Last Friday, Justice Thomas J. McNamara, an acting justice of the State Supreme Court in Albany, issued a temporary restraining order preventing the enforcement of the New York state mandate requiring all health care workers with direct patient contact to get the H1N1 and seasonal flu vaccines.  Justice McNamara scheduled a hearing for October 30 and consolidated three lawsuits challenging the mandate brought by a group of emergency room nurses, New York State Public Employees Federation, and the New York State United Teachers Union.  In addition to these cases, a nurse from Poughkeepsie, N.Y., filed a lawsuit in State Supreme Court in Manhattan challenging the mandatory vaccinations.

The full requirements of the New York mandate can be read here.  The New York Times blog post on the ruling cites a September 24, 2009 statement from State Health Commissioner Richard F. Daines, M.D. to explain the reasoning behind the mandate:

“Questions about safety and claims of personal preference are understandable. 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 percent 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.”

After the temporary restraining order was issued, the State Department of Health officials said in a statement (reported by the NYT):

“In two weeks the Department is scheduled to be in court, where we will vigorously defend this lawsuit on its merits. We are confident that the regulation will be upheld. The Commissioner of Health and the State Hospital Review and Planning Council have clear legal authority to promulgate the mandatory regulation. As one court said in a 1990 ruling rejecting a challenge to regulations requiring mandatory rubella vaccinations and annual tuberculosis testing for health care workers: ‘Hospitals . . . exist for the benefit of their patients. They exist to cure the sick. The Legislature of this State has charged the Commissioner of Health with the responsibility of making hospitals safe places to get well. These regulations are tailored to accomplish that end.'”

In addition to the lawsuits challenging the New York mandate, the New York Civil Liberties Union testified before the New York State Assembly Committees on Health, Labor, Education, Higher Education and Workplace Safety, and sent a letter to Mr. Daines explaining that the mandate “conflicts with well established legal principles and public health policy” and “violates the right of competent adults to direct the course of their medical care and treatment.”  The NYCLU argues the H1N1 vaccine is distinguishable from other mandatory vaccines because the mortality rate for those who contract H1N1 is lower (compared to smallpox), and the vaccine is not 100% effective in preventing the disease, treating it, or preventing transmission (unlike the vaccines for measles, mumps, and rubella, diphtheria, polio, and tuberculosis). Furthermore, the NYCLU points out that,

“If significant numbers of health care workers refuse to be inoculated and are fired, health care facilities could be seriously understaffed at the very moment HINI is expected to cause a surge in hospital visits. And if health care workers are confused and upset about compulsory vaccinations, what are their patients to think? As reports of health care workers refusing vaccinations become public, confusion and worry will grow in the general population. And even if vaccination is the appropriate medical option for individuals, people may become increasingly reluctant to choose that option.”

Part of the reasoning behind the mandate is to keep health care workers healthy, so they can care for patients.  New York already has a shortage of nurses, and maximizing the number of working nurses will be critical if H1N1 causes an influx of patients.  As the NYCLU points out, however, if a significant number of nurses (and other health care workers) are fired because they refuse the vaccination, the mandate will prevent many healthy nurses from caring for patients.  George Annas, professor of health law and bioethics at Boston University School of Public Health, adds that “if enough physicians and nurses refuse vaccination, the mandate will be unenforceable, since no responsible public health official would try to close a hospital for failure to comply with the mandate in the midst of a flu epidemic.”  How many health care workers would choose dismissal over vaccination?  Enough to close a hospital?  More than how many, without the mandate, would miss work after catching the flu?  How will these changes in staff size and flu exposure impact patient health?  In the previous post, I cited Professor Art Caplan’s estimation that if all health care workers were vaccinated against the seasonal flu, there would be 40% fewer flu-related patient deaths.  How does that number adjust for the dangers of H1N1 flu, the effectiveness of the H1N1 vaccine, and the loss of health care workers who refuse vaccination?

– Kelly Lowenberg