Clinical practice guidelines and the legal standard of care: warnings, predictions, and interdisciplinary encounters.
Duty of care (Law)
Practice guidelines (Medicine) (Usage)
Medical personnel (Malpractice)
Medical personnel (Laws, regulations and rules)
|Publication:||Name: Health Law Journal Publisher: Health Law Institute Audience: Professional Format: Magazine/Journal Subject: Health; Law; Sports and fitness Copyright: COPYRIGHT 2011 Health Law Institute ISSN: 1192-8336|
|Issue:||Date: Annual, 2011 Source Volume: 19|
|Topic:||Event Code: 350 Product standards, safety, & recalls; 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation|
|Legal:||Jurisdiction: Canada; United States|
Medical malpractice is an increasingly complex area of law, largely due to the intersection of law and science that it demands. There is ongoing debate over the appropriate role that science should play in the legal context, and medical malpractice will invariably continue to be at forefront of such discussions. In order to integrate scientific information appropriately into the legal context, various tools have been used to supplement and support the testimony of experts. One of the most prominent of these tools is the clinical practice guideline (CPG). In this article, the role of CPGs in medical malpractice litigation will be discussed, and some of the problematic aspects of their use will be highlighted, in an attempt to facilitate prudent integration of medical science into the law. Bridging this interdisciplinary gap is essential in order for both professions to continue to act and evolve in the best interests of the public they serve.
This article aims to provide useful insight to both health care and legal professionals. To that end, the article includes basic overviews of the medical malpractice system, evidence-based medicine (EBM), and CPGs in order to increase the accessibility of subsequent material for readers from various disciplines. Part I contains a brief overview of the medical malpractice system, including the elements of a medical negligence claim and the major critiques of the malpractice system. Part II provides an overview of EBM, CPGs, and their relationship. In Part III, the primary problems, limitations, and biases inherent in CPGs are discussed in relation to their use in the legal context. Finally, Part IV discusses the role of CPGs in determining the standard of care in light of the legal significance of professional custom and recent Canadian case law.
PART I: Medical Malpractice Law in Canada
The term "malpractice" is generally used to describe medical negligence actions, although the term's definition has not been clarified by legislation or the courts. (1) For the purposes of this discussion, "malpractice" will be used to describe negligence, and the terms will be used interchangeably.
Plaintiffs in medical negligence actions, as in all negligence cases, must prove several discrete elements in order to succeed. As outlined by Ellen Picard and Gerald Robertson, these elements are:
a) the defendant must owe the plaintiff a duty of care;
b) the defendant must breach the standard of care established by law;
c) the plaintiff must suffer an injury or loss; and
d) the defendant's conduct must have been the actual and legal cause of the plaintiff's injury. (2)
The existence of a doctor's duty to a patient is not typically an area of serious contention in medical malpractice cases, as the duty arises upon formation of the doctor-patient relationship. (3) However, some issues may arise in scenarios where multiple practitioners are involved, and the extent to which individual doctors may rely on the duty of others is unclear. (4) Picard and Robertson explain that the duty placed on a doctor is multifaceted and includes "attendance, diagnosis, referral, treatment and instruction." (5)
The second element that must be proven in a successful medical negligence action is a breach of the standard of care. A doctor will be liable for damages that result from care that falls below the standard of "a reasonable medical practitioner considering all the circumstances." (6) This standard of care is a modified version of the generic "reasonable person" negligence standard, recognizing that doctors hold themselves out as possessing specialized skill and expertise, and are expected to conduct themselves with reasonable competency in relation to their qualifications. (7) The standard of care is further modified based on an individual doctor's qualifications such that medical specialists must meet a higher standard of care than general practitioners. (8) This elevated standard reflects the fact that specialists hold themselves out to possess further specialized training and ability. (9) It is important to highlight the comparative nature of standard of care determinations, as this is a key conceptual underpinning that dictates the standard of care analysis, particularly in the context of medical negligence. The role of CPGs in negligence law is most significant in relation to assessing the standard of care, and this determination provides the backdrop for the subject matter of this article.
If the standard of care has not been met, a plaintiff must still show that he or she has suffered damages, such as injury or other losses, due to the substandard care in order to succeed. (10) If the care provided does not result in damage, a lawsuit in negligence would not provide relief to the plaintiff, and (11) other avenues may be more appropriate for patients in such cases.
The fourth element, causation, is another important and highly contested issue in many medical negligence cases. In order to establish causation for the purposes of negligence, the plaintiff must show actual (factual) and legal (proximate) causation. (12) The courts have employed several legal tests for determining factual causation, which continues to be an evolving aspect of negligence law. (13) Proximate causation, also referred to as remoteness, is a device used to limit liability to only "that which was 'foreseeable' to a reasonable person in the defendant's position." (14) The medical malpractice system, particularly in the United States, has been the subject of criticism and debate surrounding its role in relation to the health care system. Critics point to the direct costs of medical malpractice litigation, which include the costs of litigation itself and damages paid to successful plaintiffs, and the indirect costs such as "defensive medicine." (15) Defensive medicine refers to "a deviation from sound medical practice that is induced by a threat of liability." (16) In a study by David Studdert and colleagues, physicians from six specialties with high liability costs were surveyed about the frequency and nature of their defensive practices. (17) Nearly 93% of study respondents reported practicing defensive medicine. Fifty-nine percent of respondents reported ordering unnecessary tests, 33% reported prescribing more medication than medically indicated, and 52% reported referring to specialists in unnecessary circumstances.18 Survey respondents also reported engaging in avoidance behaviours such as avoiding to care for high-risk patients (39 % of respondents) and avoiding certain procedures of interventions due to liability concerns (32% of respondents). (19) Clearly, such defensive medicine practices could have undesirable effects upon both patient care and health care costs.
While it is acknowledged that some of the direct costs associated with malpractice litigation are socially desirable, including the compensation of victims, critics argue that litigation costs are often excessive. (20) According to Michelle Mello, excessive costs occur when more resources are expended than are necessary to achieve a "correct" result, or alternatively, when an "incorrect" result is reached and compensation is granted to a plaintiff who is not an authentic malpractice victim. (21)
Criticisms of the medical malpractice system have also been aimed at the low rate of malpractice claims compared with the estimated number of injuries that result from medical negligence. Studies show that only about 15 out of every 1000 victims bring a lawsuit in this area.(22) Furthermore, critics point out that only a small number of prospective litigants have viable claims, while the large majority of cases (up to 95%) are rejected by plaintiff counsel. (23) Even if a breach of the standard of care and causation can be proven, the quantum of damages may be insufficient to justify litigation. (24) Economic disparity between would-be plaintiffs and defendant insurers is a major concern in medical malpractice cases, particularly in Canada where the Canadian Medical Protective Association spends an average of $100,000 to $150,000 in taking a case to trial. (25)
Not all commentators agree, however, that the medical malpractice system is at fault for the challenges faced in this area. Tom Baker, in response to common criticisms of the medical malpractice system, describes what he calls the "medical malpractice myth":
Baker claims that this "myth" is based on nothing more than urban legend, selective references to academic studies, and the occasional true story, all reinforced by simple repetition until it is believed to be true. (27) He also contends that the problem does not lie in medical malpractice litigation, but rather in the amount of medical negligence that actually occurs, which he refers to as an "epidemic." (28) Baker further argues that increases in malpractice insurance rates are a function of the cyclical nature of the insurance industry rather than medical malpractice litigation, and that any legislative changes to the malpractice system will therefore be ineffective at easing the insurance burden on health care professionals. (29)
As new legal approaches are developed and tools such as CPGs are considered for use in the medical negligence system, the critiques and policy concerns discussed above are often underlying the debate. In order to determine the appropriate role of scientific aids such as CPGs in a legal context, it is essential to examine the development and purposes of such instruments, as well as any biases or limitations inherent in them.
PART II: Clinical Practice Guidelines and Evidence-based Medicine
The concept of EBM is intimately related to modern CPGs. EBM has been defined as "the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients." (30) In medicine and other health care disciplines, the use of EBM is becoming the expected approach because it is thought to offer "the most trustworthy advice available to clinicians concerning medical management." (31) In determining which empirical evidence decisions should be based upon, EBM places an emphasis on a "hierarchy of evidential reliability, in which conclusions related to evidence from controlled experiments are accorded greater credibility than conclusions grounded in other sorts of evidence." (32)
Recent years have brought the continued development of outcomes research and the widespread use of computers in the analysis and recording of data, which has facilitated the rapid expansion of medical knowledge. (33) In order for this rapidly expanding body of knowledge to become successfully integrated into health care practices, the scientific community has devised methods of compiling and synthesizing EBM information which allows practitioners to access and utilize it effectively. One of the major ways this is accomplished is through the development and dissemination of CPGs.
CPGs have emerged largely as a response to the problem of inconsistent care among health care providers, and proponents believe that consistency will bring about an overall improvement in the quality of care delivered. (34) The Institute of Medicine defines CPGs as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." (35) The "appropriateness" attached to particular health care decisions, however, may vary between different guidelines when driven by different considerations. The broad spectrum of CPG developers includes medical societies, third-party payers, malpractice insurance carriers, and other stakeholders whose goals vary from quality of care improvement to cost-containment. (36) It is not surprising, given this variation in the developers and purposes of CPGs, that there is often considerable variation in their recommendations regarding the same subject matter.
The development of CPGs today typically involves a multidisciplinary expert group that reviews all the available evidence, identifies relevant evidence to the subject of the CPGs, and converts that information into a workable clinical form. (37) However, there is no current international or national standardization of CPGs, and thus the development process may vary significantly between guideline developers.
Although some authors regard CPGs as an embodiment of EBM, (38) others have recognized that, despite the significant overlap between the two terms, they are not completely interchangeable. (39) A practitioner may be practicing EBM without using CPGs, particularly when CPGs are unavailable or outdated, of may practice according to a CPG and not be practicing EBM, depending upon the circumstances of the case and the particular CPG used. (40) Other forms of EBM exist aside from CPGs, and although the vast majority of CPGs are now based on EBM, some guidelines may still be based on the traditional approach of using professional consensus rather than empirical evidence. (41) These differences become particularly relevant when CPGs are utilized in the legal context, as discussed below.
PART III: Clinical Practice Guidelines--Problems, Limitations, and Bias
Clinical practice guidelines arguably represent an important innovation in medical science and a vehicle with immense potential to improve patient care, yet they are not free from inherent limitations and problems that may affect their appropriate roles in health care and legal contexts. First, CPGs are developed using a wide range of methodologies and are created for a variety of purposes, leading to conflicting CPGs that deal with overlapping subject matter. Second, CPG recommendations may have limited applicability to individual cases and could result in "cookbook medicine". Third, CPGs may become outdated relatively quickly and require significant time and resources to update. Finally, CPGs are often subject to various biases in their development, some of which may not be immediately apparent.
A. Variation and Conflict Among Guidelines
There are significant differences in the methodologies underlying the development of various CPGs. As of 2009, the National Clearing House had registered 2373 guidelines produced by 285 different organizations. (42) Few of these organizations submit their final guideline product for external review and developers retain "considerable latitude to establish their own working rules." (43) While the intricacies of the approaches to evaluating and integrating scientific information are beyond the scope of this article, CPGs can be subdivided broadly by whether they are based on EBM or expert consensus. There is, of course, significant overlap between these categories, as consensus opinions may be based on assessments of the best available evidence and there are inevitable gaps in empirical evidence which must be filled by expert opinion. (44) The important consideration for our current purposes is whether guideline recommendations are ultimately decided by the direction of empirical evidence or by the opinions of experts, even if the experts happen to ground their opinions in empirical evidence. This dichotomy could prove particularly useful in considering which CPGs are appropriately applicable to determining the legal standard of care.
While the EBM trend continues to take off and the scope of medical scientific knowledge continues to expand, commentators have recently suggested that "most current articles called 'guidelines' are actually expert consensus reports," a direction, they say, that is far from the original intent of the Institute of Medicine. (45) While this may be distressing for some medical researchers, the trend may have significant potential to increase CPG use for legal purposes, as discussed below. On the other hand, as commentators point out, this may amplify the impact of any biases the experts involved may have. (46)
In the current absence of any widely accepted standardization, regulation, or certification of CPGs, and considering the range of guideline developers, it is safe to assume that significant variation exists in the scientific rigor applied to evidence-based guideline development. Similarly, the quality and comprehensiveness of the expert panels involved in consensus-based guideline development is also highly variable. (47) Such variations further complicate the use of CPGs for both medical and legal purposes and warrant careful consideration prior to reliance upon a particular CPG.
Some groups, however, have taken recent steps toward the standardization of CPGs. The AGREE (Appraisal of Guidelines for Research & Evaluation) Collaboration created an instrument to promote validated criteria for CPGs that allows for an objective assessment of their quality. (48) The instrument looks at several aspects of guideline development including scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, and editorial independence. (49) Despite the potential utility of this instrument, there is currently no requirement that developers or users employ it when using or creating CPGs. Perhaps greater acceptance and utilization of such instruments by medical and legal users would apply pressure to developers to achieve high ratings and ultimately lead to more consistent and reliable CPGs. Today's users, unfortunately, do not yet enjoy the benefits of standardization in CPG development.
Given the number of published CPGs and the variation in CPG developers, methodologies, and purposes, it is unsurprising that different CPGs with conflicting recommendations are relatively commonplace. (50) For health care practitioners who seek to rely on CPGs in clinical decision-making, the problem of conflicting CPGs may diminish much of the benefits they expect to gain from using them, and may lead to confusion and decreased use of guidelines. (51)
For those that seek to use CPGs in a legal context, particularly as evidence of the standard of care, conflicting guidelines pose similar problems. It is difficult for courts to rely on a CPG to establish a standard if it is unclear which CPGs are most authoritative and appropriate. Courts may, as in American jurisprudence, allow both sets of CPGs and either allow for the trier of fact to determine which is most credible, or permit the defendant to follow either CPG to satisfy the standard of care. (52) It is also possible that individual CPGs would be excluded from consideration if they were shown to be unreliable or inapplicable in the circumstances. In either case, the difficult task of determining which CPG is appropriate would likely require the assistance of experts to resolve.
B. Applicability and Autonomy
A major challenge with the use of CPGs is the applicability of recommendations to a particular clinical case or set of circumstances. Guidelines that were developed in reference to a particular population or set of circumstances may not be applicable to patients outside of that population. It would be virtually impossible to create a CPG that is capable of fully accounting for the considerable variation of individual cases and the "innumerable factors that come into play in certain cases." (53) Each human body is unique and finds itself in somewhat unique circumstances; therefore it is a truly insurmountable task to attempt to develop any guide to health care interventions that would be appropriate for all of them. Furthermore, the application of CPGs may not be practical in clinical contexts for which they were not specifically developed. Emergency medicine specialists have expressed particular frustration with legal expectations to follow CPGs that have not been developed with a view to the realities of the emergency medicine context, an environment that often involves relatively limited time and resources. (54)
Doctors often express the applicability issue as a concern over a trend toward "cookbook medicine", which many practitioners view as a threat to their professional autonomy as well as to quality care. (55) Until relatively recently in the history of medicine, individual doctors have enjoyed much more freedom to exercise individual professional judgement than they do today. (56) Commentators point to CPGs as a form of medical regulation, and some argue CPGs are "designed to change and control the behaviour of clinicians and institutions." (57) In fact, it has been suggested that one of the reasons medical societies develop their own guidelines is to provide "a means of defending against competing guidelines promulgated by health care payers" because payers' guidelines "are influenced by insurers' cost consciousness, are frequently more restrictive and perceived as a threat to physicians' autonomy." (58) If the legal system were to demand adherence to CPGs, serious infringements on individual professional autonomy could result.
James Reinertsen argues, however, that concerns over the loss of individual clinical autonomy need to be addressed by medical professionals working more cooperatively to apply the best science available. (59) Reinertsen notes that the public has lost trust in medicine over the past 20 years as it has come to realize that the best scientific knowledge is being applied neither effectively nor consistently by the medical profession. (60) He postulates that clinicians must give away a measure of autonomy to their colleagues, in what he calls a "Zen-like paradox", in order to regain it. (61) Reinertsen also directly addresses concerns about "cookbook medicine" stating, "all great chefs and expert pilots use cookbooks and checklists, and diners and flyers are grateful that their experiences are not created entirely from scratch." (62) He further suggests that clinicians think of CPGs as more like jazz scores than cookbooks, consisting of a "basic chord structure and melody line (clinical science) with a great deal of latitude for improvisation (the art of medicine)." (63)
C. Outdated Guidelines
Health care practitioners have a duty to keep their knowledge and skills up to date. In this regard, one court in the United States held that "there is no tenable policy reason why a physician should not be required to keep abreast of the advancements of his profession." (64) The realities of today's rapid scientific advancement, however, may make this task extremely difficult. In fact, it has been suggested that in order to maintain current knowledge, a clinician practicing general internal medicine "would have to read nearly 20 articles per day, 365 days per ayear--an impossible task." (65) In order to deal with this challenge and avoid such absurd expectations, CPGs are frequently used to assist busy practitioners. This necessary reliance on CPGs by doctors, however, heightens the need for the guidelines to be current and up-to-date themselves.
Research has suggested that outdated guidelines may be a widespread and serious problem. In one study, one half of guideline developers surveyed reported an absence of formal procedures for keeping their CPGs up to date. (66) This finding is undoubtedly concerning for doctors that expect CPGs to be comprehensive, systematic, and up-to-date.
A study by Paul Shekelle and colleagues investigated the rate at which CPGs developed by the Agency for Healthcare Research and Quality (AHRQ) became outdated. (67) Investigators found that three quarters of the reviewed guidelines needed updating. (68) Furthermore, the study revealed that 90% of the guidelines were still valid after 3.6 years while only 50% were still valid after 5.8 years. (69) Even if 90% of CPGs are up-to-date, there may be serious and unacceptable consequences in many medical contexts resulting from the remaining 10%. Arguably, the specific context within which a guideline operates should be considered when acceptable proportions of outdated CPGs are being determined. The steep decline in up-to-date CPGs observed between 3.6 and 5.8 years calls into question the reasonableness of reliance on CPGs that are more than a few years old.
Shekelle and colleagues also note that, in their analysis, they conservatively assumed that outdated CPGs did not become invalid until the date of their study. (70) This assumption means that the lifetime of each outdated CPG in the study was actually equal to or shorter than the length assumed, which likely caused a general overestimation of the average lifetime of the CPGs. (71) The authors took this assumption into account and recommended that CPGs should be reassessed at least every three years. (72) Ideally, the authors suggest, a rotating panel of experts should undertake a process of ongoing guideline development where "automated literature searching could be conducted at regular intervals (e.g. every 6-12 months) and relevant citations reviewed by subgroups of the panel." (73)
Another consideration in this study is that only CPGs from a single guideline developer were reviewed. The various AHRQ guidelines, when originally developed, were "considered to represent state-of-the-art management of the selected conditions" and "were perceived to have advanced significantly the science of practice guideline development." (74) CPGs developed by other groups may not have been as high quality or progressive as the AHRQ guidelines, thus the rate at which other CPGs become outdated could potentially be much higher than this study's results would suggest.
The issue of outdated CPGs is further complicated by the time and resources required to update them. The development process of one set of CPGs required approximately one and a half years before the results were ultimately published, which was not considered an unusual amount of time for CPG development. (75) Once published, there can still be "considerable lag time, sometimes years, before current research and practice guidelines find their way into clinical practice." (76) One researcher estimated that it takes approximately two years to develop CPGs and disseminate them to practitioners. (77) This researcher also suggested that, due to rapid medical advances, guidelines in some fields are outdated before they are even generally available. (78) Again, the subject matter and context of a CPG are important considerations. Furthermore, a study comparing the development and updating processes of two CPGs concluded that the major costs, in the form of personnel time, were identical between the two processes. (79) This suggests the need for improved methods of updating and underscores the heavy burden of maintaining updated CPGs. Eloise Clark and colleauges also note that guideline development and revision may both consume and compete for similar resources. (80) Such economic realities could delay these processes and ultimately result in more CPGs becoming out of date. (81)
D. Bias in Guideline Development
Several forms of bias may influence the recommendations published in CPGs. The focus of most commentary has been primarily on the individual experts of guideline development committees and their ability to make wholly objective decisions in the face of various influences. Allan Detsky has identified that the most common forms of bias in CPG development are financial ties to industry or long service to government. (82) In addition, Detsky points out other forms of bias that may be less obvious. He notes that previously established "stakes" in certain issues, such as past involvement in related research, may dominate a committee member's views when sitting on a guideline committee. (83) Additionally, how the committee member makes a living may result in bias if the recommendations of the CPG have the potential to affect utilization of the member's services. (84) Finally, Detsky mentions the inherent influences of personal experience, such as the prescription of unnecessarily new and expensive medications simply because one's colleagues have abandoned the use of older and cheaper alternatives. (85) Others also note that the specialty composition of a guideline panel can introduce an additional form of bias, where specialty societies may use CPGs to enlarge their area of expertise. (86)
Among these sources of bias, financial and experiential ties to industry and government seem to have received the most attention from researchers and commentators and have been the subject of widespread criticism. One critic of such industry entanglements writes, "[t]wisted together like the snake and the staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous." (87)
A frequently cited study by Niteesh Choudry and colleagues of 44 CPGs found that 87% of responding CPG authors had some form of interaction with the pharmaceutical industry. (88) Fifty-eight percent had received financing for research and 38% had been paid consultants or employees for a pharmaceutical company. (89) On average, the CPG authors in the study interacted with 10.5 different companies. (90) Also of interest is that while only 7% of authors believed that pharmaceutical industry relationships influenced their own recommendations, 19% believed that their coauthors' recommendations were influenced by such relationships. (91) This data clearly shows that pharmaceutical industry influences are prevalent among guideline developers, raising serious concerns about bias in CPGs. The effects of such biases, through widespread distribution of CPGs, have the potential to influence the clinical decision-making of an enormous number of health care practitioners.
More recently, researchers examined the extent and scope of conflicts of interest in 50 CPGs developed by the American Academy of Neurology. (92) The study revealed that over 90% of the CPGs studied had at least one author with a conflict of interest, including research-related (45% of authors), clinical practice-related (42% of authors), and personal income (33% of authors) relationships. (93) With the exception of research-related conflicts, which included both industry and government relationships, the conflicts of interest identified were in relation to pharmaceutical, medical device, biotechnology, or medical consulting companies. (94) Distressingly, this data suggests that little progress has been made toward eliminating bias from CPG development in the six years since the study by Choudhry and colleagues. However, these studies may have more to do with differences among CPGs directed at particular specialties, such as neurology in this case, rather than trends in CPG development generally. In any event, this recent data illuminates the ongoing need for caution when relying on CPG recommendations in both medical and legal contexts.
In response to such studies and the resulting criticism, some commentators and guideline developers have made efforts to address bias concerns. The AGREE Instrument, discussed above, contains the criteria that all group members must declare any conflicts of interest and that the views or interests of the funding body have not influenced the final recommendations. (95) Proponents of the AGREE Instrument acknowledge, however, that this approach may be somewhat lacking in light of the findings by Choudhry and colleagues that suggest authors tend to underestimate the influence of industry on their own recommendations. (96) Others have suggested that disclosure is simply not enough to control bias. Allan Sniderman and Curt Furberg make several suggestions for CPG reform, including detailed disclosure of all financial relationships with industry and the disqualification from decision-making processes of committee members who receive substantial benefits from any company whose products may be under consideration. (97) They further recommend that sponsoring or promoting medical associations should develop joint codes to govern conflicts of interest and refuse industry funding for sponsorship, underwriting, or promotion of CPGs. (98) Despite problems of bias, experts with conflicts of interest are often academic leaders and may offer valuable input in CPG development. For this reason, commentators have typically suggested models of involvement for such thought leaders that only exclude them from discussion and voting on recommendations or evidence that relates to their conflicts. (99)
Although it may be possible to create systems to remove a large degree of industry influence from CPG committees, CPG users must be cognizant that industry bias may still be deeply embedded in CPG recommendations by influencing the research upon which CPGs are based. There is a serious concern that "the evidence base of health care is being distorted fundamentally" by industry influences on research. (100) This underlying issue is largely beyond the scope of this article; however it should be mentioned that "[s]trong and consistent evidence shows that industry sponsored research tends to draw conclusions favourable to industry and industry sponsored studies were much more likely to reach conclusions that were favourable to the sponsor than were non-industry studies." (101) Consequently, these influences raise questions and concerns not only about CPGs, but the entire system of EBM.
PART IV: Standard of Care and Clinical Practice Guidelines
As mentioned above, the primary role of CPGs in medical malpractice litigation relates to the determination of the standard of care expected of a health care practitioner. In the medical context, such a determination can involve highly technical issues that neither judges nor juries have the expertise required to fully understand. The Supreme Court of Canada addressed this issue in ter Neuzen v Korn (ter Neuzen), in which a patient contracted the Human Immunodeficiency Virus during an artificial insemination procedure and the appropriate standard of care was a central issue. (102) In the majority judgement, Sopinka J confirmed the general rule that "when a doctor acts in accordance with a recognized and respectable practice of the profession, he or she will not be found to be negligent." (103) The rule was justified on the ground that "courts do not ordinarily have the expertise to tell professionals when they are not behaving appropriately in their field." (104) Therefore, a health care practitioner will generally have met the requisite standard of care if they conform to "standard practice", which may also be referred to as "general practice", "common practice", or "customary practice." (105)
There is, however, an important exception to the general rule regarding conformity with professional custom. Where a standard practice of custom "does not conform with basic care which is easily understood by the ordinary person who has no particular expertise in the practices of the profession," the standard practice will itself be found negligent. (106) In light of the increasing complexity of medical science, this seems to be a rare situation indeed. In the health care context, there are almost invariably factors that practitioners take into account that may not be readily apparent to the layman. Sopinka J refers to the classic case of this exception, Anderson v. Chasney, where the customary practice failed to include counting sponges or attaching strings or tape to them during throat surgery to ensure none are left in the throat. (107) Sopinka J agreed with the concurring judgement of Coyne JA at the Court of Appeal, and held that "as an exception to the general rule, if a standard practice fails to adopt obvious and reasonable precautions which are readily apparent to the ordinary finder of fact, then it is no excuse for a practitioner to claim that he or she was merely conforming to such a negligent common practice." (108)
There has been related academic debate about the appropriate role of tort law and CPGs in the medical realm. Brian Hurwitz described the issue in the British Journal of Medicine:
If tort law is viewed as an instrument for positive change in health care, it is tempting to support a legal obligation on doctors to follow the most scientifically valid approaches and to continue to update their approaches. The legal expectation that professionals merely act in accordance with professional custom may seem to provide no incentive for advancement. In response to such arguments, Mello contends, "judicial deviation from custom in malpractice cases represents an imprudent use of tort law to engineer the practice of medicine." (110) She points out that there is "a fundamental distinction between what tort law is trying to achieve and what health care reformers are trying to achieve." (111) She further argues that to demand a standard above the professional custom would not give fair notice to doctors and would be an inefficient way of bringing improvements to health care quality due to the high administrative costs of litigation. (112) Finally, Mello questions whether judges and juries are "competent to determine what the appropriate standard of care is in medical encounters," (113) a sentiment which seems to echo Sopinka J's reasoning in ter Neuzen.
It appears from ter Neuzen that the standard of care for medical negligence in Canada will generally be set at the level of the professional custom, and the courts will not typically look further into technical matters. Therefore, the appropriateness of establishing the standard of care based on CPGs must depend on the standard that each CPG embodies. Daniel Jutras noted that, "for clinical practice guidelines to have an important role in malpractice litigation the degree of care they require must be as close as possible to the degree of care required by law." (114) When a CPG reflects standard or customary practices, it would be an appropriate indicator of the legal standard of care. Conversely, when a CPG reflects ideal practices which have not yet become customary within the profession or specialty, it may set a higher standard than the law demands. (115)
One of the problems with determining the role that CPGs should play in assessing the standard of care is that many commentators disagree about "whether CPGs represent a minimum baseline, a not-yet-attained ideal, or a customary practice that lies somewhere in between these two extremes." (116) The variation in CPG purposes, as discussed above, is particularly relevant in this regard. It is essential, if CPGs are to be used appropriately by the courts, that judges and juries are aware of these differences and are presented with evidence regarding whether or not the standards set by CPGs represent customary care. As I alluded to earlier, CPGs based largely on expert consensus rather than EBM may be more appropriate tools to determine the standard of care. EBM-based CPGs may include non-customary approaches from recent scientific research, whereas consensus may be difficult to achieve outside of professional custom and therefore is more likely to reflect an appropriate legal standard of care.
By definition, a custom must be generally accepted by the community to which it belongs. In this vein, health care practitioners' attitudes toward CPGs and the degree of compliance with them are relevant considerations. One study examining Canadian physicians' attitudes about clinical practice guidelines found that while most physicians felt that CPGs are convenient sources of advice and education likely to improve the quality of care, less than 40% had changed their practice in the previous year as a result of referring to CPGs. (117) Moreover, the study found that "Canadian physicians consult CPGs far less often than traditional sources of information such as colleagues and consultants, review articles, textbooks, pocket notes and original research articles in journals." (118) These findings cast doubt on whether any CPGs can be properly equated with customary care as long as CPGs themselves are not customarily used by health care professionals. It is still possible that CPGs will contain recommendations that are equivalent to those available from other sources and may thereby accurately reflect a customary practice. However, there would presumably be a much stronger correlation between CPGs and custom if the use of CPGs was itself a customary practice.
The debate around whether CPGs represent custom is presently an important line of inquiry. However, this concern may eventually evaporate if current trends toward EBM and CPG utilization continue. The adherence to EBM as a basis for clinical decisions is becoming the medical norm. As an extension of EBM practice, the utilization of rigorously developed CPGs is likely to follow suit and become a more widespread and frequent practice. Given the rapid expansion of medical knowledge and research discussed above, CPGs will likely become an essential tool for any practitioner of EBM. Once the use of CPGs is itself the standard practice in a health care field, their recommendations will quickly become professional customs. At that point, any distinction between CPGs generally and professional custom loses its significance. The only question that appears to be looming is not whether CPG recommendations will become medical custom, but rather which CPGs will define those customs.
From a legal standpoint, these customs will also soon define the standard of care, not because the courts decide that CPGs are the standard, but because the health care professions themselves are adopting them as custom. The narrow exception to professional custom as the legal standard of care referred to in ter Neuzen is virtually inapplicable to CPG recommendations. The recommendations of CPGs continue to be based on increasingly higher levels of technical complexity as scientific research expands, shielding nearly all CPG recommendations from court scrutiny. Moreover, the likelihood that the recommendations contained in CPGs, when based on quality scientific research and developed by a panel of reputable experts, will "not conform with basic care which is easily understood by the ordinary person" (119) is extremely remote indeed. It is unthinkable that numerous researchers and guideline committee members would all rail to recognize such obvious problems prior to publication.
Clinical practice guidelines have typically been introduced into court proceedings via expert witnesses, yet research has shown that guidelines do not appear to greatly influence the need for medical experts in malpractice litigation. A study by Andrew Hyams and colleagues found that only 4% of lawyers surveyed reported that CPGs decreased the need for experts, while 11.8% said CPGs increased the need for experts, and the remaining majority said they had no effect. (120)
Due to the need to extract a single standard of care from the diversity of medical opinion during litigation, a phenomenon known as the "battle of the experts" often ensues, where "hired guns clash with opposing opinions, neither of which is any more empirically supportable than the other." (121) Mello argues that, despite suggestions to the contrary, a greater reliance on CPGs in litigation will not ameliorate the "battle of the experts" problem. (122) As she explains:
The scenario that Mello describes may not be far from coming to fruition, if it has not already. If CPGs generally come to set the legal standard of care for the purposes of medical malpractice, as I have argued they likely will, the key determination before the court will be which CPG recommendations properly apply in a particular case. As Mello indicated, this will be a determination that requires expert testimony. It would be misguided, therefore, to expect that CPGs will reduce the time and costs required for medical malpractice litigation by reducing the need for expert witnesses.
It is in the context of expert witness testimony that much of the problems and limitations of CPGs discussed in this article will likely need to be addressed in future cases. David Brushwood outlines that experts will likely be asked to address issues of relevance, reliability, and authenticity of CPGs. (124) The relevance issue, similar to the applicability and conflicting guidelines concerns discussed above, relates to whether a CPG applies to the facts of the case. (125) In the case of conflicting CPGs, it is reasonable to expect that experts would have to justify the use of a particular CPG over a conflicting one. The determination becomes not whether a CPG is merely relevant, but whether it is more relevant than others. The reliability issue, as Brushwood describes it, is "whether guidelines developed at an earlier time can later be confidently applied across a wide range of therapeutic situations." (126) I would suggest that reliability inquiries should also include expert testimony regarding any biases that may be present and the steps that developers have taken to eliminate them. On the authenticity issue, Brushwood suggests that experts will be called upon to show that the guidelines "were current and were endorsed by the group that issued them" at the time of the alleged negligence. (127) At this stage, the research on outdated CPGs and the relative rate at which the particular subject was evolving at the time should be primary considerations upon which experts would provide testimony.
C. Recent Canadian Jurisprudence
Since ter Neuzen, Canadian courts have relied upon CPGs to varying degrees in medical malpractice litigation to establish that a practice was customary. Once established as custom, such practices typically become the standard of care required to avoid negligence. The balance of authority between CPG recommendations and expert testimony appears to be shifting toward a greater reliance on CPGs, apparently precipitated in part by expert witnesses themselves.
In Dobie v Dlin, CPGs were crucial to the standard of care question. (128) The Supreme Court of British Columbia agreed with defence counsel's argument that the case revolved around "application of published guidelines as to the treatment of arrhythmias, the evolution over time of those guidelines and the application by physicians of those guidelines in their clinical practice." (129) For these reasons, the Court also agreed that it was not open to find negligence if the customary practice of the profession was met. (130) This exemplifies the virtual immunity to court scrutiny that CPG recommendations enjoy when they become customary practice. Additionally, when one expert witness was cross-examined about an aspect of his testimony that conflicted with a CPG, the witness accepted the CPG's recommendation and changed his position to conform with the CPG. (131) This reluctance of experts to contradict authoritative guidelines reveals another path by which CPG recommendations can become accepted as customary practice.
In contrast, many courts still show a reluctance to allow CPGs to set the standard of care directly. The Ontario Superior Court in Bafaro v Dowd held that CPGs are "not equivalent to, and should be distinguished from, the legal standard of care to be applied by the Court." (132) The courts in recent decisions regarding CPGs have paid particular attention to disclaimer statements in CPGs, which discourage their use as the standard of care. (133) This reluctance, however, may be gradually disappearing.
In Cojocaru (Guardian ad litem of) v British Columbia Women's Hospital, CPGs (134) were heavily relied upon to determine the appropriate standard of care. The court held that the defendant doctor had a legal obligation to inform the patient, in accordance with two authoritative CPGs, about the risks and state of scientific knowledge regarding safety of a particular treatment. This case exemplifies how CPGs are increasingly being used as key determinants of the standard of care. Although introduced via expert witnesses, CPGs ultimately set the standard of care for informed consent in this case, with relatively little reference to expert opinion beyond the recommendations of the CPGs.
In a more recent case, Kelleher J of the British Columbia Supreme Court reviewed several judgements regarding CPGs and the standard of care in medical negligence. (135) Justice Kelleher referred to the disclaimer in the CPG at issue and upheld previous rulings that CPGs do not set the standard of care per se, but also held that CPGs "may be relevant as evidence providing substance and specific content" to the general standard of care in that profession. (136) Therefore, as CPGs become more authoritative within health care professions, their strength as evidence may be enough to set the standard of care in many situations, despite judicial hesitance to make the leap directly from CPGs to the standard of care.
In one case reviewed by Kelleher J, the court quoted from the text, Professional Liability in Canada, for the proposition that "failure by a physician to comply with standards recommended or established by the College of Physicians and Surgeons or the Canadian Medical Association will be strong evidence of negligence." (137) This statement may foreshadow increased differentiation of CPG developers by the courts when weighing CPG evidence. As I have argued, such differentiation will likely be among the primary roles of the courts in future standard of care determinations.
Justice Kelleher also cited Downey v St Paul's Hospital, in which the essential role of experts to comment upon and interpret guidelines and policies was emphasized. (138) As discussed, experts will likely have an expanded role in future medical negligence cases that will include providing information to the court about CPGs. The unfortunate consequence of this development will be that resources required [or litigation will only increase, further exacerbating some of the key challenges of the medical malpractice system such as the financial disparities between plaintiffs and defendant insurers.
The increasing complexity of medical science has dramatically changed the way health care practitioners practice their professions. This complexity has also raised challenges for the medical malpractice system and the ability of courts to determine appropriate behaviour in such technical areas. The development of CPGs promises to bring new approaches and challenges to both of these fields. Unsurprisingly, increased scientific complexity is not likely to simplify health care or legal decisions, but instead promises to ascend them to new heights of their own complexity. CPGs will likely be instrumental to these changes.
As the use of CPGs becomes more widely accepted by health care professionals as standard practice, these guidelines will become more indicative of the standard of care in negligence cases. Due to the technical nature of CPGs and their subject matter, courts will have little latitude to question their reasonableness as standards of care.
If CPGs are becoming so crucial to medical malpractice litigation, it is essential that courts, litigators, and medical experts understand how CPGs relate to customary practice and any problems, limitations, or biases that may affect their use. Relevant considerations include whether a CPG is consensus-based or EBM-based, the developer and purpose of the CPG, the methodology used in its development, the age of the CPG in relation to the rate of evolution of the field and known rates of outdating, its applicability to the particular facts of the case, and the procedures employed to minimize or eliminate biases used by the developer.
These considerations can only be resolved with the assistance of expert witnesses. Therefore, the role of experts in medical malpractice will continue to evolve and expand as the area develops. Unfortunately, economic challenges for plaintiffs will likely continue to increase as a result.
The challenges and increased complexity that the further integration of CPGs into medical negligence litigation carries with it may only be symptomatic of a greater problem. The reality is that a breaking point is fast approaching where courts will no longer be capable of making just decisions on the standard of care in medical malpractice. Particularly when juries are involved, even the assistance of expert explanations cannot possibly provide an adequate understanding to allow untrained individuals to rule effectively on highly complex and technical matters. While a greater understanding of CPGs in this context by judges, lawyers, and experts may provide a temporary bandage solution, the problem can only be truly cured through major reform to the system itself. While I do not propose a specific solution to this enormous challenge, it is apparent that scientifically trained experts may need to be more directly involved in the adjudication of these cases if the integrity of the system is to be maintained into the future.
(1) Ellen Picard & Gerald Robertson, Legal Liability of Doctors and Hospitals in Canada, 4th ed (Toronto: Thomson Canada, 2007) at 211-212.
(2) Ibid at 212.
(3) Ibid at 213.
(4) Ibid at 213-216.
(5) Ibid at 213.
(6) Ibid at 225.
(8) Ibid at 227.
(9) Crits v Sylvester (1956), 1 DLR (2d) 502 at 508 (Ont CA), aff'd  SCR 991.
(10) Picard & Robertson, supra note 1 at 257.
(11) Ibid at 257-258. One avenue open to patients may be reporting to licensing or regulatory bodies such as the College of Physicians and Surgeons of the province in which the practitioner is licensed.
(12) Picard & Robertson, supra note 1 at 269.
(13) See Snell v Farrell,  2 SCR 311, SCJ No 73; Athey v Leonati,  3 SCR 458, SCJ No 102; Cook v Lewis,  SCR 830; Hollis v Dow Corning Corp.,  4 SCR 634, SCJ No 104; Resurfice Corp. v Hanke, 2007 SCC 7,  1 SCR 333.
(14) Picard & Robertson, supra note 1 at 289, citing Overseas Tankship (UK) Ltd v. Morts Dock & Engineering Co,  AC 388, [19611 1 All ER 404 (PC).
(15) Michelle M Mello, "Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation" (2001) 149 U Pa L Rev 645 at 645-646.
(16) David M Studdert et al, "Defensive Medicine Among High-Risk Specialist Physicians in a Volatile Malpractice Environment" (2005) 293 Journal of the American Medical Association 2609 at 2609.
(18) Ibid at 2612.
(19) Ibid at 2613.
(20) Mello, supra note 15 at 646.
(21) Ibid at 646-647.
(22) John Limbert, "Our approach to medical malpractice has many flaws" (2003) 23 Lawyers Weekly 7.
(26) Tom Baker, The Medical Malpractice Myth (Chicago: University of Chicago Press, 2005) at 1.
(27) Ibid at 1
(28) Ibid at 19.
(29) Ibid at 19-21.
(30) Arnold J Rosoff, "Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines" (2001) 26 J Health Pol 327 at 327.
(31) Brian Hurwitz, "How Does Evidence Based Guidance Influence Determinations of Medical Negligence?" (2004) 329 British Medical Journal 1024 at 1024 [Hurwitz, "Evidence Based Guidance"].
(32) Ibid at 1024.
(33) Rosoff, supra note 30 at 328.
(34) David B Brushwood, "Liability Implications of Innovative Drug Therapy: The Significance of Clinical Guidelines in Establishing the Legal Standard of Care" (2002) 15 Journal of Pharmacy Practice 279 at 280.
(35) Rosoff, supra note 30 at 328, citing M Field and K Lohr, eds, Clinical Practice Guidelines: Directions for a new Proram 8 (Washington, DC: Institute of Medicine, 1990).
(36) Patricia R Recupero, "Clinical Practice Guidelines as Learned Treatises: Understanding Their Use as Evidence in the Courtroom" (2008) 36 Journal of the American Academy of Psychiatry and the Law 290 at 298.
(37) Ash Samanta, Jo Samanta & Michael Gunn, "Legal Considerations of Clinical Practice Guidelines: Will NICE Make a Difference?" (2003) 96 Journal of the Royal Society of Medicine 133 at 133.
(38) Rosoff, supra note 30 at 328.
(39) Recupero, supra note 36 at 298.
(40) Carter L Williams. "Evidence-based Medicine in the Law Beyond Clinical Practice Guidelines: What Effect Will EBM Have on the Standard of Care?" (2004) 61 Wash & Lee L Rev 488.
(41) Rosoff, supra note 30 at 329.
(42) Allan D Sniderman & Curt D Furberg, "Why Guideline-Making Requires Reform" (2009) 301 Journal of the American Medical Association 429 at 429.
(43) Ibid at 429.
(44) Ibid at 429-430.
(45) Terence M Shaneyfelt & Robert M Centor, "Reassessment of Clinical Practice Guidelines: Go Gently Into That Good Night" (2009) 301 Journal of the American Medical Association 868 at 868.
(47) Sniderman & Furberg, supra note 42 at 429.
(48) Valerie A Palda, Dave Davis & Joanne Goldman, "A Guide to the Canadian MedicaI Association Handbook on Clinical Practice Guidelines" (2007) 177 Canadian Medical Association Journal 1221 at 1221. For introduction on the AGREE instrument, see AGREE Enterprise, "Introduction to AGREE II" online: AGREE
(49) Palda, Davis & Goldman, supra note 48 at 1223.
(50) Sniderman & Furberg, supra note 42 at 429.
(51) Brushwood, supra note 34 at 281.
(52) Recupero, supra note 36 at 296-297, referring to James v Woolley, 523 So 2d 110 (Ala 1988) and Levine v. Rosen, 616 A 2d 623 (Pa 1992). The latter described approach is known as the "two-schools-of-thought" analysis.
(53) Recupero, supra note 36 at 296.
(54) William Naber & W Frank Peacock, "Do specialty group guidelines wreak havoc with ED liability?", ED Legal Letter (1 February 2009) 21.
(55) Recupero, supra note 36 at 296.
(56) Brian Hurwitz, "Clinical Guidelines and the Law" (1995) 311 British Medical Journal 1517 at 1517.
(58) Mello, supra note 15 at 651.
(59) James L Reinertsen, "Zen and the Art of Physician Autonomy Maintenance"(2003) 138 Annals Internal Medicine 992 at 993.
(60) Ibid at 992.
(61) Ibid at 994.
(64) Brushwood, supra note 34 at 286, citing May v Moore 424 So 2d 596 (Ala 1982).
(65) Terence M Shaneyfelt, "Building Bridges to Quality" (2001) 286 Journal of the American Medical Association 2600 at 2600.
(66) Jako S Burgers et al, "Towards Evidence-based Clinical Practice: An International Survey of 18 Clinical Practice Guideline Programs" (2003) 15 International Journal for Quality in Health Care 31.
(67) Paul G Shekelle et al, "Validity of the Agency for Healthcare Research and Quality Clinical Practice Guidelines: How Quickly Do Guidelines Become Outdated?" (200 l) 286 Journal of the American Medical Association 1461.
(68) Ibid at 1466.
(69) Ibid at 1461.
(70) Ibid at 1464.
(72) Ibid at 1466.
(74) Ibid at 1462.
(75) Brushwood, supra note 34 at 281.
(76) Robert I Simon, "Standard-of-Care Testimony: Best Practices or Reasonable Care?" (2005) 33 Journal of the American Academy of Psychiatry and the Law 8 at 8.
(77) Brushwood, supra note 34 at 287.
(79) Eloise Clark, Edward F Donovan & Pamela Schoettker, "From Outdated to Updated, Keeping Clinical Guidelines Valid" (2006) 18 International Journal for Quality in Health Care 165 at 165.
(80) Ibid at 166.
(82) Allan S Detsky, "Sources of Bias for Authors of Clinical Practice Guidelines" (2006) 175 Canadian Medical Association Journal 1033 at 1033.
(86) Shaneyfelt & Centor, supra note 45 at 868.
(87) Ray Moynihan, "Who Pays for the Pizza? Redefining the Relationships Between Doctors and Drug Companies. 1: Entanglement" (2003) 326 British Medical Journal 1189 at 1189.
(88) Niteesh Choudhry, Henry Thomas Stelfox & Allan S Detsky, "Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry" (2002) 287 Journal of the American Medical Association 612 at 614.
(92) Robert Holloway et al, "Conflicts of Interest for Authors of American Academy of Neurology Clinical Practice Guidelines" (2008) 71 Neurology 57.
(93) Ibid at 59.
(94) Ibid at 58.
(95) Palda, Davis & Goldman, supra note 48 at 1222-1223.
(96) Ibid at 1223.
(97) Supra note 42 at 431.
(99) See Gordon Guyatt et al, "The Vexing Problem of Guidelines and Conflict of Interest: A Potential Solution" (2010) 152 Annals of Internal Medicine 738 at 739.
(100) Moynihan, supra note 87 at 1190.
(102)  3 SCR 674, SCJ No 79.
(103) Ibid at para 38.
(104) Ibid at para 38.
(105) See ibid at paras 39-47 where Sopinka J treats various terms used by courts and authors as equivalent.
(106) Ibid at para 43.
(107) Ibid at para 45, referring to Anderson v Chasney, [19491 4 DLR 71 (Man CA), aff'd  4 DLR 223.
(108) Ibid at para 51.
(109) "Evidence Based Guidance", supra note 31 at 1027 [emphasis in original].
(110) Supra note 15 at 684.
(111) Ibid at 692.
(112) Ibid at 692-693.
(113) Ibid at 693.
(114) Daniel Jutras, "Clinical Practice Guidelines as Legal Norms" (1993) 148 Canadian Medical Association Journal 905 at 907.
(116) Mello, supra note 15 at 680.
(117) Robert SA Hayward et al, "Canadian Physicians' Attitudes About and Preferences Regarding Clinical Practice Guidelines" (1997) 156 Canadian Medical Association Journal 1715 at 1722-1723.
(118) Ibid at 1722.
(119) ter Neuzen, supra note 102 at para 43.
(120) Andrew L Hyams et al, "Practice Guidelines and Malpractice Litigation: A Two-Way Street" (1995) 122 Annals of Internal Medicine 450 at 453.
(121) Mello, supra note 15 at 684.
(122) Ibid at 685.
(123) Ibid [emphasis in original].
(124) Supra note 34 at 284.
(128) Dobie v Dlin, 2002 BCSC 356,  BCJ No 507.
(129) Ibid at para 42.
(131) Ibid at para 156.
(132) Bafaro v Dowd,  OJ No 3474 (Ont Sup Ct) at para 34-35, citing De Jong v Owen Sound General,  OJ No 809 (Ont Gen Div), aff'd  OJ No 979 (CA).
(133) See Loffler v Cosman, 2010 ABQB 177,  AJ No 509 at para 140; and Olsen v Jones, 2009 ABQB 371, [20091 AJ No 774 at para 17.
(134) 2009 BCSC 494, [20091 BCJ No 731 at para 65.
(135) Kern v. Forest, 2010 BCSC 938,  BCJ No 1364.
(136) Ibid at para 161-163 [emphasis in original].
(137) Koch v Brydon, 2008 SKQB 464,  SJ No 733 at para 21, citing John A Campion & Dianna W Dimmer, Professional Liability in Canada (Ontario: Carswell, 1994).
(138) Downey v St Paul's Hospital, 2007 BCSC 478,  BCJ No 700 at para 88.
Dylan Kozlick *
* Dylan Kozlick, DC, JD studied chiropractic at Canadian Memorial Chiropractic College in Toronto, Ontario and subsequently spent several years in private chiropractic practice. Dr. Kozlick obtained his law degree from the University of Victoria and is currently articling with Ramsay Lampman Rhodes in Nanaimo, British Columbia.
Medical malpractice premiums are skyrocketing. "Closed" signs are sprouting on health clinic doors. Doctors are leaving the field of medicine, and those who remain are practicing in fear and silence. Pregnant women cannot find obstetricians. Billions of dollars are wasted on defensive medicine. And angry doctors are marching on the state capitols across the country. All this because medical malpractice litigation is exploding. Egged on by greedy lawyers, plaintiffs sue at the drop of a hat. Juries award eye-popping sums to undeserving claimants, leaving doctors, hospitals, and their insurance companies no choice but to pay huge ransoms for release from the clutches of the so-called "civil justice" system. Medical malpractice litigation is a sick joke, a roulette game rigged so that the plaintiffs and their lawyers' numbers come up all too often, and doctors and the honest people who pay in the end always lose. This is the medical malpractice myth. (26)
If the presumption is that courts should consult clinical guidelines because they reflect customary standards of care, then the authority of newly developed guidelines that make recommendations departing from usual practice would be diminished, as would guidelines motivated by cost cutting ... But if the presumption is that guidelines should be consulted by the courts because they provide evidence of standards justified in relation to evidence rather than custom, this would radically strengthen the normative dynamic of the law in actions alleging medical negligence. (109)
It is true that there exists a diversity of opinion among physicians as to the proper standard of care, but it is equally true that there exists a diversity of opinion among guideline promulgators ... Litigants would probably need to use expert witnesses to select among these guidelines and to convince the trier of fact that their chosen guideline represents the true standard of care; thus, the "battle of the experts" would not be eliminated, but rather supplemented with an additional "battle of the guidelines." (123)
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