Measles, Mumps, Rubella . . . Swine Flu?

Ian Group, Government Law Review member

It is relatively rare that in adulthood we are faced with vaccinations as most are administered during childhood, for federal law requires United States residents to be vaccinated for diseases such as measles, rubella and polio.[1]  Similarly, New York State requires residents be vaccinated for measles, mumps, and rubella.[2]  But whereas shots as we know them are like a right of passage for children, the widely publicized 2009-H1N1 epidemic presented health care workers in New York State with an interesting dilemma: a regulation requiring them to get an immunization shot for the virus. 

In his response to the epidemic, the Commissioner of the New York State Department of Health, Dr. Richard F. Daines, M.D., announced a regulation from the New York State Hospital Review and Planning Council requiring all health care workers[3] in New York State be vaccinated with both the seasonal flu and 2009-H1N1 flu vaccination by November 30th of this year.[4]

The H1N1 virus and its vaccine are not entirely new: a recent outbreak of the virus was in 1976 in Fort Dix, New Jersey[5] and early approval for an H1N1 vaccine was in 1980.[6]  A variety of H1N1 strains have been documented as far back as 1918.[7]  This past April, the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency[8] because the 2009 strain of the H1N1 virus “affects, or has significant potential to affect, national security.”[9]  This declaration allowed the Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA)—which allows “use of an unapproved medical product or an unapproved use of an approved medical product” after declaration of an emergency which justifies emergency use—to allow for use of various forms of the 2009-H1N1 vaccination.[10]  While H1N1 is not new to virology, the 2009-H1N1 vaccinations treat a new strain and thus required that the FDA issue an EUA to immediately respond to the state of emergency.  

Thirteen days before HHS declared a public health emergency, Dr. Daines announced the regulation requiring all health care workers in New York State get vaccinated with both the seasonal flu and 2009-H1N1 vaccinations.[11]  Dr. Daines cited the following as his rationale for compulsory vaccination:

Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates.  On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50% rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.[12]

 Were Dr. Daines’ reasons a legitimate exercise of the State’s police power that has, in the past, allowed for compulsory vaccinations?  Required vaccinations are a part of our lives because we hold a common belief in their necessity and prevention of harmful viruses.  Contrary to this belief is the notion that people have freedoms inherent to the Constitution that allow us to say “no” when the government tells us to put something in our body.  While the regulation Dr. Daines speaks of requires both a seasonal flu vaccine and the 2009-H1N1 vaccination, this discussion specifically focuses on the 2009-H1N1 vaccination.[13]

Three significant decisions, from the United States Supreme Court, the New York Court of Appeals and the New York State Supreme Court, touch on the theme of compulsory vaccination and whether they can be implemented by a state.  However, I believe they ultimately fall short of setting the precedent requiring the 2009-H1N1 vaccine.

In Henning Jacobson v. Commonwealth of Massachusetts, the United States Supreme Court upheld the constitutionality of a Massachusetts law requiring state residents be immunized with a smallpox vaccination by means of the state’s police powers to protect the public health and safety of its citizens.[14]  In Jacobson, the petitioner argued that the Massachusetts law, which would subject him to a criminal sentence upon refusal to become vaccinated, was unreasonable and violated “the inherent right of every freeman to care for his own body and health in such way as . . . seems best.”[15]  The Court disagreed, holding that the inalienable rights of the Fourteenth Amendment “are subject to such reasonable conditions as may be deemed by the governing authority of the country essential to the safety, health, peace, good order, and morals of the community.”[16]

While the New York State Board of Health’s call for all professional health care workers to vaccinate themselves as a means to put patient interest above their “own sensibilities”[17] was seemingly a valid exercise of the state’s police power to protect the public health and safety of its citizens, it did not quite run parallel to the facts in Jacobson.  The Jacobson decision seems to past muster under the Supreme Court’s analysis because it comports with the majority of the Fourteenth Amendment’s rights of personal liberty (i.e. our right to put what we want in our bodies) and is absent any question as to the equal protection of the law (because it is applied universally to all Massachusetts residents).[18]  The Court asserts:

 It is said, however, that the statute, as interpreted by the state court, although making an exception in favor of children certified by a registered physician to be unfit subjects for vaccination, makes no exception in case of adults in like condition.  But this cannot be deemed a denial of the equal protection of the laws to adults; for the statute is applicable equally to all in like condition, and there are obvious reasons why regulations may be appropriate for adults, which could not be safely applied to persons of tender years. 

 If this emergency is so vast—vast enough to declare a public emergency followed by an emergency use authorization of the 2009-H1N1 vaccines—how would solely vaccinating health care workers “protect the public collectively against such danger[19]” of the 2009-H1N1 virus?  Dr. Daines cited the need for fully immunized staff in hospitals to be able to deal with such an epidemic[20] but if this epidemic is in such a state of emergency, will immunization of our health care workers even matter?  Does this purported duty to patients outweigh even health care workers’ priority for the vaccination?

In Viemester v. White, the New York Court of Appeals looked at the issue of a compulsory vaccination for smallpox.  The court followed the Jacobson decision, in part, holding:

While we do not decide, and cannot decide, that vaccination is a preventative of smallpox, we take judicial notice of the fact that this is the common belief of the people of the state, and with this fact as a foundation, we hold the statute in question is a health law, enacted in a reasonable and proper exercise of the police power.[21]

What exactly is the common belief under Viemester? The court says, “[t]he common belief . . . is that [the smallpox vaccination] has a decided tendency to prevent the spread of this fearful disease and to render it less dangerous to those who contract it.”[22] 

Dr. Daines stated that a vaccination of health care staff will result in hospitals with better staffing to handle the 2009-H1N1 epidemic.  Is the common belief in New York State that the 2009-H1N1 vaccination has a “tendency to prevent the spread” of the virus and “render it less dangerous to those who contract it?”[23]  The vaccination itself wasn’t approved through the standard FDA process but was allowed to forego this process by means of the EUA.  Dr. Daines stated, “[b]efore its approval the new H1N1 vaccine also underwent . . . the most careful development, production and testing processes leading scientists, clinicians and public health authorities can devise.”[24]  Based on the surrounding circumstances, it seems that the 2009-H1N1 vaccinations were the best solution under the circumstances (i.e. a state of emergency, which called for FDA to issue an EUA and thus allowed vaccination to forego normal procedure and enter the market for use).  But is this sufficient to convince a court to uphold mandatory vaccinations?  I seriously question whether or not the 2009-H1N1 vaccines passes the Viemester “common belief” standard — the vaccinations have neither been through normal FDA testing nor on the market for very long.

            In the 1990 decision Ritterband v. Axelrod, the New York Court of Appeals looked at a New York State Department of Health regulation requiring physicians get vaccinated for rubella. The Albany county court held that “the state could lawfully mandate that physicians be vaccinated against rubella as a valid exercise of the State’s police power”[25] because it is a “low risk procedure”[26] which prevents the spread of the virus from patients to staff.[27]   

Through Ritterband, Viemester, and Jacobson, the argument in favor of the recent 2009-H1N1 vaccinations will be the exercise of the state’s police power.  Furthermore, Ritterband supports that an exercise of the police powers can focus on a specific group of health care providers, specifically physicians.  But are the 2009-H1N1 vaccines as “low risk” as the rubella vaccination?  Wouldn’t the EUA preclude as conclusive an answer to the latter question as another vaccination that goes through the FDA’s standard procedure for approval?  Even if early vaccinations were created as recently as the 1980s, and even if the FDA properly approved them, the flu virus is constantly changing[28] and thus so must our vaccinations.[29] 

 On October 9th, a New York Supreme Court issued a temporary restraining order pausing the state’s regulation requiring vaccinations.[30]  I think the merits of the case would have spoken to the haste in which the New York State government seemed to be acting.  It does not appear that health care workers object to vaccinations in general.[31]  And aside from religious or other personal beliefs, health care workers are at an increased risk of infection and would thus be likely proponents of vaccinations.  However, in instances where there is a state of emergency and where a vaccination is not widely accepted as a means of preventing the disease, it seems as though we are on a different playing field and the application of the state’s police powers may not extend as far as it has in the past.  Immunizations are widely accepted by the general public and that is what seems to lead the courts to uphold the ones our government determines are required.  In this case, however, Dr. Daines argues that “the same scientific standards and methods that we believe should govern all our health care practices”[32] went into approving the 2009-H1N1 vaccinations.  Both the EUA and his call to put personal interests aside make this statement less convincing.  I think he needed a different logic.

Author’s Note:

On October 22, 2009 Governor David Patterson announced the end of the controversy requiring New York health care workers to receive a mandatory vaccination for the influenza.[33]  Both the Governor and State Health Commissioner Dr. Robert Daines cite both the low supply and high demand for the vaccine noting that the inadequacy to vaccinate those most seriously at risk (like pregnant women and young children) is compelling enough to suspend the vaccination requirement.[34]  The regulation that required mandatory vaccination stipulated: “If the commissioner determines the vaccine supplies are not adequate given the numbers of personnel to be vaccinated or vaccine(s) are not reasonably available, the commissioner may suspend the requirements(s) to vaccinate and/or change the annual deadline for such vaccinations(s).”[35] 


[1] State News Serv., Mandatory Vaccinations: What the State Law Requires, N.Y. Times, Jan. 20, 1991, at 6, available at http://www.nytimes.com/1991/01/20/nyregion/mandatory-vaccinations-what-the-state-law-requires.html.

[2] Id.

[3] Anemona Hartocollis, Mandatory Flu Vaccination for N.Y. Health Workers Is Criticized, N.Y. Times, Oct. 13, 2009, available at http://www.nytimes.com/2009/10/14/health/policy/14vaccine.html.

[4] N.Y.S. Dep’t of Health, Mandatory Flu Vaccine for Health Care Workers: Commissioner Tells Health Care Workers: Mandatory Flu Vaccine is in the Best Interest of Patients and Workers, http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm (last visited Oct. 22, 2009); N.Y.S. Dep’t of State, Frequently Asked Questions, http://www.health.state.ny.us/diseases/communicable/influenza/seasonal/providers/questions_and_answers_-_health_care_worker_mandatory_influenza_immunization.htm#h1n1_vaccine (last visited Oct. 22, 2009).

[5] Center for Disease Control and Prevention, Key Facts About Swine Influenza, http://www.cdc.gov/flu/swineflu/key_facts.htm (last visited Oct. 22, 2009).

[6] Initial United States approval of an H1N1 vaccine was in 1980 for initial strains of the H1N1 virus.  Sanofi Pasteur H1N1 vaccination, Package Insert, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf (last visited Oct. 22, 2009).  Additionally, the “Medimmunue” vaccination was approved in 2003.  Medimmune, Package Insert, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf (last visited Oct. 22, 2009).

[7] Shanta M. Zimmer, M.D. & Donald S. Burke, M.D., New England J. of Medicine, Historical Perspective — Emergence of Influenza A (H1N1) Viruses (2009), available at http://content.nejm.org/cgi/reprint/NEJMra0904322.pdf.

[8] 21 U.S.C. § 360bbb-3(b)(1)(C) (2006).

[9] Richard E. Besser, M.D., Acting Director, Department of Health & Human Services, Center for Disease Control and Prevention (May 2, 2009), http://www.cdc.gov/h1n1flu/eua/pdf/rRT-PCR_swineflu_test_kit.pdf.

[10] Center for Disease Control and Prevention, Interim Questions and Answers About Emergency Use Authorization http://www.cdc.gov/h1n1flu/eua/qa.htm (last visited Oct. 22, 2009).  The FDA approved use of five vaccinations by means of EUA.  Id.  

[11] N.Y.S. Dep’t of Health, Mandatory Flu Vaccine for Health Care Workers: Commissioner Tells Health Care Workers: Mandatory Flu Vaccine is in the Best Interest of Patients and Workers, http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm (last visited Oct. 22, 2009).

[12] Id.

[13]  My discussion of the H1N1 vaccination stems from the haste with which it was brought to the market.  In the cases I discuss, the vaccinations — for smallpox and rubella— fall within a “common belief” of the state: they were widely held to be preventative of the disease they sought to combat.  The manner in which H1N1 vaccine was approved — through emergency use procedures — seems hasty and while it may prevent spread of the disease, the fact that it is not yet part of our “common belief” for its preventative nature of the H1N1 virus I believe its use should be optional for even the most basic concerns (that it could have unforeseen side effects or that it has not undergone as extensive a trial period as other vaccinations have received).

[14] Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905).

[15] Id. at 26.

[16] Id.

[17] N.Y.S. Dep’t of Health, Mandatory Flu Vaccine for Health Care Workers: Commissioner Tells Health Care Workers: Mandatory Flu Vaccine is in the Best Interest of Patients and Workers, http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm (last visited Oct. 22, 2009).

[18] Jacobson, 197 U.S. at 27.

[19] Id. at 30.

[20] N.Y.S. Dep’t of Health, Mandatory Flu Vaccine for Health Care Workers: Commissioner Tells Health Care Workers: Mandatory Flu Vaccine is in the Best Interest of Patients and Workers, http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm (last visited Oct. 22, 2009).

[21] Viemeister v. White, 179 N.Y. 235, 241 (1904).

[22] Id. at 239.

[23] Id.

[24] N.Y.S. Dep’t of Health, Mandatory Flu Vaccine for Health Care Workers: Commissioner Tells Health Care Workers: Mandatory Flu Vaccine is in the Best Interest of Patients and Workers, http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm (last visited Oct. 22, 2009).

[25] Ritterband v. Axelrod, 562 N.Y.S.2d 605, 611 n.1 (N.Y. Sup. Ct. 1990).

[26] Id. at 610.

[27] Id. at 611.

[28] Center for Disease Control and Prevention, Key Facts About Swine Influenza, http://www.cdc.gov/flu/swineflu/key_facts.htm (last visited Oct. 22, 2009); Center for Disease Control and Prevention, How the Flu Virus Can Change: “Drift  and “Shift,” http://www.cdc.gov/flu/about/viruses/change.htm (last visited Oct. 22, 2009).

[29] Center for Disease Control and Prevention, Key Facts Seasonal Flu Information, http://www.cdc.gov/flu/protect/keyfacts.htm (last visited Oct. 22, 2009).

[30] New York Judge Puts Hold on Mandatory Flu Shots, http://www.cnn.com/2009/HEALTH/10/16/new.york.vaccine.mandate/index.html.

[31] Id.

[32] N.Y.S. Dep’t of Health, Mandatory Flu Vaccine for Health Care Workers: Commissioner Tells Health Care Workers: Mandatory Flu Vaccine is in the Best Interest of Patients and Workers, http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm (last visited Oct. 22, 2009).

[33] Governor David A. Paterson Announces Suspension Of Flu Shot Mandate For Health Care Employees Due To Shortage Of Vaccine, Oct. 22, 2009, http://www.ny.gov/governor/press/press_1022094.html.

[34] Id.

[35] Id.

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1 Comment

Filed under Constitutional Law, Health Law, Uncategorized

One response to “Measles, Mumps, Rubella . . . Swine Flu?

  1. I worry about the Healthcare Law. Will it have bad reprocussions on my parents ? Will the advances overshadow the negative aspects?

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