Defending medical negligence claims: a surgeon's guide (part I)

The defence of disclosure and consent is particularly significant to surgical practice, because it is at the point of treatment by surgery that risk disclosure by the surgeon and consent by the patient becomes relevant. This is because, unlike previous stages of the doctor-patient relationship, such as the stage of consultation or diagnosis, bodily invasion of a serious nature occurs during surgery.


Introduction
No one would disagree that defending a medical negligence claim is not a desirable option for any medical practitioner. However, surgeons appear to be particularly vulnerable to this predicament. According to the conclusions of a WHO study published in 2008, of the 234 million surgeries that were taking place every year globally, 3-16% of surgeries conducted in developed countries resulted in unnecessary complications with nearly 8% leading to death and the death rate in major surgeries conducted in developing countries was nearly 10% [1]. Findings of a cross-sectional descriptive study of complaints of medical negligence received and investigated by the Healthcare Excellence Unit of the Ministry of Healthcare and Nutrition during 2008 and 2009 concluded that the majority of complaints are related to specialties involved with surgical operations [2]. On the other side of the world, in the USA, which has a reputation for high rates of medical malpractice claims, the extent to which surgical errors dominate the medical negligence landscape was captured thus after a twenty-year study of national malpractice claims [3]: …Johns Hopkins patient safety researchers estimate that a surgeon in the United States leaves a foreign object such as a sponge or a towel inside a patient's body after an operation 39 times a week, performs the wrong procedure on a patient 20 times a week and operates on the wrong body site 20 times a week. … They identified 9,744 paid malpractice judgments and claims over those 20 years, with payments totaling $1.3 billion. Death occurred in 6.6 percent of patients, permanent injury in 32.9 percent and temporary injury in 59. 2

percent.
In this cross-global context, it would be useful for surgeons practising in Sri Lanka to have some insight into defending medical negligence claims. First of all, not every surgical error will result in an injury. Secondly, not every error which causes an injury would come to the knowledge of the patient. Thirdly, not every patient who becomes aware that an injury has been caused by an error will make a claim against the surgeon [4]. However, the few surgical errors which reach the stage of such a claim being made can result in medical negligence litigation and necessarily call for the defendant surgeon to construct a defence.
Before exploring the avenues available for formulating a legal defence in a medical negligence lawsuit, it is necessary to recall the basic ingredients which need to be proved by a claimant in such a lawsuit: (a) that the defendant doctor and/or hospital owed a duty of care to the claimant; (b) that such duty of care was breached; (c) that such breach caused an injury; and (d) that such injury resulted in loss to the claimant. If all of these ingredients are found to be present in an incident of surgical error, liability for medical negligence is most likely to ensue. Since the last ingredient involves proof of facts purely within the domain of the claimant, it is not relevant to surgical practice itself. Therefore, this paper examines some key factors upon which a surgeon facing medical negligence litigation can develop his defence and avoid liability for negligence by either challenging proof of or offering defences against the other three ingredients.

1) Absence of a duty of care
As the ingredients of a medical negligence lawsuit indicate, a threshold fact that must be proven is that the doctor owed a duty of care to the claimant. If a doctor is able to successfully challenge that fact, the lawsuit would fail without going as far as delving into expert opinions on the medical care that was provided. The law certainly does not recognize a duty to rescue; and, in this sense, no doctor owes a duty of care to voluntarily offer medical services to a stranger who is not already his patient. However, consider a surgeon who plays the role of a Good Samaritan and assists in a situation However, once the professional doctor-patient relationship is established, a legal duty of care commences and a surgeon who undertakes operating a patient will owe that duty to the patient. In some exceptional cases, a doctor may also owe a duty of care to third parties who are not merely bereaved relatives making a claim on injuries suffered as a result of a patient's death. For instance, in Froggart v. Chesterfield and North Derbyshire Royal NHS Trust [6] the claimant was not the patient. The claimants were the husband and son of the patient who had been subjected to an unnecessary mastectomy, after negligent misdiagnosis of breast cancer. The injuries suffered by both claimants were of a psychiatric nature: the husband, for having developed an adjustment disorder, following the profound and lasting shock of seeing his wife undressed for the first time after surgery, and the son, for undergoing moderate PTSD upon his mother repeating to him the negligent advice that she had cancer and was likely to die. The psychiatric injuries here were caused by an incident of misdiagnosis, but had the mastectomy been a result of surgical error, the surgeon could have equally been held liable for the said injuries. Though it may seem that this case is at the extreme end of the spectrum of duty of care, it is important to be aware of such judicial trends, at least in order to know of one's extent of duty and how even a minor surgical error can have snowballing repercussions in medical negligence litigation.
In McFarlane v. Tayside Health Board [7] too the claimant was not the patient himself, but the wife of a patient who had undergone a vasectomy operation. The patient had been negligently informed that his sperm counts were negative and, thus, he and his wife no longer required contraception. When the claimant gave birth to their fifth child and sued the surgeon for pain and suffering and the inconvenience of pregnancy and childbirth, the House of Lords in a majority decision held that she was entitled to such damages. Although the negligent act in this case was not a surgical error, but rather, inaccurate communication, if the surgeon was that communicator, he could very well have been the bearer of liability. However, it is important to note that a duty of care is not owed to all future sexual partners as was held in another case where wrongful pregnancy was claimed.
In Goodwill v. BPAS [8], the claimant was not the wife of the patient who had undergone failed vasectomy, nor was she his partner at the time of the surgery and, thus the defendants did not have any knowledge of her. Therefore, this type of scenario allows for a doctor to defend his case by arguing that the claimant has failed to establish a proximate relationship between them and thereby contend that he did not owe any duty of care.
2) Adherence to the acceptable standard of care A surgical error would amount to a breach of the duty of care, i.e. medical negligence, only if it falls outside the acceptable standard of medical care. The test adopted in law in order to determine the acceptable standard was settled by two seminal decisions of the Courts of England: The test is the standard of the ordinary skilled man exercising and professing to have that special skill… , where court was of the view that an unwanted pregnancy, whether as a result of negligent advice or negligent surgery, was a personal injury in the sense of an "impairment", a view confirmed by the House of Lords in the McFarlane case (discussed above). In this latter type of cases, it is recommended that there be full and frank disclosure of risks associated with male and female sterilization in compliance with evidence-based clinical guidelines issued by the Royal College of Obstetricians and Gynaecologists. Of course, not every surgeon who deviates from clinical guidelines will be found negligent in every case, but the importance of adherence to guidelines as a defence (and even more so, as a mechanism to prevent surgical error) is worth noting.
On another note in relation to what constitutes the acceptable standard of care, it may appear unfair that the same standard of care exercised by senior experienced doctors should be expected from junior doctors. So is it a defence to say that a surgeon is on his first day at the job and, therefore, cannot be held to the same standard of care as that of a senior consultant surgeon? The law sees otherwise. Because the test adopted to determine the acceptable standard of care is ultimately an objective one based on the reasonable doctor, inexperience is not a defence and, rightly so. For, healthcare service standards should not be inconsistent with patients exposed to fluctuating levels of care. Accordingly, in Wilsher v. Essex Area Health Authority [15], Glidewell LJ observed thus: In my view, the law requires the trainee or learner to be judged by the same standard as his more experienced colleagues. If it did not, inexperience would frequently be urged as a defence to an action for professional negligence.

3) Resource limitations
In light of the fact that inexperience is not a defence, a question arises as to whether the law recognizes any factors which excuse a deviation from the acceptable standard of care. For instance, particularly in a country with limited resources such as Sri Lanka, there may be numerous occasions where unavailability of sufficient resources stands in the way of adopting the best surgical procedures. While it has been said that "the standard of care expected will depend on the situation...[T]his is an important consideration in relation to the situation in Sri Lanka considering the under staffed status of our government and private hospitals and the lack of facilities.. [16]", research has found that counsel defending Government medical practitioners acknowledge this reality: .  [20].
Although in all of the above cases, courts were primarily concerned with negligence by institutions rather than individuals, there is no legal impediment which prevents an individual surgeon facing a medical negligence lawsuit to raise insufficient resources as a defence and attribute to the hospital direct liability for negligence. Of course, a counter argument can also be made that, if a surgeon is aware of insufficient resources, he may still have been negligent by not referring the patient to a better-equipped facility.

4) Deflection of direct liability to the hospital
Speaking of resource limitations and direct liability of hospitals, there can be other shortcomings within the system which could absolve individual doctors, including surgeons. Studies in which the causes of surgical error, including wrong-site surgery, have been researched reveal that defects in the system contribute significantly to these errors. In a study in the USA, 82% of the claims under review were found to have been caused by system factors [21]. Such factors can include communication breakdowns, lack of supervision, lack of institutional controls/formal system to verify the correct site of surgery, lack of a checklist to make sure every check was performed, exclusion of certain surgical team members, reliance solely on the surgeon for determining the correct surgical site, unusual time pressures (e.g., unplanned emergencies or large volume of procedures), pressures to reduce preoperative preparation time, procedures requiring unusual equipment or patient positioning, team competency and credentialing, availability of information, organizational culture, orientation and training, inadequate or incompetent staffing, environmental safety/security and continuum of care [21,22]. Research in Sri Lanka has also revealed that system errors dominate the medical negligence landscape [2].
In this systemic backdrop, one criticism is that "it is morally unacceptable to pin blame solely on individuals, and artificial to isolate them from their wider working environments and culture [23]." As a former Chief Medical Officer of the UK NHS pointed out: Factors such as the adequacy of training programmes, mechanisms for competence assessment and supervision, protocols for drug administration, checking and fail-safe procedures to prevent the wrong drug dosage (or route of administration)…are all features of the organization, not the individual. If mishaps are to be avoided in the future, accountability for mistakes and lapses in standards of care will have to be viewed as systems failures as well as poor performance on the part of an individual [24].
Furthermore, it has been said that human errors may very well be "organisational accidents", in which event, a hospital can be considered to be directly responsible for adverse medical events caused by its work environment, team/staffing, management decisions and organisational processes (e.g. work time directives, facilities/equipment provided and service delivery models) [25].
Considering the wide array of causes of surgical errors and the larger system within which individual doctors function, there may be medical negligence cases where the facts allow total/partial blame to be placed on the system and a surgeon can defend himself by shifting the responsibility to the hospital or healthcare administration authority. For instance, if a surgical error was caused by faulty equipment, this being a circumstance beyond the knowledge and control of the surgeon himself, there is no question that the hospital should directly bear responsibility and, accordingly, the defence of the individual surgeon should stand. Thus, if a surgeon can prove that a system failure materially contributed to the error, there is a likelihood of deflecting or mitigating liability for medical negligence. In a previous paper I have analysed decisions of courts in several jurisdictions where hospitals have been held directly responsible for medical negligence, as well as legislation which provides for direct liability of hospitals, and I have argued that system errors should be given more attention in the Sri Lankan healthcare context [4].
For example, in Dabare v. Director, Castle Street Maternity Hospital and others [26], a local case where the District Court found medical negligence, but the matter was settled in appeal, the plaintiff was an infant who was alleged to have The Sri Lanka Journal of Surgery 2016; 34(4): 21-26 suffered cerebral palsy and myoclonic epilepsy as a result of medical negligence. Among the long list of acts of negligence set out in the plaint were failures by hospital staff in general and lack of or delayed procedures. Although the defendant hospital was held to be vicariously liable for the acts of its staff, the facts of this case could have lent themselves to a finding of direct liability, based on a breach of the primary duty of the hospital to provide a proper system of care. For example, in Robertson v. Nottingham Health Authority [27], court held that the hospital had breached its primary duty because of significant breakdowns in the systems of communication surrounding the birth of the braindamaged child (even though the case was dismissed due to lack of causation). This is, however, a difficult defence strategy to navigate, because the more common judicial approach is not to first determine the material cause of the error, but to examine the relationship between the health authority and the individual doctor, based on the control test.
In Collins v. Hertfordshire County Council [28], the surgeon was preparing to perform a jaw operation on the plaintiff's husband, and instructed the junior house surgeon, over the phone, to collect certain materials, including procaine. The junior house surgeon misheard the item as being cocaine. During the operation, a lethal dosage of cocaine was injected into the husband which resulted in his death. The plaintiff brought an action against the hospital authority. On the issue of vicarious liability, the hospital authority was held responsible for the acts of the resident junior house surgeon (a student who was employed full-time in that capacity), since it had the power to direct her on what to do and how to do it.
However, in the case of the surgeon that same power did not exist; thus the hospital authority was not found vicariously liable for the surgeon's acts and he had to bear liability alone for his acts. Furthermore, the irony in the Sri Lankan litigation context is that, where cases concern surgeons in Government practice, it would be highly unlikely that a defence of faulty equipment and other system errors which point at the larger State agent would be forthcoming. This is because the Attorney General's Department would often represent the individual Government doctor, as well as the Ministry of Health or relevant Government hospital in a medical negligence lawsuit and, therefore, the defence of the individual would not be constructed in a manner which adversely affects that of the healthcare administrator.

5) Emergency
There could also be instances where there are departures from the acceptable standard of care, due to emergency situations, thus posing the issue of whether these departures are acceptable as a defence when surgical errors occur during emergency care. Even in the Garcia case, the judge considered a hypothetical situation in an emergency room and noted that, though a specialist may be present on site, he would not be exclusively available for the claimant patient as he might be engaged with another medical emergency. Furthermore, "since what is expected of doctors is 'reasonable care', it is appropriate to take into account the situation in which the doctor is administering treatment. It would, for example, not be reasonable to expect a doctor who has been called out to the site of a train crash to provide the level of care that would be available in a well-equipped intensive care unit." In fact, this should ideally be the basis of justification even for a defence built upon resource limitations.

6) Judgment error not amounting to negligence
If a surgeon can establish that an adverse medical incident occurred as a result of a judgment error, he may not be liable for medical negligence. In the Canadian Supreme Court case of Wilson v. Swanson [20], a surgeon operated on the patient after a preliminary diagnosis that indicated a cancerous growth in the stomach. During the surgery, he removed more of the organs of the patient, believing that the growth was cancerous, even though it would have been revealed that the growth was benign, had he conducted a more conclusive diagnosis. However, court distinguished between an error in judgment and negligence on this basis: An error in judgment has long been distinguished from an act of unskillfullness or carelessness or due to lack of knowledge. Although universally accepted procedures must be followed, they furnish little or no assistance in resolving such a predicament as faced the surgeon here. In such a situation a decision must be made without delay based on limited known and unknown factors; and the honest and intelligent exercise of judgment has long been recognized as satisfying the professional obligation.
Therefore, if a surgeon is able to prove that the injury was a result of an error in judgment, it could serve as a defence.