During the past several years, numerous studies have been conducted regarding advance directives (that is, living wills and durable powers of attorney (DPAs) for health care). Studies have examined how many individuals have executed advance directives, who is more likely to execute such directives, and whether factors such as education, income, race, religiosity, or family status affect the likelihood of having executed an advance directive or one's willingness to do so. Studies have also investigated the effectiveness of different educational strategies aimed at increasing the number of individuals who execute these documents. Finally, a number of researchers have looked at the implementation of advance directives (that is, whether they are followed in the institutional setting).

Although we now have a better understanding of some of these issues, one area that has been virtually ignored is the reliability, validity, and overall user friendliness of the advance directive forms themselves, and, in particular, of the statutory advance directive forms.

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention (CDC) in 1995, and 81 percent of these women were of childbearing age (13 to 44 years). It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind.

Researchers, scientists, and physicians in Uganda have become increasingly aware of the need to develop a systematic approach to reviewing bio-medical research conducted in their country. Much of this awareness and their concern stems from Uganda's high seroprevalence of human immunodeficiency virus (HIV) and the consequent large influx of research monies and HIV researchers from developed countries, including the United States and Great Britain.

We report on the proceedings of a five-day symposium on bioethical principles governing clinical trials, which convened in Jinja, Uganda in September 1994. The thirteen male and female workshop participants included representatives from the Uganda Ministry of Health, Makerere University, the Uganda AIDS Commission, Uganda's National Council of Science and Technology, and the National Chemotherapeutic Laboratory. These representatives included ethicists, physicians, researchers, and pharmacists, all of whom have conducted research themselves. Initial workshop sessions focused on the history of human experimentation and the development of protections for human participants in medical research, both in the United States and internationally.

In theory, a competent patient may refuse any and all treatments, even those that sustain life. The problem with this theory, confidently and frequently asserted, is that the circumstances of real patients may so confound us with their complexity as to shake our confident assumptions to their core.

For instance, it is not the case that one may always and easily know which patients are competent. Indeed, evaluation of decision-making capacity is notoriously difficult. Not only may reasonable and experienced evaluators, say a judge and a psychiatrist, disagree, but also a person's capacity may change from hour to hour and may extend to some decisions yet not to others. And yet it is on this subtle art of capacity evaluation that life and death decisions often turn, especially when patients decline life-sustaining treatment.

An evaluation of capacity may consider the impact of serious medical or psychiatric illness, as well as the patient's life circumstances.

The United States Court of Appeals for the Seventh Circuit held, in Murrey v. United States (73 F.3d 1448 (7th Cir. 1996)), that claims for a physician's failure to obtain a patient's informed consent are not barred by the Federal Tort Claims Act (FTCA) as a species of misrepresentation. The court further held that the claim was not barred by the failure to include the issue of informed consent in the administrative claim. This decision reduces the burden on plaintiffs to state every cognizable claim consistent with the facts in an administrative proceeding; the failure to do so would prevent them from raising the claim in court.

The patient, Thomas Murrey, a sixty-eight-year-old U.S. veteran, sought treatment at a Veteran's Administration (VA) hospital in North Chicago, Illinois. VA doctors diagnosed him with prostate cancer, and advised him to undergo surgery to remove his entire prostate.

In Campbell Soup Co. v. Allstate Insurance Co. (913 F. Supp. 451 (W.D. Mich. Jan. 9, 1996)), the United States District Court for the Western District of Michigan, Southern Division, held that a health plan's coordination of benefits (COB) clause, covered under the Employee Retirement Income Security Act (ERISA), does not preempt a similar no-fault automobile insurance clause in the absence of irreconcilable conflict. The court found that ERISA's policy of shielding plans from unanticipated claims could only be furthered when the plan had expressly disavowed such claims. Because the ERISA plan in this case did not specifically subordinate itself to the no-fault policy, the district court found that the no-fault COB clause controlled. However, to escape this ruling, ERISA plans need only redraft their COB clauses specifically to disclaim liability in case of conflict with provisions of no-fault insurance policies. This caveat substantially limits the scope of the court's ruling.

In St. Francis Regional Medical Center v. Blue Cross & Blue Shield of Kansas (49 F.3d 1460 (1995)), the United States Court of Appeals for the Tenth Circuit upheld Blue Cross/Blue Shield of Kansas's anti-assignment requirement, on the grounds that the Employee Retirement Income Security Act (ERISA) preempted a hospital's claim against Blue Cross. The court also held that public policy supported anti-assignment requirements in health plans not covered under ERISA.

When drafting ERISA, Congress did not explicitly address assignability of health care benefits. According to the court of appeals, congressional silence constituted an intent to allow the parties to negotiate freely the assignment of health care benefits. Examining non-ERISA health plans, the court adopted a balancing test to determine the validity of anti-assignment clauses; it found that anti-assignment requirements promote freedom of contract and may include medical costs.

In Martin v. Ortho Pharmacetrtical Corp. (No. 78520,1996 Ill. LEXIS 5 (Jan. 18, 1996)), the Supreme Court of Illinois held that, although a federal regulation requires pharmaceutical manufacturers to provide direct warnings to consumers about the dangers associated with oral contraceptives, this regulation does not constitute an exception to the learned intermediary doctrine and the manufacture will not be held strictly liable. The court declined to recognize an exception for manufacturers of contraceptives due to important policy considerations and the legislative intent underlying the learned intermediary doctrine. The doctrine is based on the assumption that prescribing physicians, not pharmaceutical manufacturers, are in the best position to provide direct warnings to patients concerning the dangers associated with prescription drugs. The decision may affect patients whose medical care providers are unable to account for drug propensities or patient susceptibilities. Additionally, patients with forgetful or inarticulate health care providers are at risk.

The Indiana Court of Appeals, in JKB, Sr. v. Armour Pharmaceutical Co. (No. 49A029506CV341, 1996 WL 22708 (Ind. Ct. App. Jan. 24, 1996)), held that the state's Blood Shield Act does not protect pharmaceutical companies that produce blood-derived products from product liability suits based on injuries attributable to tainted blood supplies. Blood shield statutes help to guarantee adequate blood supplies by limiting the liability of blood banks. This holding limits the defenses available to pharmaceutical companies sued under product liability theory.

The defendant, Armour Pharmaceutical, produces and sells clotting factor agents, which are derived through plasmapheresis. Plasmapheresis is a costly and complex donation process through which the plasma and red blood cells of a donor's blood are separated. After separation, the process returns the red blood cells to the donor but retains the plasma.

In Planned Parenthood Affiliates of Michigan v. Engler (73 F.3d 634 (6th Cir. 1996)), the United States Court of Appeals for the Second Circuit held that § 400.109(a) of the Social Welfare Act of Michigan (Mich. Comp. Laws Ann. § 400.109(a) (1994)) impermissibly conflicts with the Medicaid Act (Social Security Act tit. XIX, 42 U.S.C. §§ 1396 et seq. (1988)) as modified by the 1994 Hyde Amendment (Pub. L. No. 103-112, § 509, 107 Stat. 1082-1113 (1994)), insofar as the § 400.109(a) only provides state funding for abortions necessary to save the life of a mother, and not for abortions resulting from rape or incest. The court held that the Hyde Amendment defines medically necessary abortions that must be funded by states participating in the federal Medicaid program, and that the amendment is not merely a federal appropriations bill.

The Court of Appeals of Minnesota, in State v. Saunders (No. C9-95-907, 1996 Mnn. App. LEXIS 60 (Jan. 16, 1996)), held that the statutory offense of practicing medicine without a license was not unconstitutionally vague as applied to a claim involving a farmer who offered a home remedy to cure cancer. The court held that, although Minnesota Statute § 147.081 subd. 3(3) (1994) contains general language and undefined terms, the statute contains sufficient particularity to show ordinary persons what conduct is prohibited, and thereby passes the void-for-vagueness test. The court stated that, according to the statute, while a person holding a license to practice medicine is permitted to engage in a broad range of conduct, those without that license are proscribed from engaging in that same range of conduct.

The defendant, Mr. Saunders, a dairy farmer, claimed that he could cure ill people by injecting an ill person's blood into a cow and then feeding that person the cow's colostrum.