Vaccines are one of the "ten great public health achievements" in the twentieth century according to the Centers for Disease Control and Prevention. Yet as a growing number of states allow exemptions from mandatory vaccination laws for religious, philosophical, and personal reasons, nonvaccination rates are on the rise. At the community level, increased exemptions lead to reduced herd immunity and increased vaccine-preventable outbreaks.
This Note addresses the community issues by applying a concept from tort, products liability, and food safety law: the duty to warn. Ultimately, this Note suggests imposing a duty to warn the public (and particularly vulnerable individuals who rely on herd immunity because they cannot be vaccinated for medical reasons) about vaccination levels in schools and day-care facilities. With such a warning, vulnerable individuals can avoid exposure to low-vaccination areas and reduce their risk of contracting injurious, preventable diseases. This duty to warn balances the interests of parents seeking exemptions and vulnerable individuals seeking to avoid harm.
The data required for such a warning--aggregate immunization rates--already exist because many states require schools and day-care facilities to report such data to public health officials. Moreover, publicly disseminating vaccination levels in the aggregate would avoid privacy issues. The warning should be required by statute, creating a standardized system that is easily understood and simplifies facility comparison. Covered entities would be required to publicly post their current vaccination levels as green, yellow, or red, thus building on the public's familiarity with the stoplight paradigm: green is good, yellow means caution, and red signals stop or avoid. The statutory limits for each color would be based on herd immunity thresholds and the Healthy People 2020 goals. Effectiveness could be increased by adding emotional indicators: a smiling face with green and a frowning face with red. If successful, the warning could be expanded to other entities such as pediatrician offices.
CONTENTS INTRODUCTION I. VACCINE POLICY BACKGROUND A. A Brief History of Mandatory Vaccination Laws, Their Constitutionality, and the Inclusion of Nonmedical Exemptions B. Current Policies and Trends C. Effect of Exemptions on Individuals and Communities D. Negative Externalities and Strategies to Address Them II. LEGAL BASIS FOR THE PROPOSED DUTY TO WARN A. Negligent Failure to Warn B. Product Defect Liability and Allergen Warnings C. Mandated Warnings: The Food Allergen Labeling and Consumer Protection Act of 2004 D. Application in Infectious Disease Cases III. PROPOSED DUTY TO WARN AND REGULATION A. Scope and Statutory Considerations B. Potential Benefits C. Potential Limitations CONCLUSION APPENDIX INTRODUCTION
"We got into Wellington!" Already eager to relocate your family to beautiful San Diego, your excitement grows exponentially knowing your children will attend such a prestigious private school. But then, by chance, you learn that over half of the school's kindergarteners are unvaccinated. You feel overcome with relief realizing what a fortunate discovery this is: Sam, one of your children, is unvaccinated due to severe allergies and, as a result, relies on the protective herd immunity created when others are vaccinated. (1) Being exposed to other unvaccinated children significantly increases Sam's risk of contracting a disease (2) that could leave him paralyzed, brain damaged, deaf, or even dead. (3) Using the map of San Diego school vaccination rates you fortuitously found, (4) you select another school that better balances Sam's needs for quality education and a safe--that is, vaccinated--learning environment.
But what if this database didn't exist? The San Diego map represents a unique resource provided by a local nonprofit watchdog group; similar information is not readily available in other areas. Parents have some options: if they are savvy, they can find reports for their state, and sometimes region, through their local public health authority (5) or the Centers for Disease Control and Prevention (CDC); (6) or parents can call public and school officials to inquire about community and school-level vaccination data if they are available. But what about less savvy parents, or parents who don't know about herd immunity? And what about other entities such as day-care facilities, where children can foreseeably be exposed to unvaccinated and even infected children? What if avoiding areas with high exemption rates was more like avoiding allergens in food products, where allergic individuals know and trust that warnings like "Contains peanuts" will be posted where food should be avoided?
This Note proposes a statutorily imposed duty to warn in the context of vaccine exemptions, allowing medically exempted children and their parents to avoid exposure to areas with high vaccine exemptions and thus reducing the risk of contracting an injury inducing, vaccine-preventable disease. The warning would be imposed on schools and day-care facilities, and could be expanded to other entities, such as pediatrician offices, if successful. The warning would be statutorily imposed, creating a standardized system that would be easily understood by the public and allow for comparison across facilities. The warning would build on people's familiarity with the stoplight paradigm: green is good, yellow indicates caution, and red signals stop or avoid. The statutory limits for each color could be based on herd immunity thresholds for common diseases and the Healthy People 2020 goals. (7)
Each entity would then be required to publicly post its vaccination coverage level using green, yellow, or red. Effectiveness could be increased further by combining colors with emotional indicators, such as a simple happy face graphic with green and a sad face with red. (8) Consumers would then be able to avoid red and yellow areas and reduce their risk exposure.
Part I begins by discussing current vaccine policy, vaccination trends, negative externalities that result from religious- and philosophical-based vaccine exemptions, and previously recommended strategies for addressing those negative externalities. Part II then presents and analyzes the legal basis for a duty to warn in the vaccine exemption context, looking at general negligence law, products liability law and allergen warning requirements, the Food Allergen Labeling and Consumer Protection Act of 2004, and previous case law addressing duties to warn where contagious diseases are involved. Finally, as alluded to above, Part III details the proposed warning, including its scope, regulatory considerations, potential benefits, and potential limitations.
VACCINE POLICY BACKGROUND
The CDC lists vaccination as one of the "ten great public health achievements" in the twentieth century. (9) Because of vaccines, smallpox has been eradicated and morbidity for other infectious diseases--including diphtheria, polio, measles, mumps, rubella, and haemophilus influenzae type B (Hib)--has been reduced by 99-100% since 1900. (10) State-based mandatory vaccination laws gave effect to the powerful tool found in vaccines and "played a substantial role in [generating the significant] disease reductions." (11) But increased nonmedical exemptions to vaccination laws threaten herd immunity and create negative externalities for communities and individuals who are unable to be vaccinated.
A Brief History of Mandatory Vaccination Laws, Their Constitutionality, and the Inclusion of Nonmedical Exemptions
Cities and states began passing mandatory vaccination laws in the early nineteenth century in response to several smallpox outbreaks. (12) In 1809, Massachusetts passed the first vaccination law requiring its citizens to be vaccinated against smallpox. (13) Less than twenty years later, in 1827, Boston passed the first school vaccination law requiring proof of smallpox vaccination for children entering the public school system. (14) Other states followed suit, and by 1905, many Americans found themselves under a legal obligation to be vaccinated. (15)
With this legal obligation, however, came strong and--to this day--unwavering resistance based on several grounds, including: doubted efficacy, safety concerns, religious or philosophical beliefs, and liberty interests that call for minimal government interference with individuals' personal choices. (16) Those opposed to mandatory vaccinations refused to comply with vaccine requirements and took action to repeal and challenge the existing laws. (17)
When the issue came to the Supreme Court in 1905, the Court unequivocally held that states can require vaccination under the police power, which authorizes states to pass "reasonable regulations ... [to] protect the public health and the public safety." (18) Seventeen years later, the Court affirmed that cities and states can exclude unvaccinated children from public schools "for the protection of the public health." (19)
In an unfortunate turn for vaccine challengers, the Court in Jacobson stressed a state's authority to pass vaccination laws even where individual liberties may be at stake, stating: "[T]he liberty secured by the Constitution of the United States ... does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint." (20) Moreover, various jurisdictions have consistently held that the Americans are not constitutionally entitled to nonmedical exemption from mandatory vaccination laws. (21) Despite this lack of obligation, the majority of states permit individuals to obtain vaccine law exemptions based on religious or philosophical beliefs. (22)
While states passed the first vaccination laws in response to smallpox, measles drove the enactment of modern vaccination laws. As Walter A. Orenstein and Alan R. Hinman stated, "It was control of a real...