Physician Liability for Failure to Obtain Informed Consent for HIV Drug Therapy
Academy member Dr. Brian Boyle has graciously offered to aid the Academy membership by writing a series of articles addressing several areas of law and HIV. Dr. Boyle is both a practicing HIV physician and an attorney, and initiated this project to offer current legal information that we hope Academy members will find enlightening and helpful.
The article that follows is the second of a series of four planned articles that will be published both in The Nexus and at our Website (www.aahivm.org). The other suggested topics are legal issues with difficult patients, and employment issues in HIV practices. These topics could change if current issues suggest more timely topics, and your feedback on the series is welcome (send e-mail to firstname.lastname@example.org).
Jerry Calumn, AAHIVM Executive Director and Nexus Executive Editor
American common law has long recognized that all patients have a right to determine what will or will not be done to their bodies. Accordingly, before any medical therapy, a patient is entitled to be provided with information that he or she can use in deciding whether or not to consent to that particular course of therapy. The legal name for this concept is the doctrine of informed consent.
The doctrine of informed consent necessarily encompasses two separate concepts: (1) that there must be consent to any medical treatment, and (2) that the consent provided by the patient must be an informed one. Consent is usually considered invalid if it is obtained from a patient who did not receive all of the relevant and applicable information that would have allowed him or her to make an informed decision. Physicians who treat patients and who do not obtain informed consent from the them may subject themselves to liability. The purpose of this article is to discuss informed consent in the particular context of HIV drug therapy.
Informed Consent and HIV Therapy
Physicians treating HIV patients with drug therapy face heightened exposure for liability based on failure to obtain informed consent. Although the occurrence of side effects and toxicities is a known risk with any type of drug therapy, overall, the incidence of side effects and toxicities is somewhat greater with HIV medications compared with others. Although the drugs used to treat HIV infection usually confer considerable benefit and extend life expectancy, they also have significant potential for side effects and toxicities, which at times can be fatal. Adequately informing patients of the potential risks and benefits of antiretroviral therapy presents unique and special challenges for HIV practitioners.
Of course, as a starting point, the mere occurrence of side effects or toxicities does not by itself create liability for the practitioner. Under certain circumstances, however, patients may be able to pursue a liability case against a practitioner when (1) they have suffered an injury as a result of a medication side effect or toxicity and (2) that medication side effect or toxicity was not brought to their attention by the practitioner such that they could provide informed consent to the therapy. Although standards vary from state to state, generally speaking, in most states, the practitioner must advise a patient of the risks and benefits of, and available alternatives to, a proposed plan of drug therapy. In assessing whether the practitioner should be held liable for failure to obtain an informed consent, the courts generally consider three basic issues: (1) whether the particulars of the situation imposed a duty to disclose upon the practitioner; (2) which particular risks, benefits, and alternatives should have been disclosed; and (3) assuming that the practitioner did breach his or her duty to disclose based on these two criteria, whether that breach was the proximate cause of the injuries sustained by the patient.
Tests for Liability
The particular tests for determining liability vary to some degree from state to state. The two primary models used are the "prudent patient" and the "prudent physician" models. The former focuses on the information that a reasonable patient would require, and the latter focuses on the standard of practice of physicians in a particular community. Both models objectively determine proximate cause-that is, a jury must determine not whether the particular patient involved in the lawsuit would have consented to the procedure, but rather, whether an objective, "reasonable patient" would have done so.1 However, a minority of courts have used a subjective test for proximate cause (i.e., whether the particular patient in question would have consented).2
As discussed above, medical practitioners clearly have a duty to disclose to their patients the known risks of a drug before prescribing it; in fact, it should be assumed that the mere fact of writing a prescription imposes such an affirmative duty. The thornier issue is to determine exactly which risks, benefits, and alternatives must be disclosed. The law requires that all material information be disclosed. Materiality, to a large degree, requires the application of common sense to the situation. As a general rule, prudent practitioners should ask themselves what information they would like to have in order to decide whether to begin a particular course of drug therapy. Although extremely rare side effects or toxicities have been held by the courts to be immaterial by their nature, the likelihood of the occurrence of a side effect or toxicity as well as its potential severity is a critical factor that bears heavily on the determination of materiality.3
Practitioners may take several precautions to limit their exposure to liability for failure to obtain informed consent:
Provide complete information. Err on the side of providing too much information rather than too little.
Keep a written record of information given. Make a record of the specific risks, benefits, and alternatives of which they advised the patient. At trial, it is much more persuasive to a judge or jury to produce a medical record made at the time the advice was given to the patient, rather than to rely on the practitioner's recollection of what was said during an office visit, which may have lasted only a few moments and may have taken place several years before the trial. If, as is strongly recommended, notations concerning the advice given are made in the patient's chart, they should be detailed. Avoid conclusory notations such as "patient advised of risks of medication." The better practice, as well as the better protection, is to record details of the particular risks, benefits, and alternatives disclosed.
Provide printed materials. Practitioners should also consider providing patients with copies of materials the practitioners have drafted themselves or have culled from medical journals concerning the known risks of a particular course of drug therapy. A copy of a drug's package insert can also be provided, although its technical language may require explanation. A patient to whom such material was provided will face a difficult time proving that he or she was not adequately advised before embarking on a course of treatment. It may also be advisable to develop a standard list of risks, benefits, and alternatives provided to patients for those HIV-related drugs or therapies that are frequently prescribed.
Develop standard informing procedures. The development of habits and routines will greatly aid practitioner in recalling whether the proper information was given to obtain informed consent. Practitioners may then testify as to their habits and routines, even though they may not recall all the details of an individual office visit, and may confidently and truthfully testify that they must have advised the patient in a particular manner because it is their standard practice to do so.
Provide information on alternative therapies. Because so many of the more commonly prescribed HIV drugs have serious side effects, it is incumbent on the practitioner to provide adequate guidance about less risky alternatives. Failure to consider and discuss more conservative courses of treatment invites a finding of malpractice, as the following case demonstrates.
In Hutchinson v. United States (91 F2d 560 [9th Cir. 1998]), a physician had prescribed the steroid prednisone for a patient with an asthmatic condition. It is well known that the use of prednisone involves a risk of the development of aseptic necrosis, which in this case did in fact develop. The theory of liability advanced against the prescribing doctor was that he failed to advise the patient that other drugs with far fewer risks of side effects were available for the treatment of the condition. Although the trial court ruled in favor of the physician and found that the reasonable patient would have consented to the use of prednisone, whether or not he was advised of the availability of more conservative drugs, the appellate court reversed that ruling. The appellate court found persuasive the evidence that the patient previously had obtained good results from more conservative drugs. Had the physician advised the patient more fully of the potential side effects of prednisone and offered the patient the opportunity to continue with the more conservative course of treatment, the doctor might well have avoided liability in this case.
This legal principle will almost certainly be applied to the prescription of HIV medications. Much like the medical principle of "First, do no harm," this legal principle directs that if treatment outcomes are relatively equivalent, health care providers should prescribe the medications or regimen least likely to cause toxicity, especially in the case of medications whose toxicities may be severe or life-threatening. All HIV medications have some side effects or toxicities; however, patients and practitioners alike recognize that some carry higher risk than others. Some cases have already been filed regarding the use of HIV medications that have caused severe, life-threatening rash or hepatotoxicity, and others are certain to follow.
Obtain a thorough patient history. The unique side effects associated with some HIV medications also require that a physician obtain an extremely thorough medical history regarding the patient's prior experiences with particular HIV medications. Without that knowledge, the practitioner may be unable to effectively advise the patient of particular risks. For example, certain antiretrovirals such as abacavir have the potential for a catastrophic reaction upon rechallenge. Practitioners will be unable to communicate effective advice regarding this risk if they are unaware that the patient had prior therapy with that particular medication. In other words, the risks are different for drugs whose effects depend on the patient's past history with them. Obtaining the needed history can be difficult at times because patient memories often lapse, and some medications may come in combinations of which the patient may not be aware. Given this, it is incumbent upon the practitioner to obtain information the patient may not have. These efforts should include, at a bare minimum, asking the patient detailed questions regarding past medical therapy, showing the patient all of the involved pills in order to refresh his or her memory, reviewing medical records, and obtaining information from all physicians who previously cared for the patient.
The principles outlined in this article are general legal principles that provide some guidance regarding medical liability and appropriate steps that may be taken by health care providers to decrease their risk of malpractice litigation. Of course, the law is slightly different in every state, and for details of a particular state's law one should consult a local lawyer. The abiding principle for both improving patient care and avoiding liability should be disclosure of all relevant information so that the patient can make an informed decision regarding treatment options.
For further information about this topic or for questions regarding the contents of this article, please send correspondence to TJBradleylaw@aol.com.
This article was provided by American Academy of HIV Medicine. It is a part of the publication The Nexus.