Published March 28, 2016
In a 3 to 0 decision, a court of appeals in Michigan has upheld a decision by Judge Paul Denenfeld...
— William Wilberforce
While stricter vaccine requirements for employees, schools and day care centers spread across the United States, families continue to file vaccine injury claims in the federal Vaccine Injury Compensation Program (VICP). Recent published reports indicate that the government’s system in place to field these claims is a grueling, bureaucratic process, while two out of three claimants are turned away without compensation.
During the early 1980s when parents began filing DPT vaccine injury lawsuits against vaccine manufacturers after their children were brain injured by DPT vaccine, pharmaceutical companies asked Congress for liability protection. In response, Congress set up a federal vaccine injury compensation program (VICP) under the 1986 National Childhood Vaccine Injury Act. While the vaccine compensation program was intended to be a simplified, non-adversarial, expedited and more just alternative to a lawsuit in providing an economic safety net for children injured by federally recommended and state mandated vaccines, independent analyses are finding it is anything but that.
Most Americans are unaware that, under federal law, no one can directly sue a pharmaceutical corporation selling vaccines in the U.S. after a vaccine injures or causes the death of a child or adult. The 1986 law gave drug companies partial immunity from product liability in civil court. A 2011 U.S. Supreme Court decision gave the pharmaceutical industry total liability protection for all FDA licensed vaccines recommended for children—even if the vaccine manufacturer could have made a vaccine safer.1
The VICP is funded by a $0.75 tax on each dose of vaccine sold and given. The money is placed in a Trust Fund reserved for vaccine injury claim payments, which is supposed to serve as a kind of self-insurance program for children and adults receiving government recommended and mandated vaccines.
Children and adults who have been injured or died following receipt of government recommended vaccines are required to sue the Secretary of DHHS. When federal health officials, who are represented by Department of Justice attorneys, decide to oppose the awarding of compensation, vaccine injury claims are adjudicated through the U.S. Court of Claims (sometimes referred to as “Vaccine court”).
There are a number of problems with the way the VICP has been implemented since Congress created it in 1986. For example, there has been little publicity about the program over the years largely because the federal government has not promoted the program’s existence. Because many families do not understand the judicial process related to filing claims of vaccine injury, some miss short deadlines for filing a claim, which is only two years after a vaccine death, and three years after a vaccine injury. Furthermore, the claims resolution process can take years, a far cry from the original administrative decision making process that was supposed to have a 240-day deadline.
According to a 2014 report examining the VCIP published by the Government Accountability Office (GAO), most of the 9,800 claims filed in the VICP since 1999 “have taken multiple years to adjudicate.” The arbitration process spanned five years for most claims filed between 1999 and 2014, and only 11% of claims took one year or two years, while another 11% were still pending and processing as of March 31, 2014. The average time to adjudicate claims was 3.5 years and one case took 14 years to be resolved.
The money collected from the tax on vaccines purchased and administered in the U.S. for the Vaccine Injury Compensation Trust Fund, managed by the Department of Treasury, totaled nearly $2.9 billion in 2009. In 2013, approximately $254 million in vaccine injury compensation was paid, up from $126 million per year paid between 1999 to 2009. Overall, the VICP paid out $2.8 billion in compensation from 1988 to 2014.2
As of January 2016, the total awarded to Americans who have become permanently injured or died after receiving federally recommended vaccines has increased to $3.3 billion.3
More than $3 billion in awards may sound like a big amount, but a closer look at the statistics reveals that two out of every three children applying for vaccine injury compensation have been turned down. Child health and vaccine safety advocacy organizations, such as the National Vaccine Information Center (NVIC), have been very critical of the way the VICP is being implemented by federal agencies and maintain it has not been living up to the spirit and intent of the law passed by Congress in 1986 for many years.4
The Department of Justice report clearly indicates that the flu vaccine is the government recommended vaccine most often associated with severe reactions and permanent disability among adults, with 79 cases of flu vaccine injury during 2014 and three cases involving deaths.5
Most of the flu vaccine-related injuries were associated with Guillain-Barre Syndrome, an autoimmune and neurological disorder that is listed as a warming on the flu vaccine package inserts. Other injuries reported after influenza vaccinations include acute disseminated encephalomyelitis, transverse myelitis, shingles, neuropathic demyelination, seizures, neuropathy, brachial plexopathy, rheumatoid arthritis, optic neuritis and Bell’s palsy.6
A settlement related to a flu shot injury hit headlines recently and falls into the top 20% of highest amounts paid by VICP to a vaccine injured person. Sarah Behie, a nurse’s aide at Lehigh Valley Hospital in Pennsylvania, received a flu shot in October 2010 and shortly thereafter received a diagnosis of Guillain-Barre syndrome.
In June 2014, nearly four years since Behie had been paralyzed and confined to nursing homes, she was awarded her nearly $12 million in federal vaccine injury compensation. The government chose to concede, rather than oppose the award, and plaintiff’s attorneys and Justice Department attorneys negotiated an appropriate settlement to pay up to $11.6 million for Sarah Behie’s lifetime medical care, as well as more than $1 million for her lost wages, pain and suffering.
Even though an annual flu vaccination was not a requirement for employment at Lehigh Valley Hospital in 2010 when Behie was employed, it is now.7
In addition to Guillain-Barre syndrome, another serious reaction related to flu vaccine is Sirva, a shoulder injury due to improper vaccine administration. Sirva is the first recognized side effect caused by the vaccine provider. A 2011 Institute of Medicine report officially listed Sirva as a vaccine side effect due to improper injection given too high on the arm, causing injury to the musculoskeletal structures of the shoulder (i.e., tendons, ligaments) and resulting in chronic pain, limited range of motion and nerve damage.8
From 2011 through 2015, the VCIP paid approximately $18 million to 112 Sirva victims. More than half of those payments were awarded during 2015. For example, the government paid more than $1 million to Latasha George, a Louisiana nurse who experienced Sirva following her 2010 flu vaccination.9
1 Parker CB. Federal program for vaccine-injured children is failing, Stanford scholar says. Stanford Report July 6, 2015.
2 Most Claims Took Multiple Years and Many Were Settled through Negotiation. Government Accountability Office Nov. 21, 2014.
3 HRSA. VICP Data & Statistics. Jan. 1, 2016.
4 Fisher BL. Vaccine Injury Compensation: Government’s Broken Social Contract with Parents. NVIC.org Nov. 2, 2015.
5 Matanoski VJ. Report from the Department of Justice. Department of Justice June 5, 2014.
6 Government Pays Compensation to 80 Flu Vaccine Injuries and Deaths. Health Impact News Dec. 6, 2014.
7 Hall P. Lehigh County woman paralyzed after flu shot wins $11.6 million for treatment. The Morning Call June 10, 2014.
8 Adverse Effects of Vaccines: Evidence and Causality. Institute of Medicine Aug. 25, 2011.
9 Dugan IJ. Vaccine Injury Payouts Rise. The Wall Street Journal Aug. 24, 2015.