Legal developments from bioethics conference

Advance care directives among hot topics

At the most recent annual conference of the American Society of Bioethics and Humanities, advanced care directives, access to investigational drugs, and parental nonconsent to medical treatment were considered some of the top legal developments in bioethics in 2009.

A panel discussion on legal developments was conceived and organized by Thaddeus M. Pope, JD, PhD, of Widener University School of Law in Wilmington, DE. Lois Shepherd, JD, associate professor of public health sciences and professor of law at the University of Virginia in Charlottesville, discussed the trends in advance care planning.

While some states are putting their effort toward having citizens complete advance care directives, that is only one direction, which Shepherd believes is "continuing an older model." "There might be some value in that, but the newer recognition is that we need to have continual conversations, consultations, and these really shouldn't be done in lawyers' offices; they should be done with a doctor's help," Shepherd says.

The reason she selected this particular topic for one of the top legal developments in bioethics is the fact that advance care planning got pegged with the tagline of "death panels" in this year's health care reform debate.

At the conference, Shepherd discussed a bill set forth by the House of Representatives during the summer. Although it didn't continue through the legislative process, Shepherd thinks the idea of planning for one's death, and having such conversations reimbursed for physicians to incent them to conduct them, gained traction. The bill that was presented during the summer would have reimbursed for advance care planning conversations every five years, or when there was a change in condition, or admission to a facility, Shepherd says. "But it was misunderstood and politically exploited, and so that's out," she says. "But I think we will see that the idea is not over."

The idea is pertinent for those 65 and older, when planning really becomes imperative. "So, it becomes [a situation where] a physician can talk about, 'Look, here's the prognosis, and here's the kind of choices that are going to have to be made in the future. Where are you particularly?' Not an abstract diagnosis, but where is this patient?" Shepherd notes.

She calls the heated debate that occurred surrounding this bill, with the implication that doctors just wanted to hurry up and pull the plug on very ill patients, "so overblown and wrong."

Access to investigational drugs

Shepherd also discussed the relatively new development of patients or parents or surrogates suing pharmaceutical companies to gain access to investigational drugs.

There was a case two years ago in which a nonprofit filed a lawsuit against the Food and Drug Administration "saying that there was a constitutional right to save one's own life by getting access to Phase I drugs" for terminally ill patients, says Shepherd. However, the Third Circuit Court said there was no such constitutional right. This lawsuit was intended to gain access for an individual who is terminally ill and has no other available therapies, "except maybe a chance at a clinical trial, and for some reason they can't qualify for the clinical trial," says Shepherd.

A recent case centered on a University of Virginia student suffering from head and neck cancer, whose mother sued a pharmaceutical company. In the suit, she charged that a particular drug company had promised access to an investigational drug for her child. In this case, the trial judge had ordered this pharmaceutical company to give the boy an investigational or experimental drug. The appeals court subsequently reversed it, Shepherd says. "But it's interesting to me that even though that case did not end up winning, ultimately, with the right facts, you can make a compelling case to the manufacturer to supply drugs, if a promise has been made, for example," she says.

Parental nonconsent to medical treatment

Mary Anderlik Majumder, JD, PhD, an assistant professor of medicine with the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston, says the committee decided on this topic as one of the top developments "because there has been just another slew of cases that have made it into the national media." For example, there was the case of Daniel Hauser in Minnesota, a 13-year-old boy with Hodgkin's lymphoma, whose mother took him on the run rather than consent to continuing medical treatment, even though the treatment was working.

It was "pretty clear that the judge had authority to order treatment," she says, and the difficult decision that he had to make was to continue the boy in the custody of his parents after his mother took him on the run. Ultimately, the judge decided to leave him in the parents' care, and he received appropriate treatment for his illness.

The background to this topic is complex, however, Majumder notes, and it sometimes creates confusion. In 1974, the Department of Health and Human Services regulated that states that received federal money for child protection services came with the requirement that the states that received money had to have a religious exemption in their law. "So, you couldn't go after parents for neglect if they were not treating their child medically for religious reasons," she says.

Still, that regulation didn't prevent the court from ordering medical services if a child needed it, but you couldn't charge the parents with neglect, Majumder says. "So, not many states had religious exemptions related to their child neglect or their criminal laws," she says. "And most of the states [added] them, because that was one of the strings attached to getting federal money." In 1983, the federal government changed its policy, "but the states haven't necessarily removed those provisions."

Regarding the ethical considerations of parental nonconsent for their children to receive medical treatment, Majumder thinks the "American Academy of Pediatrics got it right when it said there shouldn't be religious exemptions to these laws. On the other hand, you should always try to negotiate with parents, and going to court should be a last resort. So, whether it's a religious reason or a cultural reason, if parents are refusing treatment, you should try to understand where they're coming from. You should be open to negotiation — you know, what's essential, what's not." You shouldn't immediately call child protective services, she says.

There also were two cases discussed that involved parental nonconsent for medical treatment, she says. One in Oregon involving a 15-month-old child with a blood infection. "The parents were charged with second-degree manslaughter and second-degree criminal mistreatment," Majumder says. "The wife was totally acquitted, and the father was found guilty of criminal mistreatment, which is a misdemeanor. Manslaughter is a felony, so it was a lesser charge." The father was sentenced to 60 days in jail and five years' probation.