In a ruling widely awaited in the burgeoning field of biotechnology, the state Supreme Court held Monday that patients must be told if their discarded bodily tissue has commercial potential--but that they have no broad legal right to share in resulting profits.
The decision came as a victory for the University of California, medical researchers and industry groups who had warned that granting unprecedented commercial rights to patients could stifle important scientific research and development.
Nonetheless, the court, seeking to balance important competing interests, also cleared the way for a former leukemia patient to continue his lawsuit on the grounds he had not been properly informed that a cell sample taken from tissue removed from his body during an operation could be used commercially.
In their ruling, the justices, citing a patient's rights to "privacy and autonomy," held unanimously that a physician must disclose any personal interest--such as impending research on a potentially lucrative product--that might affect his or her professional judgment.
But by a vote of 5 to 2, the court declined to extend to patients a broad property interest in discarded tissues. Such a ruling would cause widespread confusion and conflict over the legal title to such material and would "threaten to destroy" the economic incentive for important medical research, the court said.
Thousands of human cell lines--cultures of cells capable of continuous and indefinite growth in vitro--already exist in tissue repositories and researchers make tens of thousands of requests for their use, the justices noted.
"If the use of cells in research is (legally threatened), then with every cell sample, a researcher purchases a ticket in a litigation lottery," Justice Edward A. Panelli wrote for the court.
Justice Stanley Mosk, who dissented along with Justice Allen E. Broussard, said it was both "inequitable and immoral" to deny the patient in the case a chance to share in the profits from the cell line developed from his tissue.
The ruling came in a case that has drawn broad attention in medical and industry circles. Biotechnology products already have been developed for the treatment of such diseases as diabetes, hepatitis and hemophilia, and researchers are seeking ways to treat AIDS, arthritis, cancer and a host of other maladies, according to the Industrial Biotechnology Assn. The case arose from a lawsuit by John Moore, a 44-year-old Seattle businessman who underwent removal of his spleen during treatment of leukemia at the UCLA Medical Center in 1976.
A UCLA physician, Dr. David W. Golde, and a researcher, Shirley G. Quan, determined after the operation that Moore's cells were scientifically unique and potentially valuable. Through the process of genetic engineering, they developed a cell line that could produce commercially viable pharmaceuticals.
As permitted by law, the university, doctor and researcher patented the process and signed contracts to develop the products with two firms, the Sandoz Pharmaceutical Corp. and the Genetics Institute Inc. An anti-cancer drug that was produced from the research now is undergoing clinical testing. Golde received 75,000 shares of stock in Genetics and the physician and university received $440,000 in research grants from Genetics and Sandoz.
After learning of these efforts, Moore brought suit in 1984 against the university, the physician and researcher and the two companies, charging he had not been properly informed of the commercial potential of the excised tissue. He sought a share of what was believed to be as much as $3 billion in market potential from the product.
In 1986, a Los Angeles Superior Court judge dismissed the case. But in a landmark decision, a state Court of Appeal reinstated the suit, ruling 2 to 1 that patients like Moore retained a personal-property right to excised bodily tissue. The university and others involved could be sued for the "wrongful conversion" of such property if they used it for medical research and development without Moore's consent, the appeal court held.
Attorneys for the university and other defendants in the suit appealed to the state Supreme Court. They argued that medical patients retained no property interest in abandoned tissue that in itself was valueless. Recognizing such a right would lead to uncertainty and conflicting legal claims, impede the exchange of research material and development of products that could benefit wide segments of society, the defendants contended.
Allen B. Wagner, attorney for the university, welcomed Monday's ruling as an encouraging rejection of the idea that patients retain a right to profits from abandoned tissue. A ruling to the contrary, he said, "could have sounded the death knell to the university physician-scientist."
Moore's attorney, Sanford M. Gage of Los Angeles, said that while he was disappointed that the court declined to declare a property-right to the tissue, the ruling still could allow Moore to win significant damages if he can prove he was not properly informed of plans for the use of the tissue.
"To my knowledge this is the first time in the country a court has held that a doctor must disclose his non-medical motives behind patient care and his own pecuniary interest," Gage said. Moore "feels he's been vindicated and is feeling very good," the attorney said.
Cynthia E. Fruchtman, a Los Angeles attorney and expert in genetic engineering, said that in recent years medical institutions have provided more details to patients about the potential use of discarded tissue for research.
"This decision will probably force researchers to talk more to patients--which is not a bad idea--and improve the general public's understanding of medical research and what it's all about," Fruchtman said.