Vaccine Injury Compensation: A Failed Experiment in Tort Reform?

by Barbara Loe Fisher

On Nov. 14, 1986, President Ronald Reagan signed the National Childhood Vaccine Injury Act of 1986 into law, instituting first-time vaccine safety reforms in the U.S. vaccination system and creating the first no-fault federal vaccine injury compensation program alternative to a lawsuit against vaccine manufacturers and pediatricians. Twenty-two years later, on Nov. 18, 2008,
I made a statement to the Advisory Commission on Childhood Vaccines (ACCV) and questioned whether the compensation program is fatally flawed and so broken that it should be repealed. Many parents are wondering whether it would be better to return to civil court without restrictions to sue 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 applying for federal vaccine injury compensation have been turned away empty-handed even though to date $1.8B has been awarded to more than 2,200 plaintiff's out of some 12,000 who have applied. Today, nearly 5,000 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 to vaccine victims.

At the time of the law's creation in 1986, Congress said they were committed to setting up a fair, expedited, non-adversarial, less traumatic, less expensive no-fault compensation mechanism alternative to civil litigation. But Congress also acknowledged that any legislation providing liability protection must also be equally committed to preventing vaccine harm. The Act contains strong safety provisions, including first-time mandates for doctors to record and report serious health problems, hospitalizations, injuries and deaths after 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 I testified in Congress in 1999 and again at the Nov. 18 ACCV meeting, there has been a betrayal of the promise that was made to parents about 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 to the childhood vaccine schedule.

I pointed out that federal court judges are beginning to look back at the legislative history of the Act, which so clearly affirms the intent of Congress when creating it. In recent court decisions, judges have agreed with parents and their attorneys that the compensation program has become far too difficult for plaintiffs. A recent state Supreme Court ruling also reiterated that Congress never intended to shield vaccine manufacturers from ALL liability for vaccine injuries and deaths when it could be demonstrated that a safer product could have been marketed.

In a Supreme Court of Georgia ruling on October 6, 2008 in American Home Products v. Ferrari, 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.

Justice Carley 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."

During the ACCV meeting, longtime plaintiff's attorney Sherry Drew gave a moving description of the suffering that families with vaccine injured children endure and, during public comment at the end of the meeting, Jim Moody, of SafeMinds, and Vicky Debold, RN, PhD joined me in urging the Committee to recommend to the new Secretary of DHHS that more vaccine injured children be compensated. This was echoed by outgoing parent ACCV member Tawny Buck, of Alaska, who has a DPT vaccine injured daughter and new ACCV parent member Sarah Hoiberg, of Florida, who has a five-year old DTaP vaccine injured daughter.

In the 1986 Vaccine Injury Act, the Institute of Medicine was directed to review the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in landmark reports to Congress in 1991 and 1994 providing that evidence. IOM announced at the 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 evidence regarding the biological mechanisms for injury and death in association with varicella zoster (chicken pox), hepatitis B, meningococcal and HPV vaccine. There will be several public workshops during the Committee's two- year study.

NVIC has been calling for basic science research into the biological mechanisms of vaccine injury and death for more than two decades. Without understanding how and why vaccines can cause brain and immune system dysfunction, there will be no way to develop pathological profiles to help scientifically confirm whether or not an individual has been injured or died from vaccination.

The truth about vaccine risks lies in the science, properly designed and conducted. The upcoming IOM review may be hampered by a lack of biological mechanism studies published in the medical literature but the review is also an opportunity to point the way to fill in those gaps 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 into poor health after vaccination should be given a fair hearing in the federal vaccine injury compensation program and generously compensated when no other plausible cause can be found for what happened to them after vaccination. Congress intended the vaccine injury compensation program to be non-adversarial, fair, generous and humane. If it cannot function the way it was intended to function, then parents have every right to call for its repeal and a return to unrestricted lawsuits.

Click here to read my entire ACCV statement with live links to the 1986 Vaccine Injury Act, U.S. Court of Appeals decisions, congressional testimony and other original sources.

Click here for ACCV meeting minutes and dates for upcoming meetings, which can be accessed via tele-conference call by the public who cannot attend the Rockville, Maryland meetings in person.

Flu & You: Know Your Options

by Barbara Loe Fisher

These days you can't turn around without being reminded that the "flu" season is just around the corner and it is time for every American - but especially infants, kindergarteners through high school graduates and anyone over 50 - to get a shot of influenza vaccine. But there are lots of new questions about whether the influenza vaccine is ineffective in children and whether it is also ineffective in the elderly at the same time there are growing doubts about whether many doctors and health officials have told the public the truth and nothing but the truth about the risks associated with infectious disease and the risks associated with vaccination.

Christian Broadcasting Network (CBN) has produced several investigative reports on vaccination during the past several years and a recent CBN report on influenza vaccine examined the validity of the annual influenza mortality figure that the CDC routinely uses (36,000 deaths per year in the U.S. from influenza). The report also presented several perspectives about getting a flu shot versus using a more natural approach to staying well in the flu season. (See VIDEO of report as well as VIDEO outtakes not included in the broadast story featuring Vitamin D Council Executive Director John Cannell, M.D. on pandemic influenza, Heather Maurer on how she made an educated flu shot decision for her child; Virginia Health Commissioner Karen Remley, M.D. on why public health officials like flu shots; and my comments on "cradle-to-grave" vaccine policies and development of a "supervaccine.")

Joseph Mercola, M.D., a champion of the holistic health and wellness lifestyle and strong advocate for the informed consent ethic in medicine, frequently offers alternative perspectives about infectious disease and vaccination. See Dr. Mercola's past newsletters discussing flu vaccination and other vaccination topics at and view a speech I gave at the Natural Living Conference sponsored by Holistic Moms Network on his website.

In the coming months, the push for Americans to get flu shots will increase but how many will understand the government-acknowledged risks and precautions for inactivated, injected influenza vaccine or the live virus nasal influenza vaccine which are more fully outlined in the manufacturer's product inserts available on the web and at pharmacies and in doctor's offices?

How many Americans know there are practical steps to take during the flu season that will not only help protect against all infections, including actual influenza as well as other "flu-like illnesses" that can often be mistaken for influenza? (Only about 20 percent of all "flu-like" illness is actually influenza and only three strains of the many strains of type A and type B influenza that may be circulating during the year are actually included in the influenza vaccine).

To prevent and treat influenza or flu-like respiratory illness that does not involve fever over 103 F., pneumonia or serious complications which may require medical intervention, the National Vaccine Information Center offers the following non- toxic suggestions:

1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamin D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.

Whatever you do this flu season - whether or not you choose to vaccinate - become vaccine educated and know your options.

Knowledge is power and an informed, empowered consumer is one who can stand up for the right to freely exercise informed preventive health options.

See and for more information. Please email if you would like to volunteer to work in your state to help NVIC educate Americans about vaccination or have special expertise you would like to share. NVIC is also looking for volunteers in the Northern Virginia and greater Washington, D.C. area to assist our staff with many exciting and challenging projects.

"The federal government finds of that 36,000, about 1,000 people die directly from the flu virus. Blame for the remaining 35,000 deaths goes to diseases like pneumonia that may follow the flu. However there's no clear scientific connection between the flu and these more serious afflictions. That means most of the time the shot would have little impact in actually preventing death. Barbara Loe Fisher heads of the non-governmental National Vaccine Information Center. She says the repeated references to 36,000 seems to be an attempt to scare people into getting the shot. Fisher suggests the public is smart enough to decide independently. A free market would be better, she believes. "If we allow vaccines to be subject to the test of the marketplace, then the public will use those vaccines they consider to be safe, effective, and necessary," Fisher says......Dr. John Cannell, Executive Director of the Vitamin D Council, suggests the reason we even have a flu season is because our vitamin D levels drop. That takes place naturally as we get less and less sun with the approach of winter. Cannell explains that less sun means we produce less vitamin D in our skin. "Pretty much any disease, any infectious disease, that is more common in winter is a target of vitamin D," Cannell says. He says that's true even of some serious non-seasonal, prolonged diseases such as tuberculosis. Early in the 19th century, TB sanitariums where people would get sun were one of the few ways to recover from "consumption," as it was known. So Cannell suggests babies get a 1,000 units a day and those two and older get 2,000 units. Many adults and some children need to take more than that. For kids, that can come as a single daily drop of liquid D. Cannell says a recent discovery explains vitamin D's role in the flu season. The vitamin triggers your body to produce its own antibiotics against flu as well as colds." - Gailon Totheroh, CBN News Service (November 4, 2008) VIDEOS at and http: //

"Led by Dr. Peter Szilagyi, researchers at University of Rochester studied 414 children aged 5 and younger, who came down with the flu during the 2003-2004 or 2004-2005 flu seasons. These children were compared with over 5,000 controls who did not have influenza during the same seasons. Turns out that flu shots seemed not to make much difference: Kids who got immunized did not get the flu at lower rates than unvaccinated kids. In fact, the immunized youngsters were just as likely to be hospitalized or to visit the doctor as kids who never received the vaccine.......Targeting the correct strain is a always a bit of a guessing game, however; researchers make their best scientifically based prediction as to which flu virus will be making the rounds in a coming season, but they often have to make these predictions up to nine months ahead of time, in order to keep up with the lengthy vaccine manufacturing process. "In some circumstances, it is like forecasting the weather," says Dr. Geoffrey Weinberg, professor of pediatrics at University of Rochester. "Sometimes we are right on, and sometimes we are off." - Alice Park, Time Magazine (October 6 2008) le/0,8599,1847794,00.html

"The influenza vaccine, which has been strongly recommended for people over 65 for more than four decades, is losing its reputation as an effective way to ward off the virus in the elderly. A growing number of immunologists and epidemiologists say the vaccine probably does not work very well for people over 70, the group that accounts for three-fourths of all flu deaths. The latest blow was a study in The Lancet last month that called into question much of the statistical evidence for the vaccine's effectiveness. The authors said previous studies had measured the wrong thing: not any actual protection against the flu virus but a fundamental difference between the kinds of people who get vaccines and those who do not. This contention is far from universally accepted. And even skeptics say that until more effective measures are found, older people should continue to be vaccinated, because some protection against the flu is better than none. Still, the Lancet article has reignited a longstanding debate over claims that the vaccine prevents thousands of hospitalizations and deaths in older people. "The whole notion of who needs the vaccine and why is changing before our eyes," said Peter Doshi, a doctoral candidate at M.I.T. who published a paper on the historical impact of influenza in May in The American Journal of Public Health ." - Brenda Goodman, New York Times (September 2, 2008) html

Vaccines, Politics & Media: Both Sides?

by Barbara Loe Fisher

With a little help from his friends, a man who has made millions from creating and promoting forced use of vaccines has begun the process of canonizing himself. Frustrated that his new book attempting to debunk the autism-vaccine connection is not selling well, Paul Offit is desperately trying to lose the Dr. Proffit label and morph into a martyr even as he continues to lead a public attack begun in 2007 on those questioning vaccine safety and defending informed consent to vaccination.

The day before Halloween, Offit's good friend TV doc Nancy Snyderman gave him a helping hand when she attempted to relentlessly browbeat the intellectually honest and affable Matt Lauer into agreeing with Offit that public debate about vaccines and autism is dangerous and should immediately cease. Gritting her teeth through a steely grin and hissing "It is NOT controversial" at her stunned NBC-TV colleague over and over again, Snyderman's on-camera meltdown was an unexpected Halloween treat for Moms making breakfast for the kids.

The interesting thing about Snyderman's glowing video tribute to her friend and subsequent tantrum when Lauer innocently labeled the vaccine- autism topic a "controversy," was her insistence that public debate should stop because her hero had gotten "death threats" presumably from distraught parents of vaccine injured autistic children. That same sentiment was forwarded by medical reporters at Newsweek magazine and ABC- TV, who appeared to agree with Offit's point of view that citizens questioning vaccine safety and forced use of vaccines are dangerous.

Adopting a strategy similar to the one that Merck pro-actively employed in 2006 to roll out the poorly tested and reactive Gardasil vaccine, Offit and his colleagues are demonizing parents and doctors questioning vaccine safety by characterizing them as ignorant, crazed, anti-science religious fanatics with a penchant for violance. In a desperate play for sympathy, pro-forced vaccination proponents agreeing with Offit's big stick approach are trying to deflect attention from the fact that they, themselves, created the current climate of fear, distrust, and anger. The bitterness now being expressed by parents, who have been belittled, harassed and threatened by hostile doctors inside and outside of government for standing up for their right to protect their children from vaccine injury and death, was inevitable.

When mothers and fathers take their healthy sons and daughters to pediatricians to get vaccinated and then witness them suffering vaccine reactions and regressing into chronic poor health within hours, days and weeks of getting sometimes 5 to 10 vaccines on one day, they are not going to accept an illogical, unscientific explanation like "it's all a coincidence." When mothers and fathers are thrown out of pediatricians offices and denied child medical care for asking questions about vaccines; or reported to child protective services for refusing to get children every vaccine; or denied exemptions to vaccines by government officials taking a militant "no exceptions" stance, they are going to feel angry.

At the same time, pediatricians, who become pediatricians to help children stay well, are not going to willingly accept the possibility that something they injected into a child injured or killed that child. When they cannot answer questions parents ask about vaccines, they are going to feel angry. The debate is so contentious because it is about life and death issues that affect everyone but neither those questioning vaccine safety nor those defending it serve their causes well by engaging in physical intimidation and threats against each other.

What should be troubling for doctors practicing medicine and journalists reporting on it is the Statist approach being taken by influential doctors like Offit, Greg Poland and Peter Hotez in response to three decades of reports by parents that children are being harmed by vaccination. Those who simultaneously develop new vaccines, help make national vaccine policy and promote forced use of vaccines certainly have the right to earn a profit from the products they create. They also have the right to promote an ideology in which they deeply believe. But Americans, who cherish freedom of thought, speech and action, should think long and hard about all efforts to pit citizen against citizen and marginalize those asking for credible scientific investigation into vaccine risks and the right to make informed, voluntary vaccination decisions.

A more reasoned, open minded approach to the vaccine safety debate was taken by pediatrician James Sears, M.D. and ER physician Travis Stork, M.D., who anchored an Oct. 28 episode of "The Doctors." The new CBS daytime show featured a segment airing different views about vaccine risks and mandatory vaccination in which Julia Berle, of TACA, and I appeared. To the credit of the show's producers, a spirited but civilized debate was allowed.

Both of the show's doctors joined an AAP pediatrician guest in strongly encouraging vaccination. However Dr. Sears and Dr. Stork also encouraged parents to become informed and supported the right of parents to make voluntary decisions about vaccines.

The show has elicited heated discussion on "The Doctors" website and a staff member monitoring the discussion boards yesterday told posters "Time to remind everyone that there is a person behind every screen name. Let's remember to address the topic without personally attacking another member because their views are different from yours. We all can learn from everyone's viewpoint, let's try to keep this discussion progressing in the manner intended." Immediately following this advice, posters who had been attacking one another found common ground even as they agreed to disagree.

At the vaccine freedom rally in Trenton sponsored by the New Jersey Coalition for Vaccination Choice on October 16, pediatrician Larry Palevsky, M.D. encouraged parents to continue speaking out and working for the legal right to voluntary vaccine decision-making. He challenged doctors to open their minds about vaccine risks, stating:

"As Einstein said, we can't solve problems by using the same kind of thinking we used when we created them. I challenge my colleagues in medicine to listen and learn that there is more to know than what we've been told...... Engage in a more scientific dialogue and not in the rhetoric that keeps coming from those who have a stake in keeping the status quo of one-size-fits-all vaccinations and an ever- increasing vaccine schedule. Take whatever fear you have about speaking out, and turn it into being responsible to our children in a new way."

Another doctor, who has had the courage to step up to the plate and ask her fellow physician colleagues to consider the possibility that vaccine risks are not equal for all and must be examined more thoroughly, is former NIH Director Bernadine Healy, M.D.. In a CBS-TV interview last May, she expressed the view that scientific research must go forward to identify individuals genetically or biologically vulnerable for suffering vaccine injury.

Healy told CBS investigative journalist Sharyl Atkisson: "I don't think you should ever turn your back on any scientific hypothesis because you're afraid of what it might show..... there may be this susceptible group. The fact that there is concern that you don't want to know that susceptible group is a real disappointment to me. If you know that susceptible group, you can save those children. If you turn your back on the notion that there is a susceptible group - what can I say?"

The fear and dread that new vaccine developers and promoters like Offit, Poland and Hotez may have is that their vaccines will not be welcomed with open arms by a public concerned about vaccine risks. But the way to remove public concern about vaccine safety and effectiveness is not to back questioning parents and doctors into a corner and club them into submission and silence.

In the meantime, an editor at the Atlanta Journal Constitution in Georgia is calling for a rejection of a bill to allow New Jersey residents the same freedom that citizens living in 18 other states have: the legal right to exercise conscientious belief exemption to vaccination. And a large HMO in the Midwest is forcing all of its 26,000 employees to get a flu shot every year or be fired.

Tomorrow, all Americans have the opportunity to go to the polls and vote for the candidates they believe will best represent them at the local, state and federal government level. Understanding the positions of candidates on vaccine safety and informed consent issues is important.

We cannot let those who are afraid of the truth about vaccination silence the voices of those who have paid the ultimate price for that fear. Stand by for announcements coming soon about how you can join NVIC in becoming an activist citizen and educate members of your community about the importance of standing up for the right of all Americans to make informed, voluntary decisions about vaccination.

"People think of me as this wild-eyed maniac," Offit says. "If I sat down with them for 10 minutes, they'd see that my motivation is the same as theirs. You want what's best for kids." Asked how he ranks the intensity of the vitriol aimed at him, Offit says simply, "Abortion, doctors who perform abortions." Nobody's firebombing pediatricians' offices, and there's no moral dilemma here about when life begins. But the overarching question-what happened to my baby?-is still impossible to answer, and the anger is real and it's deep. Some parents of children with autism tell stories with an eerily similar start: an infant who was happy and healthy until she got her shots. Then, suddenly, she lost eye contact and language. Parents' dreams for their babies are buried in sadness, their pockets are emptied to pay for therapies, their worries about their children's future haunt them even as they're trying to get through the screaming, splattered minutes of the day." - Claudia Kalb, Newsweek (November 3, 2008)

"Dr. Gregory Poland, director of the Mayo Vaccine Research Group at the Mayo Clinic in Rochester, Minn., and a vocal proponent of universal flu vaccination, says he is no stranger to such harassment. Among the most egregious things -- I got a letter once railing against my involvement in vaccines and hoping that something serious would happen to me and hoping that something serious would happen to one of my children," he said.....But some people connected to groups that believe a vaccine-autism link exists say that they, too, have been the targets of hateful speech. "I've been called a baby killer," says Rebecca Estepp, national manager of the autism support group Talk About Curing Autism. "One woman got into my face this summer and told me I was going to cause millions of children to die. Emotions are running high because this involves the health of our children....Poland said he believes legislation should be considered to offer special protection to those in the field of vaccine research. "Since this affects not only a person and his or her family, but indeed the public health, special provisions should be considered in terms of legal consequences," he said. "This was done, for example, in the case of abortion protesters.".....Dr. Peter Hotez, immunologist at George Washington University in Washington, D.C., and father of a daughter with autism, said he believes that federal public health agencies, including the surgeon general's office and the National Institutes of Health, must take a more active role in dissuading the link between vaccines and autism. "[These organizations] have to be willing to speak out and make strong statements that vaccines do not cause autism," he said. "These organizations have been conspicuous by their silence." - Dan Childs, ABC-TV (October 31, 2008) id=6150482

" Parents fail to get their children inoculated for a variety of reasons: ignorance of the requirement; concern over how much it will cost; misunderstanding that for the vaccine to be effective against some diseases, children must get follow-up shots....More problematic are the parents who willfully ignore the requirement, substituting their judgment for that of experts who must guard the public health. In New Jersey, the state Legislature is being asked to approve a bill that would allow parents to opt out of mandatory vaccine requirements. The measure was prompted by a new requirement in New Jersey -- the first in the nation -- that pre- schoolers get annual flu shots.....The bill in the New Jersey Legislature would allow parents a "conscientious exemption" as long as they swear they have "sincerely held" objections to immunizations. No doubt many parents have sincerely held beliefs, but allowing them to opt out of vaccination puts the lives of their children at risk as well as the lives of others....The vaccine-autism link has been thoroughly debunked. States should not back off mandatory vaccination laws, and local school districts and health departments should do a better job of enforcing compliance." - Mike King, Atlanta Journal Constitution (October 29, 2008) ervices/content/opinion/stories/2008/10/29/vaccinesed .html

" BJC HealthCare, the shining beacon for traditional medical care throughout the Midwest, has made getting a flu shot mandatory for its 26,000 employees. That goes for all employees, even the ones who never come in contact with patients. If anyone refuses, it is going to be considered a breach of the fitness for duty requirement, meaning anyone who refuses to be vaccinated is subject to dismissal. Many employees are unhappy over this new edict. Some employees who see the policy as a blatant violation of their privacy believe it should be at the discretion of the individual to decide what medications to take. Others think the way the policy was presented created an atmosphere of intimidation. When the policy was initially presented to employees, was made clear that without compliance, the employee could no longer work at BJC. Still others suspect that BJC is getting a kickback from the vaccine's manufacturer. Employees receiving the flu vaccination are required to sign a waiver that totally absolves BJC of any liability if the employee is harmed by the vaccine."- Barbara Minton, (November 2, 2008)