Has The Time Come For A Veterinary Vaccine Injury Act ?

 

Commentary by Dennis W. Macy, DVM, MS

President-Elect and Diplomate ACVIM - Oncology

 

Adverse events following vaccination of companion animals are considered uncommon but are more likely with certain vaccines. In many areas of the country, the risk from anaphylaxis associated with leptospirosis vaccination has long been recognized. As a consequence, in those areas where leptospirosis is rare, the risk of an adverse event with leptospirosis vaccination is greater than the risk of the disease and thus many veterinarians in these nonendemic areas have chosen not to vaccinate against leptospirosis. Rabies vaccination is also associated with adverse events including the potential for autoimmune disease, anaphylaxis, granuloma formation, soreness at the injection site, and tumor development in cats. Because rabies is a fatal disease in both humans and animals, it is mandated by law that dogs and cats be vaccinated against rabies in many parts of the country. Despite the fact that adverse events associated with rabies vaccination may result in death or the development of a tumor at the injection site which may result in death or the development of a tumor at the injection site, which may result in more than $3,000 in treatment costs, owners really don't have a choice whether their pet receives the mandated rabies vaccines. In many parts of the country, pet owners must have their animals vaccinated for rabies or face a court appearance. Rabies laws usually apply to dogs and / or cats regardless of how low the risk of contracting rabies may be for an individual pet. Most veterinarians support routine rabies vaccination for dogs and cats for the protection of not only the pet, but also for public health reasons. It could, however, be argued that the risk of rabies in a cat living in a high-rise in Denver, Colorado is much less than the risk of developing a fatal sarcoma as a result of receiving the mandated three year rabies vaccine annually as required by law (Denver has not had a case of terrestrial rabies in over 20 years). Although the risk : benefit ratio this situation would tend to favor not vaccinating for rabies, neither the client nor the veterinarian has that choice. In order to comply with local law, the three year rabies vaccine must be given annually or the owner will face a possible court appearance. The risk of developing a vaccine site tumor has been estimated by the Vaccine Associated Feline Sarcoma Task Force to be between 1 / 1000 and 1 / 10,000 cats receiving rabies or feline leukemia virus vaccines and the risk of developing vaccine site tumors increases with the number of these vaccines administered,

Who is financially responsible if the owner complies with the law and the cat develops a fatal adverse event such as a vaccine-associated sarcoma ?

Currently, the clients whose cat develops vaccine-associated tumors must pay thousands of dollars for the treatment of this adverse vaccine even that was caused by a veterinarian administering a USDA-approved vaccine.

What recourse does the client who didn't want their cat vaccinated against rabies have against the veterinarian and the vaccine manufacture ?

Let's first look at the liability of the vaccine manufacture. Surely, based on state common law, the client should be able to hold the vaccine manufacturer responsible for providing a product that resulted in harm. This would be true if it were a human being who had an adverse reaction to DTP vaccine, but it's not the case for veterinary vaccines. Veterinary vaccine safety and approval are the responsibility of the USDA, which claims federal law preempts the state's common law. If the vaccine is produced in accordance with the USDA guidelines, recent court decisions hold the manufacturer harmless for reactions caused by vaccines ( Smith-Kiln Beecham vs. Linnbrook Farms, Circuit Court of Appeals, March 26, 1996). It is interesting to note that although the FDA controls the approval of licensure of human vaccines, the FDA claims no federal preemption, and a human vaccine manufacturer may be held liable for injury produced by their vaccines under state common law statutes.

What is the veterinarian's liability in such a situation ?

If the veterinarian provided the owner with information regarding the potential of adverse events associated with vaccination prior to vaccine administration and there is evidence of such in the medical record, the veterinarian would not be considered liable for the adverse events caused by the vaccine. If the veterinarian, however, merely administered the vaccine without providing information regarding potential adverse events prior to the vaccination, the veterinarian may be considered liable for damages associated with that product.

The courts have held that "the veterinarian or physician is a learned professional and must act as an intermediary between the drug company and the client or patient". The failure to carry out this professional responsibility may be interpreted as professional negligence. It is not the purpose of this commentary to argue the merits of the USDA's federal preemption. However, one cannot help feeling that the owners of these pets, who are damaged as a result of the administration of a mandated rabies vaccine have been wronged since they never had any choice but to vaccinate their pet regardless of the level of risk of contracting rabies. This situation raises the question whether there is a more compassionate way for veterinarians and the bioceutical industry to meet their professional responsibility to protect human and animal health against infectious diseases.

In 1984, there were five companies producing DTP vaccine at a cost of $0.11 / dose. By 1996, because of product litigation associated with severe reaction that occurred in 1 /1,750 doses of DTP (similar to the rate of tumor formation in cats receiving rabies vaccine), the number of manufacturers dropped from five to two and the cost per dose of DTP vaccines rose to $11.40 / dose. It was clear at that time that a preventative health care crisis existed in human medicine and was the basis of the 1986 Childhood Vaccine Injury Act currently in place today. This federal act recognizes that the benefits of immunizing the population against human infectious diseases outweigh the harm it produces in a very small number of children. The act also recognizes that the harm produced by vaccination can be significant, and it may even result in the death of the child. Because these vaccines are mandated by law (similar to rabies vaccines in pet animals) and the vast majority of the population as a whole are protected against serious illness as a result of DTP vaccination, society as a whole should share in the cost of the harm produced in a very small number of humans that experience serious adverse vaccine events or death following vaccinations. The human vaccine injury act requires that a small surtax be added to each dose of mandated vaccine. The tax revenue is placed in a congressional fund, and when a child dies or is seriously injured as a result of receiving a mandated vaccine such as DTP, the parents or guardians of the child may apply for compensation in U.S. claims court. The Vaccine Injury Act provides for up to $250,000 in compensation for the death of a child, and for millions of dollars in compensation if the child requires life-long support. The act has been operating since 1988, and as of September 1995, $522,000,000 had been paid out to claimants. As was mentioned earlier, the FDA, who regulates human vaccines, does not claim federal preemption, so manufacturers can be sued for vaccine adverse events as well. However, if a civil suit is filed against the physician or vaccine manufacturer, the plaintiff waives all rights to compensation under the Federal Childhood Vaccine Injury Act. Court records clearly indicate a marked decrease in legal action against vaccine manufacturers and physicians since the enactment of this legislation.

I propose that the veterinary profession sponsor a veterinary vaccine injury insurance program that encompasses injury to pet animals (dogs and cats) (over 100,000,000 in the United States) produced by mandated rabies vaccination. The goals of this act are : 1) to provide financial relief for clients whose pets have been injured by government-mandated vaccine while still encouraging vaccination against rabies for human and pet health safety; 2) to provide financial support for fund research to provide safer mandated vaccines and improve treatment of vaccine adverse events; and 3) to limit liability associated with vaccine injury and promote public confidence in veterinarians and the bioceutical industry as a responsible, caring, professional community. We have calculated that the surtax of $0.26 / dose would produce over $6.6 million dollars in revenue annually. Eighty percent of the collected tax would be dispersed to clients who have lost pets or have had pets treated for adverse events associated with rabies vaccination, 10% of the tax revenue would be used to administer the Veterinary Vaccine Injury Insurance Program, and and additional 10% of the $6.6 million would be made available to both the public and private sector to study adverse events associated with rabies vaccination administration. These research funds would be available on a competitive grant basis and administered and awarded by the combined AVMA / AAHA scientific review committee. Clients who had claims for death compensation or veterinary medical bills for the treatment of adverse events associated with rabies vaccination would apply to the Veterinary Vaccine Injury Insurance Program for reimbursements the same way claims are handled through the AVMA Insurance Trust. The amount of indemnity for loss of a pet would have to be established along with recognized adverse side effects, etc, by the combined Veterinary Vaccine Injury Commission made up of representatives from organized veterinary medicine, industry and the USDA. In order for a client to be eligible for such a compensation, the veterinarian's medical records must have adequately documented the administration of the rabies vaccine, the adverse reactions, and their treatment. Specifically, the medical records must indicate the rabies vaccine manufacturer, lot number, site of injection, and the veterinarian administering the rabies vaccine, in addition to the date and any other products administered to the patient. Good documentation of the adverse event must also be in the medical record, and evidence that the veterinarian informed the client of potential adverse events associated with vaccination would also be required. It would also be a requirement that any adverse reactions be reported by the veterinarian within 30 days to the Veterinary Vaccine Injury Insurance Program. As with the human vaccine injury act, any client filing a civil lawsuit against the manufacturer or veterinarian would waive all rights to compensation under the proposed Veterinary Vaccine Injury Insurance Program. I believe that this program would offer a remedy for wrongs that currently does not exist for clients whose pets are injured as a result of receiving a mandated rabies vaccine. It provides a win-win situation for the veterinarians, vaccine manufacturer and pet owner, and treats all rabies vaccine manufacturers equally. The quarter tax per dose is clearly affordable by veterinary clientele. The medical record documentation would not be an additional burden since most of the information required under the new program should already be in veterinary medical records. The program will, however, encourage better compliance with the vaccine documentation and the reporting of vaccine adverse adverse events. Currently, it has been estimated that less than 10% of serious adverse events following vaccination are reported to the manufacturer for the USDA. The under-reporting of vaccine adverse events delayed the recognition and underestimated the significance of vaccine-associated sarcomas in cats by individuals in the commercial and public sector. The inclusion of a research fund component in the legislation would ensure that we are not in the same position 10 years from now, in just paying damages, and that we have moved ahead and fostered the development of new knowledge of the pathogenesis of these vaccine-induced injuries, and perhaps the development of methods to avoid them in the future. The tax on individual doses would be adjusted every two years based on previous two years claims. The better the vaccines, the lower the tax. The proposed program would only include mandated rabies vaccines where the veterinarian and clients have no real choice but to vaccinate their pet. Although serious adverse vaccine events occur with feline leukemia and leptospirosis vaccines, owners and veterinarians have a clear choice either to vaccinate or not to vaccinate, and thus the choice to assume or not to assume the risk associated with those individual vaccines. It is not the attempt of the proposed program to shift the responsibility for a choice, but rather to take responsibility when given no choice.

Advantages

of the

Veterinary Vaccine Injury Insurance Program

Please note, we encourage your comments concerning Dr Macy's proposed "Veterinary Vaccine Injury Act" as we have been asked to, and will, forward all comments along to Dr Macy.

 

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