Guidelines Now Set Liability Standards
By Armand Leone, Jr.
Use of health-care practice guidelines issued by federal government agencies and physician specialty organizations are on the rise.1
Everyday, practice guidelines are issued in all areas of health care in an effort to formalize current medical practice standards. With each new guideline, the practice of medicine becomes less of an art and more of a set of algorithms — algorithms that increasingly are being used to determine liability in medical malpractice suits.
Attorneys engaged in the prosecution and defense of medical malpractice claims need to use existing practice guidelines when representing their clients. As the number of guidelines increases, this task becomes more formidable.
Currently, there are more than 20,000 health-care standards, clinical practice guidelines, laws and regulations published by more than 500 medical organizations and state and federal agencies. (See Health Care Standards Directory 1993 (ECRI, Plymouth, Pa. meeting.) For the general practitioner who occasionally works on a medical malpractice claim, these standards and guidelines can be overwhelming.
In 1989, the federal government established the Agency for Health Care Policy and Research and has directed this agency to convene non-governmental expert panels to develop clinically relevant practice standards and assessments (collectively referred to in this article as “guidelines”) for health-care procedures. 42 U.S.C.S. Sections 242b, 242m and 242o (1978 and Supp. 1992).
This agency, through its Office of Health Technology Assessment, has published more than 118 health-care guidelines. Besides highly esoteric subjects, the agency has issued guidelines on more commonplace issues such as: cardiac catheterization in a free-standing setting, debridement of mycotic toenails, diagnosis and treatment of impotence, hydrotherapy (whirlpool) baths for treatment of decubitus ulcers, melodic intonation therapy and patient selection criteria for percutaneous transluminal coronary angioplasty.
While the agency does not technically endorse its published guidelines, the agency publishes them under the auspices of the U.S. Department of Health and Human Services (HHS), whose logo is included on the document. Ultimately, physicians, patients and courts will view these guidelines as endorsed by the U.S. government.
Medical specialty groups, such as the American College of Cardiology, the American College of Surgeons and the American College of Radiology, have published practice guidelines for member physicians. Recommendations of specialty accreditation organizations carry great weight within each medical specialty and ultimately affect the standard of care rendered by their members.
These organizations issue a variety of guidelines ranging from standards to committee opinions and consensus reports. The weight accorded to each guideline varies, with standards being the most persuasive evidence of the applicable care.
Translating Standards to Treatment
For example, the American College of Radiology (ACR), in conjunction with the American Cancer Society and the American College of Surgeons, recently has promulgated standards for breast cancer treatment, which afflicts one out of every nine women.2 These standards recommend conservative lumpectomy with radiation therapy and represent a significant change from current practice under which most women with breast cancer are treated with mastectomy.
The result of these new ACR standards is that, with few exceptions, most women with modest or small-size breast tumors would be good candidates for breast conservation. The past-president of the American Cancer Society, Robert V.P. Hutter, believes that these standards represent a formalization of current practice among the medical specialties involved in breast cancer. This formalization of current practice ultimately will determine the standard of care for treatment of women with breast cancer.
The ACR also has published standards for other radiological procedures, such as for the performance of screening mammography, magnetic resonance imaging and antepartum obstetrical ultrasound.
In an attempt to disclaim the impact of its standards, the ACR provides the following notice to its member radiologists:
The standards of the American College of Radiology (ACR) are not rules but attempt to define principles of practice that should generally produce high quality radiological care. The radiologist may exceed an existing standard as determined by the individual patient and available resources. The standards should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtain the same results. The ultimate judgment regarding the propriety of any specific procedure or course of conduct must be made by the radiologist in light of all circumstances presented by the individual situation. Adherence to ACR standards will not assure successful outcome in every situation. It is prudent to document the rationale for any deviation from these suggested standards in the radiologist’s policies and procedures manual or, if not addressed there, in the patient’s medical record.
Despite attempts to limit the applications of published standards, however, the ACR and other medical specialty groups are creating a nationalized standard of care through the publication of practice guidelines.
Practice guidelines already have been used by third-party payors as a measure of the appropriateness of care for reimbursement purposes. In 1984, the American College of Cardiology (ACC) adopted parameters for the implantation of pacemakers in cardiac patients. HHS’s Health Care Financing Administration established a policy that Medicare only would reimburse physicians for pacemaker implants that satisfied the ACC guidelines.
By 1988, this HCFA policy resulted in a decrease in the frequency of pacemaker implantation from 202 implants per 1,000 Medicare patients to 176 implants per 1,000. Guidelines for hospital admission tests issued by the American College of Physicians are now used by various state Blue Cross and Blue Shield plans to determine the tests it will pay for and those it will not.
Just as compliance with medical guidelines is used to determine the appropriateness of care for reimbursement purposes, compliance with medical guidelines is being used to establish the presence or absence of medical malpractice liability at trial. By establishing practice guidelines, the traditional “community standard of care” is being eroded and is being replaced by a national standard. As one can readily imagine, plaintiffs try to argue that a failure to follow a guidelines is per se negligence, while defendants argue that adherence to them is an absolute defense against liability.
There are few reported cases that even discuss health-care guidelines in determining the applicable standard of care.3 Plaintiff attorneys who are knowledgeable about the relevant guidelines generally are able to settle a case based on the physician’s non-compliance. In situations where the applicable guidelines have been followed, plaintiff attorneys can avoid the expense of beginning an action with little chance of recovery.
Defense attorneys generally are more familiar with health-care guidelines, because they are made aware of these standards by their client physicians. Often, the plaintiff’s attorney is unaware of relevant practice guidelines that can make or break the case.
The Third U.S. Circuit Court of Appeals is one of the few courts that has addressed the application of health-care guidelines in determining liability for medical negligence. In Titchnell v. U.S., 681 F.2d 165 (3d Cir. 1982), an elderly plaintiff suffered a stroke after receiving swine flue vaccine under the National Swine Flu Immunization Program of 1976. 42 U.S.C. Sections 247(j)-(1) (1976). At issue was whether the immunization center was negligent for failing to take a medical history before administering the vaccine to the plaintiff.
The Allegheny (Pa.) County Health Department guidelines applicable to the swine flu immunization program were received into evidence by the trial judge, and the government appealed a finding in favor of the plaintiff. Those guidelines required the clinic to:
Ascertain that the vaccinee (or his guardian) understands the Information/Registration Form by asking the following questions:
a) Do you understand the form which you have read and signed?
b) Do you have a chronic heart, lung, liver or kidney disease or diabetes?
c) Are you less than 18 years of age? Do you have any other medical questions? Are you allergic to eggs? Do you have fever? Have you received measles vaccination within the past 14 days or a vaccination containing diphtheria, pertussis or tetanus antigen within the last 24 hours. Titchnell, 681 F.2d at 171, n.5.
The only question asked of the plaintiff before receiving the vaccination was whether he was allergic to eggs.
There was no direct expert testimony or other direct evidence at trial that standard medical practice required a medical history to be taken. The guidelines and testimony of clinic personnel, however, established that oral questions that should have been asked were not asked.
The clinic nurse, the district health officer, and an expert on causation were the experts on which the court relied. All of them based their opinions regarding the clinic’s deviation from the acceptable standard of care on the defendant’s failure to follow the guidelines.
The Third Circuit held that on this evidence a fact finder could (and did) find negligence caused by a deviation from standard accepted medical practice. The failure to ask these additional questions was a failure to use the proper precautionary measures.
The Third Circuit’s rationale for using the guidelines as evidence of the applicable standard of care in Titchnell is sound. It is both proper and desirable that health-care facilities promulgate guidelines and define responsibilities for their own personnel. Such guidelines serve to orient and instruct personnel as to their responsibilities and, further, help assure consistency and quality in the health care rendered. It may be reasonably expected that such procedures will, at a minimum, conform to the recognized standard of care at the time the guidelines are promulgated.
No Standard Established
Guidelines, of course, do not in and of themselves establish the accepted standard of care. They may have been more or less stringent than required by accept standard medical practice. They do, nevertheless, provide relevant evidence as to what the standard practice was.
Just like the Allegheny County guidelines provided relevant evidence of the standard of practice within all the clinics of that county, the medical specialty guidelines provide evidence of the standard of practice expected of all physicians certified in a given medical specialty. Where a given guideline is not promulgated by a recognized medical specialty organization (such as a private insurer’s risk management guideline for performance of an office procedure), that guideline is not relevant evidence on the issue of the applicable standard of care, because it does not reflect a generally recognized standard of care within the profession. Quigley v. Jobe, 1992 Colo. App. LEXIS 420 at 3 (Nov. 19, 1992).
The use of health-care guidelines to assess negligence also has been discussed in the context of nursing malpractice. Louisell & Williams, Medical Malpractice, § 16A.06 (Matthew Bender 1983). Armed with the proper standards, guidelines and directives, a plaintiff’s attorney can articulate a specific standard of care the “reasonable prudent nurse” must follow and can clearly demonstrate how a nurse in a specific situation failed to meet that standard. Guarriello, “Nursing Malpractice Litigation: Toward Better Patient Care,” 18(10) Trial, 78-79 (1982); see also Ramsey v. Physicians’ Memorial Hospital, Inc., 373 A.2d 26 (Md. Ct. Spec. App. 1977) (failure of nurse to follow emergency-room procedure).
Using a health-care guideline is directly analogous to the well-established New Jersey principle that the violation of a statute or ordinance is evidence of negligence.4 The same analysis applies: Where the provisions of a statute or ordinance are germane to the type of hazard involved in the defendant’s asserted duty, a violation permits an inference of negligence.
Where the provisions of a health-care guideline are germane to the type of hazard involved in the defendant’s asserted duty, a failure to follow that guideline also should permit an inference of negligence.
The standardization of medical specialties began as an effort to assure that the same high quality of care would occur regardless of the location of the physician’s practice. Guidelines were issued by various governmental agencies and medical specialty organizations. It was inevitable that these very same guidelines would be used by third-party payors and courts as evidence of the appropriateness of the care given patients.
The complexity and variety of medical practice guidelines today requires physicians and lawyers to continually monitor the current health-care guidelines relevant to their practices. Except for the most simple medical malpractice case, lawyers should be familiar with the health-care guidelines in order to properly represent their clients. Familiarity with the relevant guidelines allows more effective pretrial discovery and maximizes the attorney’s chances of a successful settlement or outcome at trial.
1. “Practice Parameters’ Impact Growing,” Radiology Today, December 1992, at 15.
2. Kathleen M. Moore, “Agencies Adopt New Standards for Breast-Conservation Treatment,” Radiology Today, December 1992, at 15.
3. Bradford v. McGee, 534 So.2d 1076 (Ala. 1988) (export opinion based on recommendations of the American College of Obstetrics and Gynecology); James v. Woolley, 523 So.2d 110 (Ala. 1988) (expert quoted a technical bulletin of the American College of Obstetrics and Gynecology); Pollard v. Goldsmith, 572 P.2d 1201 (Ariz. 1977) (expert accepted guidelines of Committee on Trauma of the American College of Surgeons regarding prophylaxis against tetanus and wound management).
4. Braitman v. Overlook Terrace Corp., 68 N.J. 368, 385-86 (1975); Shatz v. TEC Technical Adhesives, 174 N.J. Super. 135, 144 (App. Div. 1980) (violation of a statute); Rodgers v. Reid Oldsmobile, Inc., 58 N.J. Super, 375, 385 (App. Div. 1955) (violation of an ordinance).
A. Leone, Medical Practice Guidelines Are Useful Tool in Litigation, Medical Malpractice – Law & Strategy, Vol X, No. 6, (April 1993).