempt to make patients better. Thus, when unexpected or unwanted, adverse outcomes occur, a judgment made against a clinician involves serious criticism of his or her professional abilities. The deference shown to doctors by the law even some 50 years ago was quite remarkable in the current climate of medical negligence.
One such case was Hatcher v. Black, decided in 1954.6 Here the claimant, Mrs. Celia Hatcher, a 30-year-old radio broadcaster, underwent a thyroidectomy because of toxic goiter. On the night before the operation, she asked Mr. Tuckwell, the consultant surgeon, if there was any risk to her voice and he told her there was none. Unfortunately, the risk materialized and seriously impaired her employment. Mrs. Hatcher sued in part because Mr. Tuckwell had, she claimed, negligently advised her that there was no risk and that had she known there was some, she would have taken the alternative medical treatment.
In his summing-up to the jury, Lord Denning suggested that “In hospital where people who are ill come for treatment there was always a risk, no matter what care was used. It would be wrong and bad law to say that simply because a mishap occurred, the hospital or doctors were liable … It would mean that a doctor examining a patient or a surgeon operating at the table, instead of getting on with his work, would be forever looking over his shoulder to see if someone was coming up with a dagger … The jury must not find the doctor negligent simply because one of the risks inherent in an operation had actually taken place or, in a matter of opinion he had made an error of judgment.” Further on, he said, “What should a doctor tell a patient … He [Mr. Tuckwell] told a lie; but he did it because in the circumstances it was justifiable … but the law does not condemn the doctor when he only does what a wise doctor so placed would do. And none of the doctors called as witnesses have suggested that Mr. Tuckwell was wrong. All agreed that it was a matter for his own judgment. If they do not condemn him, why should you? It is for you to say whether you think Mr. Tuckwell told her there was no risk whatever, or he may have prevaricated to put her off as many a good doctor would, rather than worry her. But even if you think he did tell her, is that a cause for censure?”
Following such a direction, the jury acquitted Mr. Tuckwell not only on the count of “failure to inform” but also on the accusation that the operation was performed in a careless fashion.
In 1957, Justice McNair set out guidelines relating to the standard of care in medical cases. The test, to be described below, came to be known as the Bolam test (after the claimant’s name in the case in question), and this test was subsequently incorporated as a standard into most medical negligence cases. The test at that time and in this particular case was specifically directed to the standard of care in diagnosis and treatment, and it is unclear whether it was intended to apply to the warning of risks associated with treatment to be given to competent patients prior to treatment. Subsequently, the test was taken to cover all aspects of medical care, including the standard relating to the duty of disclosure of risks prior to obtaining consent.
Justice McNair based this direction on an earlier Scottish judgment given by the Lord President (Clyde), who said,7 “The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care.”
To which McNair8 added “in all the circumstances,” and suggested that English (as opposed to Scottish) courts would not have any difficulty with this proposition. McNair then continued to reformulate the dictum by stating, “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.”
The “Bolam test” (it is not a law) stood essentially unaltered in English law for 40 years, despite many legal attempts to challenge it. In effect, the test produces a low standard of care, since a “responsible body” could be any small group who accepted the practice in question as being proper, even though they might not undertake the same practice themselves. There are many sad examples of patients with very serious medical injuries who were denied compensation because of this test—for example, Hills v. Potter in the 1980s.9
In a complex case in the mid- to late 1990s, known as Bolitho10 (the name of the unfortunate child who eventually died after a series of respiratory arrests and was not seen by a doctor until major brain damage had occurred), a significant judgment modified the Bolam test by insisting that the opinions of a group of experts had to be able to withstand logical analysis. This put some authority back into the hands of the judiciary, in that they could help determine what should have been done. In the House of Lords, Lord Browne-Wilkinson stated, “It was, the House held, to be expected that in most cases, in the light of the evidence of a professional body of opinion in support of the defendant’s conduct, such conduct would be demonstrably reasonable. If, however, the professional opinion called in support of the defence case was not capable of withstanding logical analysis, then the court would be entitled to hold that the body of opinion was not reasonable or responsible.”
The test is quite distinct from that applied in most European jurisdictions. According to Article 7: 453 of the Dutch Civil Code, for example, a healthcare provider shall exercise the level of care expected from a conscientious healthcare provider. At first sight, the two tests are virtually identical. In fact, there is a gulf between them. The standards of a “responsible body of medical men” are radically different from “conscientious healthcare providers,” because in the latter case it is the court which decides, not the medical colleagues, as in the first case (information courtesy of Ewoud Hondius).
Thus, whatever the jurisdiction, the three stages of a medical negligence claim are to establish:
A duty of care
The standard of care
It is important to note that it is the courts that decide whether an action or lack of an action is negligent. Doctors, as experts, do not decide negligence; we can only give our opinion on each of the three elements of a claim—i.e., was there a duty of care? Would a responsible body have made or undertaken this particular judgment or action or not? If not, did that action or lack of it cause the problem in question? It is the judge or the jury who decide negligence. In United Kingdom law (and in US, Australian, Canadian, and Indian law, among others), the standard of proof for medical negligence cases is on a “more-likely-than-not” basis—unlike the level set in criminal law, namely, “beyond all reasonable doubt.”
Courts, not medical doctors, decide whether an action or lack of an action is medical negligence.
In a 2001 thesis entitled “The Economic Analysis of German Medical Malpractice Law,” Wieland outlines the different basis for the standard of proof in German medical law relative to UK law.11 To claim compensation for pain and suffering, a medical malpractice claim, like any other tort law claim, would be based on § 823 I of the German Civil Code (Bürgerliches Gesetzbuch, BGB): “a person who, intentionally or negligently, unlawfully injures the life, body, health, freedom, property or any other absolute right of another is bound to compensate for any damage arising therefrom.”
In addition, the courts have developed some principles on how to treat a particular type of malpractice. To be liable, the physician has to fulfill at least three conditions—i.e., firstly, he has to commit a malpractice; secondly, this malpractice has to cause a violation of the protected rights of the patient (e.g., a bodily harm); and thirdly, this violation of rights has to cause a damage for the patient (e.g., pain and suffering). These conditions have to be examined in detail.
In general, German tort law allocates the burden of proof to the plaintiff (claimant). He or she has to establish and prove the facts supporting the case, which is called “principle of full proof.” In medical malpractice cases, the plaintiff at least has to prove, firstly, the malpractice; secondly, the causal relation between the malpractice and the violation of life, body or health; thirdly, a damage; and fourthly, the causal relation between the violation of life, body, or health and the damage. Thus, difficulties arise for proof of negligence and especially for proof of the causal relations.
In Germany, the causation giving rise to liability is determined by § 286 of the Code of Civil Procedure (Zivilprozessordnung, ZPO), which requires as a standard of proof probability bordering on certainty (“es muss mit an Sicherheit grenzender Wahrscheinlichkeit feststehen”). This means that the judge has to be personally convinced with such a high probability that doubts have no chance of arising.
If any doubts remain, the claim will be completely reversed. This “all-or-nothing” principle is also an important characteristic of the German system. Although the standard of proof in § 287 ZPO simplifies the measure, because only a considerable probability (“erhebliche Wahrscheinlichkeit”) of evidence for causation is required, it is only applicable for proving the remoteness of damage, not for proving the causation giving rise to liability. Thus, the first step for the patient is to prove causation giving rise to liability with probability bordering on certainty. This is where the patient’s difficulties in providing evidence mostly arise.
There is little uniformity in the criteria for medical malpractice across those countries around the world which still have a tort-based system.
The law in the various other member states of the European Union is not uniform and is “in development” in many of the smaller and newer entrants. In the smaller states, medical negligence cases are relatively rare, so reliance is generally placed on other larger jurisdictions, namely, the United Kingdom, Germany, and France where there is, or was until 2002 in the case of France, an established tort-based process relating to medical negligence.
In 1974, New Zealand adopted a government-funded system for compensating people with personal injuries, including medical injuries (operated by the Accident Compensation Corporation, or ACC). This replaced the former tort-based system, and the ACC is now the primary method of dealing with medical injuries. Reforms in 2005 removed the final fault element from the compensation criteria for medical injuries, making it a true no-fault system. Unfortunately, no new system is problem-free, and various criticisms have been raised12 (and apply to other no-fault schemes discussed below).
Many observers believe that levels of ACC compensation are inadequate, particularly in comparison with tort jurisdictions. This is especially a problem for patients—usually women and the elderly—who are not in paid employment at the time of the injury and thus are unable to claim earnings-related compensation.
Compensating treatment injuries, while excluding most other illnesses from the ACC system, is bound to produce tensions, because ACC assistance is generally higher than that received from the health and welfare systems. This is particularly troubling in the area of birth abnormalities, such as cerebral palsy, in which babies with similar needs could be eligible for very different kinds of support.
Although the system is structured to support efforts to improve patient safety, the potential gains are still a long way from being fully realized. After 30 years of the ACC and 9 years of independent complaint resolution, New Zealand hospitals appear no safer (or more dangerous) than those in other Western countries. The adverse-event rate of 12.9% stands midway between the levels recorded in two countries with shared medical traditions in training and practice: Australia (16.6%) and the United Kingdom (10.8%). Although the recent reforms are expected to bolster efforts to create a culture of learning, the task of making health care safer is daunting and will not be achieved through medicolegal reform alone.
In 1975, Sweden introduced a nationwide no-fault patient-injury compensation plan. The plan was not introduced because malpractice insurance costs were high, but because so few injured patients were receiving compensation through the tort-based system. With certain exceptions, compensation is provided for loss that occurs as a result of injury related to hospitalization or medical care. This system spread to the other Scandinavian countries and continues to be modified with time.
In 2002, France scrapped the tort-based medical negligence claim system. Under the French implementation of the Scandinavian system, patients who believe they have suffered rather than benefited from medical care bring claims before their region’s government-appointed review board, which is responsible for determining whether compensation is in order and, if so, how much. For a patient to be paid, the board does not have to find the doctor at fault, or that medical negligence caused whatever pain and suffering the patient is experiencing. Money for patient relief comes from a national compensation fund, but the same problems apply as described for the New Zealand no-fault scheme.
In general terms, for hospital doctors it is clear that there is a duty of care once the patient is in front of them in the clinic. This was set out by Lord Nathan13 in an old text in which he states, “The medical man’s duty of care arises … quite independently of any contract with his patient. It is based simply upon the fact that the medical man has undertaken the care and treatment of the patient … It is clear then that the duty of care which is imposed on the medical man arises quite independently of contract. It is a duty … which is based upon the relationship between the medical man and his patient, owing its existence to the fact that the medical man has assumed responsibility for the care, treatment or examination of the patient as the case may be.”
The only real question as far as the surgical specialties are concerned is when does that duty of care begin? Does a referral letter that has been read, but not acted upon, constitute a dereliction of duty? In the case of an emergency, does a call from a nurse answered by the doctor indicate that a duty of care has fallen on that doctor?
The only relevant decision in English law was in the case of Barnett v. Chelsea and Kensington Hospital Management Committee in 1968.14 Judge Nield stated, “At about 5 a. m. on January 1st, 1966, three night watchmen drank some tea. Soon afterwards all three men started vomiting. At about 8 a. m., the men walked into the casualty department … which was open. One of them, the deceased, when he was in the room in the hospital lay on some armless chairs. He appeared ill. Another of the men told the nurse they had been vomiting after drinking tea. The nurse telephoned the casualty officer, a doctor, to tell him of the men’s complaint. The casualty officer, who was himself unwell [readers should note the date] did not see them but said they should go home and call in their own doctors. The men went away, and the deceased died some hours later from what was found to be arsenical poisoning. Cases of arsenical poisoning are rare and even if the deceased had been admitted to the hospital and treated, there was little or no chance that the only effective antidote would have been administered to him before the time he died … Is there, on these facts, shown to be created a relationship between the three night watchmen and the hospital staff such as gives rise to a duty of care in the defendants which they owe to these three men? … Ihave no doubt that [the nurse] and [the doctor] were under a duty of care to the deceased.”
It is clear from what has been said about the Bolam test that the doctor involved in the treatment of a particular patient should have the skills appropriate to the task he or she is undertaking. This is no different in law from other specialists’ fields of activity.15 “Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill.”
This was recognized by Lord Bridge in Sidaway v. Governors of the Bethlem Royal Hospital:16 “The language of the Bolam test clearly requires a different degree of skill from a specialist in his own special field than from a general practitioner. In the field of neuro-surgery it would be necessary to substitute for the … phrase ‘no doctor of ordinary skill,’ the phrase ‘no neurosurgeon of ordinary skill.’ All this is elementary, and … firmly established law.” Furthermore, in a separate case: “The more skills a person in a specialist field possesses, the higher the standard of skill expected of him. However, he is not required to attain the highest degree of skill and competence, merely a reasonable level of skill within that field. The Bolam test will therefore be applied simply by substituting surgeon, dermatologist, etc. in the place of doctor without gloss either way.”
Thus, if an individual is undertaking parotid surgery, he should have the reasonable levels of skill of someone who regularly undertakes parotid surgery. This would suggest that the occasional parotid surgeon who undertakes only one or two operations a year might not fare well in a case in which an unexpected and unwanted complication occurred. This suggests, in turn, that specialist procedures should be undertaken by specialist groups. Before the Bolitho test, it was possible to have a small group of surgeons support the actions of another surgeon who undertook the very occasional specialist procedure, but since then this position has been very difficult to maintain.
The standard of care for parotid surgery means that such specialized operations should only be performed by surgeons specifically trained and skilled in the procedure.
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