National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (NVICP) was created in 1986 as a no-fault alternative to the traditional legal system for resolving vaccine injury petitions. According to the US Health and Human Services, it was created after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates, which they believed could cause a resurgence of vaccine preventable diseases. Any individual, of any age, who received a covered vaccine and believes he or she was injured as a result, can file a petition. Parents, legal guardians and legal representatives can file on behalf of children, disabled adults, and individuals who are deceased. According to the vaccine-injured and their loved ones, the program has failed miserably as a litigious, broken system where the injured are up against a government vaccine program, government owned vaccine patents, government health officials who administer the program and government paid attorneys from the Department of Justice. There is no judge, no jury of your peers and no discovery. Claimants feel the system is set up for their claims to fail.

Contrary to what the government and media would like us to believe, vaccine injury in this country is hardly rare. More than 30,000 “adverse events” are now reported annually to the official federal monitoring program for vaccine safety, with some 200,000 cases listed since 1990. Many experts, however, believe the injuries are underreported by a factor of ten because the system of collecting adverse events is not required by law. This means that up to two million Americans may have experienced an adverse event during that time.

Thankfully, most events (roughly 85%) were considered mild (localized pain and swelling, low-grade fever, etc.), but the rest were far more serious, including encephalopathy (brain damage), seizure disorders, chronic arthritis and neurodevelopmental disorders including, many parents argue, autistic regression. To put it another way, anywhere from 4,500 to perhaps 45,000 serious vaccine injuries occur every year in the United States.

Many of the injured, most of them children were eligible to file for monetary damages from the National Vaccine Injury Compensation Program (NVICP), which some people incorrectly call “vaccine court.” “Vaccine Court” is not a Court of law. In vaccine Court there is no judge, no jury and the most basic rules of law do not apply.

Sadly, a staggeringly few cases have actually received compensation despite the science backing their claim and their doctor’s/hospital’s medical reports clearly showing causation. This claims program could not be more broken. Despite Congress’s intentions, NVICP has produced inadequate vaccine safety, inadequate warnings about vaccine risks and insufficient compensation for the vaccine-injured. What follows is a description of the program, a list of critically needed reforms, and information on what parents need to know.

National Vaccine Injury Compensation Program (NVICP) Basics

Congress established the NVICP in 1986 to create a standardized national immunization program that indemnifies the medical/pharmaceutical industry from lawsuits, compensates those injured, and promotes safer vaccines. NVICP was seen as beneficial to increasing public trust in vaccines and honoring the social compact, much like our society looks after veterans because they fought to defend the collective good. Congress made it fundamentally clear that compensation must be swift, generous and awarded in a non-adversarial manner. In exchange, parents of vaccine-injured children (“petitioners”) must file in NVICP first, before suing in civil court. They petition against the Department of Health and Human Services (HHS), and not vaccine manufacturers.

The government recognizes certain vaccine-induced outcomes, which appear on the “Vaccine Injury Table,” including death, anaphylaxis, chronic arthritis, seizure disorder, encephalopathy, vaccine-strain measles, vaccine-strain polio and paralytic polio. Injuries must manifest within hours or days, though some have a thirty-day window. If families meet the exacting requirements for a table injury, they have a presumption of compensation. For non-table injuries however, they must show causation based on a “preponderance of the evidence.” What’s more, petitioners have to file within three years of the first symptoms, an unfair rule that is contrary to the American court system and does not respect states’ rights of tolling for minors.

Many people know of NVICP through its Omnibus Autism Proceeding, which took over eight years to litigate. More than 5,000 vaccine-autism claims were filed and the cases were “tested” under two theories: Mercury-induced autism and MMR vaccine-induced autism. Six test cases were heard. All of them lost. To date, HHS insists that no claims have been compensated for autism within the program.

CRITICALLY NEEDED REFORMS

HHS has turned a basic administrative compensation process into a “highly adversarial, lengthy, expensive, traumatic and unfair imitation of a court trial for vaccine victims and their attorneys,” charges Barbara Loe Fisher of the National Vaccine Information Center, who was instrumental in drafting the original law. She is not alone. Even the program’s former Chief Special Master, Gary Golkiewicz, said the government, “altered the game so that it’s clearly in their favor. (The government) has a vested interest in vaccines being good. It doesn’t take a mental giant to see the fundamental unfairness in this.”

NVICP also eliminates incentives for companies to produce safer vaccines, while allowing them to make products that are mandated by the Federal government for schoolchildren, without any liability whatsoever. The program should be eliminated, but if Congress won’t go along, it must take steps to reform NVICP, including:
Extend the Statute: The brief statute of limitations is considerably shorter than most legal actions in civil court involving injury to minors. Petitioners must file “no more than 36 months after the first symptom or manifestation of onset or of the significant aggravation of such injury after the administration of the vaccine.” If a claim is brought beyond that date, it will be dismissed and barred from further action in courts of law. Children’s Health Defense Executive Director Lyn Redwood, RN, MSN, learned this the hard way. “Nobody informed me that my son’s vaccines contained mercury” she says. “Unfortunately, by the time we found out and realized he was suffering with autism induced by mercury neurotoxicity, we were outside the statute of limitations.”

Level the Playing Field: The legal deck is stacked against petitioners from the start. Attorneys for HHS work for the Justice Department and have at their disposal all the money, power and access to experts that our Government can command. Special Masters who hear cases are DOJ employees. Meanwhile, petitioners are denied access to government data that would be provided under normal discovery rules in civil court. This must stop. And though NVICP is required to cover “reasonable attorney’s fees and costs,” delayed and below-market reimbursements deter many of the most experienced lawyers and medical experts from participating. NVICP must increase fees for petitioners’ attorneys and speed up payments. And the program must stop using injury-award funds to finance studies that help keep many injuries “off-table.” Children’s Health Defense finds it reprehensible that NVICP money has financed one-sided studies used to turn away claims.

Revitalize the Table: The law was written to cover the seven vaccines children received in 1986: polio, diphtheria, pertussis, tetanus, measles, mumps and rubella. But today the CDC calls for 70 doses of 16 vaccines, and nine new vaccines have been added to the childhood schedule since 1986, more than doubling the possibility of injury. Despite this, only one new table injury has been added: anaphylaxis within four hours of hepatitis B vaccine. On the contrary, in the early 1990s HHS eliminated most table injuries, despite the NVICP’s mission to provide a presumptive, no-fault administrative remedy. HHS removed “residual seizure disorder” from the table, for example, nullifying presumptive compensation for children with seizures immediately after the DPT vaccine. As a result, nearly all DPT seizure-disorder cases became off-table, requiring lengthy litigation with varying results. HHS also redefined “encephalopathy” to exclude most cases from on-table compensation. That’s why 90% of all NVICP claims must be hard-fought in litigation, and why three-quarters of all cases are dismissed.

Children’s Health Defense believes that if an injury meets the preponderance of evidence that vaccines were implicated, then the injury must be added to the table immediately and NVICP must inform all claimants previously denied for the same or similar injury that their claim is now recognized as compensable. We also call for an advisory panel to periodically evaluate the injury table, constituted of 30% parents/vaccine injured. There must be fair and open hearings every two years into vaccine-neurodevelopmental disorder connections, in order to keep up with the science and hold the government to safety standards with the most recent data available.

Eliminate Table-Injury Hearings: If the claimant’s medical evidence substantiates an injury that meets the requirements on the table of injuries, their petition must be approved without hearing, discovery or delay. This would make NVICP the true no-fault, non-adversarial program Congress intended in to be.

Increase Awards: Petitioners are entitled up to $250,000 in the event of a vaccine-related death and a maximum of $250,000 for pain and suffering. These caps have not changed since 1986. The death claim should be raised to $1,000,000 and the pain-and-suffering cap eliminated. NVICP must also begin paying without limitation medical, physical/occupational therapy, rehabilitation, medical monitoring, special diets, supplements, educational/tutorial therapy, and other expenses incurred from injury to death. The law likewise requires NVICP to compensate generously. But this is rarely the case. Why? Children’s Health Defense believes that HHS and DOJ view vaccine-injury compensation as undermining public trust in a universal vaccine program. The higher the awards, government officials worry, the greater the distrust.

Increase Awareness: The law requires “reasonable efforts” to inform the public about the existence of the NVICP, but the total budget for publicity is just $10,000 a year, versus the $4 billion budget for federal vaccine promotion and development. NVICP has compensated fewer cases than the actual number of vaccine injury cases because of ignorance about vaccine injury, and about the compensation program. Children’s Health Defense demands far more funds, in the millions of dollars, for annual public-awareness campaigns on vaccine safety and vaccine-injury compensation.

Provide Alternatives: For the vaccine-injured, NVICP is their only recourse. This must change. Cases dismissed for untimely statute-of-limitations filing must be allowed to proceed in civil court, and all petitioners should have an “opt-out” provision to sue in court after 240 days in NVICP with no final judgment.

WHAT PARENTS SHOULD KNOW

How to File: A complete set of rules is listed at the NVICP site. The good news is that most petitioners can begin by filing a “short-form” claim on their own, which doesn’t require a lawyer. If your case goes to trial, you can find an attorney to represent you.

Evidence Needed: If you plan on filing a claim, begin gathering all your documentation now, including medical records, vaccine records, test results and even emails between you and your pediatrician. Anything you have to show that your child suffered an injury shortly after vaccination will help you with your case.

What’s Covered: Depending on the type and degree of the injury, NVICP compensation can cover a wide range of products and services for the vaccine-injured, everything from physical therapy and occupational therapy to, yes, applied behavioral analysis (ABA) therapy (used almost exclusively to treat autism).

Successful Cases: Recent cases have won substantial awards of millions of dollars over the lifetime of the individual. Many children with ASD have also won compensation, although the government refuses to admit paying for autism cases – even as it underwrites ABA therapy for the vaccine injured. Your best bet is if you can prove a table injury. But never mention the word “autism.” Many lawyers are catching on to this strategy, and children with ASD are being compensated for vaccine-induced encephalopathy and/or seizure disorders.

Laughing All the Way to the Bank: Vaccine Makers and Liability Protection—Conflicts of Interest Undermine Children’s Health: Part III

By the Children’s Health Defense Team

[Note: This is Part III in a series of articles adapted from the second Children’s Health Defense eBook: Conflicts of Interest Undermine Children’s Health. The first eBook, The Sickest Generation: The Facts Behind the Children’s Health Crisis and Why It Needs to End, described how children’s health began to worsen dramatically in the late 1980s following fateful changes in the childhood vaccine schedule.]

…the unprecedented health crisis beleaguering American children began around the same time that Congress passed the National Childhood Vaccine Injury Act.

When it comes to telling the story of vaccine injuries and how frighteningly commonplace they have become, denial, censorship and lies seem to be ruling the day—for now. However, future public health historians will surely acknowledge that the unprecedented health crisis beleaguering American children began around the same time—1986—that Congress let the genie out of the bottle by passing the National Childhood Vaccine Injury Act (NCVIA).

While the Act marked a depressing turning point for American children and their families, it was a bonanza for the pharmaceutical industry. The industry protections offered by the Act—which essentially awarded vaccine makers blanket immunity from liability for injuries resulting from childhood vaccines, “no matter how toxic the ingredients, how negligent the manufacturer or how grievous the harm”—sparked a gold rush of vaccine development.

By the close of 2017, analysts valued the highly consolidated global pharmaceutical market at over $1.1 trillion (U.S. dollars).

The big four

The Act’s banishment of liability as a business worry catapulted vaccines from a “neglected corner of the drugs business” into a major economic driver of the medical and pharmaceutical industries. In the U.S., four companies have been the principal beneficiaries of the no-liability business environment for childhood vaccines. The four pharmaceutical giants—GlaxoSmithKline (GSK), Merck, Pfizer and Sanofi Pasteur—manufacture every vaccine on the U.S. childhood schedule. In addition to the “big four,” companies such as Seqirus and MedImmune (AstraZeneca) have been crowding into the increasingly lucrative adult vaccine market.

By the close of 2017, analysts valued the highly consolidated global pharmaceutical market at over $1.1 trillion (U.S. dollars). The four leading vaccine makers ranked third, fifth, sixth and seventh globally in terms of total revenues. All four also registered increases in annual revenue from 2017 to 2018–5%-6% for Merck and GSK and 2%-3% for Pfizer and Sanofi.

Manufacturers of Vaccines for Children and Adolescents in the U.S.

 

The companies’ strong vaccine sales helped ensure these record profits. For example, Pfizer’s $136-a-shot Prevnar-13 vaccine (with four doses advised before preschool age) earned the company nearly $4 billion in a single year, “about double what it made from high-profile drugs like Lipitor and Viagra.”

There are also other factors working in favor of record-breaking vaccine profits, outlined in a 2014 report in The New York Times on “soaring” vaccine prices. These include:

  • Market entry of new vaccines at “once-unthinkable” prices
  • Reformulation of old vaccines with a higher price tag
  • Requirements for multiple doses and boosters
  • Monopoly market positions for some vaccines
  • Patents on manufacturing processes (vaccine patent applications rose “tenfold in the 1990s to more than 10,000”)
  • Guaranteed purchases by the federal government (Vaccines for Children Program)
  • Guaranteed coverage by private insurance and the Affordable Care Act, meaning that “patients often do not notice the prices.”

Convicted felons

None of the leading vaccine manufacturers are strangers to lawsuits or large financial settlements for drugs in their product line that, unlike vaccines, are subject to courtroom liability. Over the past decade, in fact, GSK, Pfizer, Merck and others have paid out billions in punitive settlements for products deemed to be deceptive or harmful. In the case of Merck, the company’s payouts included $950 million in federal fines following evidence of a “deliberate corporate conspiracy” related to its bestselling painkiller Vioxx. The FDA approved the drug in 1999, but Merck reluctantly withdrew it from the market in 2004 after studies showed that it doubled serious health risks and had resulted in at least 60,000 deaths. Merck pleaded guilty to criminal charges over its illegal marketing of Vioxx and settled 27,000 lawsuits for $4.85 billion.

Dubbed by some as the “Help Pay for Vioxx” vaccine, Gardasil has been a major revenue booster.

Merck enjoys a unique monopoly position for four vaccines, including its blockbuster human papillomavirus (HPV) Gardasil vaccine and both measles-mumps-rubella vaccines (MMR and MMR-plus-varicella or MMRV). Merck brought Gardasil to market in the aftermath of the Vioxx scandal. Dubbed by some as the “Help Pay for Vioxx” vaccine, Gardasil has been a major revenue booster. In a single quarter of 2016, for example, in which Merck posted a profit of $2.2 billion, the company saw a 38% jump in sales of HPV vaccines (due to “increased pricing and demand”). Similar trends have been evident for Merck’s other vaccines, with a 27% increase in MMRV vaccine sales in the same quarter of 2016 after the CDC added the vaccine to its pediatric stockpile. Growing global vaccine sales, including in China, helped Merck continue to “beat Wall Street expectations” in 2018.

What, me worry?

From a consumer standpoint, Merck’s track record with Vioxx raises the question of whether the American public can believe the company’s claims about the safety of its vaccines. Can a company that confessed to illegal activity and paid out almost $5 billion to settle lawsuits for a drug it knew to be harmful be considered trustworthy when it markets expensive and profitable vaccines such as Gardasil? The same question can be asked regarding the other vaccine manufacturers.

In 2007, Merck had to recall over a million doses of two childhood vaccines because it “could not guarantee the products’ sterility.” A year later in 2008, an investigation by the Philadelphia Inquirer described an unpublished FDA review of one of Merck’s largest U.S. vaccine plants, which identified contaminated children’s vaccines and a failure to follow good manufacturing practices. The review noted 49 areas of concern in all. What was the plant leadership’s response to the FDA’s troubling findings? “Nobody’s perfect.” Considering that pharmaceutical companies want to continue injecting our children with liability-free and largely untested vaccines from pregnancy on, this executive’s cavalier attitude hardly inspires confidence.

 

Click on the image above to get your free copy of our new eBook: Conflicts of Interest Undermine Children’s Health.

In our FREE eBook, Conflicts of Interest Undermine Children’s Health, CHD takes the position that conflicts of interest and unethical behavior encumber the key public and private players involved in U.S. and global vaccination programs to such an extent that public skepticism is not only understandable, but justified. The loss of confidence in vaccine safety must be addressed with independent, unbiased science. As we publish subsequent parts of the eBook, we will illustrate how lack of integrity and ethical betrayals are impeding sound public health policy and vaccine safety science, while gravely undermining children’s health.

 

 

$4 Billion and Growing: U.S. Payouts for Vaccine Injuries and Deaths Keep Climbing

The Health Resources & Services Administration just released new dollar figures reflecting payouts from the National Vaccine Injury Compensation Program. The payouts for vaccine injuries just went past the whopping $4 billion mark. Using the government’s own conclusion that only 1% of all vaccine injuries are reported, the $4 billion is just the tip of the iceberg. Despite assurances from CDC and our Federal agencies that all vaccines are safe, the payouts say otherwise. Vaccine injuries can and do happen—to previously healthy children and adults. Consumers deserve to know the facts about the full range of vaccine risks.

By the Children’s Health Defense Team

In most public health communications about vaccination, officials gloss over vaccine risks, dismissing any possible “side effects” as mild. However, vaccination programs have always resulted in more serious vaccine injuries for some. In the 1970s and early 1980s, for example, the diphtheria-pertussis-tetanus (DPT) vaccine and its whole-cell pertussis component had chalked up so much vaccine damage that a television documentary likened receiving a DPT shot to playing “vaccine roulette.”

After the DPT debacle began attracting widespread attention, vaccine manufacturers started pressuring Congress for protection from vaccine injury lawsuits. Congress obliged. In 1986, President Reagan signed into existence a radical piece of legislation—the National Childhood Vaccine Injury Act (NCVIA)—which launched what the Act described as an “alternative remedy to judicial action for specified vaccine-related injuries.” A key component of the legislation involved creating the National Vaccine Injury Compensation Program (NVICP), which was given responsibility for deciding (through the workings of a special “vaccine court”) whether specific injuries and individuals would be eligible for financial compensation.

While government-funded Department of Justice (DOJ) lawyers vigorously represent and defend the interests of HHS and vaccine manufacturers, the consumer-unfriendly system forces the vaccine-injured to meet an exceptionally high burden of proof.

Over the vaccine court’s 30-year history, individuals and families have filed over 20,000 petitions for vaccine injury compensation. This month, even as 12% of filed petitions remained unadjudicated, the payouts crossed over the $4 billion threshold. This amount was awarded in response to barely a third (31% or 6,276) of the filed petitions. There is no telling how much more money the taxpayer-funded program might have shelled out if the court had not chosen to dismiss the remaining petitions (56%)—possibly doing so fraudulently in at least some cases.

Running the Gauntlet

Over the three decades, despite the stated intent to furnish an “accessible and efficient forum for individuals found to be injured by certain vaccines,” the NVICP has devolved into a protracted and litigious David-versus-Goliath battleground. The vaccine court, in actuality, is “not a court at all but…a consumer-funded government claims program that uses…employees of Health and Human Services (HHS), rather than judges to make decisions on compensation.” While government-funded Department of Justice (DOJ) lawyers vigorously represent and defend the interests of HHS and vaccine manufacturers, the consumer-unfriendly system forces the vaccine-injured to meet an exceptionally high burden of proof. For dismissed claims, there is no assurance that the program will even cover attorneys’ fees and costs.

Children’s Health Defense recently called attention to a glaring example of the NVICP’s pro-industry and anti-vaccine-injured bias. In 2007 and 2008, DOJ attorneys exhibited “highly unethical and appallingly consequential official misconduct” during an Omnibus Autism Proceeding (OAP) orchestrated to determine the fate of 5,400 families who had filed claims for vaccine-induced autism. The potential value of the claims exceeded $100 billion—an amount that “would have bankrupted the [compensation] program many times over.” HHS’s Department of Justice lawyers, “under pressure” to deprive petitioners of their rightful relief, successfully achieved that aim through allegedly fraudulent means. In September 2018, Children’s Health Defense Chairman Robert F. Kennedy, Jr. and Rolf Hazlehurst (parent of one of the vaccine-injured children involved in the OAP) requested that the DOJ Inspector General and Congress investigate this fraud and obstruction of justice by HHS and DOJ officials.

Individuals who file claims with VICP must meet specific “medical criteria” and are out of luck unless their illness, disability, injury or condition is covered in the NVICP’s Vaccine Injury Table and manifests within a specified time frame. As an illustration of the difficulties that NVICP petitioners may encounter, consider someone who experiences myocarditis (heart inflammation) following vaccination. A 2018 article in BMJ Case Reports recently observed that myocarditis is one of “the more serious vaccine-related sequela” and “has been reported following many different vaccines.”

Another recent article in a European medical journal describes post-vaccination reports of myopericarditis (inflammation of both the pericardium and the heart muscle) and other autoimmune disorders and offers two extremely plausible mechanisms “by which vaccines can cause autoimmune reactions.” In the Vaccine Injury Table, however, the only place where cardiac symptoms are mentioned is in connection with anaphylaxis—with the table’s notes indicating that “there are no specific pathological findings to confirm a diagnosis of anaphylaxis”—and most autoimmune illnesses are also conspicuously absent.

Tip of the Iceberg

By anyone’s accounting, the $4 billion paid out to date by the NVICP is an attention-getting amount of money. However, that amount pales in comparison to the billions of dollars’ worth of autism claims that the vaccine court unfairly dismissed. According to HHS, moreover, “fewer than 1% of vaccine adverse events are reported,” and studies confirm that many health providers are unfamiliar with the system for reporting vaccine injuries. The shocking underreporting of vaccine injuries also fails to account for the fact that one in six individuals who experience an “adverse event following immunization” (AEFI) have a recurrence with subsequent vaccination, often rated as “more severe than the initial AEFI.” If even a small percentage of these unreported and recurrent vaccine injuries were brought forward for compensation, the entire NVICP house of cards—and the CDC’s deceptive claims of unassailable vaccine safety—would crumble.

A Gold Rush: Liability Protection Encourages More Vaccines

Instead, whether intended or not, the end result of the 1986 Act and the NVICP has been to create a “gold rush” environment that encourages manufacturers to develop even more vaccines, while conveniently exempting them from liability for the injuries and deaths that result from their powerful immune-system-altering products. With no incentive to make vaccines safe and a large and lucrative market guaranteed by the Centers for Disease Control and Prevention’s childhood vaccine schedule—as well as a growing effort to foist unnecessary and dangerous vaccines on adults—vaccine manufacturers appear to have it made. The public and vaccine safety advocates must continue to remind the government that the approximately 6,300 claims that have been compensated over the NVICP’s 30-year history represent the very tip of the iceberg.

Unanswered Questions from the Vaccine Injury Compensation Program

A Review of Compensated Cases of Vaccine-Induced Brain Injury

Is the Vaccine Injury Compensation Program (“VICP”) of the U.S. Court of Federal Claims a fair forum? This is not a trivial question as it is the only forum in which parents may bring claims for vaccine injury to their children.

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A Dose of Reality for Specialized Courts: Lessons from the VICP

The latest in a long line of reform proposals, health courts have been called “the
best option for fixing our broken system of medical justice.” And, if health courts’
supporters are to be believed, these specialized courts are poised to revolutionize
medical malpractice litigation: They would offer faster compensation to far more
people, while restoring faith in the reliability of legal decisionmaking. But these
benefits are, as some leading supporters have acknowledged, “hoped for, but
untested.” The question remains: Will health courts actually operate as effectively as
proponents now predict?

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Victim Friendly National Childhood Vaccine Injury Compensation Act: You’ve Got to Be Kidding!

Anyone who has yet to engage in practice governed by the National Childhood Vaccine Injury Compensation Act, a step required for all current vaccine injury and death claims as a condition precedent to litigation in a private forum, should proceed with great caution.

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