Advisory Commision on Childhood Vaccines, November 18, 2008
Statement of the National Vaccine Information Center
Barbara Loe Fisher, Co-founder & President
Advisory Commission on Childhood Vaccines
“The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform? ”
November 18, 2008
Mr. Chairman and Members of the Advisory Commission on Childhood Vaccines:
My name is Barbara Loe Fisher and I am co-founder and president of the non-profit organization known today as the National Vaccine Information Center (www.NVIC.org) that worked with Congress on the National Childhood Vaccine Injury Act of 1986, which included the Vaccine Injury Compensation Program (VICP) for which this Advisory Commission has provided guidance for the past 20 years. Along with our organization’s first president, environmental law attorney Jeffrey Schwartz, who was a principal co-architect of the Act, NVIC co-founder Kathi Williams and I were all parents of DPT vaccine injured children. We participated in four years of deliberations with congressional staff, representatives from the American Academy of Pediatrics (AAP), vaccine manufacturers, and the Departments of Health and Human Services (DHHS) and Justice.
The Vaccine Injury Act included in Title 3 of Public Law 99-660
http://history.nih.gov/01Docs/historical/documents/PL99-660.pdf was historic for several reasons.
It was the first acknowledgement by this society that vaccine injuries and deaths are not a myth but are real with catastrophic consequences for the lives of the vaccine injured and their families, who take care of them. The law was passed by Congress at the specific request of pharmaceutical companies threatening to stop making vaccines without product liability protection, as well as organizations representing pediatricians reluctant to give childhood vaccines without liability protection. It is a matter of public record that the Departments of Health and Human Services and Justice were strongly opposed to the legislation.
The young parents of vaccine injured children, who came to the table in the early 1980’s at the request of congressional staff to fight for the rights of vaccine consumers and the vaccine injured, agreed to work on the Act because of promises made by Congress and the AAP that the proposed legislation would provide a fair, expedited, non-adversarial, less traumatic, less expensive no-fault compensation alternative to civil litigation. We believed we were participating in the development of a law which would give – in the words of the then AAP Chairman – “simple justice to children.” In fact, Congress made it clear that congressional intent was to create a system that would be “expeditious and fair” to the vaccine injured and be unlike a trial in order to offer an attractive“non-adversarial” alternative to a lawsuit against vaccine manufacturers and physicians.
Parents had two conditions for coming to the table: first, there would be no agreement to an exclusive remedy system that would bar a lawsuit if federal compensation was denied or too little was offered to meet the injured child’s lifetime needs; or if it could be demonstrated a vaccine manufacturer could have made a safer vaccine, or had engaged in criminal fraud or gross negligence; and second, the Act must contain provisions to make vaccines and policies safer so fewer children would be harmed and need compensation.
We knew then, as we do now, that a law shielding vaccine manufacturers and providers from liability for vaccine harm must also contain strong provisions to ensure that the safest vaccines and policies are in place.
The final Act did include important safety provisions requiring doctors to give parents written vaccine benefit and risk information before children are vaccinated; to record serious health problems following vaccination in the child’s medical record; to keep a permanent record of all vaccines given including the manufacturer’s name and lot number; and to report serious health problems, hospitalizations, injuries and deaths that occur within 30 days of vaccination to a new, centralized federal Vaccine Adverse Events Reporting System (VAERS). The Act also directed the Institute of Medicine (IOM) to conduct a review of the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in four major reports by IOM to Congress in 1991 and 1994 providing that evidence.
All through the Act the words “safety” and “safe” are repeated over and over again and there is language emphasizing prevention of vaccine reactions such as “to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines” and “to reduce the risk of any major adverse reactions to the vaccine that may occur.” All of the vaccine safety provisions are in the Act because parents of vaccine injured children insisted any law providing liability protection must also help prevent vaccine harm.
In 1999, I gave congressional testimony http://www.nvic.org/Loe_Fisher/blfvicp82899.htm outlining the reasons why parents, who participated in good faith in creating the Act, felt betrayed by how it had been implemented. I stated:
“There is bitter disappointment and pervasive unhappiness among parents and the plaintiff’s bar with the current structure and administration of the vaccine injury compensation program….public opposition to forced vaccination with multiple vaccines in the absence of adequate scientific evidence documenting vaccine safety and effectiveness is growing…and when parents are unable to obtain financial assistance to care for a severely vaccine injured child, public faith in the mass vaccination system is further eroded.”
I noted that, in 1989 Amendments, the House of Representatives re-directed the U.S. Court of Claims “to provide for a non-adversarial, expeditious and informal process for the resolution of petitions filed under the Program,” a sentiment that was reiterated in the 1989 House and Senate Conferee Report, which made it clear Congress was unhappy that the claim’s process had become complicated, time-consuming and emotionally draining for petitioners. The Report stated “The re-invention of the adversarial process will serve neither to compensate injured children nor maintain the stability of the immunization program in the U.S.”
In preparing to make this statement today, I reviewed the legislative history of the Act and spoke with plaintiff’s attorneys and parents, who have applied for compensation for their vaccine injured children, as well as parents being told by pediatricians that their healthy children must get 69 doses of 16 vaccines from birth to age 18 to comply with federal recommendations and, in some states like New Jersey, are mandated to give their children three dozen doses of more than a dozen vaccines to go to school.
I sincerely regret having to come here today to reiterate much of what I told Congress in 1999, as well as provide further evidence that this program is not operating in a way that lives up to the spirit and intent of what legislators intended when parents with vaccine injured children agreed to work on this Act 25 years ago, believing the vaccine injured and their attorneys would be treated with fairness, compassion, and good will in this program.
What has happened over the past two decades since the Act’s passage?
Although the vaccine manufacturers and pediatricians may have been primarily concerned with liability protection while Congress was anxious to protect vaccine supply and delivery, parents in the 1980’s were assured that a federal compensation system would even the playing field for vaccine victims and their attorneys. We were assured that, unlike a lawsuit in civil court, the federal compensation system would be based on the presumption that a vaccine or combination of vaccines caused the child’s injury or death if no other demonstrated cause could be found. The emphasis was on presumption and there was recognition that thispresumption, in the absence of scientific data and certainty, would be in the plaintiff’s favor even if that presumption would result in some children being compensated who were not, in fact, vaccine injured.
The emphasis on presumption was integral to the integrity of a no-fault, expedited vaccine injury compensation system. There continues to be a lack of scientific understanding of the specific biological mechanisms involved in most vaccine-associated injuries and deaths and an absence of pathological profiles to conclusively prove which health problems following vaccination are, in fact, vaccine-induced and which are not. These gaps in scientific knowledge and uncertainty means that a no-fault vaccine injury compensation system must err on the side of presumption of causation rather than proof of causation to offer a viable administrative alternative to a lawsuit.
Even so, the architects of the Act knew that presumption could not be arbitrary but had to be predicated on evidence that, when certain signs and symptoms were present following vaccination and those signs and symptoms were followed by permanent injury or death, the vaccine could be presumed to have played a role in the absence of a demonstrated biologically plausible alternative cause.
The mechanism to facilitate presumption agreed upon by all parties participating in the development of the Act was a Table of Compensable Events, known as the Vaccine Injury Table. This Vaccine Injury Table, devised after exhaustive review of vaccine medical literature and years of discussion with doctors, vaccine manufacturers and parents was designed to remove much of the burden of proof of cause and effect that exists in an adversarial vaccine injury lawsuit in civil court.
For example, the Table was intended to spell out the signs and symptoms associated with DPT vaccine induced brain inflammation, including seizures within 72 hours ( a DPT vaccine-induced adverse event which had been acknowledged in more than 60 years of medical literature) in order to provide a framework to allow for a presumption of causation under the Act. Therefore, the Table was inserted into the law by congressional sponsors to ensure that the compensation process would remain, essentially, administrative rather than litigious.
The reality of what has occurred during the past two decades is something quite different.
In the 1990’s, DHHS chose to wield discretionary authority given under the Act to change the rules and eliminate almost all on-Table adverse events that would allow for presumption of causation. With the assistance of the Department of Justice, DHHS turned the administrative compensation process into a highly adversarial, lengthy, expensive, traumatic and unfair imitation of a court trial for vaccine victims and their attorneys. The only difference is that the trial is now conducted in the U.S. Court of Claims in front of one individual who acts as judge and jury.
Ironically, parents who helped create the Act in the 1980’s were told that Congress needed to grant the Secretary of DHHS broad discretionary authority to alter the Vaccine Injury Table so the Secretary could expand the list of presumptions for injuries associated with existing and future vaccines to make the system more inclusive not less inclusive. We never imagined DHHS wouldtake away existing presumptions from the Table because the stated purpose of the Act was to err on the side of compensating potential vaccine victims in order to offer an effective alternative to vaccine injury lawsuits.
But DHHS did not just remove signs and symptoms of potential vaccine reactions from the Table of Compensable Events. Federal health officials also used discretionary authority to arbitrarily redefine what constitutes a permanent vaccine injury. For example, DPT vaccine induced encephalopathy, the first signs of which can be manifested by seizures, has long been recognized by the medical community. In a move to make compensation more difficult to obtain, DHHS redefined the clinical signs that have been used for more than a century to diagnose an “encephalopathy.” One attorney representing vaccine injured children in the program commented that the re-writing of the medically recognized definition of “encephalopathy” by DHHS “is so restrictive that it is believed by petitioners’ counsels across this country that they will never again see an injury to a child that falls within the definition’s narrow confine” for the purpose of awarding uncontested compensation.
The National Vaccine Information Center has repeatedly called for DHHS under rule making authority, as well as Department of Justice and U.S. Court of Claims officials to make the federal compensation process more fair and humane for petitioners, their families, expert witnesses and plaintiff’s attorneys. For example, DHHS has the power to add “death within 72 hours” of vaccination to the Table as a presumption event. The Department of Justice can choose to make it less traumatic for vaccine victims and their families by including in compensation awards guardianship costs; fairly calculating lost future income and expenses for housing modifications and special education; and providing mental health counseling for parents coping with their vaccine injured child’s 24-hour needs – instead of fighting most special needs costs identified by life care planners and doctors advising families.
The U.S. Court of Claims can make it possible for more attorneys to represent vaccine victims in the program by awarding interim fees to plaintiff’s attorneys, a discretionary authority affirmed by the U.S. Court of Appeals in the Avera decisionhttp://www.ll.georgetown.edu/federal/judicial/fed/opinions/07opinions/07-5098.pdf. And both Justice and U.S. Court of Claims officials can refrain from trying to discredit and destroy the reputations of plaintiff’s expert witnesses in what is perceived by parents as an attempt to frighten and discourage doctors from testifying on behalf of vaccine injured children.
What I heard most often when speaking with parents and plaintiff’s attorneys was that the compensation process is filled with a “mean-spiritedness” and a growing hostility on the part of DHHS, Justice and U.S. Court of Claims officials toward plaintiffs, their families, experts and attorneys. Whether that is true in every case, I don’t know, but there certainly is a sense that parents feel their children are pawns in a political tug of war that compels those in government responsible for administering the compensation program to protect the reputation of the current vaccine system at all costs – even if it means denying compensation to vaccine victims in order to limit the numbers of children acknowledged by government as having been harmed by vaccines being promoted by government.
In retrospect, the fact Congress made DHHS and Justice – two government agencies opposed to passage of the Act – responsible for making the Act work is perhaps its greatest operational flaw.
What are other signs that obtaining federal compensation has become a highly adversarial, time consuming process and that the Act does not do what Congress intended it to do?
In 1986, federal health officials recommended 23 doses of seven vaccines be given to children from two months to six years of age and most of these were mandated by states. The Act, in fact, was supposed to protect the supply of those seven vaccines for tetanus, diphtheria, pertussis, polio, measles, mumps and rubella. Since then, 46 doses of nine new vaccines have been added to the CDC recommended schedule for girls (43 doses of eight new vaccines for boys) and many state health departments have either mandated most of them or are in the process of mandating them. Today, there are twice as many opportunities for vaccine injury or death to occur during childhood than before the Act was passed more than two decades ago.
But with this increased vaccine adverse event risk exposure, what has been done to minimize increased vaccine risks and also to fairly compensate those injured by one or more of the new vaccines?
DHHS has recommended every one of the nine new vaccines for universal use, which allows all nine to be added to the compensation program. This gives automatic liability protection to the drug companies marketing these nine new vaccines as well as to all doctors administering them.
When parents look at the Table of Compensable Events, what do they see? They see that no signs, symptoms or injuries have been added to the Table for these nine new vaccines – except anaphylaxis within four hours for hepatitis B vaccine. They see that if their child is injured or dies after getting one of these vaccines, they are in for a long, hard fight to obtain federal compensation in the U.S. Court of Claims.
And when they check out the statistics on the Health Resources & Services Administration (HRSA) website (http://www.hrsa.gov/vaccinecompensation) they find out that two out of three individuals applying for vaccine injury compensation have been turned away empty handed even though to date about $1.8B has been awarded to more than 2,200 plaintiffs out of some 12,000 who have applied. And they learn that nearly 5,000 of the 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 listed on the Table of Compensable Events. Yet there is $2.7B sitting unawarded in the Trust Fund and people suggesting all sorts of ways to use that money for all sorts of reasons other than for compensating vaccine victims.
The fact that the compensation program is not working the way parents were promised it would work and Congress intended it to work is also demonstrated by the fact that parents of vaccine injured children and their attorneys have been forced to seek justice in the civil courts. In a series of federal court cases beginning with the 1996 U.S. Supreme Court case Donna E. Shalala, Secretary of Health & Human Services v Margaret Whitecotton http://www.law.cornell.edu/supct/html/94-372.ZO.html the judicial system has reminded DHHS, Justice and the U.S. Court of Claims that Congress intended the compensation program to be an “expeditious, just and non-adversarial” alternative to a lawsuit.
In the landmark 2005 Althen case, http://caselaw.lp.findlaw.com/data2/circs/fed/045146p.pdf the Court of Appeals for the Federal Circuit affirmed that the burden of proof for vaccine victims filing under the Act should be lessened. The Court made it clear a person need only show a vaccine was the likely cause of the injury and that experts presenting evidence in favor of compensating the vaccine victim can base their opinions on circumstantial evidence rather than conclusive scientific evidence.
In the 2006 Capizzano case, http://www.ll.georgetown.edu/Federal/judicial/fed/opinions/05opinions/05-5049.pdf the Federal Court of Appeals held, once again, that the petitioner does not need to present peer-reviewed scientific literature proving causation but need only provide a medical theory linking an injury to the vaccine, a logical sequence of cause and effect, and a temporal relationship between them as evidenced by medical records or expert opinion, especially the opinion of doctors who have treated the child.
After two decades, the federal courts are speaking and, importantly, judges are looking back at the legislative history which so clearly affirms the intent of Congress when creating the Act .In a Supreme Court of Georgia ruling on October 6, 2008 in American Home Products v. Ferrari, http://www.gasupreme.us/pdf/s07g1708.pdf the justices unanimously held that the National Childhood Vaccine Injury Act does not give a vaccine manufacturer blanket immunity from vaccine injury lawsuits if it can be proven that the company could have made a safer vaccine.
Georgia Supreme Court Justice George Carley wrote that the 1986 law and “the congressional intent behind it shows that the Vaccine Act does not pre-empt all design defect claims.” He added that Congress did not “use language which indicates that use of the compensation system is mandatory” but only “an appealing alternative” to the courts. He wrote that there is no evidence that“FDA approval alone renders a vaccine unavoidably safe” and said “We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval,”adding that to do so would have “the perverse effect” of granting complete immunity from liability to an entire industry” and he concluded that “in the absence of any clear and manifest congressional purpose to achieve that result, we must reject such a far-reaching interpretation.”
Judge Carley got it exactly right. There was no intent by Congress in 1986 to totally remove all liability from drug companies marketing vaccines for injuries and deaths cause by those vaccines. And there was no intent by Congress to put a law in place that would absolve federal agencies from their responsibility to ensure that vaccines and vaccine policies are necessary, safe and effective. That is because Congress did not just want to protect the vaccine supply. The lawmakers also agreed with parents of vaccine injured children that everything possible must be done to make vaccines and vaccine policies safer to minimize vaccine injuries and deaths.
In the opening Section 2101 of the Act, which established a National Vaccine Program, there is a clear statement of purpose, which is: “to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines.” Under this section, there is a subsection entitled “Evaluating the Need for and the Effectiveness and Adverse Effects of Vaccines and Immunization Activities” which acknowledges there was no a priori assumption on the part of lawmakers that every vaccine industry produces is an automatic candidate for a universal use recommendation by the CDC and inclusion under the Act for the purpose of liability protection.
Section 2127 of the Act is entitled “Mandate for Safer Childhood Vaccines” and it directs DHHS to “promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market” and “to make or assure improvements…with respect to the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches of vaccines and research on vaccines in order to reduce the risks of adverse reactions to vaccines.”
While this language, which was included at the request of parents of vaccine injured children, does not address responsibilities of this Commission in providing oversight on the implementation of the Act’s compensation mechanism, this Commission was charged under the Act with advising the Secretary in implementing responsibilities under Sections 2125 and 2127 about the “need for childhood vaccination products that result in fewer or no significant adverse reactions; gathering information on adverse reaction reporting requirements; and obtaining, compiling, publishing and using credible data related to the frequency and severity of adverse reactions associated with childhood vaccines.”
There is enough blame to go around when looking at why the 1986 National Childhood Vaccine Injury Act has not lived up to the spirit and intent that prompted the 99th Congress to work so hard to create and pass it. Congress itself walked away from providing oversight after the 1989 Amendments were passed, even though sporadic attempts have been made in the House and Senate in bills that sought to address substantive issues such as extending the statute of limitations and increasing the $250,000 death benefit and pain and suffering limit.
There is little that can be done to recapture a dream of justice that has turned into a nightmare for thousands of families with vaccine injured children, who have been denied federal compensation, while vaccine manufacturers and doctors have enjoyed unprecedented liability protection for the past two decades. That liability protection has made it easy for four dozen doses of nine new vaccines to be added to the childhood vaccine schedule, some of them fast tracked, without any studies being conducted to evaluate the potential long term adverse health effects of giving children an unprecedented number of vaccines throughout childhood.
That liability protection has made it easy for the CDC and AAP to narrow contraindications to vaccination so severely that almost no health condition qualifies as a reason not to vaccinate, placing many more vulnerable children at higher risk for suffering vaccine reactions that are often dismissed by pediatricians and government health officials alike as “a coincidence.” It is no wonder that estimates for reporting of vaccine associated health problems, hospitalizations, injuries and deaths by vaccine providers to the VAERS system is only between one and ten percent.
The fact that unprecedented numbers of highly vaccinated children are now suffering from chronic disease and disability compared to a quarter century ago calls into question the wisdom of an Act, which has made it easier for industry to rush to market new vaccines that government officials mandate while shielding vaccine makers and providers from liability for any harm that is done. The fact that there has been no attention paid by industry and government to minimizing vaccine risks, including no scientific research – as the Act called for – into identifying individuals at high risk for suffering vaccine adverse responses so their lives can be spared – speaks volumes about the disconnect between the intent of Congress to prevent vaccine injuries and deaths and the intent of those operating the federal compensation system to deny they exist.
For this reason, many parents I have spoken with maintain that the Vaccine Injury Compensation System is a failed experiment in tort reform that should be repealed. They believe the vaccine injured should be able to return to the courts, where discovery is allowed, to sue vaccine manufacturers for design defect and failure to warn and sue pediatricians who carelessly implement one-size-fits-all vaccine policies rather than adhere to the precautionary principle to “First, do no harm.”
The decision of whether or not the Vaccine Injury Compensation Program is worth saving belongs to the smart, vaccine educated parents with young children today, who you will be hearing from as they stand up in greater numbers across this country for the legal right to make informed, voluntary vaccine decisions for their children. I promise you, they will not wait another quarter century for those of you operating this program to do what you were supposed to do a long, long time ago.
The National Vaccine Information Center will continue to inform and educate the public and legislators about the history of the National Vaccine Injury Act of 1986 and why safety, not liability protection, must always come first in America’s public health programs.
(SOURCE: National Vaccine Information Center)