Medical advances: Can justice keep up?

As science speeds forward, the courts are left to sort out the implications of many of the advances it creates.

By Tanya Albert, AMNews staff. Nov. 25, 2002. Additional information

Is a child born through in vitro fertilization two years after his father has died eligible for Social Security benefits? And now that physicians can determine a person's susceptibility to certain diseases through genetic testing, how should they counsel patients and their relatives? And what happens to frozen embryos couples create if they decide to divorce?

Medical advances tend to create technical and/or moral questions that patients, physicians and politicians on the front lines are left to ponder. And while legislatures can try to manage these social questions by passing laws, it's often the court system -- through interpretation of those laws -- that puzzles out the answers.

Some new tools, such as telemedicine and online prescribing, bring about technical issues that must be addressed. But other advances, particularly those in the area of reproduction, have allowed physicians to offer treatments that have left some sticky issues in their wake.

It could be said that the law generally lags behind science when it comes to answering these types of questions. But in reality, that's the nature of law.

"The law is not the proactive arm of the government," said Terry Gaffney, a Washington, D.C.-based lawyer who specializes in pharmaceuticals and medical devices with the law firm Womble Carlyle. "When there are problems, that is when people come to the law."

The Massachusetts Supreme Court tackled the in vitro issue, saying that a child born through in vitro fertilization after a parent dies is eligible for Social Security. That, perhaps, was one of the easier questions to answer. Others can get a bit stickier.

While several states have tackled the frozen embryo battle that ensues when couples divorce, the implications surrounding that question are ones that the courts will wrestle with for years to come. And since DNA testing is soon expected to become more readily available, it likely won't be long before courts are struggling with that issue as well.

"It takes time to play out," said Paul S. Appelbaum, MD, American Psychiatric Assn. president and director of the law and psychiatry program at the University of Massachusetts Medical School in Worcester, Mass. "And the law treats other professions the same way."

The law has successfully grappled over the decades with issues created by the invention of scientific advances, and legal experts say there is no question that it can handle the questions that medical advances throw its way.

Embracing technology

The beauty of the common law is that it allows itself to embrace new technology, Gaffney said.

"That's why, by definition, the law needs to catch up," he said. "It may happen after the [scientific advances], but it generally works well."

Technology has significantly changed the practice of medicine in the past 100 years, forcing courts to establish guidelines for when someone can be taken off a ventilator, what constitutes informed consent in a research project and whether an electronic signature on a prescription is acceptable.

It's been nearly 30 years since the New Jersey Supreme Court ruled that Karen Ann Quinlan could be taken off a ventilator, a scientific invention never dreamed possible in the 1800s.

And more recently, the courts have tackled the issue of medical research on human beings.

"In the past decade, it has been a hot issue," Dr. Appelbaum said. "There was little legal guidance to answer questions of what is the criteria to consent to research: Can someone else consent for the person? If so, who? Are there limits to human research?"

After the fax machine was invented, questions arose as to whether physicians could fax patients' prescriptions to pharmacies. The laws shifted, accepting electronic signatures as an official record, said Dallas lawyer Jane Taber, who chairs the health law practice group at the firm Gardere Wynne Sewell.

"The next questions will deal with the Internet," she said.

For example, patients are able to buy prescription drugs directly from a pharmacy over the Internet without a prescription from a physician. The drugs are shipped from countries without laws as strict as U.S. laws.

"What will the law do now?" asked Dallas lawyer Raymund King, MD, who is part of the health care litigation section at Cowles & Thompson. "No one ever dreamed a patient could get a drug without a prescription."

And no one ever dreamed about some of the questions telemedicine is raising. The technology is a wonderful way for patients in remote areas to access physicians in big cities and sometimes in other states. But if something goes wrong in the treatment, questions are likely to arise about which state laws apply in a lawsuit.

"Who would have ever thought a doctor practicing in California could be sued in Alaska?" Dr. King asked.

But Internet and telemedicine questions will be some of the easier questions courts confront. A host of other medical advances will raise questions that will force the judicial system -- and society itself -- to struggle with moral and ethical questions.

Ethical questions on the horizon

The court system is expected to help clear up controversies surrounding frozen embryos, stem cells, DNA and organ transplantation, legal experts say.

"Genetics will be a hot issue," Dr. Appelbaum said. "As we have the ability to scan DNA quickly and cheaply for mutations, we have the potential to identify areas where people have higher risks."

But what happens to the newfound knowledge is unclear at this point, experts said.

If tests show a woman is predisposed to breast cancer, should her insurance company be allowed access to such information?

And what should a physician tell the woman about the results, asked Frederick A. Provorney, director of the Science and Technology Law Center at Albany Law School, Albany, N.Y.

"It doesn't mean she will develop it," he said. "What type of counseling does she get? Depending on that, you can see lawsuits down the road."

One of the potential legal questions Provorney sees: "Was the counseling adequate enough?"

Organ transplantation could be another of the hot-button issues as the debate over the best way to procure and allocate organs for donation heats up. Should relatives of someone who dies while waiting for an organ decide to take on the current allocation system through a lawsuit, it is possible the courts will be forced to delve into the issue, Gaffney said.

And although courts have been ruling on frozen embryos for a couple of decades, it's an area that's expected to pick up more steam. There have been about a half-dozen cases decided, and opinions have varied greatly. A Kansas court has said an embryo is property. A Louisiana court has said it is a crime to destroy one.

With hundreds of thousands of embryos being stored in IVF clinics nationwide and stem cell research now possible, Atlanta lawyer John Mayoue said physicians can expect to see more courts confronted with cases on embryos.

"It's going to come back to a debate that is reminiscent of the abortion debate," Mayoue said. "Is it property, is it a thing or is it something in between? Medicine has gone far beyond what the law has considered."

Mayoue said he thought the courts were going to need guidance from ethicists, theologians and scientists as they consider the issue.

"The disputes have not ripened in the court system," he said, "but I think it is going to flood courts in the coming years."

ADDITIONAL INFORMATION:

Run, justice run: When law takes the lead

In most cases, medical advances drive court cases, but on some occasions a court decision can be the impetus for further research.

In the early 1990s, women with silicone gel breast implants filed a lawsuit claiming that the implants wreaked havoc on their immune systems. There wasn't scientific evidence to substantiate the claims, but based largely on circumstantial evidence, they were awarded millions.

Three or four years later, the scientific studies were completed. They disproved the theory that the implants were behind the problems.

"Courts have to deal with the issues before them," said Minneapolis trial lawyer Joseph M. Price, a partner with Faegre and Benson, who specializes in cases involving pharmaceuticals and medical devices. "Like in golf, you play it where it lies."

Hormone replacement therapy could end up in a similar boat.

A plethora of lawsuits were filed after a study released in July concluded that the benefits didn't outweigh the risks of HRT. But there are still a lot of unanswered questions about the treatments.

The lawsuits will continue to move forward, even as scientists continue to study the therapy.

"If there are only a few studies out there, some early lawsuits could be tried with the wrong result," Price said.

Similar questions also surround vaccines and autism, Price said. There are thousands of lawsuits saying there is a link between the two.

"There are all those cases out there and no science to support the hypothesis," Price said. "It may take several years to know whether this is valid. In the meantime, the cases go forward. The case is tried no matter what the science will ultimately be."

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