A California appeals court ruled this week that human tissues and cells remain a person's property when taken for medical purposes and that the individual is entitled to share in the profits if they are used commercially.
The decision, in a case that has been closely followed by scientists across the country, is the first attempt by a court to address the complicated legal and ethical issues surrounding the increasingly common use of human tissue for commercial purposes.
"This is one of the most important cases of the decade," said Dr. Arthur Caplan, director of the Center for Biomedical Ethics at the University of Minnesota. "If people thought the Baby M case a landmark, this one is much more significant. This case will have an extremely major impact."
The case arises from a 1984 lawsuit filed by John Moore, a 43-year-old soda salesman from Seattle, against the University of California Board of Regents. The suit charged that researchers at the University of California at Los Angeles (UCLA) took cells from Moore's cancerous spleen and, without his knowledge, developed a series of potentially profitable biotechnology products from them.
The 2-1 appeals court decision on Thursday reversed an earlier ruling that dismissed the suit. Lawyers for the university said yesterday they will appeal the decision to the California Supreme Court.
"This decision emphasizes the rights of the patient to be fully informed of any commercial exploitation that is being conducted on their own property," said Jonathan Zackey, a lawyer representing Moore.
Regardless of whether there is an appeal, scientists said yesterday the decision will have a major impact on biomedical research because so much of it depends on human tissues and genetic material.
"It opens up a Pandora's Box, a terrible can of worms," said Robert D. Goldman, chairman of the cell biology department at Northwestern University and a council member of the American Society for Cell Biology. "It's going to cause incredible difficulties and escalate the price of research."
Scientists say that if the ruling is upheld by the U.S. Supreme Court, where an appeal eventually could go, they would be required to pay every patient from whom they obtain tissue subsequently used in research.
The nation's burgeoning biotechnology industry also could face lawsuits from donors seeking a share in the profits of products developed from their tissues or genetic material.
Most medical research involves the extensive use of discarded tissue or blood samples. The tissues or blood cells are used to create cell lines, colonies of disembodied cells that will grow in a laboratory
dish when fed appropriate nutrients. They are essential in many areas of biomedical research, because all diseases can be traced to some malfunction of individual cells.
By studying and manipulating these diseased cells, researchers can gain a detailed understanding of how their normal processes can go awry.
"In recent history, we have seen the human body assume astonishing aspects of value," the court said in its opinion. "Taking the facts of this case, for instance, we are told that John Moore's mere cells could become the foundation of a multibillion-dollar industry from which patent holders could reap fortunes," it said.
The case revolves around the fact that Moore's blood was discovered to have unique properties that helped stimulate protection against leukemia. Researchers hope they eventually will be able to use products derived from it as a cancer therapy.
Once Moore's physicians became aware of this, they patented a cell line developed from his blood, according to Moore's lawyers. Dr. David W. Golde, the UCLA cancer specialist who treated Moore, then sold rights to the patent to a Boston-based biotechnology firm in a deal that Moore's lawyers say was worth $3 million.
Scientists said yesterday it could be very difficult to determine the extent to which a commercially useful cell line is derived exclusively from a single patient.
Cell lines are typically grown in bottles and, although the first cells may have come from a patient, their descendents have often been modified by a series of scientific procedures.
"In some cases you don't take anything more than information from someone's cell," said George Rathman, president of Amgen Inc., a Los Angeles-based biotechnology company. "You are not using any part of that guy's body other than to analyze it and get data."
Others say that if an experiment relies at all on a patient's cells or tissues, then that person has a firm right to share in any profit that is derived from the research.
"Any individual has an absolute right to know what a researcher proposes to do with his or her bodily materials," said Caplan. "You should be told even if they are not of any value. People have a right to decide whether their bodily parts or tissue should be included in experiments."
Justice Ronald M. George, in a dissenting opinion, wrote that the patient's extracted blood and tissue should not be considered commercial or private property. He added that the patient believed the blood and tissue was worthless until the physicians exercised their education and expertise to create the useful cell line.
George compared Golde's research to a sculptor creating art from a pile of clay.