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Saturday, October 24, 2009

Compensating Adverse Flu Vaccine Reaction Victims

As the US flu vaccination program rolls out, the numbers are also growing for those who have reported adverse consequences from the H1N1 vaccine. The victims and their families are also lining up for benefits available in the workers’ compensation system as well as the Federal program. The existence of these programs have received little publicity and may be difficult for the public to navigate without adequate representation. 

The US Centers for Disease Control and Prevention (CDC) announced this week that pandemic activity has now increased in the US. Tom Frieden, MD, director of the CDC, said, "We have had up until now many millions of cases of pandemic influenza in the U.S. And the numbers continue to increase." President Obama signed an Executive Order declaring the Swine Fu as a national emergency. Hospitalization and death rates have increased, yet again. Over 60 million have been immunized early for seasonal flu, so that providers would be available to administer  H1N1 vaccine when it becomes available. . 

Even though the supply has been tardy for the H1NI vaccine, the companies that supply the product have promised an additional flow of supply to meet the demand. The European pharmaceutical companies, Novartis’s Focetria, GlaxoSmithKline’s (GSK’s) Pandemrix, and Baxter’s Celvapan are under contract to supply a huge volume of vaccine to the US. Novartis alone has a $979 million contract to supply H1N1 vaccine to the US Department of Health and Human Services (HHS) which amount to 251 million does and the total 35% projected US supply. It is anticipated that the US supply may not arrive until the first quarter of 2010.

A recent Washington Post-ABC News Poll reflects that Americans are more worried than ever about the H1N1 flu. In a matter of weeks, from August 2009 to October 2009 those reportedly worried about getting the H1N1 flu increased from39% to 52%.  The CDC has been reluctant to advertise the need to about the vaccine because the supply has been limited and they were attempting to avoid public panic. Their program will pick up as the supply becomes increasingly available.

Adverse effects from the flu vaccine already are being reported. Deaths have been reported associated with the deaths of at least four nurses with 2009 H1N1The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States. The data is publically available through the CDC WONDER on-line database.

Workers’ Compensation programs have provided compensation benefits in the past resulting from adverse reactions to vaccines. In many jurisdictions, vaccinations afforded to employees resulting in a benefit to the employer against possible disastrous business consequences, have been considered to be “a mutual benefit.” Therefore, any disease arising from such vaccination has been deemed compensable.

Additionally, a Federal program has been established to shield the vaccine producers from liability claims. On October 1, 1988, the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created the National Vaccine Injury Compensation Program (VICP). The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims hears the claims.

As of July 1, 2005, trivalent influenza vaccines have been added to the Table under this Category. Trivalent influenza vaccines are given annually during the flu season either by needle and syringe or in a nasal spray.  All influenza vaccines routinely administered in the U.S. are trivalent vaccines covered under this Category.  

The criteria for filing a claim under the VICP are the following:
  • You may file a claim if you received a vaccine covered by the VICP and believe that you have been injured by this vaccine.
  • You may also file a claim if you are a parent or legal guardian of a child or disabled adult who received a vaccine covered by the VICP and believe that the person was injured by this vaccine.
  • You may file a claim if you are the legal representative of the estate of a deceased person who received a vaccine covered by the VICP and believe that the person’s death resulted from the vaccine injury.
  • You may file a claim if you are not a United States citizen.
  • Some people who receive vaccines outside of the U.S. may be eligible for compensation. The vaccines must have been covered by the VICP and given in the following circumstances:
    • the injured person must have received a vaccine in the U.S. trust territories; or
    • if the vaccine was administered outside of the U.S. or its trust territories:
      1. the injured person must have been a U.S. citizen serving in the military or a U.S. government employee, or have been a dependent of such a citizen; or
      2. the injured person must have received a vaccine manufactured by a vaccine company located in the U.S. and returned to the U.S. within 6 months after the date of vaccination.
  • In addition, to be eligible to file a claim, the effects of the person’s injury must have:
      1. lasted for more than 6 months after the vaccine was given; or
      2. resulted in a hospital stay and surgery; or
      3. resulted in death.
The VICP program has paid over $1.8 billion dollars from 1989 through 2009. Over 2,300 families have been paid to date with over 2,200 attorneys representing clients in such matters. "Compensated" are claims that have been paid as a result of a settlement between parties or a decision made by the U.S. Court of Federal Claims (Court). Approximately 18% of the benefits were paid to adults who received vaccines during the existence of the program. Since the program was expanded to adults who received vaccinations, the proportion of benefits to adults under the program has  increased proportionally. Nearly 52% of program awards in 2007 and 2008 went to adult vaccine recipients.

As the H1N1 vaccination program unfolds, those who suffer adverse reactions will be seeking benefits from both, the State workers’ compensation programs, as well as the VICP. Adequate dissemination of information concerning eligibility and procedural access to the programs will be of great benefit to the victims and their families.