Vaccine Injury Compensation: A Failed Experiment in Tort Reform?

Vaccine Injury Compensation: A Failed Experiment in Tort Reform?
by Barbara Loe Fisher, from the NVIC newsletter.

On Nov. 14, 1986, President Ronald Reagan signed the NationalChildhood Vaccine Injury Act of 1986 into law, instituting first-timevaccine safety reforms in the U.S. vaccination system and creating thefirst no-fault federal vaccine injury compensation program alternativeto a lawsuit against vaccine manufacturers and pediatricians.

Twenty-two years later, on Nov. 18, 2008,I made a statement (Statement— Barbara Loe Fisher, Nov 18, 2008 — Advisory Commission on ChildhoodVAccines) to the Advisory Commission on Childhood Vaccines (ACCV) andquestioned whether the compensation program is fatally flawed and sobroken that it should be repealed.

Many parents are wondering whetherit would be better to return to civil court without restrictions tosue vaccine manufacturers and doctors for injuries and deaths their children suffered after receiving federally recommended vaccines. During its two-decade history, two out of three individuals applyingfor federal vaccine injury compensation have been turned awayempty-handed even though to date $1.8B has been awarded to more than2,200 plaintiff's out of some 12,000 who have applied.

Today, nearly5,000 vaccine injury claims are sitting in limbo because they represent children, who suffered brain and immune system dysfunction after vaccination but have been diagnosed with regressive autism,which is not recognized by the program as a compensable event. There is $2.7B sitting in the Trust Fund which could have been awarded tovaccine victims.At the time of the law's creation in 1986, Congress said they werecommitted to setting up a fair, expedited, non-adversarial, lesstraumatic, less expensive no-fault compensation mechanism alternativeto civil litigation. But Congress also acknowledged that anylegislation providing liability protection must also be equallycommitted to preventing vaccine harm.

The Act contains strong safetyprovisions, including first-time mandates for doctors to record andreport serious health problems, hospitalizations, injuries and deathsafter vaccination and give parents written benefit and risk information before a child is vaccinated. But few of the safety provisions have been enforced and, as Itestified in Congress in 1999 and again at the Nov. 18 ACCV meeting,there has been a betrayal of the promise that was made to parentsabout how the compensation program would be implemented.

Obtaining compensation has become a highly adversarial, time-consuming,traumatic and expensive process for families of vaccine injured children and far too many vaccine victims have been denied compensation while vaccine makers and doctors have enjoyed liability protection and dozens of doses of nine new vaccines have been added tothe childhood vaccine schedule.I pointed out that federal court judges are beginning to look back atthe legislative history of the Act, which so clearly affirms theintent of Congress when creating it.

In recent court decisions, judgeshave agreed with parents and their attorneys that the compensation program has become far too difficult for plaintiffs. A recent stateSupreme Court ruling also reiterated that Congress never intended toshield vaccine manufacturers from ALL liability for vaccine injuriesand deaths when it could be demonstrated that a safer product couldhave been marketed.In a Supreme Court of Georgia ruling on October 6, 2008 in AmericanHome Products v. Ferrari, the justices unanimously held that theNational Childhood Vaccine Injury Act does not give a vaccine manufacturer blanket immunity from vaccine injury lawsuits if it canbe proven that the company could have made a safer vaccine.

Georgia Supreme Court Justice George Carley wrote that the 1986 law and "thecongressional intent behind it shows that the Vaccine Act does notpre-empt all design defect claims." He added that Congress did not"use language which indicates that use of the compensation system ismandatory" but only "an appealing alternative" to the courts. Justice Carley wrote that there is no evidence that "FDA approvalalone renders a vaccine unavoidably safe" and said "We hesitate tohold that a manufacturer is excused from making changes it knows willimprove its product merely because an older, more dangerous versionreceived FDA approval," adding that to do so would have "the perverseeffect" of granting complete immunity from liability to an entireindustry and he concluded that "in the absence of any clear andmanifest congressional purpose to achieve that result, we must rejectsuch a far-reaching interpretation. "During the ACCV meeting, longtime plaintiff's attorney Sherry Drewgave a moving description of the suffering that families with vaccineinjured children endure and, during public comment at the end of themeeting, Jim Moody, of SafeMinds, and Vicky Debold, RN, PhD joined mein urging the Committee to recommend to the new Secretary of DHHS thatmore vaccine injured children be compensated.

This was echoed byoutgoing parent ACCV member Tawny Buck, of Alaska, who has a DPTvaccine injured daughter and new ACCV parent member Sarah Hoiberg, ofFlorida, who has a DTaP vaccine injured daughter.In the 1986 Vaccine Injury Act, the Institute of Medicine was directedto review the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in landmark reports toCongress in 1991 and 1994 providing that evidence. IOM announced atthe ACCV meeting that it has recently been contracted by the Health Resources & Services Administration (HRSA) to assemble a Committee of scientific experts to review of the medical literature for evidenceregarding the biological mechanisms for injury and death inassociation with varicella zoster (chicken pox), hepatitis B,meningococcal and HPV vaccine.

There will be several public workshopsduring the Committee's two- year study.NVIC has been calling for basic science research into the biologicalmechanisms of vaccine injury and death for more than two decades.Without understanding how and why vaccines can cause brain and immunesystem dysfunction, there will be no way to develop pathologicalprofiles to help scientifically confirm whether or not an individualhas been injured or died from vaccination.The truth about vaccine risks lies in the science, properly designedand conducted.

The upcoming IOM review may be hampered by a lack ofbiological mechanism studies published in the medical literature butthe review is also an opportunity to point the way to fill in thosegaps in knowledge and the need for additional research that could become part of a national vaccine safety research agenda.In the absence of scientific certainty, all children who regress intopoor health after vaccination should be given a fair hearing in the federal vaccine injury compensation program and generously compensatedwhen no other plausible cause can be found for what happened to themafter vaccination. Congress intended the vaccine injury compensationprogram to be non-adversarial, fair, generous and humane. If it cannot function the way it was intended to function, then parents have everyright to call for its repeal and a return to unrestricted lawsuits.