Legal Challenge to H1N1 Vaccine Expands

11:44 AM, Oct 16, 2009   |    comments
H1N1 Vaccine
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By BRIAN TUMULTY
Gannett Washington Bureau

WASHINGTON - A group that's challenging a state requirement that all health care workers in New York get vaccinated for swine flu said Thursday that it's seeking a federal injunction to halt nationwide distribution of the vaccine.

"We are arguing this is a new drug and it must go through the proper testing for safety and efficacy,'' said attorney Jim Turner, who wants to stop other states from following New York's lead in mandating vaccinations.

The Food and Drug Administration, which announced Sept. 15 that it had approved the H1N1 vaccine for distribution, says the vaccine is merely a change in strain from the typical seasonal flu vaccine and doesn't require testing as a new drug.

U.S. District Judge Reggie Turner of the District of Columbia has not set a hearing date.  Attorney Turner argues that if H1N1 is just a seasonal variation in the flu, the federal government shouldn't have treated it as a national health emergency and set out to buy 250 million doses.

"The Catch-22 argument is that the FDA is putting out the message that this flu that is walking across the world ... is so unique and so deadly that we must buy millions of doses,'' he said.

The Obama administration began distributing the H1N1 vaccine nationwide this month, with plans to make the first 40 million doses available by Oct. 31.  Four firms - CSL Limited, MedImmune LLC, Sanofi Pasteur Inc., and Novartus Vaccines and Diagnostics Limited - have been approved to produce the vaccine under federal contract.

The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends that pregnant women, health care workers, people aged 25-64 with chronic illnesses, and people working with children under 6 months old should be first in line for the vaccine.

But Cherryl Robbins, a patient care technician at St. Francis Hospital in Poughkeepsie who is 24 weeks pregnant, doesn't plan to get vaccinated.  "The state declared an emergency in order to get this drug through,'' said Robbins, a plaintiff in the lawsuit seeking to overturn New York's mandatory vaccination requirement for health care workers.  "Personally, I don't think there is a crisis.''

Robbins has been told that if she's not vaccinated by the end of November, she will be dropped from the December work schedule.  She currently works four days a week on a part-time schedule.  Robbins, 33, has miscarried once and said she won't do anything that might endanger her unborn baby.  "I don't want to have any risk of something happening,'' she said.

Other plaintiffs include Mary Kuchman, a billing specialist at Highland Hospital in Rochester who doesn't have contact with patients and interacts only minimally with physicians.  "There was no choice in the matter: Get vaccinated or lose your job,'' Kuchman recently told the Rochester Democrat and Chronicle.

Health care legal expert James Hodge Jr. doubts the federal court will overturn New York's mandatory vaccination program for health care workers.  "This is not some recent flash-in-the-pan vaccine that we hope works,'' said Hodge, a professor of health law and ethics at Arizona State University Law School.  "This was produced under the very same standards as any other flu vaccine and is without question - and until proven otherwise - just as safe as any other vaccine for flu.''

Mandatory vaccination laws date back as far as 1809, when Massachusetts required vaccinations to prevent the spread of smallpox, according to a recent report by the Congressional Research Service.

In 1827, Boston became the first city to require public school students to be vaccinated, also against smallpox.  "Many modern school vaccination laws are the result of measles outbreaks in the 1960s and 1970s,'' the CRS report said.

States require schoolchildren to be vaccinated against diphtheria, measles, rubella, polio and other diseases.  "In addition, various state laws also require vaccination against hepatitis B and meningococcal disease for incoming college and university students,'' the report said.

The Supreme Court has upheld the right of states and localities to enact mandatory vaccination laws to protect public health and safety. States generally allow exemptions for religious, philosophical or medical reasons.  Hodge said it's important to distinguish the mandatory action taken by the New York Health Department from a compulsory one.  "If these folks don't want to take the vaccine, don't take it,'' Hodge said.  "You may not practice your profession, perhaps. You may have your licensure challenged as to whether you may continue to provide health services.  But you have that choice.''

A compulsory program is akin to saying, "Come over here, we'll strap you down and shove this vaccine in your arm,'' Hodge said.  "These folks are challenging something that government has a legitimate right to do, which is set up conditions for the exercise of specific privileges, like practicing medicine or nursing, based on what's right for the public's health," Hodge said.

Gannett ContentOne - Washington, D.C.

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