Introduction
The Medical Malpractice Restatement of the American Law Institute, formally known as the Restatement (Third) of Torts: Medical Malpractice, and approved in May 2024, presents the Institute’s first treatment of the law of medical malpractice litigation.Footnote 1 Advocates will ask courts to adopt it, and many of its provisions will have a salutary effect.Footnote 2 One provision, however, would have the opposite effect. § 6(b) attempts a sea change in the law to create a special, defendant-only rule that would authorize the use of practice guidelines as a substitute for expert testimony about the standard of care.Footnote 3 This article explains why courts should reject requests to adopt § 6(b).
As out-of-court statements about medical practice not subject to cross-examination, practice guidelines are undisputably hearsay documents that would be excluded under the rules of evidence in every federal and state court save for a rule-based exception.Footnote 4 Since their advent, courts have treated them as equivalent to “learned treaties” and, under that exception to the rule against hearsay, allowed both plaintiffs and defendants to use them periodically as either exculpating or inculpating evidence when they are established as reliable by an expert’s admission on cross-examination or by another expert’s testimony.Footnote 5 Ordinarily Restatements deal only with common law issues and do not apply when there is specific statutory law but, notwithstanding that stricture, the Medical Malpractice Restatement adopted § 6(b).Footnote 6 If adopted by courts, it would create a two-tier system of evidence for practice guidelines.
For plaintiffs, practice guidelines would remain hearsay documents that could still be used but only under the learned treatise hearsay exception. For defendants, there would be a sharp, controversial departure from the hearsay rules that would create a new “one-sided” defensive shield which would: (1) elevate practice guidelines to stand-alone, non-hearsay evidence if promulgated from an “authoritative” entity, and (2) authorize only defendants to use that evidence as a substitute for expert testimony. Thus, when practice guidelines are relied upon by defendants, they would ipso facto be transformed into non-hearsay, prima facie evidence. But documents do not change their hearsay character depending on who offers them into evidence.
However, practice guidelines are not the panacea that the Restatement envisions. Many guidelines, even when developed by “authoritative sources,” are replete with objectivity and credibility issues; others promote special-interest agendas; some conflict with each other; and many miss the mark of accounting for individual variations in patients that are necessary for proper care. Some guidelines are even promulgated to give their members litigation advantages over plaintiffs. More important, there is no precedential support for this new provision, and the reasons given for it in the new Restatement do not withstand critical analysis. § 6(b) would also violate a number of the foundational principles of the civil justice system, rendering it more akin to tort reform than a restatement of the law. This article shall embark on a deeper discussion below.
Part I of this article begins with an overview of the Institute’s approach to Restatements. Part II examines practice guidelines that provide the basis for the controversy within the Medical Malpractice Restatement. Part III then details the lack of jurisprudential support for the rule. Part IV critically analyzes the reasoning put forth to support the rule. Part V explains how the rule would violate foundational principles. And finally, Part VI explains why the Restatement’s approach is law revision, rather than a restatement of the law. The article concludes with the recommendation that courts not adopt § 6(b) and, instead, continue to treat practice guidelines as hearsay evidence that is admissible only under the specific circumstances of Federal Rules of Evidence § 803(18) or its cognate state rules, to be read into evidence, not themselves entered as evidence.
I. Developing and Using Restatements of the Law
The ALI does not lightly venture into new areas of law at the level of a Restatement.Footnote 7 The development of a Restatement is “often a grueling, expensive and time-consuming task.”Footnote 8 The current project to update tort law and produce a Restatement (Third) of Torts, which includes the recently adopted Medical Malpractice Restatement, is now in its thirty-second year.Footnote 9
A Restatement seeks to create greater certainty in the law, overcome obsolete or purposeless legal complexities, and advance legal change that accords with the demands of modern life.Footnote 10 But while the process to produce a Restatement is rigorous, it does not guarantee consensus about the resulting Restatement provisions.Footnote 11 Moreover, a Restatement is not law; it is only a “recommendation to courts to adopt sections of the Restatement in the process of common-law adjudication.”Footnote 12
A Restatement’s content is heavily defined by a Reporter or Reporters, who “structure the project, define its scope, prepare drafts, and present their work for review by various stakeholders.”Footnote 13 The reality is “that every Restatement is necessarily the brainchild of the Reporter and his or her associates.”Footnote 14 However, Reporters do not enjoy unrestrained discretion in drafting a Restatement. The prime source of law for Restatements is the case law of American courts.Footnote 15 And while Restatements are not bound to existing law, in proposing variations to clarify and simplify the law and secure the better administration of justice, Restatements are constrained by the need to find support in existing law.Footnote 16
In keeping with those strictures, much of the Medical Malpractice Restatement adheres, as it should, to established law, particularly § 5(a),Footnote 17 which provides that the all-important applicable standard of care “is the care, skill, and knowledge regarded as competent among similar medical providers in the same or similar circumstances.”Footnote 18 For several years, many states had relied on a locality standard, which required that a physician “possess and exercise that degree of skill and care ordinarily employed in similar circumstances by physicians in good standing in his own community.”Footnote 19 That rule thwarted many meritorious claims, but courts drew justification for the rule from differences in experience and conditions of practice among local health care providers that contrasted with those in other locations.Footnote 20 But that rule has now been largely debunked. As one court explained more than four decades ago, the “locality rule has been quite properly criticized as a relic of the nineteenth century which has no relevance to the realities of modern medical practice.”Footnote 21 Or, as more practically stated by the Mississippi Supreme Court in its landmark decision of Hall v. Hilbun:
We would have to put our heads in the sand to ignore the “nationalization” of medical education and training. Medical school admission standards are similar across the country. Curricula are substantially the same. Internship and residency programs for those entering medical specialties have substantially common components. Nationally uniform standards are enforced in the case of certification of specialists… . Regarding the basic matter of the learning, skill and competence a physician may bring to bear in the treatment of a given patient, state lines are largely irrelevant.Footnote 22
The new Restatement makes clear that the locality rule is no longer sustainable and that, instead, a national reasonable physician standard of care defines the obligations of a healthcare provider.Footnote 23 Nonetheless, as discussed in Section V(C) below, by allowing the medical profession or other “authoritative” sources to craft practice guidelines that could then be used as a standard of care, § 6(b) could resurrect locality rules through the back door.
The new class of defendant-only, potentially dispositive evidence that is envisioned by § 6(b) will tilt the scales of justice in favor of the medical profession, not just by opening the door to locality rules, but also by providing defendants with a new class of prima facie evidence that would eliminate the need for expert testimony and by stripping away plaintiffs’ rights to cross-examination. And this is being proposed for a fraught area of law where plaintiffs already face significant disadvantages.Footnote 24
II. The Rise and Problematic Nature of Practice Guidelines
A. The Advent and Theory of Practice Guidelines
Practice guidelines came to the fore in the latter half of the twentieth century, although their existence took form earlier.Footnote 25 They developed in response to studies that demonstrated that medical care was wildly uneven, that customary medical practices lacked solid scientific support, and that some medical and surgical procedures were overused as a habitual response that lacked legitimate bases.Footnote 26 Research demonstrated, for example, inexplicably large differences in diagnostic procedures utilized and treatment options pursued, including when to perform surgery, among Medicare beneficiaries across medical and surgical specialties and that medical providers used quite different diagnostic and treatment approaches for the same patient issues, yet nothing in medical science supported many of the approaches that were followed.Footnote 27 As a result of that growing disaffection with the quality of health care, medical groups, starting with the American College of Physicians, began to craft practice guidelines intended to improve the state of medical care.Footnote 28
The federal government joined the efforts, creating the Agency for Health Care Policy & Research (“AHCPR”)Footnote 29 in 1989 “to enhance the quality, appropriateness, and effectiveness of health care services and access to those services.”Footnote 30 Congress charged an office within the AHCPR with responsibility for “facilitating the development, periodic review, and updating of clinical practice guidelines,” in order to “assist practitioners in the prevention, diagnosis, treatment, and management of clinical conditions.”Footnote 31
Soon, different medical organizations and groups decided to participate in the act, resulting in a “plethora of diagnostic and therapeutic treatment recommendations from many national medical organizations.”Footnote 32 Among those attempting to develop guidelines were the American College of Physicians, the Blue Cross and Blue Shield Association, and the American Medical Association, which worked with a wide range of medical specialty societies.Footnote 33 The American Council of Medical Specialty Societies urged even broader participation throughout the medical profession and their groups in defining medical standards through guidelines in 1987.Footnote 34 By 1994, more than 1600 guidelines developed by more than sixty organizations existed,Footnote 35 causing the American Medical Association to attempt to catalog them in an effort to assist doctors in narrowing their choices to an appropriate set of guidelines.Footnote 36 A short seventeen years later, the Editorial Board of the Annals of Internal Medicine stated that “the development of thousands of clinical practice guidelines by hundreds of groups in dozens of countries creates its own tangle for clinicians to unravel.”Footnote 37 The editors of the Annals explained that this “dizzying array of diagnostic and therapeutic options, along with the wide variation in evidence to support them, challenges the provision of rational medical care” and “could very well become part of the very problem they aim to solve.”Footnote 38 In fact, the National Guideline Clearinghouse, created as part of the AHCPR, reported the existence of so many guidelines that cataloging them no longer made sense and funding for the effort expired.Footnote 39 As reported by the Clearinghouse, there were 471 different guidelines for hypertension and 276 for stroke as of 2013.Footnote 40
As guidelines proliferated, litigation critics and special interest groups sought to convert them into defensive tools that would provide safe harbors for medical defendants. Although intended to assist physicians and patients in reviewing care alternatives and strategies, they quickly were co-opted by insurers to determine health insurance coverage.Footnote 41 Tort reformers quickly latched onto them to use in tort-reform defensive shield lawsFootnote 42 but as policy makers came to understand the inherent problems with practice guidelines, those efforts fritted away.Footnote 43 Later, some academics, including the main Medical Malpractice Restatement Reporter,Footnote 44 argued for litigation reforms based on practice guidelines; other commentators demurred pointing to the many problems that made that an impossibility.Footnote 45 But the problems inherent in practice guidelines do not end with their proliferation; they go much deeper.
B. Quality and Credibility Problems with Practice Guidelines
It is self-evident that all practice guidelines are not equal. As Professor Dan Dobbs, a leading torts authority, recognizes, “[a]ny organization—a local medical society, a hospital, a national association of medical specialists, or state-organized commissions can publish protocols or guidelines.”Footnote 46 Even actuarial service firms, utilizing actuarial methodologies rather than medical science, can develop practice guidelines.Footnote 47 Different guidelines addressing the same topic provide inconsistent and conflicting blueprints for diagnosis and treatment because there is no “centralized authority to coordinate, vet, approve, and catalog guidelines,” and there is “an absence of a universal methodology to create guidelines.”Footnote 48 Each professional organization that chooses to promulgate a guideline “decides freely which, if any, framework they will use to construct guidelines,” and the guidelines produced remain “susceptibl[e] to bias and conflicts of interest,” while they also often “suffer from a lack of rigor and applicability.”Footnote 49
Clinical Practice Guidelines (CPGs), are deemed the closest to the gold standard in the medical profession because they are supposedly evidence-based, rather than consensus documents from a medical association’s leaders.Footnote 50 Even so, as a committee of the Institute of Medicine found in 1990, “the process of systematic development, implementation, and evaluation of practice guidelines based on rigorous clinical research and soundly generated professional consensus, although progressing, has deficiencies in method, scope, and substance.”Footnote 51 The validity of CPGs has not improved in the intervening decades. In 2012, a study of 130 CPGs found that they failed to meet the quality standards set by the Institute of Medicine.Footnote 52 A recent, respected study on the efficacy and propriety of clinical practice guidelines, published in Injury, showed that up to fifty percent of guidelines are considered untrustworthy within the profession.Footnote 53
In fact, researchers found that CPGs often “promote more care rather than more effective care,” prioritize “use as marketing and opinion-based pieces rather than roadmaps to improved medical care,” and display an inability to overcome “population-based recommendations” in favor of actual individualized needs.Footnote 54 Researchers also complain that “it remains unclear which CPGs are still authoritative,” given that “[o]ptimal medical procedures change over time,” and the difficulty in “determin[ing] when the weight of evidence has caused a justifiable shift against a certain treatment that should result in a change to the relevant CPGs.”Footnote 55 A factor that explains why CPGs may remain unchanged long after their useful life has ended is that CPGs typically “cost at least $200,000 to produce and substantial amounts to revise.”Footnote 56
CPGs, as well as other practice guidelines, can also reflect different standards of care for the same diagnosis. Some seek optimal care, while others, such as the Federal Guidelines for Opioid Treatment Programs, explicitly state that they “describe a minimum acceptable standard for the operation of OTPs.”Footnote 57 The Institute for Medicine’s famous study, To Err is Human, declares that “[t]he development and availability of standards for patient safety can serve several purposes.”Footnote 58 One of those purposes seeks to “establish minimum levels of performance.”Footnote 59 For example, the American Psychological Association’s CPG for Treatment of Depression indicates only that the guidelines are “aspirational,” not “exhaustive” or “definitive” and “may not be applicable to every professional and clinical situation.”Footnote 60
Perhaps one explanation for the vote of no confidence is that even the more rigorous CPGs engender uneven methodologies,Footnote 61 variance in quality,Footnote 62 and a failure to keep up with advances in scientific and medical knowledge.Footnote 63 In fact, researchers uniformly recommend that CPGs be updated every three to five years.Footnote 64
Beyond that, many guidelines are riddled with objectivity and credibility issues that cast serious doubt on any claim to self-authentication. For example, one study of practice guidelines led by Dr. Justin Kung disclosed that ninety-one percent of co-chairs of guideline drafting committees and many other guideline committee members had serious conflicts of interest, guideline committees rarely included patient representatives or information scientists, and many guidelines were outdated.Footnote 65 And as found by Professor Avraham:
Authors [of practice guidelines] often have conflicts of interest that may or may not be disclosed, guidelines are created that recommend conflicting treatments, and there is no system in place to ensure that CPGs are updated or that outdated recommendations are removed from circulation.Footnote 66
Take, for example, oncology, which has competing CPGs for lung cancer which use different update protocols so that the choice of the guideline will reflect different snapshots of contemporary treatment knowledge.Footnote 67 Thus, their conflicts do not reflect differences in philosophy, as other guidelines might, as much as differences based on the timing of their publication.
One set of oncology guidelines, promulgated by the National Comprehensive Cancer Network, is updated several times a year to keep up with rapid advances, which takes on high importance given the nature of modern cancer research.Footnote 68 The other set, offered by the American Society of Clinical Oncologists, is revisited significantly less often.Footnote 69 As a result, the first would appear to reflect the latest science, while the other seems to lag behind. Yet, a study in the Journal of Thoracic Disease discusses the relative weaknesses of both guidelines, as well as some alternatives developed by foreign medical organizations.Footnote 70 It found the American Society’s CPG “lack[s] a continuous or time-predefined updating, and, at least at some time points, their applicability in this rapid evolving field is substantially limited,” noting that at the time of this 2018 study, the guidelines were still based on 2015 knowledge.Footnote 71 At the same time, the National Network’s CPG, which had been updated in December 2017, provides different recommendations for treatment yet provided weaker comparative tools to help clinicians make decisions on courses of treatment.Footnote 72 Yet another criticism of the National Network’s CPG is the absence of as robust a methodologic background as others employed.Footnote 73 There may be instances where a health-care provider could justifiably use either CPG, but there are also times where, based on representations made to the patient about the currency of the treatment or the depth of rigor employed, that only one would be appropriate. The approach taken by the Restatement leaves no room for those types of considerations, especially if the guidelines are introduced as stand-alone evidence.
Still, both are likely to be viewed as “authoritative” under § 6(b) and, in places, may demonstrate express differences, not unlike the experts that plaintiffs and defendants would call to the stand. In testimony, defense experts sometimes testify that the defendant conformed to the standard of care.Footnote 74 Yet, in a significant number of states, plaintiffs are then entitled on cross-examination to ask about the expert’s personal practices, which might involve a higher standard of care than his testimony suggested was sufficient.Footnote 75 Thus, for example, Illinois courts recognize that “where the expert says the standard of care requires procedure A and only procedure A, but that he personally performs procedure A and, for various reasons, additionally performs test B,” that has relevance to the expert’s credibility on the applicable standard of care.Footnote 76 Other states take the same approach.Footnote 77
More troubling, practice guidelines have often been devised for the express purpose of providing defendants with litigation advantages. The American Colleges of Medicine, with its various specialty practices, are thought to be among the premier medical organizations of the United States. Clearly, they meet § 6(b)’s definition for authoritativeness, yet even they can devise practice guidelines to skew litigation against plaintiffs.Footnote 78
Even when guidelines do not suffer from objectivity and credibility issues, due to the sui generis nature of medical illnesses and conditions, many guidelines will not have sufficient specificity to address the same or similar conditions in the case at hand, a point that is at least partially conceded in the Restatement.Footnote 79 Researchers have noted that progenitors of guidelines do not account for “personal circumstances and medical history” and therefore fail to “tailor care” appropriately, while typically providing “blanket recommendations” that can be contraindicated by a patient’s individualized needs.Footnote 80 Instead, practice guidelines are “best suited for clinical scenarios that are simple and standardized,” rather than those that involve additional levels of complexity due to multiple health issues.Footnote 81
Apart from the objectivity and credibility issues, there is also the problem created by conflicting guidelines. In 2009, the United States Preventive Services Task Force recommended a guideline that women, ages forty to forty-nine, who do not have family histories of breast cancer, should no longer routinely receive mammograms or be encouraged to perform breast self-exams.Footnote 82 The American Medical Association called the change from a guideline issued seven years earlier that recommended screening every one to two years “ill-advised.”Footnote 83 The American Cancer Society reached the opposite conclusion with the same data and recommended a completely different guideline.Footnote 84 Today, the United States Preventive Services Task Force recommends screening every other year beginning at age forty,Footnote 85 while the American Cancer Society endorses yearly screening no later than age forty-five.Footnote 86 Despite those changed guidelines, individual patients may require different recommendations based on family history, other health issues, and their environmentFootnote 87 —essentially a more individualized assessment than guidelines could provide. Similar issues have arisen with respect to prostate-specific antigen (PSA) tests as a means to detect prostate cancer.Footnote 88 Three national guidelines, promulgated by the United States Preventive Services Task Force, the American Cancer Society, and the American Urological Association, recommend that men start prostate cancer testing at age fifty or fifty-five years old, but discontinue it at age seventy.Footnote 89 Yet guidelines also exist from at least 607 cancer centers accredited by the Commission on Cancer, seventy-eight percent of which have no upper limit on when to cease screening.Footnote 90
Another well-publicized conflict was the disagreement between the Infectious Diseases Society of America (IDSA) and the International Lyme and Associated Diseases Society (ILADS) over proper treatment for Lyme disease.Footnote 91 The IDSA adopted restrictive guidelines that seemed to deny that chronic Lyme disease existed.Footnote 92 The panel it convened to develop guidelines “believed that Lyme disease can be easily treated, and cured, with short-term antibiotics.”Footnote 93 After receiving complaints that insurers did not cover those treated under the IDSA guidelines, while doctors prescribing long-term antibiotics to treat it as a chronic condition were subjected to investigation and prosecution because they departed from the guidelines, the Connecticut Attorney General became involved, eventually threatening an antitrust action against the IDSA.Footnote 94 His investigation found that the IDSA guidelines substantially ignored or diminished the science to reach its conclusions, utilized people who had substantial financial interests in companies making relevant drugs or diagnostic tests, or consulted insurance companies, which were chosen to be part of the panel to draw the guidelines because of a predisposition to deny that Lyme disease was a chronic condition, and froze out those who might dissent from that predisposition.Footnote 95 To settle the matter, the IDSA agreed to reassess its guidelines using an neutral review panel,Footnote 96 but the old problematic guidelines remained in place in the interim.Footnote 97 Even the process for approving the revised guidelines proved problematic, with the Connecticut Attorney General suggesting that it was inconsistent with the settlement.Footnote 98 Despite these problems, § 6(b) would treat the guidelines with a preferential status capable of rebutting alternative standards of medicine.
None of this should be surprising given that there is no structural mechanism or standards for the development and maintenance of practice guidelines. To fill the gap, the Institute of Medicine issued guideline standardsFootnote 99 but, without an enforcement mechanism, guideline promulgators remained free to do as they like. Others have called for a guideline-certifying agency or for government control but that is practically and politically inconceivable.Footnote 100 The resistance to the loss of professional autonomy and independence that could happen with “cookbook medicine” is too ingrained in the medical profession, to say nothing of the distrust of government processes.Footnote 101
With scant acknowledgement of these inherent problems,Footnote 102 the Institute has endorsed this controversial and problematic experiment as a recommendation to courts that puts a heavy thumb on the scale in favor of malpractice defendants.Footnote 103 Of equal concern, the approach adopted in the Restatement lacks jurisprudential support.
III. The Restatement’s Approach to Practice Guidelines Lacks Jurisprudential Support
As the Medical Malpractice Restatement concedes, there is little case law support for § 6(b).Footnote 104 It justifies proceeding with a rule change anyway by claiming this dearth of support is because defendants have greater access to medical experts, do not bear the burden of proof, and, therefore, have seldom pressed the use of practice guidelines on appeal.Footnote 105 And while Restatements historically do not address matters of evidence, leaving that to advisory committees and local law,Footnote 106 it claims that § 6(b) is not delving into matters of evidence because it is not a rule of evidence but rather a substantive legal change. We examine these claims, as well as the relevant case law.
A. No Jurisdictional Support for Changing Hearsay to Prima Facie Evidence
The proposition that defendants have not pressed for judicial approval for the use of practice guidelines as substantive evidence does not justify launching a new rule creating exculpatory evidence for them. If anything, that defendants have not sought this change should be a strong indication that it is not needed, at least in the view of defendants. And rather than enjoy limited case law support, as the Reporters suggest,Footnote 107 there in fact is no case law support for recharacterizing practice guidelines as non-hearsay documents when they are offered by defendants. The main authority cited in support of § 6(b) is a concurring opinion in an unreported case, Frakes v. Cardiology Consultants, P.C. Footnote 108
However, the claim of support is imaginary. In Frakes, in apparent compliance with the hearsay exception for learned treatises, the defense used a table from the American College of Cardiology “very effectively to impeach” the plaintiff’s expert.Footnote 109 The defense then had their experts testify that the table represented the standard of care and offered it into evidence.Footnote 110 In affirming a defense verdict because no expert questioned the table and deferring to the trial court’s sound discretion in admitting evidence, the court nonetheless held, “[w]e hesitate to give an unqualified endorsement to the concept that a hearsay document can be transmitted into non-hearsay by virtue of its adoption by a witness.”Footnote 111
In his concurring opinion, Judge Koch observed that “[p]roperly authenticated clinical practice guidelines are relevant to the question of the proper standard of care and should be admitted as substantive evidence if introduced through a witness who can lay a proper foundation.”Footnote 112 Although he suggested the guidelines “can be extremely helpful in cases calling into question whether a physician chose the wrong course of diagnosis or treatment or should have gone further in attempting to understand or correct the situation,” he still denied that they should be viewed as “conclusive evidence of the standard of care.”Footnote 113 He further stated that “[p]roof of compliance with practice guidelines should not necessarily establish due care; just as proof of non-compliance should not establish negligence per se.”Footnote 114 Calling this concurrence the “most direct authority” to support the Restatement’s position on practice guidelines,Footnote 115 stretches this one-judge, four-paragraph opinion beyond all recognition. Judge Koch did not posit that practice guidelines could be self-authenticating or that, standing alone, they could be a substitute for expert testimony or that they could be sufficient to defeat a plaintiff’s claim. Significantly however, after more than a quarter of a century, no subsequent decision in Tennessee or in any other jurisdiction has relied on Judge Koch’s suggestion that practice guidelines should be admitted as substantive evidence.
It is also a stretch to claim, as the Restatement does,Footnote 116 that two other cases, Arpin v. U.S.,Footnote 117 and Dalmia v Palffy,Footnote 118 partially support allowing practice guidelines to substitute for the standard of care. Both decisions involve expert-witness qualifications—Footnote 119 neither call for practice guidelines to serve as stand-alone substitutes for expert testimony or as establishing a standard of care. In Arpin, where plaintiff’s decedent husband was seen by a resident physician who misdiagnosed the patient but not by the supervising physician, it was held that the plaintiff’s expert was unqualified to opine that the supervising physician had a duty to examine the plaintiff.Footnote 120 In a passing comment, the court noted that Medicare reimbursement rules excuse attending physicians from having to examine or otherwise observe a resident’s patient.Footnote 121 The court pointedly did not hold, as the Restatement reporters claim,Footnote 122 that the Medicare rule established a standard of care,Footnote 123 but held, based on the facts presented, that the “breach of the duty of care [was] so fundamental as not to require expert evidence to establish.”Footnote 124 And in Dalmia, the court held that it was not an abuse of discretion for the trial court to find that plaintiff’s expert opinion was not generally accepted or supported by strong science methods.Footnote 125 Although the defense offered some practice guidelines that confirmed issues with the plaintiff’s expert’s testimony, there was no holding that practice guidelines constituted a standard of care because the “[p]laintiff failed to offer any reliable evidence to support his opinion.”Footnote 126
While no court has approved the use of practice guidelines as prima facie evidence of the standard of care, courts in New York, Ohio, and the Eleventh Circuit reviewing a Daubert determination have rejected claims that practice guidelines constitute the standard of care that can, standing alone, compel the rejection of a plaintiff’s evidence or case.Footnote 127 None of these cases are referenced in the comment or Reporters’ Note to § 6(b).Footnote 128
The proposed rule would also be a sharp departure from all other Restatements on professional liability. There is no such prima facie provision or, for that matter, defendant-only provision, for lawyers, accountants, or other professionals and those practicing skilled trades.Footnote 129 For all other professionals, there is no special rule for guidelines and industry standards; if used by either party, either inculpatorily and exculpatorily, it occurs under the learned treatise exception to the rule against hearsay.Footnote 130
B. Asymmetry is Unfounded Because the Value of Guidelines from an Authoritative Source Does Not Differ When Used by a Plaintiff or Defendant
Turning to the asymmetrical aspect of this new rule, the Restatement does not cite a single case to support the limitation of § 6(b) that would prevent plaintiffs from also using practice guidelines in an inculpatory manner. That “one-way street” feature has been a common element in tort reform proposals, driven by legislators’ desires to assure physicians that practice guidelines could not be used against them.Footnote 131 But those politics are not supposed to be part of the common law calculus.
In general tort law, as set forth in Restatement (Third) of Torts: Liability for Physical and Emotional Harm § 13, Comment e, industry standards are available for use as non-conclusionary evidence of negligence by both plaintiffs and defendants;Footnote 132 that is, they can be used as both inculpatory and exculpatory evidence. That rule is an extension of the general rule that all relevant, probative evidence is admissible both ways, by both parties, to the litigation.Footnote 133 But § 6(b) would change that by nonsensically decreeing that practice guidelines offered by defendants would be non-hearsay, prima facie evidence sufficient to defeat a claim while practice guidelines offered by plaintiffs would remain hearsay that could only be utilized under the learned treatise exception.
There is not a single case in American jurisprudence holding that practice guidelines can only be used as a shield and that plaintiffs could not make equal use of them as a sword. Indeed, there are cases such as those cited in the Reporters’ Note to § 6(b),Footnote 134 that recognized the exculpatory use of guidelines. However, none of those cases held that plaintiffs could not also make inculpatory use of them. To the contrary, empirical evidence shows that practice guidelines have been relied upon routinely as a basis for or to support inculpatory standards of care. In fact, studies of all the cases decided in the nearly two decades from January 1, 1980 through May 31, 1994 that involved practice guidelines, showed that a majority involved plaintiffs using guidelines.Footnote 135 Another study of records conducted by malpractice insurance companies from January 2000 through March 2010 found that guidelines were used as inculpatory evidence at three times the rate they were used exculpatorily.Footnote 136
Indeed, the concurring opinion in Frakes which the Reporters claim is the most direct support for the use of practice guidelines, supports plaintiff’s usage: “[Practice guidelines] can be extremely helpful in cases calling into question whether a physician chose the wrong course of diagnosis or treatment or should have gone further in attempting to understand or correct the situation.”Footnote 137
Support for symmetrical use is widespread.Footnote 138 Indeed, even the plaintiff-oriented cases collected in the Reporters’ Note all indirectly hold that plaintiffs have equal access to practice guidelines to prove the standard of care;Footnote 139 otherwise, the decisions would have simply held that guidelines cannot be used by plaintiffs to establish a standard of care rather than explaining why they were not proper in those particular cases. As noted by Professor Rosoff:
Should the use of CPGs be a “two-way street,” with this form of evidence available equally to both parties? The answer would appear clearly to be “yes.” In virtually every other context evidence that is seen as legitimate and admissible by the court is allowed on an equal basis to both parties. Giving providers assurances that guidelines can be used only in their favor may be an important step toward gaining their support; but allowing such one-sided use of evidence in a court of law raises disturbing questions of fairness and of validity under the U.S. Constitution’s Fifth and Fourteenth Amendments’ due process and equal protection mandates, and under state constitutional principles as well.”. Footnote 140
Others who have studied the issue agree:
[P]ermitting physicians to use CPGs as an affirmative defense in malpractice litigation while denying plaintiffs the right to use this evidence to prove their own case would also be problematic. Restricting one party’s access to relevant, probative, and otherwise admissible evidence on a key element of a legal claim is an anomaly in the law and requires strong justification. There is no such justification for restricting the use of CPGs. Thus, CPGs should either be available to all parties or to none.Footnote 141
There have been prior attempts to restrict the use of practice guidelines to just shields for defendant providers, similar to the asymmetrical provisions of § 6(b), but those have been part of partisan tort-reform agendas. Beginning in the early 1990s, medical and related organizations began to push for practice guideline shield laws.Footnote 142 Four states—Maine, Florida, Minnesota and Vermont—enacted such laws as part of tort-reform campaigns but the Florida, Minnesota and Vermont programs failed and were abandoned.Footnote 143 And in Maine, guidelines were only promulgated for approximately one to two percent of medical practice, and the law was allowed to expire.Footnote 144 Maryland also enacted a statute to encourage guideline development but the statute provided that any practice guidelines developed could not be used in litigation, and was thereafter repealed in 1999.Footnote 145
As far as the so-called substantive law distinction is concerned, while transforming the characterization of practice guidelines to substantive evidence when used by defendants is technically substantive, the fact remains that § 6(b) would change the hearsay rules of evidence, since the new rule would authorize what is undeniably hearsay to be used as substantive non-hearsay evidence. Therefore, however characterized, this new rule still transgresses the prohibition against using learned authorities as substantive evidence and would constitute an evidence rule modification.
Given the lack of authority for transforming practice guidelines into non-hearsay evidence, the absence of a single case authorizing the restriction of practice guidelines for standard of care purposes solely to defendant providers, and the multiplicity of cases allowing their use by plaintiffs, there is no jurisprudential basis for § 6(b).
IV. Section 6(b) Relies on Flawed Reasoning
With the scarcity, indeed absence, of case law support, the Restatement makes two arguments in support of § 6(b): (1) practice guidelines represent aggregate experts’ views that are better than those of experts hired for litigation purposes; and (2) practice guidelines may represent a higher level of competence so that compliance would reflect a higher level of care.Footnote 146 However, there is no empirical evidence to support either of those contentions; they are merely rank speculation. The Restatement also contends that the possible higher level of competence, and the possibility that guidelines may only capture one of several alternative approaches, are reasons for the asymmetrical defendant-only limitation.Footnote 147 None of that makes any sense.
A. The Criticism of Litigation Experts is Unfounded and Does Not Support the Rule
Given the wide range of practice guidelines and their frequent objectivity and credibility issues, it does not follow that they represent a “better view” than an expert who has studied the particulars of a case at issue, especially when no empirical evidence exists to support that conclusion. And, since defendants have a greater access to credentialed experts,Footnote 148 this seems to be a complaint that is primarily directed at plaintiff’s experts, when, in fact, it is not uncommon for plaintiff’s experts to be some of the leaders in their field of medicine.Footnote 149 Indeed, the difficulties that already exist in prevailing as a plaintiff in a medical malpractice lawsuit and the tremendous costs required,Footnote 150 incentivize plaintiff lawyers to retain the best experts available. In that sense, plaintiff’s lawyers perform a gatekeeping function to weed out incompetent and unqualified expert witnesses.Footnote 151
In addition, significant disincentives exist to deter any but the most well-credentialed experts from participating as plaintiff’s experts. Among other things, defendants regularly refer opposing experts to professional organizations and state medical boards, who treat the testimony as the practice of medicine.Footnote 152 In addition, experts have been sued by defendants who claim that the testimony breached a duty of professional competence.Footnote 153 If anything, this argument reveals an inherent prejudice against plaintiff’s experts, not sound reasoning on which to launch substantial changes in the law.
Beyond that, the complaint about litigation experts is not well thought out. Given the wide range of practice guidelines available,Footnote 154 guidelines chosen by defendants are likely be a “hand-picked” judgment about competent medical care that validates what the physician did. There is no requirement that the defendant have been aware of the practice guideline being offered in court or that the defendant testify that he relied upon it in the belief it provided the standard of care. Instead, the treatment accorded practice guidelines by § 6(b) will guarantee that defense counsel or defense experts will scour the panoply of available guidelines to identify one that accords with the defendant’s conduct. Furthermore, because authoritativeness, applicability, relevance, and compliance will likely be contested issues, expert testimony will still be needed. Thus, either way there will be hand-picking and expert testimony. The subjective stereotyping of plaintiff experts is therefore a slim reed on which to predicate a policy change. Rather, expert credentials and qualifications of litigation experts are matters for cross-examination and the adversarial system, not the basis for a new law.
B. That practice guidelines may represent a higher level of competence is just more speculation
There is no empirical evidence that guidelines represent a higher level of care. Indeed, given the many inherent problems, conflicts of interest, and non-medical considerations involved with practice guidelines,Footnote 155 it can be equally argued that at least some practice guidelines from “authoritative” sources represent a potentially lower level of competence. If, however, alleged over-competence is the stated reason to deny plaintiffs equal access to § 6(b), and the Restatement was true to this reasoning, it would have provided that where practice guidelines represent the normal level of competence in the practice of medicine they could be used as well by plaintiffs as inculpatory evidence. That it does not reveals that this is just straw-grasping, not sound reasoning.
C. Relevancy and Authoritativeness Add No Support to the Rule
Much of the comment to § 6(b) involves the requirement that a guideline be relevant and authoritative,Footnote 156 as though that provided some foundation or support for the rule, but that is not the case. Requiring relevancy adds nothing since in all cases only relevant evidence is admissible.Footnote 157 Relevancy therefore is already a requirement both generally and under the learned treatise hearsay exception. So too for the authenticity requirement. For a guideline to be used under the learned treatise exception it must be “established as a reliable authority by the expert’s admission or testimony, by another expert’s testimony, or by judicial notice.”Footnote 158 There was no need to change that rule or propose an allegedly new substantive rule to realize those requirements.
But the authenticity requirement points out a major flaw in § 6(b). Under its provisions, the focus of authoritativeness is on the issuing entity, while under Rule 803(18) the focus is on the reliability of the guideline.Footnote 159 Thus, under § 6(b) authoritative guidelines are those from entities that have “appropriate expertise and integrity and speaks with authority in a relevant portion of the medical-provider community.”Footnote 160 This is entirely circular and would seem to confer authoritative status on guidelines devised by any coterie of medical providers that form an association.
Consider, for example, the Alliance for Hippocratic Medicine, the group that challenged the Food and Drug Administration’s approval and rules for use of mifepristone to end a pregnancy and its OTC availability.Footnote 161 The group was formed in 2022 and claims its purpose is to uphold and promote the “fundamental principles of Hippocratic medicine” and to provide “healthcare with the highest standards of excellence based on medical science.”Footnote 162 It boasts a nationwide membership of “approximately 30,000 physicians,”Footnote 163 “many of whom are OB/GYNs or emergency-room doctors.”Footnote 164 Under the entity-only focus of the § 6(b) standards, any guidelines this group of well-credentialed health care providers developed would receive authoritative status and asymmetrical treatment, despite a transparently political purpose anchored in a self-described “pro-life” agenda. Granting such authoritativeness merely because the group claims to be an expert national advisory association of medical specialists makes little sense. It is possible that their guidelines could be sterling, unaffected by their political slant, but it is also possible that they would adhere to an agenda that promotes a political goal at the expense of patient care. That is why much more is required than simply an inquiry into whether the issuing organization is an expert entity. Even Judge Koch’s concurrence, which the Reporters claim supports them, recognized that foundational requirement: “Properly authenticated clinical practice guidelines are relevant… if introduced through a witness who can lay a proper foundation.”Footnote 165
Some states have taken a more realistic approach to guidelines. For example, Illinois holds that guidelines promulgated by medical specialty societies, health insurers, and other health organizations have significant evidentiary value, yet are not complete answers to the applicable standard of care.Footnote 166 Still, as of April 2024, “most states have not officially made provisions for practice guidelines.”Footnote 167
States may have taken a cue from a leading torts treatise that explains the logical limits of guidelines:
Courtroom use of standards prescribed in advance to establish limits on liability of defendants presents some inherent problems. As a means of limiting a patient’s rights, standards might have the most legitimacy if they were generated by governmental agencies with public representatives. But such standards are likely to be politically driven, for example, by cost-cutting motives, and may not reflect good assessment of responsible medical care. On the other hand, if standards-in-advance are generated purely by medical professionals, perhaps with an eye to potential liability, then medical professionals and not the public processes of courts or legislatures would be deciding the patient’s rights.Footnote 168
The Restatement seems to indirectly acknowledge these flaws when it states that more case law development is needed to determine what represents authoritative and material guidelines.Footnote 169 But launching a new rule without case law support on the speculative hope that eventually, it could be made workable through trial and error, is inimical to the Restatement process.
The linchpin for allowing hearsay evidence is that certain classes of evidence are trustworthy.Footnote 170 Thus, Federal Rule of Evidence § 803(18) properly looks to the reliability of the guidelines. In the case of practice guidelines, that is particularly important because many guidelines have inherent bias and conflicts of interest that are not readily apparent on the face of the guideline.Footnote 171
D. Claims in Support of Asymmetry Also Fail
Claims in support of the second aspect of § 6(b), that its asymmetry is appropriate because some guidelines are over-competent or that a case might involve alternative methods of treatment, also do not suffice. Not all guidelines are over-competent and not all cases involve alternative methods of treatment. As already noted, there is an inherent inconsistency in the over-competent argument.Footnote 172 Nor does it follow from the possibility of different views about the method of treatment in a given case that the use of practice guidelines as standard of care evidence should be restricted in all cases to just defendant providers. While differing views might be a reason a defendant provider might want to use a particular practice guideline, practice guidelines are not irrebuttable for either side. If a plaintiff presents a practice guideline about one method of treatment, the defendant would be able to rebut with a practice guideline about the method that she followed. The possibility that in some cases there may be differing methods of care does not require that plaintiffs be banned from also using them in an inculpatory manner.
The asymmetry aspect of § 6(b) would be nothing short of an anomaly. American jurisprudence is based on the premise that justice is blind.Footnote 173 A foundational rule of evidence is that all relevant evidence is admissible by either party.Footnote 174 And while many types of evidence are excluded, hearsay being a prime example, the exclusions apply equally to all parties. To overcome this bedrock principle of evenhandedness requires strong policy justifications. Examples of the types of exceptions tolerated include bad character evidence and rape-shield laws but, even there, the one-sided exclusions are for the purpose of maintaining fundamental fairness.Footnote 175 That justification does not exist in the case of practice guidelines.
E. Other Conceptual Flaws Exist in the Proposal
There are also other conceptual flaws as well. There is an inherent inconsistency in the rule’s treatment of the conclusive effect of practice guidelines. On the one hand, the Restatement states that practice guidelines are not conclusive but may support a no-liability finding, yet the comments and Reporters’ Note make clear that the rule is intended to authorize the use of practice guidelines by defendants to provide “stand alone” evidence of a standard of care that would “obviate the need for expert testimony.”Footnote 176 That would be conclusory.
Finally, § 6(a) would directly contradict the rationale underlying the learned treatise exception to the rule against hearsay. As noted by the Advisory Committee of the Federal Rules of Evidence in its explanation for the learned treatise exception:
The writers have generally favored the admissibility of learned treatises, [citations omitted] … but the great weight of authority has been that learned treatises are not admissible as substantive evidence though usable in the cross-examination of experts. The foundation of the minority view is that the hearsay objection must be regarded as unimpressive when directed against treatises since a high standard of accuracy is engendered by various factors: the treatise is written primarily and impartially for professionals, subject to scrutiny and exposure for inaccuracy, with the reputation of the writer at stake. 6 Wigmore §1692. Sound as this position may be with respect to trustworthiness, there is, nevertheless, an additional difficulty in the likelihood that the treatise will be misunderstood and misapplied without expert assistance and supervision… .
The [learned treatise] rule avoids the danger of misunderstanding and misapplication by limiting the use of treatises as substantive evidence to situations in which an expert is on the stand and available to explain and assist in the application of the treatise if declared. The limitation upon receiving the publication itself physically in evidence, contained in the last sentence, is designed to further this policy.Footnote 177
There is nothing in the over fifty-year history of practice guideline use under that rule which would necessitate changing that rule, and especially changing it to favor only defendants.
In sum, the scant rationale provided for § 6(b) does not survive critical analysis nor does it support the wholesale change in the law that § 6(b) represents. Absent sound reasoning and principles, § 6(b) should not be adopted.
V. The Restatement’s Approach to Practice Guidelines Violates Foundational Principles of the Civil Justice System
A basic premise of civil justice is that for every wrong there is a remedy.Footnote 178 For far too long, medical malpractice plaintiffs were denied justice at the hands of the “locality rule.” As confirmed by the Restatement, that rule has now been swept aside in favor of a national standard of care.Footnote 179 Nonetheless, decades of tort-reform legislation has created substantial barriers to justice and caps on damages, making medical malpractice litigation the most arduous litigation possible.Footnote 180 Still, there are basic foundational principles that adhere: justice is blind,Footnote 181 parties have a right to cross-examination,Footnote 182 parties cannot set their own standard of careFootnote 183 and procedures should not unduly delay the quest for justice.Footnote 184
A. The Rule Denies Equal Justice
Justice is supposed to be blind; it bides no favor and suffers no inequality. All who seek justice are treated evenhandedly, regardless of class, race, wealth or power. Neither evidence nor substantive rules are supposed to tilt the scales for or against either party. But § 6(b) would violate this fundamental principle.
Practice guidelines are indisputably hearsay documents. Any party can use them under the “learned treatise” exception as either exculpating or inculpating evidence when they are established as reliable by an expert’s admission on cross-examination or by another expert’s testimony.Footnote 185 That rule treats all parties equally; it affords no special weight to evidence when proffered by defendants. But, under § 6(b), when practice guidelines are relied on by defendants, they would ipso facto be transformed into non-hearsay prima facie evidence.. Since that evidence “can, standing alone, provide sufficient evidence of compliance with a standard of care to obviate the need for expert testimony concerning the standard of care,”Footnote 186 it would give special weight to guidelines offered by defendants and could lead to unjust results. That is incompatible with the principle of equal justice.
B. The Rule Could Eviscerate Plaintiff’s Right to Cross-Examination
As envisioned by § 6(b), the rule would “obviate the need for expert testimony concerning the standard of care.”Footnote 187 Such stand-alone evidence would necessarily be self-authenticating. And while the Restatement notes that ordinarily a sponsoring expert witness will be necessary,Footnote 188 it is clearly anticipated that when practice guidelines are offered by defendants, they may be deemed self-authenticating so that, without any further evidence, explanation or sponsoring witness, they may be sufficient to defeat the plaintiff’s claim.Footnote 189 That would allow the introduction of potentially dispositive evidence without any opportunity for cross-examination, an astonishing proposition that is inconsistent with fundamental trial fairness.
The critical role that cross-examination plays in the quest for justice has been lost in the § 6(b) proposal. In the words of John Henry Wigmore, cross-examination is “beyond any doubt the greatest legal engine ever invented for the discovery of truth.”Footnote 190 One of the primary objectives of the rules of evidence is to place important safeguards around hearsay evidence to protect the rights of litigants to test evidence by cross-examination.Footnote 191 In the case of practice guidelines, those safeguards have heightened significance because of the lack of standards or regulatory framework for the sound, objective development or updating of practice guidelines.Footnote 192 There is no requirement for disclosure of bias, motive, funding sources, conflicts of interest, or any other aspect of the process by which the guideline was created, the exact type of information that would go to credibility, authenticity, and reliability. Nor is there any requirement that guidelines be updated to keep abreast of medical developments. But stand-alone guidelines that are not subject to cross-examination would leave it to trial counsel to explain meaning and import. It does not take much imagination to see what mischief could ensue.
The concept that practice guidelines could be self-authenticating also seems to run afoul of the principle underlying the Federal Rules of Evidence § 201, which prevents judicial notice of facts unless they are not subject to “reasonable dispute” because they are established by either common knowledge or “sources whose accuracy cannot be reasonably questioned.”Footnote 193 That same “not reasonably questioned” standard should underly the reliability and trustworthiness of practice guidelines used as litigation evidence. It is present in the learned treatise hearsay exception, either by way of expert admission during cross-examination or through a sponsoring witness, but lacking in § 6(b), and there is nothing in § 6(b) that will cure or offset that defect.
C. The Rule Would Impermissibly Allow the Medical Profession to Set Its Own Variable Standards of Care for Litigation Purposes
§ 6(b) could have another far-reaching effect. It would enable medical entities, or like-minded individuals, to devise medical standards of care, thus affording the medical profession opportunities to enact its own standard of care to justify practices that would otherwise be deemed substandard. And, as discussed below, those standards could resurrect locality rules.
A fundamental principle of tort law is that parties are not entitled to set the standards by which they are to be judged. As famously observed by Judge Learned Hand, “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests, however persuasive be its usages.”Footnote 194 That principle is most often found in connection with customary practices.Footnote 195 The same principle applies with respect to practice guidelines. The medical profession can never set the medical standard of care, because, in doing so, it would be setting its own standard of care. Thus, in Adams, the court held that a medical or scientific community cannot set a “litigation standard” for when its members are sued:
If the CAP and ASC can define what constitutes admissible expert testimony in their members’ professional negligence cases, then there is no apparent reason why other groups whose members face lawsuits cannot do the same. For example, why couldn’t pharmaceutical companies adopt guidelines setting high standards of proof for establishing that a plaintiff’s injury was caused by a given drug and justify doing so based on their experience with the complex nature of pharmacology and their expertise in the field? Why couldn’t an association of prison guards and wardens presume to define the meaning of “deliberate indifference” or the requirements for admission of evidence in custodial litigation? They can’t because courts do not allow interested groups to set evidentiary or other litigation standards.Footnote 196
Many other professions already have practice guidelines, and there is a multitude of industry and trade group standards or guidelines.Footnote 197 Many of the groups that promulgated those guidelines and standards would be deemed “authoritative” under the § 6(b) definition. Under current law, those guidelines and standards are available to both plaintiff and defendants to use both inculpatorily and exculpatorily.Footnote 198 But if § 6(b) were adopted, what would stop any of those entities from claiming, by analogy, that their guidelines or standards should also be prima facie evidence available only to members of the organizations? If professional guidelines issued by “authoritative” organizations are so inherently reliable in the field of medicine that they do not need expert testimony to support them, why stop with medical guidelines? Would not defendants in many other professions, trades or industries welcome the opportunity to declare their own standards and create rules that would only be available to their members?
D. The Restatement’s Attempt to Limit Admissible Guidelines to those Derived from Authoritative Sources Provides a Meaningless Qualification that Will Likely Increase the Cost of and Delay Medical-Malpractice Litigation
Purportedly, the new rule would not allow defendants to use all practice guidelines. To weed out substandard guidelines, the rule is limited to “authoritative” guidelines.Footnote 199 But how would authoritativeness be determined? A comment in the Restatement suggests that “authoritative status might be shown primarily through evidence that the organization or entity issuing the guideline has appropriate expertise and integrity and speaks with authority in a relevant portion of the medical-provider community.”Footnote 200 Other potentially relevant considerations include “(1) the body issued the guideline after a period of careful, open deliberation, and (2) the guideline is designed to guide medical care in the best interest of patients.”Footnote 201
These factors provide no real guidance to courts. It would seem to permit county medical associations to reinstate local customs through promulgation of a guideline, despite the modern rejection of that standard in the courtsFootnote 202 and in the very same Restatement.Footnote 203 Despite the multiple references to national standards in § 5 and its comments, no similar restriction is placed on practice guidelines in § 6(b).
Beyond the prospect for reinstating local guidelines, read literally § 6(b) would authorize defendants to introduce any relevant practice guideline that came from an “authoritative” entity.Footnote 204 And it assigns the determination of whether a practice guideline is authoritative to a judge.Footnote 205 Unlike Federal Rule of Evidence § 803(18), where authoritativeness is either admitted during cross-examination or established by a sponsoring expert witness,Footnote 206 under § 6(b) where authoritativeness is defined by the promulgating entity, when defendants offer so-called “stand-alone” guidelines, it could potentially trigger “authoritativeness” hearings, that would be similar to a Daubert hearing.Footnote 207 Those hearings require the judge to play the role of a gatekeeper on the admission of scientific evidence by assuring its reliability through a “preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and … whether that reasoning or methodology properly can be applied to the facts in issue.”Footnote 208 Where the parties dispute the expert testimony’s admissibility, “the district court must hold an in limine hearing (a so-called Daubert hearing) to consider the conflicting evidence and make findings about the soundness and reliability of the methodology employed by the scientific experts.”Footnote 209 These hearings drain judicial resources.Footnote 210 As observed by the Fifth Circuit:.
We would be remiss if we did not note that we are troubled by the amount of judicial resources that were devoted to the Daubert hearing. In a case capable of being tried start to finish in a day and one half, not only the court but the lawyers were engaged for the better part of five days in a hearing to determine the reliability of testimony and potential prejudice of exhibits involving a well-known test that is applied in a quite straightforward manner.Footnote 211
In fact, Daubert hearings often become a “lengthy process, involving a ‘complex mini-trial.’”Footnote 212 One court detailed the “overwhelm[ing]” nature of the hearings; it required more than “500 docket entries, and there are literally boxes of reports, depositions, and affidavits submitted in support of the parties’ respective Motions to exclude experts,” along with a request to stay the trial date that, “if granted in every case, could cripple the trial calendar.”Footnote 213
A hearing on whether a particular set of guidelines constitute authoritative guidance, given the outsized stakes involved in their admissibility, will generate, at a minimum, evidence about the sponsoring organization; the qualifications, potential biases, and apparent conflicts of interest among those who drafted the guidelines; the age of the guidelines and medical developments since the guidelines were promulgated; and expert opinion about the reliability and practical use of the guidelines. State court judges, who usually preside over medical malpractice cases, often lack the resources to handle such hearings. The result is a level of complexity, difficulty, delay, and cost that cannot be justified.
VI. As a Change in the Law, if at All Appropriate, § 6(b) is for the Legislative Process, Not a Restatement
When changes are proposed in Restatements, they are supposed to be accretional; proposals that would produce “wild swings” in the law or “major innovations of matters of public policy” are inappropriate.Footnote 214 Proposing to change the character of documents based on which party offers them, making the rule one-sided, limiting cross-examination, and tilting the scales of justice, would unquestionably be major innovations that would embark into uncharted jurisprudence, as there is no case in any jurisdiction that has ever held that practice guidelines are admissible as self-authenticating, stand-alone substantive evidence or that they should only be available to defendants.
The rule also appears to be based on an unstated premise that the medical profession needs a safe harbor from malpractice litigation. But empirical evidence strongly suggests that a considerable safe harbor already exists. Given the difficulties in prevailing as a plaintiff in a medical malpractice lawsuit, including win rates that are less than half of other torts, extreme expenses, and frequently capped damages,Footnote 215 many meritorious cases are turned down because of the disincentives to reaching a compensatory and profitable result are too great.Footnote 216 Indeed, most potential plaintiffs do not sue.Footnote 217 The Institute of Medicine estimated that around one million or more injuries each year were the product of medical errors.Footnote 218 A subsequent study concluded that deaths due to medical errors alone numbered 195,000 per year.Footnote 219 In fact, the “evidence is quite clear that while many patients are injured, few ever sue.”Footnote 220 But, whether an additional safe harbor is needed is a matter for the legislative process, not a Restatement. As noted by Rosoff, treating practice guidelines as establishing the applicable standard of care “would be a substantial departure from existing law and would, presumably, require legislative action.”Footnote 221
Rosoff’s comment is based on the fundamental principle of separation of powers.Footnote 222 The Restatement’s proposal concerning practice guidelines justifies itself on the basis of policy arguments.Footnote 223 However, policy judgments that bring about such extraordinary change as the Restatement proposes, belong in the legislative realm, not within the judicial sphere. As the United States Supreme Court has declared, “[p]olicy arguments are properly addressed to Congress, not this Court. It is Congress’s job to enact policy and it is this Court’s job to follow the policy Congress has prescribed.”Footnote 224 Although the Supreme Court is not a common law court, save in admiralty cases, state courts, which are common law courts, uniformly adopt the same position.Footnote 225 § 6(b) oversteps this foundational restriction.
Conclusion
The Restatement has failed to make the case for the creation of a special new rule that would allow defendants to use practice guidelines as stand-alone prima facie evidence of the medical standard of care. In the more than half a century of experience with practice guidelines, no court has ever gone so far. There is already a proven system in place, Federal Rule of Evidence § 803(18), that evenhandedly allows both the inculpatory and exculpatory use of practice guidelines. In the absence of any sound reason or policy, or case law support to change that system, § 6(b) should not be adopted.
