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Public Warnings of the Risk in Oral Polio Vaccine WILLIAM J. CURRAN, JD, SMHyg, FAPHA The epidemiologists of the United States have been profoundly shocked by a legal decision of a prestigious Federal Court of Appeals requiring the manufacturers of oral polio vaccine to give directly to all patients a full and complete warning of the extremely slight inherent risk in taking such vaccines. The case was further appealed to the U.S. Supreme Court in an effort to have it reversed. More recently, the Supreme Court refused, within its discretionary powers, to review the case.' This leaves the decision of the Fifth Circuit Court of Appeals in effect. The fundamental issue in this matter is not a total resistance to warning patients of significant risks in therapeutic medications or in immunizations. The public health community, as well as practicing clinicians, have accepted the basic responsibility imposed on them by law and ethics to obtain the informed consent of patients to all forms of health treatment and procedures. The issue concerns the extent of the requirement of informed consent and the substantiality of the risks that must be disclosed, balanced against the harm which may result to patients in overalarming them and causing them to refuse needed treatment or immunization where the benefits to be received outweigh the inherent risks of the treatment or procedure. A brief review of the case itself, Reyes v. Wyeth Laboratories,2 is necessary to any understanding of its implications. In the spring of 1970, there was an outbreak of poliomyelitis cases in southern Texas. It was the major epidemic in the entire country at the time. Of the 33 cases reported in the U.S.A. for 1970, 22 occurred in Texas and 21 of these were located in the Hidalgo County area close to the Mexican border. The parents of the plaintiff, Anita Reyes, took the child, an infant of 8 months, to the Hidalgo County Health Clinic for polio immunization. She was given a dose of trivalent oral polio vaccine on May 8, 1970, by a public health nurse. The child was hospitalized 14 days later and was diagnosed as suffering from paralytic poliomyelitis. The virus was later determined to be Type 1, the same type which was wild in the community at the time. The drug company which had manufactured the vaccine was sued in a federal court in southern Texas and a

jury returned a verdict against the drug company in the amount of $200,000. At the trial, the only witness who testified that the child's polio was caused by the vaccine was a local general medical practitioner who treated the child after her hospitalization. The defense produced an extensive array of expert witnesses who testified or gave written depositions disputing the causation of the child's disease. The witnesses included federal officials from the Bureau of Biologics Standards and the Center for Disease Control, as well as professors from leading universities. One witness, a professor from the Johns Hopkins University, estimated the child's risk of contracting polio naturally in the community at that time as 1 in 3000. (Children from birth to age 2 or so were the group at greatest risk, since they had not been immunized as a result of earlier public programs.) On the other hand, it was undisputed that the inherent risk of contracting polio, Type 1, from the vaccine itself in one dose was then about 1 in 5.88 million. All the expert witnesses and the local health department personnel testified that it was not and would not be the practice of health officials or, private clinicians to provide warnings to patients of this extremely remote, almost unmeasurable inherent risk in the vaccine. The public health nurse who administered the vaccine testified that she read the package insert describing the risk, but did not give a warning of this risk to the child's parents. On the above facts, the jury found that the child's disease was caused by the vaccine, that a warning of the inherent risk should have been given, and that if it had been given the parents would not have had the child immunized. On appeal, the Circuit Court of Appeals affirmed the above verdict and decision. It was held that the manufacturer was liable to the injured child and that the only way it could avoid liability was to have warned the patients through package inserts or other information supplied to all patients or prospective patients of this admittedly "miniscule" risk of contracting the disease from the product. It was held that the method of distribution through a health clinic in what it called "an assembly line manner" removed the vaccine from the category of a prescription drug where warnings are given by the manufacturer only to physicians PUBLIC HEALTH AND THE LAW

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and other health professionals. The Court relied upon another polio case, Davis v. Wyeth Laboratories,3 decided in 1968, in arriving at this conclusion. The Davis case, however, had involved a mass immunization campaign conducted in 1963 and where the facts of risk and benefit ratio were quite different than in the Reyes case.4 The reasoning of the Reyes case could apply to any prescription drug distributed by a public health clinic, by an outpatient department in a hospital, by an HMO operation, and by most offices of busy private practitioners. The manufacturers would be required to warn, but also could be expected to champion the benefits of their products in direct advertising to the public. Over-the-counter distribution of many products could be expected to follow from such a system. At present, the drug industry is not advocating such practices and the Wyeth Laboratories fought vigorously against the legal implications of the

Reyes case, carrying its own appeal to the Supreme Court. Public health authorities may well need to reexamine their current practices in regard to "inforned consent" in order to meet the requirements of the Reyes case. Also, we may need to reexamine our basic systems of legal compensation for adverse results of all types of vaccines where the public interest in maintaining a safe community level of immunization is vitally involved.

References 1. Reyes v. Wyeth Laboratories, 43 Law Week 3356, December 24, 1974. 2. Reyes v. Wyeth Laboratories, 498 F. 2d 1264. 3. Davis v. Wyeth Laboratories, 399 F. 2d 121. 4. Curran, W. J. Mass Immunization Programs: A Special Legal Area? Am. J. Public Health 49:137-138, 1969.

NOMINATIONS INVITED FOR KIMBLE METHODOLOGY AWARD 1975 Members of the Laboratory Section of the American Public Health Association and all other individuals involved in public health laboratory work are invited to submit nominations for the 24th Kimble Methodology Award. Nominations must be submitted by June 15, 1975, to be considered for this year's award. The award recognizes significant contributions in the application of scientific knowledge to public health laboratory practice. Established in 1952 by Kimble Products of Toledo, Ohio, a Division of Owens-Illinois, Inc., the award is sponsored by the Conference of Public Health Laboratory Directors. The award, consisting of a $1000 honorarium and a plaque, will be presented at the annual meeting of the Conference, during APHA's 103rd Annual Meeting in November in Chicago. All expenses for travel to the meeting will be paid to the award recipient. To be considered for nomination, the candidate's work should be either a fundamental contribution which serves as a baseline for development of diagnostic methods which fall within the province of the public health laboratory or the adaptation of a fundamental contribution to make it of use in a diagnostic laboratory. The degree of professional acceptance of the methods will be considered in the award committee's choice of a winner. Nominees may be from the United States, its territories, or Canada. Authors themselves, their associates, or others may make nominations. A letter of transmittal must accompany each nomination, but documentary evidence should be signed by the nominator. Multiple-author investigations are eligible for entry in the competition. For nominations to be considered, they must be accompanied by five copies each of a summary (or curriculum vitae) with a bibliography of the publications pertinent to the nomination; a statement justifying the recommendation; and reprints of the publication(s) on which the nomination is based. Materials submitted with nominations will not be returned. Nominations received after the June 15 deadline will not be considered for the 1975 award competition. All nominations should be sent to Max D. Moody, PhD, Technical Director, Wellcome Reagents Division, Burroughs Wellcome Company, 3030 Cornwallis Road, Research Triangle Park, NC 27709.

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AJPH MAY, 1975, Vol. 65, No. 5

Public warnings of the risk in oral polio vaccine.

PUBLIC HEALTH U F - Public Warnings of the Risk in Oral Polio Vaccine WILLIAM J. CURRAN, JD, SMHyg, FAPHA The epidemiologists of the United States...
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