Friday, September 18, 2009

Liability Shield Issued for Manufacturers: What if a Swine Flu Vaccine Causes Injury?

A notice was issued in December 2007 regarding the process for seeking compensation under the 2006 Public Readiness and Emergency Preparedness Act  (PREPA).  The DHHS Secretary Sibelius has designated the Health Resources and Services Administration (HRSA) to address adverse vaccine reactions.  HRSA created a Countermeasures Injury Compensation Program, modeled on the VICP, with the potential to compensate citizens injured by "covered countermeasures" such as swine flu vaccine.  The current appropriation for such swine flu vaccine injuries is 14 million dollars.

The precise method for proving a claim is not known yet, but will be entirely non-judicial.  A physician employee of HRSA will review claims and make a determination as to whether the injured party proved that the vaccine caused their injury.  An appeals process will exist within DHHS, but will also be entirely non-judicial.  No lawyers' fees will be paid by the program, nor will there be payments for "pain and suffering."  The amount paid for a death proven to be caused by a vaccine covered by this program is approximately $300,000. 

Approximately 20 claims were paid for smallpox vaccine injuries.  A lot more was known about smallpox vaccine adverse events going into the smallpox vaccine program in 2003.  No one knows what the process will be like for this vaccine, nor how satisfactory it will be for claimants.  Dr. Vito Caserta also told me the agency will be the "payor of last resort" and will not duplicate payments received by other means.

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