Sex, Science, and the Age of Anxiety

• Publication year: 2021

92 Nebraska L. Rev. 455. Sex, Science, and the Age of Anxiety

Sex, Science, and the Age of Anxiety

Linda C. Fentiman(fn*)

TABLE OF CONTENTS

I. Introduction .......................................... 456
A. A Road Map ...................................... 459
B. The Problem ...................................... 461

II. The Legal Framework for Vaccination ................. 471
A. The Public Health Perspective: Vaccination Is a Public Good ....................................... 471
1. Substantive Due Process Requirements ........ 471
2. Is There Room for Parents to Opt Out? ......... 474
B. Regulatory Oversight and Support ................. 480
1. Federal Law ................................... 480
a. Safety ..................................... 480
b. Vaccine Development and Financing ........ 484
2. State Oversight of Vaccination ................. 486
a. Mandating Immunization (and the Exemption Process)........................ 486
b. Funding or Mandating Vaccination Coverage .................................. 486
C. Tort Liability, Alternative Compensation Schemes, and Informed Consent ............................. 487
1. Tort Liability and the National Childhood Vaccine Injury Compensation Act .............. 487
2. Informed Consent ............................. 489

III. HPV Vaccination ...................................... 493
A. The Science of Infection with Sexually Transmitted Diseases .......................................... 493
B. Reasons to Mandate Vaccination Against HPV ..... 495

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1. Achieving Herd Immunity and Protecting Vulnerable Populations ........................ 495
C. Does Mandatory HPV Vaccination Pass Constitutional Muster? ............................ 498
1. Substantive Due Process ....................... 498
a. How to Respond to Parental Concern About HPV Vaccination ........................... 501
2. Equal Protection ............................... 502

IV. Conclusion ............................................ 503

"'When you hear somebody say, "This is not about money"-it's about money.' And when you hear somebody say, 'This is not about sex'-it's about sex."(fn1)

-Senator Dale Bumpers

"In America today, there is an unprecedented assault on the human right to exercise informed consent to medical risk-taking. It is being led by one of the most powerful and wealthy corporate empires in the world: the global pharmaceutical industry. . . . What is at stake for the American people is our health and our liberty."(fn2)

-Barbara Loe Fisher, anti-vaccination activist

I. INTRODUCTION

Imagine a vaccine that could protect against multiple types of cancer and prevent the death of thousands of Americans each year, as well as the enormous financial costs and psychological stresses of annual medical-screening exams and invasive biopsies.(fn3) One might suppose that such a vaccine would be hailed as a minor miracle and that both government and private citizens would embrace this medical advance and the opportunity it presents to enhance both individual and public health. Indeed, in Australia the government pays for all chil

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dren to be immunized against this disease.(fn4) But in the United States opposition to this vaccine, and particularly to the possibility of mandatory immunization, has led to intense controversy, preventing many children, soon to be adults, from obtaining protection against the risk of developing fatal cancer.(fn5) The vaccine at issue, if you have not already guessed it, is the vaccine against the human papillomavirus (HPV).

The contention that surrounds the HPV vaccine is the latest skirmish in the culture wars. The fight is over sex, science, and whether government or individuals should take the lead to preserve the nation's posterity.(fn6) HPV is the most common sexually transmitted disease in the United States, with about twenty million Americans being infected at any one time.(fn7) HPV not only causes many types of cancer but also genital warts, which are embarrassing and stressful to many.(fn8) The debate over mandatory HPV vaccination illuminates a significant political divide in American society at the same time that it

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triggers a reconsideration of the medical and legal justifications for mandatory actions to protect the public's health. A century after the Supreme Court, in Jacobson v. Massachusetts,(fn9) upheld compulsory smallpox vaccination as an essential form of collective action necessary to the physical preservation of the polity,(fn10) the social compact underlying much of the modern democratic state is beginning to fray. The fact that the HPV vaccination implicates sex, one of life's most pleasurable activities, makes the discussion of mandatory vaccination both more complex and more interesting. However, the core issue in the vaccination debate is whether the government has the right to insist, with limited opportunities for parents to opt out for religious reasons, that children be exposed to a tiny but real risk of injury and even death in order to protect those children, as well as other children and adults, from a much greater risk of harm.(fn11) This Article asserts that it does.

This issue was raised indirectly in the U.S. Supreme Court's 2011 decision in Bruesewitz v. Wyeth LLC.(fn12) In Bruesewitz, the Court held that the National Childhood Vaccine Injury Act of 1986(fn13) preempted all defective design tort suits against vaccine manufacturers, effectively precluding state common law suits.(fn14) The Court's decision left many parents who believed that their children had been injured by vaccination without a remedy.(fn15) Mandatory HPV vaccination became a hot topic in the 2012 presidential campaign, embroiling several Republican presidential candidates. Texas Governor Rick Perry was vilified, accused of sacrificing innocent young girls on the altar of political ambition by seeking to curry favor with the pharmaceutical giant Merck when he issued an executive order mandating that sixth-grade girls be vaccinated against HPV.(fn16) On the campaign trail, Representative Michele Bachmann asserted that mandating HPV vaccination was a dangerous policy, relying on a conversation she had with a woman whose daughter had "become mentally retarded" as a result of

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receiving the vaccine.(fn17) Bachmann's statement was condemned by the American Academy of Pediatrics(fn18) and others, who charged that her statement not only lacked scientific support, but that it could also discourage childhood vaccination and thus harm the public's health.(fn19)As the 2012 presidential campaign unfolded, accusations that the Republican Party was engaged in a "war on women" multiplied, which included denying women access to a broad array of reproductive health care services.

This Article examines the question of whether the HPV vaccine should be mandated (for girls and/or boys) in the context of declining rates of childhood immunization and the potential threat to public health that this decline poses.(fn20) The Article addresses two interconnected legal issues: first, whether mandating vaccines to prevent the spread of disease is constitutional under substantive due process and equal protection principles, and second, whether parents should be permitted to "opt out" of mandatory vaccination on their children's behalf, either for all vaccines or those which prevent particular diseases. The Article addresses these issues in the context of America's growing concern about the risks to children's health and considers how our society's scientific literacy (or lack thereof) affects the response to risk.

A. A Road Map

The next section (Part I.B.) briefly sketches current vaccine controversies, focusing on special concerns raised about the HPV vaccina

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tion. Part II examines current law and science governing vaccination, connecting constitutional, regulatory, and tort law doctrines. This Part first considers the legal and scientific justifications for government vaccination mandates. It then addresses the role of informed consent in vaccination, focusing on the recent upsurge in parental efforts to opt out of vaccination for their children and examining the consequences of state laws that broaden the criteria for religious or "philosophical" exemption. Next, the Article reviews current federal oversight of vaccine safety and considers whether it is sufficient to protect children and adults from vaccination-related harms. Here, the Article offers informed speculation about the impact of the Supreme Court's decision in Bruesewitz.(fn21)

In Part III, the Article addresses concerns about the HPV vaccination. First, it explores medical and epidemiological data to address the question of whether mandatory (as distinguished from recommended) vaccination is necessary to reduce the incidence of HPV-related death, sterility, and illness. Second, it addresses legal and constitutional concerns raised by HPV's transmissibility through sexual contact. Although the HPV vaccine was originally approved and recommended only for girls because of the strong connection between HPV infection and cervical cancer, the vaccine is now approved and recommended for boys as well.(fn22) The latter recommendation and approval reflects the vaccine's efficacy in reducing the transmission of HPV between males and females and also in reducing the rising male-to-male transmission rate, which together have led to an increase of...