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HHS Extends Liability Shield to Antivirals Used for H1N1

Submitted by vermont on June 28, 2009 – 10:38 am4 Comments

jail-freeThe Department of Health and Human Services (HHS) recently provided a shield against damage claims related to the use of the antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza) in the current H1N1 influenza pandemic.

HHS Secretary Kathleen Sebelius signed a notice extending liability protection under the Public Readiness and Emergency Preparedness (PREP) Act. It was published in the Federal Register on Jun 19.

The PREP Act allows the HHS secretary to provide liability protection related to the use of various medical measures against diseases that HHS determines to be health emergencies. Protections are already in place for the two antivirals when used against H5N1 influenza and for vaccines for H5N1 and other potential pandemic flu strains, among other drugs and vaccines.

Liability protection is provided to groups and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures, according to HHS.

Gretchen Michael, an HHS spokeswoman in the Office of the Assistant Secretary for Preparedness and Response, described the antiviral-related move as routine. “This just sort of adapted the previous PREP Act documents for H1N1,” she said.

Michael said the impulse for PREP Act liability protections has come primarily from the manufacturers of the relevant products. She said the oseltamivir protection measure was not related to the reports, mainly from Japan, of abnormal behavior in some adolescents who were given the drug.

See also:

Federal Register notice about liability protection for oseltamivir and zanamivir

http://edocket.access.gpo.gov/2009/pdf/E9-14412.pdf

HHS PREP Act page with links to liability protection declarations

http://www.hhs.gov/disasters/discussion/planners/prepact/

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/jun2609liable.html




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4 Comments »

  • Christi Kendrick says:

    Is there a legal liability form we as consumers can present to our doctors, in a time of being pressured to take a drug/vaccination, that we can make them sign before we accept their poisonous pharaceuticals, making them take liability for any ill effects they may cause? They are so quick to push this stuff on us, and I want them to know up front, full well that I will personally hold them liable for any “adverse events”. In some instances they make us feel like we don’t have any choice in what we put into our bodies, and I want to have some legal protection. Is there already something like this, or can we find an attorney that is willing to put the legaleze on paper? Specifically, we need forms for the H1N1 vaccine, any other vaccine they might force down our blood stream, and any other form of pharmaceutal (cholesterol drugs, etc.) that has been proven to be ineffective, as well as dangerous. Thanks for the rant.

    [Reply]

  • Ann Watters says:

    This is criminal…What else is there to say. Change this law Please

    [Reply]

  • Ronnie says:

    Looks like we need a citizens petition againt the biotech terrorist.

    [Reply]

  • Kruizinga Hank and Judy says:

    Yes we have had the same experience here
    in Australia, so called doctors promoting
    these anti- flu injections’
    And when you say no thank you, they give you that look, so much to say you must be crazy.

    [Reply]

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