Guidelines Useful in Malpractice Cases
By Armand Leone, Jr.
The nationalization of health care in the United States began in 1989, when Congress created the Agency for Healthcare Policy and Research, 42 U.S.C. § 299. AHCPR has a broad mandate to enhance the quality, appropriateness and effectiveness of health care services. AHCPR is to establish a broad base of scientific research and to develop improvements in clinical practice. The hope is to increase health care value by increasing the effectiveness, efficiency and quality of health care through outcome analysis, 42 U.S.C. § 299b-3(a)(2).
The Forum for Quality and Effectiveness in Healthcare (FQEH) was created as a division within AHCPR to actually develop and periodically review medical practice guidelines, 42 U.S.C. § 299b. These guidelines are to be used by physicians, educators and payors to determine how diseases, disorders and other health conditions can most effectively be prevented, diagnosed, and managed clinically. 42 U.S.C. § 299b-1(a). The Institute of Medicine (IOM) assists the AHCPR in the development, dissemination and evaluation of medical practice guidelines.
Additional uses for guidelines have emerged. Courts are increasingly allowing the use of practice guidelines in medical malpractice litigation. Attorneys are using guidelines to assess the validity of potential malpractice cases and to facilitate out-of-court settlements. Insurers are utilizing guidelines to determine payment. These practice standards, which are meant to be objective statements concerning essential health care choices, help determine what is appropriate based on a scientific approach.
But the AHCPR is not the only health care organization producing guidelines, and there are more than 1,600 guidelines published by more than 60 organizations. Unfortunately, many organizations only provide a very vague description of the methods used to generate their guidelines. Some guidelines are only based upon a literature review without any randomized clinical trials.
The credibility of practice guidelines varies with the process by which the organization develops them. Accordingly, an attorney involved in medical malpractice litigation must be aware of the quality characteristics to look for to effectively use or impeach guidelines when used at trial.
The best guidelines are generally developed by multi-disciplinary teams. Because each specialty discipline approaches a problem differently, a multi-disciplinary guideline has extremely good credibility and does not favor the economic interests or biases of any one discipline. The clarity of a guideline is also important, because if the clinician cannot figure out what to do, the guideline is worthless. A good guideline projects outcomes, indicates the strength of the evidence for its recommendations, is reliable and is reproducible.
A strong guideline discloses the scientific and clinical evidence supporting it, as well as the strength of the expert consensus underlying it. Because of the rapid advancement of medical technology, the American College of Legal Medicine recommends that established guidelines be reviewed every three to five years, and new guidelines should be developed as procedures, such as laparoscopic surgery and skinny needle biopsy, become accepted as part of the general standard of care.
Another critical issue is whether the guideline appropriately defines the patient population to which it pertains. Clinical flexibility is important to treating physicians, and a good guideline identifies the generally expected exceptions to its recommendations, such as where a specific patient’s drug allergies preclude following the guideline’s recommendations for treatment. Furthermore, a guideline’s applicability may change when a patient presents with more than one disease process or condition. Accordingly, good practice guidelines must state the level of certainty of the conclusions, the providers who should use them and the patient conditions for which they are appropriate.
The individuals who actually develop guidelines in committees cannot completely prevent individual biases from affecting the objectivity, validity, and application of the guidelines which they produce. Economic biases can seriously undermine validity. Since most guidelines are drafted by medical specialty organizations which have a financial interest in supporting their specialist members, single specialty organization guidelines may be prejudiced against nonmembers and recommend treatment which only its specialty members can provide. Economic bias also results when third-party payers develop a guideline to retrospectively deny payment and save money, but promulgate the guideline under the guise of increasing healthcare value.
Another form of bias in guideline development is patient selection bias. By excluding certain age categories, gender, or ethnic races, the clinical trials upon which the guideline is based may be prejudicially skewed. Publication bias also subtly prejudices research articles in medical journals. Published articles often overestimate positive effects and underestimate negative ones. Furthermore, authors of medical articles generally seek tenure, and therefore, such authors tend to interpret data to make the study more publishable rather than more accurate.
Technological bias may result, because guidelines developed by academic physicians in an urban setting may not apply to rural physicians in a community setting. Because rural providers are less involved in developing guidelines, they are necessarily forced to rely upon parameters developed by physicians and medical institutions in urban settings. Even though guidelines set forth national standards, ideally they should be used by physicians as one piece of available information to help resolve clinical patient care decisions. However, the general trend is increasingly toward a national standard of care, with regional variation becoming the exception.
As can be expected, conflicts may develop between guidelines from different organizations. Without a standardized approach to guideline development, uncertainty and ambiguity result. The IOM has called for a single body to harmonize conflicting guidelines from differing organizations. Optometrists complain about the practice guideline for cataract treatment developed by ophthalmologists, because it recommends that follow-up care for cataract surgery be performed only by the operating surgeon. Similarly, clinical psychologists object to the guideline for treatment of depression developed by psychiatrists which recommends drug-oriented therapies, because psychologists cannot prescribe anti-depressive medications.
Another highly publicized conflict exists between mammography screening guidelines promulgated by the American College of Radiology and the National Cancer Institute compared with those from the American Medical Association. This controversy involves the appropriateness of performing annual screening mammograms for breast cancer for asymptomatic women between the ages of 40 and 49. While it is unclear what a court would do when presented with relevant but conflicting guidelines, the quality characteristics and potential biases described above are issues to be argued in deciding the evidentiary value properly assigned to them.
Practice guidelines have enormous legal implications. There is potential liability for the physicians who deviate from them, as well as for developers and implementers of guidelines. In medical malpractice litigation, the standard of care espoused by guidelines is becoming generally accepted, as guidelines are increasingly available on national med-line computer services. With such online access, a clinician’s failure to check for and to be aware of applicable guidelines can become an issue when assessing whether the required standard of care was met.
The use of clinical practice guidelines to establish the standard of care varies. Some states, such as Maine, have enacted legislation permitting the use of practice parameters as an affirmative defense in malpractice suits and expressly prohibiting evidence of a deviation from the practice parameter to be used by the plaintiff at trial. Me. Rev. Stat. Ann. Title 24 2971-2979 (1993). Even in these states, however, a physician must still determine which guideline is appropriate to apply in order to obtain this statutory immunity.
Other states allow guidelines to affirmatively establish deviations by healthcare practitioners from the applicable standard of care. In Kramer v. Milner, 1994 W.L. 411568 (Ill. App. Ct. 1st Dist., Aug. 8, 1994), guidelines for annual screening mammography for breast disease were used by the plaintiff to establish a defendant physician’s breach from the applicable standard of care for a general practitioner treating a healthy elderly woman. The Illinois Appellate Court held that the guidelines for annual screening mammography did indeed establish a standard of care, which was breached by the physician in that case. The trial court incorrectly refused to instruct the jury that it could find the defendant was negligent based on his failure to follow these guidelines.
In Masucci v. Feder, 601 N.Y.S.2d 108, 196 A.D.2d 416 (1st Dept. 1993), a New York Appellate Court reversed a trial court’s dismissal of a dental malpractice claim, because the dentist appeared to have violated the American Heart Association’s guideline for prophylactic antibiotic pre-treatment of dental patients with heart murmurs and valve problems. The plaintiff died from bacterial endocarditis after the dentist failed to follow this guideline before performing a dental procedure. The trial court erred by dismissing the dental malpractice claim, because the guideline itself established a potential breach from the standard of care. These cases show that practice guidelines can be effectively used in litigation to establish deviations from accepted standards of care.
Practice guidelines are also extremely effective in settling cases and in obtaining favorable arbitration awards in medical malpractice claims. Recently, a Hawaiian plaintiff won a $1.5 million arbitration award based on the defendant physician’s failure to follow guidelines concerning clinical breast exams. The plaintiff’s attorney relied on breast cancer screening practice guidelines in obtaining this award, without which, he said, such a result would not have been possible. A recent survey by the Harvard School of Public Health also reported that 27 percent of personal injury attorneys had declined to accept cases or settled them out of court based upon a guideline’s recommendations.
While guidelines which are developed in accordance with the AHCPR model are useful in litigation, informal guidelines are not given weight by the courts. In Rice v. Markoff, No. A-2725-93T2F, (N.J. Super. Ct. App. Div. Oct. 17, 1994), where testimony established that, as a “guideline,” a patient’s bleeding time should be maintained between 1.5 to 2 times the normal to prevent clotting when being treated with Coumadin, the Appellate Division held that this was only a “guideline” to be followed by physicians and not a formal practice guideline which could establish the standard of care. This bleeding time “guideline” simply was not a guideline that conformed to any of the IOM requirements for practice guidelines. The word “guideline” is not a term of art, and whether or not a guideline can be used as evidence of a standard of care in litigation must be decided based upon the attorney’s objective analysis of its foundation.
Attorneys should not rely exclusively on their experts to uncover all the applicable guidelines in any given case. There are numerous agencies developing guidelines, and revision continually occurs. It behooves an attorney to review the AMA’s published guidelines, as well as other sources, to determine which ones are potentially applicable in a given case. The American Medical Association publishes a directory of practice parameters as well as a monthly practice parameter updating newsletter. Attorneys should then obtain copies of the potentially relevant guidelines and provide them to their experts for review.
Equally important, the attorney must be aware of the potentially relevant guidelines during pretrial preparation. Relevant guidelines are invaluable to properly prepare interrogatories and to depose a defendant physician in a medical malpractice case. If the physician is a member of a specialty organization, any guidelines by that organization should be reviewed. When taking the deposition, the attorney should first establish with that physician that the specialty organization establishes the standard of care expected of its members. At a separate point later in the deposition, the attorney should inquire into the factual information which supports a deviation from, or conformance with, the relevant guidelines.
The relevant practice parameter should be marked as an exhibit near the end of the deposition and kept as part of the deposition transcript. The attorney should specifically question the physician concerning the guideline’s recommendations — both concerning his awareness of and his compliance with them. Even if the defendant’s attorney objects to questions concerning the guideline, the guideline becomes part of the record. By doing this, the attorney makes certain that any experts subsequently reviewing this matter will be aware of its recommendations when rendering their opinions.
Guidelines Under Daubert
The increased use of practice guidelines is consistent with the recent Supreme Court decision concerning expert testimony in Daubert v. Merrill Dow Pharmaceuticals, 113 S.Ct. 2786 (1993). The Supreme Court set forth the basis on which scientific expert should be permitted in the courtroom. The Supreme Court characterized the required inquiry as “a flexible one and its focus must be solely on principles and methodology, not on the conclusion that they generate.” The Supreme Court held that the admissibility of scientific evidence requires a consideration of at least five factors: (1) whether the theory or technique in question can be and has been tested; (2) whether it has been subject to peer review and publication; (3) whether its known or potential error rate is high or low; (4) whether there are standards controlling its operations; and (5) whether it has attracted acceptance within a relevant scientific community.
Based on Daubert, a guideline’s compliance with the IOM quality criteria and the AHCPR statutory mandates is important in establishing a foundation for the use of the guideline at trial. Congress mandated that the AHCPR’s guidelines be based upon the “best available research and professional judgment.” AHCPR’s mandate to use the best available research and professional judgment in developing guidelines, its concerns for the legal implications of guidelines, and the use of meta-analysis to support recommendations through exhaustive literature review appear to produce guidelines which meet the Supreme Court’s standards in Daubert.
Accordingly, conformance with the IOM criteria has legal significance when a litigant uses a guideline in Court. The AHCPR’s guidelines may have greater evidentiary value than those from other organizations which do not hold themselves to as a high standard. Only by a thorough understanding of quality criteria and potential biases can an attorney effectively use or refute a guideline at trial.
Practice guidelines promise to increase the value of health care in the United States. However, in order to be medically and legally useful, guidelines should meet the stringent criteria developed by the Institute of Medicine. Unfortunately, not enough guidelines currently meet those standards. Attorneys must be able to analyze the foundations of guidelines in order to determine their medical relevance and legal evidentiary value in medical malpractice litigation. The development of instantaneous online communications between physicians and guideline databanks will increase the use of practice guidelines in today’s health care system, both in the treatment room and in the courtroom.
Practice guidelines are being used by courts in appropriate contexts to establish the standard of medical care. The effective use of practice guidelines in pretrial discovery has aided the pretrial assessment and resolution of malpractice cases. Careful analysis of all guidelines by healthcare and legal professionals is important to improve the standard of healthcare and to effectively use them in evaluating potential deviations from those guidelines.
The article is reprinted with permission from the February 6, 1995 issue of the New Jersey Law Journal. © 1995 NLP IP Company.