Vaccine Supply and Innovation (1985) / Chapter Skim
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6 Liability for the Production and Sale of Vaccines
6 Liability for the Production and Sale of Vaccines
Pages 85-122
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From page 85... ...
Thus, there are potentially 51 different sets of rules on this subject in the United States. No vaccine-related product liability litigation resulting in a publicly available opinion has occurred in .
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From page 86... ...
United States, in which the U.S. government was held liable because the Division of Biologics Standards of the National Institutes of Health released a batch of Sabin polio vaccine that did not conform to its own regulatory standards (the manufacturer settled)
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From page 87... ...
1968~. In that case, Sabin polio vaccine had been administered to the plaintiff, a 39-year-old male, in a mass immunization campaign conducted with the assistance of a sales representative of the defendant.
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From page 88... ...
1974~. That case involved a young girl to whom Sabin oral polio vaccine was administered at a county department of health clinic in Mission, Texas.
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From page 89... ...
The package insert warned of the risk, and Wyeth argued that it was all that was required to discharge its responsibility. The procedures, forms, and warnings actually used in the immunization program were the responsibility of the Texas Department of Health, to which it had quite properly shipped the vaccine.
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From page 90... ...
In fact, manufacturers discontinued making Salk vaccine and concentrated on the Sabin vaccine after the government selected Sabin vaccine for its mass immunization programs in the early 1960s. Indeed, from 1968 to 1975 no Salk vaccine was manufactured in the country, although small amounts were imported.
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From page 91... ...
Givens, like Reyes, involved Sabin oral polio vaccine. However, unlike Reyes, the vaccine had not been administered in a county health clinic, but by a pediatrician in his office.
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From page 92... ...
The defendant also argued that its warning to the doctor was adequate, and should protect it from liability. The warning stated: Paralytic disease following the ingestion of live polio virus vaccines has been reported in individuals receiving the vaccine, and in some instances, in persons who were in close contact with subjects who had been given live oral polio virus vaccine.
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From page 93... ...
The public health officials and government lawyers did not realize that Reyes and Givens in the district court represented an entirely new factor in the decision to produce and sell vaccines, particularly a vaccine proposed for administration to nearly the entire population in a short period. The manufacturers and their insurance carriers, on the other hand, no doubt resented the liability burdens placed upon them by Judge Wisdom, and were perhaps not unhappy about the opportunity to have their concerns addressed in a national forum.
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From page 94... ...
. the manufacturer or distributor of the swine flu;yaccine used in an inoculation under the swine flu program, the public: or private agency or organization that 'provided an inoculation under the swine flu program without charge for such vaccine 'or its administration and in compliance with the informed consent form and procedures requirements prescribed [in the statute!
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From page 95... ...
Because there has been so little litigation directly relevant to the liability issue for vaccine manufacture and administration, the numerous swine flu cases provide the best guide to date on the legal rights of injured recipients, the liability risks of manufacturers, and the likely results of court action. It is useful, therefore, to describe this experience at some length and to-evaluate the factors that make it relevant to the general question of what vaccine manufacturers need or need not fear.
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From page 96... ...
Secretary Califano stated that with respect to those alleging GBS, the government was adopting a new policy. Persons who contracted GBS from the swine flu vaccine, in order to receive federal compensation:
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From page 97... ...
Instead claimants in most cases need only to show that they in fact developed Guillain-Barre as a result of a Swine F1U vaccination and suffered the alleged damage as a result of that condition [Statement of Secretary Califano, June 20, 19781. Secretary Califano set out two reasons for adoption of this policy: First, the informed consent form .
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From page 98... ...
The six cases that fall outside the basic pattern of the swine flu claims resolution are instructive because one of the risks that concerns potential product liability defendants is the risk of the unexpected result, particularly when it may cost millions of dollars.
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From page 101... ...
SOURCE: Torts Branch, Civil Division, U.S. Department of Justice, October 19, 1984.
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From page 102... ...
The district court rejected the study on the following grounds: [T] he mere fact that the time interval in plaintiff's case was significantly longer is not dispositive.
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From page 103... ...
Dr. Eylar's testimony has not been well received in other district courts.
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From page 104... ...
at 4281. The court first found that the statistical studies did not disprove that the plaintiff's GBS had been caused by the vaccine because their basic method was to compare the incidence of GBS in the vaccinated population against a background rate, and n the actual background rate for GBS has not yet been established .
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From page 105... ...
Poser is more of an advocate, having been retained in many of the swine flu cases, but the Court found his testimony more persuasive than that of the less-~nowledgeable witnesses presented by the government. Consideration of the medical issues does not, of course, turn entirely on Dr.
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From page 106... ...
"By rejecting in all other cases the interpretation it has given the swine flu act in Guillain-Barre syndrome cases, the government places an unfair burden, in the court's opinion, upon plaintiffs such as Mrs. Gassman who have proven that the swine flu vaccine caused a related neurological disorder.
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From page 107... ...
"The fact that GBS alone was singled out by Secretary Califano does not justify differing treatment for other 'closely related' disorders proven to have been caused by the swine flu vaccine" [533 F
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From page 108... ...
The court then set out its own notion of what informed consent requires. "We believe that encompassed in the duty to inform a patient of all material information, substantial and significant risks, is the duty to inform not only of risks that might occur from the particular treatment in question, but also any alternative treatments and the risk of no treatment at all." The court emphasized the importance of the setting of the swine flu program.
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From page 109... ...
Judge Bright, writing for the court, reversed and remanded the case to the district court for findings under the standards of Iowa's informed consent law [679 F.2d 727-7291. On remand, the district court found that the information form failed to meet the standards of Iowa law.
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From page 110... ...
Therefore the united States is not liable under either the negligence or the strict liability theory propounded by the majority. Even assuming that serum sickness was a foreseeable risk attending swine flu vaccination, I think vaccinees received adequate warning.
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From page 111... ...
It is widely believed that juries increase the unpredictability of outcomes, and tend to be more sympathetic to plaintiffs. A third important distinguishing feature is that all claims under the tort claims act must be brought in the federal district courts.
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From page 112... ...
Fourth, the swine flu program was accompanied by much more intense publicity and news coverage than regular, ongoing vaccination programs. That news coverage may have made many more people aware of the possible connection between the vaccine and GBS, it may have made more recipients consider filing claims, and it may have made doctors more sensitive to the possibility of a GBS diagnosis in persons who received a vaccination.13 Fifth, there is a difference between the swine flu claims and the claims that would confront a manufacturer of pediatric vaccines in an analogous situation.
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From page 113... ...
The doctor testified that it was his practice not to warn patients of the type of risk, and that, although he was aware of a possible risk of GBS in the fall of 1976, he did not warn the patient and would not have warned the patient even if the package insert had been different. The district court granted a summary judgment to the defendant for failure of the plaintiff to prove a causal connection between the manufacturer's failure to warn and the plaintiff's injury.
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From page 114... ...
1976) , affirmed a judgment of $705,606 for immunization of a 4-month-old baby with DTP, oral polio vaccine, and typhoid vaccine leading to convulsions, grand mal seizures, and permanent mental retardation.
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From page 115... ...
Affirmation of the punitive damage verdict in Johnson could be interpreted as a determination by a powerful regulatory body (the common law court and lay jury) that Sabin vaccine should not be administered in the United States unless preceded by an administration of Salk vaccine to unimmunized contacts, and perhaps to the child as well.
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From page 116... ...
The Kansas court's judgment that Lederle's failure to suggest preimmunization with the Salk vaccine in its package insert meets the criteria for punitive damages is currently being appealed. In a previous case, however, the Kansas Supreme Court affirmed a punitive damage award by a jury that determined retrospectively that a package insert was insufficient [Wooderson v.
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From page 117... ...
C ONSEQUENCES OF THE STATE OF VACCINE INJURY LIABILITY LAW FOR VACCINE PRODUCTION AND INNOVATION Despite clear legal rules, the manner in which claims against manufacturers alleging liability for suspected vaccine-related injuries have been handled by the courts does not provide reliable guidelines for predicting the limits and magnitude of their liability. This combines with other organizational and scientific factors to create a situation in which vaccine supply may be threatened.15~16 Causation is difficult, if not impossible, to determine with certainty in specific cases, and there is usually no other recourse to compensation for injured individuals.
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From page 118... ...
on the number and size of vaccine injury claims and settlements over the past decade, and on the provisions made by manufacturers for dealing with such eventualities (e.g., insurance) e The committee received information from most major companies actively involved in vaccine production.
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From page 119... ...
Mais, Jr. "Tort Law and Mass Immunization Programs: Lessons from the Polio and Flu Episodes, n
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From page 120... ...
Although Secretary Califano attempted to deal vigorously with the issues created by the swine flu program and its problems, in the end he, too, was unsuccessful in achieving significant gains in the institutional and legal framework within which these questions arise. It remains to be seen whether some future epidemic threat will become a tragic reality because the lesson learned from swine flu will be thought to have been: Don't act too soon.
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From page 121... ...
That check, however, does not rule out the possibility that medical personnel were quicker to consider a possible GBS diagnosis in the vaccinated population after the widespread publicity about the possible connection. Langmair, Bregman, Kurland, Nathanson, and Victor, "An Epidemiological and Clinical Evaluation of Guillain-Barre Syndrome Reported in Association with the Administration of Swine Influenza Vaccines," 119 Am.
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From page 122... ...
14. Indeed, it is telling that when the General Accounting Office studied the processing of swine flu claims at the request of Rep.
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