SPECIAL ARTICLE Clinical Practice Guidelines as Learned Treatises: Understanding Their Use as in the Courtroom

Patricia R. Recupero, JD, MD

It is important for forensic experts to understand how clinical practice guidelines may enter the courtroom, what role they may play in a trial, and how they relate to expert . Guidelines enter the record in several different ways and in several types of cases, typically with the assistance of an expert . A common vehicle for their introduction is the learned-treatise exception to the rule. Case before and after Daubert v. Merrell Dow Pharmaceuticals, Inc. helps to elucidate the scrutiny that may direct toward medical texts proffered as evidence. This article discusses the implications of different rules and relevant case law for the forensic psychiatrist. The discussion notes important considerations for the , such as how guidelines may affect the expert’s role, concerns about the reliability and of scientific evidence, and questions about whether guidelines will be used for inculpatory or exculpatory purposes in medical malpractice trials.

J Am Acad Psychiatry Law 36:290–301, 2008

In recent years, clinical practice guidelines (CPGs) Clinical Practice Guidelines have played an increasingly larger role in shaping CPGs are “systematically developed statements to both the legal standard of care and the evolving qual- 1 assist practitioner and patient decisions about appro- ity of care in modern medicine. As Simon notes, priate health care for specific clinical circumstances” “The standard of care should be distinguished from (Ref. 3, p 39). They may also be termed practice the quality of care. The standard of care is a legal parameters, algorithms, or clinical pathways.4 Since concept, normatively defined, that is applied to the the growth of outcomes research in the 1970s, the specific fact pattern of a case in litigation” (Ref. 2, p production of CPGs has grown considerably, 99). In the courtroom, CPGs may be considered spurred by the push toward simultaneous quality- medical learned treatises. As such, they may be intro- improvement and cost-containment measures.5,6 duced into evidence and may help courts to deter- Congress’ creation in 1989 of the Agency for Health mine the standard of care or to resolve other impor- Care Policy and Research (AHCPR; now, the tant questions in a case. The goal of this article is to Agency for Health Care Research and Quality help the forensic expert to understand how CPGs [AHRQ]) was intended to improve health care, in function as evidence in a trial and how they relate to part by encouraging the development of effective the role of the expert witness. practice guidelines. Thousands of CPGs are now available through an internet database maintained by the National Guideline Clearinghouse (http://www. guideline.gov/), a division of the AHRQ.7 Other Dr. Recupero is Clinical Professor of Psychiatry, The Warren Alpert sources on the World-Wide Web include the Co- Medical School of Brown University, and President/CEO, Butler Hospital, Providence, RI. This paper was presented at the American chrane Collaboration (http://www.cochrane.org/) Academy of Psychiatry and the Law’s Annual Meeting, October 28, and, in psychiatry, the Texas Medication Algorithm 2005, Montreal, Quebec, Canada. Address correspondence to: Patricia R. Recupero, JD, MD, Butler Hospital, 345 Blackstone Boulevard, Project (TMAP; http://www.dshs.state.tx.us/mh Providence, RI 02906. E-mail: [email protected] programs/TMAP.shtm).

290 The Journal of the American Academy of Psychiatry and the Law Recupero

Some states (notably, Maine,8 but also Florida,9 entific evidence to be admissible, it must have at- Kentucky,10 Maryland, Minnesota, and Vermont11) tained the level of “general acceptance” among the have attempted to use CPGs in reform and relevant scientific community. Over time, the vague health care quality improvement efforts by introduc- definition of “general acceptance” allowed for wide ing legislation that specifies how CPGs may apply in variation in the test’s application in different alleged malpractice or by authorizing the develop- courts.21 In 1949, the Supreme held in Reilly ment of CPGs formally recognized by regulatory v. Pinkus22 that a medical treatise could be used to bodies. Other states (such as Rhode Island)12 have cross-examine or impeach an expert witness even been reluctant to adopt statutory measures similar to when the witness has not acknowledged that the text Maine’s. Courts have voiced concern over the impli- is authoritative. The Supreme Court of Illinois pub- cations of such provisions for litigants’ constitutional lished two important holdings in the widely cited 1965 rights, such as due process, the right to a jury trial, case, Darling v. Charleston Community Memorial Hos- and the equal protection clause.13 Investigative re- pital.23 The court held that: (1) it is permissible to cross- ports by the General Accounting Office14 and the examine expert regarding the views of rec- Office of Technology Assessment15,16 did not find ognized authorities in their field, even if those views sufficient evidence to encourage the continued devel- are not the basis for the experts’ testimony; and (2) opment of such programs on the federal level. accreditation standards are admissible as evidence re- The scope and purpose of CPGs is the subject of garding a hospital’s duty toward its patients. The some debate. The American Psychiatric Association decision broadened the ways in which scientific tes- (APA) explains in a Statement of Intent for its CPGs timony could be evaluated for reliability, as the court in 2007 that: explained: “An individual becomes an expert by The APA Practice Guidelines are not intended to be con- studying and absorbing a body of knowledge. To strued or to serve as a standard of medical care....The prevent cross-examination upon the relevant body of ultimate judgment regarding a particular clinical procedure or treatment plan must be made by the psychiatrist in light knowledge serves only to protect the ignorant or un- of the clinical data presented by the patient and the diag- scrupulous expert witness” (Ref. 23, p 259). nostic and treatment options available [Ref. 17, p 5]. Historically, a common practice has been to allow Similarly, the “Statement of Intent” in the American the use of medical or scientific documents (i.e., Academy of Psychiatry and the Law’s (AAPL’s) Prac- learned treatises) only for the limited purpose of im- tice Guideline for Forensic Psychiatric Evaluation of peaching an expert witness. By this strategy, an attor- Defendants Raising the Insanity states: ney would attempt to undermine an expert’s testi- “These parameters are not intended to represent all mony by cross-examining the expert from a text that acceptable, current, or future methods of evaluating the witness had deemed authoritative. A conflict be- defendants for and drawing conclusions about the tween an expert’s opinion and information in the insanity defense” (Ref. 18, p S3). Intent and dis- text would raise a question of credibility, and the claimers notwithstanding, CPGs may have vast im- expert’s opinion could be impeached. Attorneys fa- plications for patients as well as physicians, and the miliar with this practice would typically coach their continued development and spread of CPGs can play expert witnesses to refuse to acknowledge any prof- a substantial role in shaping the practice of medicine. fered text as authoritative. As long as the experts re- Furthermore, as one scholar notes, “...itiseasy to fused to admit that any text was authoritative, the envision [CPGs] assuming a more prominent role in text could not be introduced as a , and fixing the legal standard for measuring the adequacy the witness’s testimony would stand. of care” (Ref. 19, p 333). In 1975, the Federal Rules of Evidence were adopted and subsequently embraced by many state Learned Treatises courts. These rules made it easier to enter the con- To understand how CPGs and other medical tents of a learned treatise into evidence and to use learned treatises are used in the courtroom, a brief them during a trial, not only for the impeachment of legal history may be informative. In 1923, the Court expert witnesses, but also for direct substantive evi- of Appeals for the District of Columbia published an dence. In federal and state courts adopting the Fed- opinion in Frye v. United States, 293 F. 1013 (D.C. eral Rules of Evidence, expert witnesses may be per- Cir. 1923),20 establishing that in order for novel sci- mitted to testify from CPGs regarding the standard

Volume 36, Number 3, 2008 291 Clinical Practice Guidelines in the Courtroom of care by reading text from the guidelines into the questions of peer review and publication of opin- record. Medical learned treatises would ordinarily be ions or assertions contained in expert witness inadmissible under the hearsay rule, because the per- testimony.30 sons or panels who published them are unavailable In 2000, the Federal Rules of Evidence were re- for cross-examination or sworn testimony. However, vised to support the standards set forth by the Su- Rule 803 provides numerous exceptions to the hear- preme Court in Daubert27 and two later cases, Gen- say rule. One of these, Rule 803(18),24 allows for the eral Electric Co. v. Joiner,31 and Kumho Tire Co. v. introduction of learned treatises that have been qual- Carmichael.32 The new Rule 70233 requires that ex- ified as reliable authorities by an expert witness or pert testimony be based on reliable principles and through . The use of medical learned methods that are applied to the facts of the case.34 As treatises in malpractice or similar cases is justified, in this article seeks to illustrate, judicial scrutiny of sci- part because “reliance on hearsay information cer- entific evidence has played a role in how CPGs are tainly is a matter of necessity for physicians . . .[who] used in the courtroom and has influenced decisions regularly rely on medical records, reports, x-rays, and of whether to accept or reject expert testimony. patient information when making a diagnosis” (Ref. 25, p 196). Rule 803(18) limits the use of learned Practice Guidelines in the treatises; it allows only the reading of passages and Courtroom Today does not permit the jury to receive the treatise as an CPGs may enter the courtroom in several types of exhibit in written form. Case law has confirmed this 26 cases, ranging from medical malpractice and work- restriction. This provision is designed to keep the ers’ compensation to criminal proceedings,35 typi- evidence “testimonial” (oral) and to prevent the jury cally functioning as some evidence of the standard of from overvaluing the treatise or from conducting its care. In addition, in establishing the basis of an ex- own fishing expedition through the entire work. pert’s opinion or in cross-examination of the expert, In 1993, the United States Supreme Court, faced information about how the expert arrived at his or with the question of what constitutes scientific her opinion and whether there is any evidence to knowledge under Federal Rule of Evidence 702, support the witness’s opinion is expected. Such in- rejected the Frye “general acceptance” test in favor of 21 formation helps to fulfill the expert’s role as stated in an analysis based on the Federal Rules of Evidence Rule 70233 or similar state rules. When CPGs sup- in its holding in Daubert v. Merrell Dow Pharmaceu- 27 port or contradict an expert’s position, they may be ticals, Inc. Daubert sets forth a standard for courts useful to the court to help place the testimony in to address when considering scientific expert testi- context. The forensic expert may also help the court mony and affords courts a means of testing scientific 28 to understand a medical learned treatise and to judge expert testimony for relevance and reliability. In whether the treatise is appropriate evidence of the many cases, CPGs may bolster an expert’s testimony standard of care in a particular case. or credibility to satisfy or survive a Daubert challenge. Rules of evidence and procedures for admitting or However, in courts applying the Daubert standard, a rejecting evidence are not uniform. “[M]any states CPG itself must meet the standard before it may be recognize a version of the [learned treatise] exception admitted as evidence through expert testimony. As narrower than that set out in Rule 803(18)” (Ref. 36, one scholar has noted: p 1267). Some courts specify that the witness must In the post-Daubert review of medical literature, the courts have relied on the treatise in formulating his opinion. question not only an article’s reliability, but the expert’s use Of these, some require that such reliance be acknowl- of literature to support his or her opinions. Consequently, medical or scientific literature ought to exhibit evidence of edged on , while others allow re- trustworthiness as demonstrated by the author; or it should liance to emerge during cross. Other courts, while at least reflect the academic trappings of an authoritative not requiring that the witness rely on the treatise, exposition by a leader in a particular field. In courtrooms require that the expert acknowledge the treatise as an where Daubert controls admissibility, the use of medical 37 literature to form conclusions not drawn in the literature “authoritative” work. (For a text to be considered itself violates the dictates of the scientific method [Ref. 29, authoritative by an expert witness, the witness, gen- p 352]. erally, must consider the work to be a source of reli- Other commentators have noted that courts, after able information among members of his field.) Some Daubert, have devoted considerable attention to courts allow the use of learned treatises on cross-

292 The Journal of the American Academy of Psychiatry and the Law Recupero examination even when the witness has not acknowl- complies with the prevailing custom is absolved of edged the text as authoritative, but its status as an liability” (Ref. 41, p 782). Plaintiffs’ attorneys seek to authority has been established otherwise (e.g., demonstrate that the defendant physician has de- through judicial notice or through another expert’s parted from an acceptable standard of care, and the testimony). In Alton v. Kitt, the court permitted an defense usually counters with evidence that the phy- expert witness to testify from the Physicians Desk Ref- sician’s actions comported with the standard of care. erence (PDR), which the court deemed to have “in- Evidence usually involves testimony from medical herent trustworthiness...asa medical text...” expert witnesses and sometimes incorporates written (Ref. 38, p 425). Arguably, most forensic psychia- documents to support arguments offered by either trists would testify that the PDR lacks inherent trust- side. In conjunction with expert testimony, CPGs worthiness, as the information it contains is the result may help a court to define the standard of care. Case of negotiations between pharmaceutical companies law helps to illustrate this practice. and the FDA. It may be necessary for the expert to The Tennessee Court of Appeals allowed the in- help the court or the jury to understand why he or troduction of CPGs published by the American Col- she believes the treatise is not reliable or relevant. lege of Cardiology and the American Heart Associa- Although it is rare that medical treatises are intro- tion.42 The guidelines survived a hearsay objection duced through judicial notice,35 some CPGs may be after several medical expert witnesses testified that deemed sufficiently trustworthy to be admitted un- the guidelines accurately represent the standard of der this rule. The Diagnostic and Statistical Manual care for exercise treadmill tests. A concurring judge of Mental Disorders (ed 4; DSM-IV), for example, wrote: “Clinical practice guidelines can materially may survive an expert’s denial that it is authoritative, assist the triers-of-fact in medical malpractice cases. if the record demonstrates that most psychiatrists rely Properly authenticated [CPGs] are relevant to the on the DSM-IV and thereby recognize it as an au- question of the proper standard of care and should be thoritative text. admitted as substantive evidence if introduced The scope of the expert’s testimony and the ad- through a witness who can lay a proper ” missibility of a particular CPG may vary depending (Ref. 42, p 16). In Ward v. United States,43 the Sixth on the type of case, the forum, the source of the CPG, Circuit rejected a plaintiff’s contention that the court the degree to which the expert believes the guidelines should not have relied on medical articles in deter- to be relevant and reliable, and the relevance and mining the standard of care in a surgical malpractice reliability of the expert’s testimony itself. While a full trial. Expert witnesses for the defense had incorpo- discussion of the ways in which CPGs may enter the rated the articles into their testimony and had qual- record is beyond the scope of this article, it bears ified the texts as reliable and authoritative evidence of noting that CPGs and other medical texts may be the standard of care for a surgical procedure. The admissible under other hearsay exceptions or other Second Circuit, in Tart v. McGann,44 admitted rules of evidence. For example, Federal Rule of Evi- CPGs published by the American Heart Association, dence 705 permits expert witnesses to “give reasons” noting that “. . . the Rule [803(18)] explicitly per- for their opinions. Some courts may allow the expert mits the of medical literature as substan- to offer a learned treatise to explain the reasoning tive evidence ‘to the extent called to the attention of behind an opinion, without needing to consider Rule 39 an expert witness upon cross-examination or relied 803(18). Courts may also prohibit the use of med- upon by him in direct examination...’aslong as it is ical treatises that do not meet criteria for judicial established that such literature is authoritative” (Ref. notice and that have not been introduced under a 40 44, p 78). While normally they cannot be introduced learned-treatise rule. When CPGs do enter the as physical exhibits, the contents of CPGs are often record, they frequently serve as some evidence of the introduced as evidence through an expert witness’s relevant standard of care, and they may still be used testimony. for impeachment purposes. CPGs and other medical learned treatises may be useful in revealing the experimental or unrecognized CPGs As Evidence of the Standard of Care nature of alternative or fringe therapies or proce- In medical malpractice litigation, the standard of dures. In Moore v. Baker,45 a woman who incurred a care is always at issue; “[i]n theory, the physician who brain injury from a blood clot following a carotid

Volume 36, Number 3, 2008 293 Clinical Practice Guidelines in the Courtroom endarterectomy sued her physician and the medical CPGs are especially relevant when they have been center, alleging that she had not given fully informed formally endorsed by a party to a case. In Price v. consent. She based her claim, in part, on the fact that Cleveland Clinic Foundation,48 a case involving al- the defendants had not informed her of an alternative leged negligent performance of blood tests for a pa- treatment, namely, chelation therapy. The Eleventh ternity suit (not a malpractice case), the court held Circuit, deciding for the defendants and upholding that scientific papers used for training employees are the trial court’s decision, noted the ample evidence not hearsay when introduced as evidence against an introduced by the defense, including a document employer. While this was not a Rule 803(18) case, it published by the American Medical Association and demonstrates how an entire document could come evidence from other medical authorities, showing into evidence in written form under ordinary eviden- that chelation therapy was not recognized or ac- tiary rules. If an employer (e.g., a hospital) uses a cepted by the mainstream medical community as an CPG to train employees, then that CPG could be alternative to carotid endarterectomy. admitted as an exhibit in paper form—not just ex- CPGs may also help to distinguish between appro- cerpts read from the stand—as evidence of what ac- priate and inappropriate risk-management practices. In tually should have transpired. As illustrated by one case, CPGs were used to show that an unusual Darling23 and discussed earlier, accreditation stan- infection control policy for the dental treatment of a dards and other professional guidelines held or en- patient with HIV (requiring the patient to go to a hos- dorsed by organizations or businesses may be admis- pital, instead of the dentist’s office, to have a cavity sible. In one medical malpractice case, the Supreme filled) was excessive and inappropriate and may have Court of Minnesota admitted a hospital accredita- amounted to discrimination against the patient.46 tion manual published by the Joint Commission on These cases suggest that CPGs may help to clarify the the Accreditation of Healthcare Organizations boundaries of mainstream medical practice. (JCAHO), which contained CPGs relevant to the CPGs can also help to define new or emerging standard of care at the hospital where the defendant standards of care. In Washington v. Washington Hos- physicians practiced, despite the physicians’ admis- 49 pital Center,47 an expert in a medical malpractice case sion that they were not familiar with the manual. based testimony in part on the American Association Obviously, when a physician has acknowledged a of Anesthesiology’s “Standards for Basic Intra-oper- particular CPG as authoritative or has stated that he ative Monitoring” and an article from JAMA entitled follows that CPG, the CPG in question may carry “Standards for Patient Monitoring During Anesthe- additional weight at trial. In a malpractice action, a sia at Harvard Medical School.” One “encouraged” defendant physician stated in his deposition that he the use of carbon dioxide monitors during elective accepted as authority a particular set of CPGs pub- surgery, and the other noted that the use of monitors lished by the American College of Surgeons. The was “an emerging standard” and was “strongly pre- court noted that the defendant may have failed to ferred.” While these standards were not require- follow one of the procedures required in the guide- 50 ments, the court noted that “[a] standard of due lines, a question of fact to be resolved at trial. care. . . necessarily embodies what a reasonably pru- dent hospital would do...andhence care and fore- Reliability, Trustworthiness, and sight exceeding the minimum required by law or Relevance of Learned-Treatise Evidence mandatory professional regulation may be necessary CPGs that would be prejudicial are typically not to meet that standard” (Ref. 47, p 182; emphasis in admissible, even if endorsed by a party to a case.51 the original). The District of Columbia Court of Courts seek to exclude any scientific evidence that Appeals found that the evidence could have helped a may mislead a jury because of bias, lack of scientific jury to determine the relevant standard of care, value, unreliability, or irrelevance. In O’Brien v. An- against which they could compare the actions of gley,52 the Supreme Court of Ohio declined to per- the defendant hospital. In some cases, an expert may mit the introduction of an editorial published in be called on to testify that a reasonably prudent JAMA stating that “[t]he best medicine often re- practitioner may be expected to follow the most cur- quires that a physician depart from packaged insert rent innovations in care even if not yet adopted recommendations” (Ref. 53, p 273) because the ed- comprehensively. itorial was written with litigation concerns in mind,

294 The Journal of the American Academy of Psychiatry and the Law Recupero making the editorial fall outside the concept of an balancing that would favor exclusion because of the impartial learned treatise. Similarly, risk manage- danger of prejudice inherent in recognizing a book ment guidelines promulgated by a liability insurance authored by the defendant in a medical malpractice carrier, even if signed by a defendant in a medical case as a learned treatise” (Ref. 56, p 991). While malpractice trial, may be inordinately prejudicial to treatises authored by expert witnesses arguably the jury. A Colorado appellate court held that such should be less prejudicial to a case, much depends on guidelines did not meet the relevance test for scien- the scientific facts of the case and the particular tific evidence, because they were created “by a private court’s approach toward admitting or excluding sci- insurance company as part of an insurance entific evidence. If Dr. Jane Doe has received fund- and did not reflect a generally recognized standard of ing from Acme Pharmaceuticals for a study she con- care within the medical profession” (Ref. 51, p 238). ducted and published on Drug X, her experience Experts may assist attorneys in sorting out potential studying the drug may qualify her as an expert wit- sources of bias or prejudice in CPGs to be proffered ness for a malpractice case in which Drug X allegedly at trial. caused harm to the patient, but a CPG she helped to Litigation bias is but one of many factors that can develop for Acme Pharmaceuticals may not be ideal detract from a learned treatise’s reliability. Conflicts evidence of the standard of care. of interest, sponsorship or funding by parties with an Judicial scrutiny of scientific treatises looks not interest in the outcome of a case, or lack of scientific only to the reliability or objectivity of a text, but also rigor may impair a text’s admissibility. In Meschino v. to its relevance to the claim it allegedly supports. In N. Am. Drager, Inc.,54 the First Circuit declined to Ellis v. Int’l. Playtex, Inc.,57 the Fourth Circuit, citing admit medical articles published in Health Devices Frye and Rule 803(18), refused to permit an expert Magazine, explaining that mere publication of an witness to read into evidence a medical article that article does not make one a reliable authority; the was insufficiently relevant to the case at hand, be- court reasoned: cause there was no evidence that the plaintiff sus- [W]e would not accept plaintiff’s argument that the con- tained the type of injuries described in the article. tents of all issues of a periodical may be qualified wholesale The court opined under Rule 803(18) by testimony that the magazine was . . . that the potential prejudicial effect of the testimony highly regarded. In these days of quantified research, and outweighed its probative value.... Wedonot believe, pressure to publish, an article does not reach the dignity of therefore, that it was unreasonable for the district court to a “reliable authority” merely because some editor, even a conclude that under these circumstances the article was most reputable one, sees fit to circulate it [Ref. 54, p 434]. likely to cause confusion or invite unwarranted speculation In a similar case, the Alabama Supreme Court held by the jury about the facts of this case [Ref. 57, p 306]. that while a medical journal may be a trustworthy The Sixth Circuit rejected testimony by a medical treatise, the articles therein are not necessarily trust- expert for plaintiffs in a toxic tort case, noting that worthy treatises themselves.55 Courts may apply sim- the scientific literature cited in the witness’s testi- ilar scrutiny to CPGs, questioning, for example, mony did not actually support the expert’s claim.58 whether guidelines are informed by empirical re- The court had also considered the fact that the expert search, whether they are subject to peer review, and coauthored a peer-reviewed paper on the chemical in how often they are reviewed or updated. question when considering the expert’s eligibility to The forensic expert’s publications, while possibly testify. In a similar holding, a United States District qualifying him as an expert in the field, may not Court disqualified an expert witness from testifying always be ideal learned treatises as substantive evi- because the basis of her testimony did not withstand dence. A witness’s assertion that a text he authored is analysis by Daubert standards.59 In its decision, the considered authoritative by other physicians may not court focused on the medical expert’s use of scientific carry the same credibility as would an impartial en- literature and reasoned that she had inappropriately dorsement. The Second Circuit upheld a trial court’s used a textbook’s explanation of acquired or adaptive decision to exclude a medical text authored by the immunity to support her conclusion that a particular physician who was a defendant in a medical malprac- chemical released from a particular product can cause tice action. The court reasoned that the book’s sensitization to that chemical. While citing relevant “. . . admission would remain subject to a balancing CPGs may strengthen an expert’s testimony when of probative value against danger of prejudice...a the CPGs support the expert’s opinion, stretching

Volume 36, Number 3, 2008 295 Clinical Practice Guidelines in the Courtroom the relevance of a text merely to footnote one’s testi- Conversely, departing from guidelines does not mony may weaken credibility. Courts may hold necessarily subject a physician to liability if the de- expert witnesses to high standards of scientific rea- parture was medically appropriate. Mirroring the soning, and even reliance on well-respected or au- cautionary statements of intent typically found in thoritative texts may be questioned on the basis of professional CPGs, one scholar has explained that: relevance. “CPGs, by their nature, are generalizations that do not necessarily apply in a given instance” (Ref. 63, p 376). In a recent case, the Mississippi Court of Ap- Shield or Sword? peals affirmed a trial court’s ruling in favor of a de- 64 Some commentators have expressed concern that fendant medical center in a malpractice case. The the adoption of CPGs, and particularly their use in plaintiff, while undergoing treatment for substantial medical malpractice trials, will spur the growth of burns and an inhalation injury incurred in an auto- “cookbook medicine,” undermining physician au- mobile accident, developed a bed sore and sued the tonomy or even detracting from the quality of care. hospital for failing to conform to guidelines suggest- Others have speculated that CPGs may be useful as a ing that patients be turned once every two hours to shield against physician liability.60 Of importance is prevent the development of such sores. The guide- that compliance (or lack thereof) with CPGs may lines that the plaintiff offered in the case were both influence whether a liability claim leads to the court- the hospital’s own standards and national guidelines. room. In an oft-cited report published in the Annals The court, in rejecting the plaintiff’s argument, of Internal Medicine in 1995, Hyams and col- noted two experts’ testimony that the guidelines were leagues61 examined malpractice claims and surveyed merely suggestions, not requirements, and that the attorneys to determine how CPGs figured into mal- patient’s condition justified a departure from the practice proceedings. Among cases actually filed in guidelines. In this case, turning the patient resulted court, attorneys used CPGs more frequently for in- in an airway obstruction that impaired his oxygen culpatory than exculpatory purposes. However, at- saturation level and thereby threatened his survival; torneys noted that when CPGs seemed to offer to ensure that he was able to breathe, the hospital exculpatory information (e.g., the defendant physi- staff had to keep the patient supine. cian’s compliance with guidelines may have been a Another concern raised by the use of CPGs as defense to liability), they were less inclined to accept evidence of the standard of care is the fact that dif- the case. The most frequently used CPGs were those ferent sets of guidelines may contain conflicting rec- promulgated by professional medical societies, hos- ommendations. There may be more than one medi- pitals, and JCAHO.61 cally appropriate course of action for a particular Individual cases vary considerably, and even the patient, but the hindsight bias that may arise in a most comprehensive and evidence-based CPGs can- malpractice trial sometimes obscures this reality. not account for the innumerable factors that come Some courts have addressed this problem directly by into play in certain cases. Contrary to the fear that allowing the jury to determine which evidence is the CPGs in the courtroom will lead to regimented, re- most compelling in a case. In James v. Woolley,65 a stricted, and mediocre care, courts have generally up- malpractice action against an obstetrician, the Ala- held sound clinical judgment, not inflexible or po- bama Supreme Court allowed testimony based on tentially outdated guidelines, as the standard of care. the technical bulletin of the American College of Adherence to CPGs of the American College of Ob- Obstetricians and Gynecologists regarding the ap- stetricians and Gynecologists was an insufficient de- propriate standard of care. While other experts dis- fense to malpractice liability where the plaintiff’s ex- agreed with the witness who cited the guidelines, the pert witness testified that the defendant physician court noted that it was the responsibility of the jury, departed from the applicable standard of care in de- not the court, to decide which experts were most laying a Caesarian section.62 The court emphasized credible. In a malpractice suit against a physician for the importance of the obstetrician’s personal training failure to diagnose breast cancer, the court allowed and experience. Adherence to CPGs is no guarantee evidence based on two conflicting sets of guide- against liability if sound clinical judgment requires a lines.66 The plaintiff introduced evidence that the different course of action. American Cancer Society recommends yearly mam-

296 The Journal of the American Academy of Psychiatry and the Law Recupero mograms for women aged 50 years and older, and the Whether engaged as a consulting or testimonial defendant offered evidence from the American Col- expert, the forensic expert can use his or her scientific lege of Obstetricians and Gynecologists that recom- knowledge to assist the attorney, who may want to mended only “regularly” scheduled mammograms, know what CPGs are available in the context of the where “regular” referred to mammograms within the case at hand and whether there is any applicable evi- physician’s discretion. The Supreme Court of Penn- dence-based medicine (EBM) relevant to the case. sylvania applied a two-schools-of-thought analysis Helping attorneys to learn about the applicable scien- and allowed the testimony, noting that a sufficient tific literature that may be useful as evidence for either number of physicians subscribe to each set of guide- party in a case is part of the forensic expert’s role. lines for both to be valid evidence. The expert witness should consider whether to cite Compliance rates with CPGs may be low, even any CPGs in his or her opinion. The decision to rely though there is evidence to suggest that their imple- on a particular medical text in forming an opinion mentation results in improvements in the process of should be carefully considered, as the selection or use care.67 Scholars have noted a tendency among clini- of an unreliable or untrustworthy text may under- cal physicians to resist information and guidelines mine the credibility of the expert’s testimony. Lipton proffered by research scientists.4 Some physicians et al.35 note several factors that may affect the validity view CPGs as a threat to their freedom to exercise or reliability of a medical treatise: fraud or scientific professional judgment and a possible threat to the dishonesty in medical research, inappropriate use of continued improvement of medical practice.63,68 medical statistics, conflicts of interest including the Compliance with guidelines, when clinically inap- pressure to publish, and inadequate peer review. propriate, may worsen risk in some scenarios. How- Even if CPGs are not cited, the expert should review ever, when a health care provider departs from a which CPGs are available and should have a reasoned CPG, and harm results, the provider’s failure to fol- justification for not relying on them in reaching an low a clinically appropriate CPG may become addi- opinion. For testimonial witnesses, the attorney or tional evidence that there was a deviation from the the court is likely to inquire as to the basis for the applicable standard of care. expert’s opinion. Particularly if CPGs or other strong EBM do not form part of the basis for the expert’s opinion, the scientific testimony may be vulnerable Implications for the Expert Witness to a Daubert challenge, and experts should apply the Some have speculated that the continued growth scientific method to the extent possible in developing of CPGs will reduce, if not eliminate, the need for an opinion. Testimonial experts should familiarize expert witnesses in medical malpractice cases.69 To themselves with the relevant CPGs, even if not citing the author, this seems unlikely. Expert witnesses are them, as opposing counsel may use CPGs during necessary to help provide context for medical learned cross-examination. Depending on the court and the treatises and to help courts to understand complex facts of a particular case, the expert may testify about scientific or clinical reasoning. Indeed, in Dartez v. whether she relied on a particular CPG or medical Fibreboard Corp.,70 the Fifth Circuit upheld a defen- learned treatise in formulating her opinion and dant’s objection to the introduction of medical arti- whether a particular CPG is authoritative, respected, cles on the grounds that the articles did not meet the recognized, generally accepted, informed by scien- limited criteria for evidence specified under the tific evidence, and relevant to the standard of care. In learned-treatise exception to the hearsay rule. The responding to such questioning, experts should be articles had been improperly introduced as exhibits prepared to indicate the potential limitations of the without the assistance of medical testimony to qual- CPG in question so that judges and juries do not take ify their implications to the jury. Furthermore, this the guideline out of context. article’s earlier discussion of the impact of bias or In medical malpractice cases, forensic experts may irrelevance on courts’ decisions to admit or exclude be asked to offer an opinion as to whether a CPG is scientific evidence may foretell an important role for reliable and relevant to the clinical situation in the the expert (i.e., helping courts to recognize potential case.71 Attorneys may seek the expert’s assistance in sources of bias in medical texts or helping to deter- authenticating a learned treatise as reliable and au- mine whether a particular CPG is relevant to a case). thoritative or may use a previously authenticated

Volume 36, Number 3, 2008 297 Clinical Practice Guidelines in the Courtroom treatise to question an expert during cross-examina- studies, consensus among leaders within a specialty, tion. During cross, the expert is likely to be asked and expert advisors. CPGs of professional medical whether he is familiar with the treatise or article in societies typically are designed to improve the care of question. To be familiar with a previously authenti- patients. They are usually informed by medical ex- cated source, the expert need not acknowledge the pertise and empirical research and are driven by pro- text as authoritative or reliable, nor must he neces- fessional standards of care and the advancement of sarily have read the document in question.72 The scientific knowledge. For these reasons, medical so- expert may need to explain to the court why, al- cieties’ CPGs may be more likely to be endorsed by though she is familiar with a text, she does not con- medical expert witnesses as reliable. In contrast, sider it trustworthy or relevant to the case. CPGs of third-party payers (such as HMOs) are of- During the discovery process, attorneys may be ten aimed at cost-containment and may be used for required to give notice to opposing counsel of an utilization review.6,68 Similarly, CPGs of malprac- intent to introduce a learned treatise into evidence; tice insurance carriers may be intended more to an attorney may also attempt to have a treatise ap- lessen the risk of malpractice than to provide optimal proved in advance (e.g., by judicial notice or request care to patients. They may be viewed as less reliable for admission). The forensic psychiatric expert may because they are influenced by a view toward litiga- be helpful during this phase, in supporting a motion tion. If physicians try to follow every CPG, they may in limine during pretrial proceedings or by advising find themselves trying to serve potentially conflicting the attorney with regard to the reliability of particular goals: to provide the best quality care for their pa- CPGs or other medical learned treatises. Gutheil and tients, to secure reimbursement for their services, and Bursztajn73 note that pretrial Daubert hearings have to avoid the risk of malpractice liability. This diffi- become an increasingly popular means of screening culty underscores the importance of clinical judg- expert testimony for admissibility. CPGs and other ment in determining which CPGs to follow, if any. professional resource documents may be useful for Although a thorough discussion of EBM in the ensuring that an expert’s testimony will survive a courtroom is beyond the scope of this article, it bears Daubert challenge. Similarly, an expert may be able noting that one of the questions the expert should to assist the attorney at this stage in discouraging the consider when evaluating a CPG or other medical court from recognizing or accepting a particular doc- learned treatise is whether the document meets the ument as a learned treatise. standards of EBM. As one scholar notes: For experts concerned about whether their testi- 74 CPGs are not the functional equivalent of EBM as some mony will trigger a Daubert challenge, Sageman scholars have suggested. In fact, it is not only possible, but lists several red flags likely to trigger a challenge, such sometimes necessary to practice EBM without using CPGs. as subjectivity and lack of testing. When an expert’s In addition, one can practice according to a CPG and not testimony triggers a Daubert hearing, Gutheil and be practicing EBM [Ref. 76, p 488]. Bursztajn offer recommendations for how forensic In evaluating a CPG for its application of EBM, one psychiatric experts may present their opinions so that 75 might ask, for example, whether the text supports its they are more likely to survive the challenge. The recommendations with meta-analyses, with double- appropriate citation of relevant CPGs based on em- masked, placebo-controlled, randomized trials or pirical, validated research and EBM should therefore with other high-standard EBM. A CPG based on a strengthen an expert’s testimony when used to in- lower standard of scientific reliability, such as expert form and reinforce the expert’s opinion. consensus, may carry less weight in the courtroom and may do little to strengthen the expert’s testi- CPGs and Scientific Research mony. On the contrary, reliance on guidelines or Medical societies, such as the American Medical documents that are not grounded in strong scientific Association (AMA), the APA, and AAPL, as well as evidence may weaken an expert’s testimony. Further- third-parties, such as HMOs and medical liability more, neglecting to incorporate relevant EBM into insurance providers, have created CPGs. In drafting, one’s opinion could trigger a Daubert challenge or a revising, and publishing CPGs, their creators rely on zealous cross-examination. a variety of sources, including randomized controlled In determining which CPGs or documents to cite, trials (RCTs), outcomes research, observational the expert should consider the impact of Daubert and

298 The Journal of the American Academy of Psychiatry and the Law Recupero its progeny on the practice of medicine and scientific the expert’s opinion is based on sound scientific rea- inquiry. The aftermath of Daubert and the growing soning and well-accepted medical practice. Attorneys importance of scientific articles and CPGs as evi- may need help in understanding this problem so that dence in the courtroom have already begun to influ- they can prepare adequately to argue a case. ence the process and publication of scientific re- In a study published in the Journal of the American search. Peer reviewers caution authors to avoid Medical Association, Shekelle and colleagues79 found prescriptive language and statements that may be that in a sample of AHRQ guidelines, over three taken out of context (in the courtroom). Some go so quarters of the guidelines were in need of updating. far as to warn the authors that statements should be They estimated that guidelines should be reviewed cloaked in disclaimers to discourage the perception every three years to assess validity. Given the rapid that they might be suggestive of a standard of care. pace of biomedical research and the relatively slow More troubling is the growth of “litigation science,” pace at which medical societies produce CPGs, fo- which scholars define as “the creation of a body of rensic experts should be conscious of the possibility scientific studies generated for and funded by litiga- that a guideline in question may be outdated, even if tion” (Ref. 77, p 621). Law firms have a considerable it appears to have been revised recently. Testimony, interest in encouraging and using scientific research like medical practice, should be informed not only by that will not only survive a Daubert hearing, but that published treatises but also by professional experi- will also tend to support the positions of the types of ence and careful consideration of the relevant factors clients they serve. Concerns about the reliability of in a particular case. such research are similar to those raised for studies funded or otherwise sponsored by pharmaceutical or Concluding Points medical device companies. Guidelines in psychiatry and mental health may With funding from law firms and other interested tend to be vague when compared with CPGs for parties playing an increasingly influential role in sci- other specialties and other medical conditions. Many entific research, one troubling question is whether guidelines in psychiatry emphasize the importance of peer reviewers and scientific journal editors are able clinical judgment, a factor that cannot be objectively to identify such conflicts of interest and litigation measured through the lens of a practice guideline. bias when authors do not make full disclosures. In These guidelines frequently outline the important recent years, several prominent medical journals have elements of a full psychiatric examination, however, come under criticism for publishing articles without such as family history, comorbid conditions, psychi- uncovering and disclosing the authors’ conflicts of atric and medical history, current medications, and interest.78 Furthermore, peer review may not be as so forth. A forensic expert may be asked, for example, rigorous in practice as in theory,21 particularly in less whether a defendant physician departed from the prestigious journals. Judges and juries typically are applicable standard of care when he or she failed to not well qualified to determine the trustworthiness of document a patient’s family history of alcoholism. A a particular journal’s peer review process or to inves- CPG appropriate to the clinical scenario and speci- tigate whether authors may have concealed conflicts fying the importance of obtaining a full family his- of interest (Ref. 77, p 621). The forensic expert could tory of all medical, psychiatric, and substance abuse assist courts and attorneys in investigating such ques- conditions may support the expert’s assertion that tions; one might look to the underlying support for a the defendant departed from the appropriate stan- study, potential conflicts of interest, federal filings dard of care. If clinical conditions necessitate or jus- for research projects, or studies in European or inter- tify a departure from recommendations in CPGs, national journals where the medical or scientific forensic experts may help judges and juries to under- community may have had more time to collect lon- stand the complex nature of clinical decision-making gitudinal data. The forensic expert may also question and the importance of an individual patient’s needs. whether contrary findings have been suppressed. Un- Forensic psychiatrists should remain conscious fortunately, scientific research, particularly rigorous that CPGs may continue to play an important role in controlled studies, can be very expensive, so it may be shaping medical practice. As one scholar explains: difficult to find wholly unbiased published research Proposals advanced to date for giving CPGs a greater role in that supports a forensic expert’s opinion, even when medical malpractice litigation can be grouped into three

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categories. One group of reformers advocates requiring During consultation with the attorney, it may be physicians and/or patients to enter into ex ante to recognize a set of guidelines as constituting a binding stan- necessary to seek clarification as to which rules dard of care. A second group has proposed that courts take will control the admissibility of your testimony judicial notice of CPGs as the standard of care, with devi- and the scientific literature you intend to cite. ations therefrom conclusively establishing negligence. A third group, by far the most influential, urges that compli- While many states’ rules of evidence are similar ance with CPGs should constitute an affirmative defense to the Federal Rules of Evidence, not all jurisdic- for physicians, but that deviations from CPGs should not tions apply the federal rules (see e.g., Ref. 80; be used as [Ref. 6, p 668]. some courts use state-specific rules of evidence or Forensic experts who expect to testify or to file affi- precedent.36 davits in conjunction with litigation may pay careful attention to emerging research, news, legislation, and Acknowledgments policies relating to CPGs and their role in shaping The author wishes to express her appreciation to Samara E. the standard of care for medical practice. 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