What Is the Vaccine Court?

Justice Scales and books and wooden gavel

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While vaccines are a safe and effective way to prevent diseases, no medical intervention is 100% risk-free. Usually, the worst side effect someone will experience after getting a vaccine is a fever or a sore arm, but a very small percentage—about one in 1 million—can have a serious or life-threatening reaction. When that happens, the person can seek compensation for a vaccine injury in the U.S. through what's commonly called the vaccine court.

What Is the Vaccine Court?

The Office of Special Masters, or "vaccine court," runs the National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the U.S. legal system. When someone thinks they’ve been injured by a vaccine, instead of filing a lawsuit against the vaccine manufacturer directly, they can seek compensation from the U.S. Court of Federal Claims.

How the VICP Works

Vaccine court works a little like a traditional one. There are two parties who present their cases, and a special master makes a determination, much like a judge. Here’s how the process works: 

  • A claim is filed: A person who believes they've been injured by a vaccine files a claim with the U.S Court of Federal Claims.
  • It is reviewed by medical staff: Medical staff at the U.S. Department of Health and Human Services (HHS) review the case and make a recommendation based on specific medical criteria.
  • A report is submitted to the court: Then the U.S. Department of Justice analyzes the petition from a legal standpoint and submits a report to the court that includes both its legal analysis and the medical recommendations made by HHS.
  • The petition is reviewed: A special master appointed by the court reviews the petition and decides whether compensation is warranted and how much—often after a hearing where both the U.S. government and the individual who filed the petition get a chance to present their evidence.
  • Compensation is awarded or case is dismissed: HHS awards any compensation and/or legal fees and costs, based on the court’s decision. If the case was dismissed, however, the person who filed the petition can appeal or file a claim against the vaccine manufacturer or health care provider in civil court.
  • The case may be settled out of court: If both parties want to minimize the risk of loss, time or expense, or they want to resolve the petition quickly, the case can be settled out of court. In fact, most compensation awarded by the VICP is the result of a negotiated settlement.

The process has its challenges. For example, the program doesn’t cover every vaccine available in the U.S., though it does cover all routinely recommended childhood vaccines, as well as some adult vaccines (including the flu shot).

Petitions can also take years to be decided by the court, and individuals are expected to provide evidence for why they believe the vaccine caused their alleged injury.

Unlike the civil courts, the VICP gives families the benefit of the doubt, so long as the injury is included in a list of conditions presumed to be caused by vaccines, known as the vaccine injury table.

What Vaccines Are Covered Under the VICP?

The vaccine injury table is a list of specific vaccines and adverse events (like an illness or medical condition) covered by the VICP. The table defines what specific injuries are associated with each vaccine, as well as when the events or conditions would have to begin in order for the court to presume the vaccine caused the injury.

If you have a condition or injury that meets the criteria outlined in the table, you don’t have to prove to the court that the vaccine caused the injury in order to be compensated, unless there’s proof it was caused by something else.

Individuals can still be compensated for conditions or events not included in the vaccine injury table, but it’s more challenging. The court won’t presume the vaccine caused the injury so it’s up to the individual petitioner to make a strong case proving that it did.

The vaccine injury table is updated periodically by the Secretary of HHS, who can add conditions or injuries to the table for either scientific or policy reasons. When they do, HHS posts a notice and gives the public an opportunity to comment.

New vaccines can be covered by the program if they are already included as a category in the table. For example, a new brand of hepatitis B would be included in the program because hepatitis B vaccines (in general) are already listed.

It's important to note that autism is not included in the list of vaccine injuries covered by the VICP.

What Is the History of the Vaccine Court?   

Before the vaccine court was established in the U.S., individuals who believed they were injured by vaccines had to go through traditional civil courts to get compensation. It was messy and expensive for families and vaccine manufacturers alike. In civil court, families had a high burden to prove a specific vaccine caused the alleged injury, and there were virtually no limits to what vaccine manufacturers could be sued for.

Not wanting to deal with the financial risk of lawsuits, pharmaceutical companies stopped making vaccines. Vaccine shortages threatened to leave kids vulnerable to potentially deadly diseases.

National Childhood Vaccine Injury Act (NCVIA)

The crisis of possible vaccine shortages led the U.S. Congress to pass the National Childhood Vaccine Injury Act (NCVIA) essentially changing the way the U.S. government addressed adverse events following vaccination.

The National Childhood Vaccine Injury Act was passed by the federal government in 1986, establishing the VICP primarily as a way to make it easier for families to get compensated for legitimate vaccine injuries as well as to keep pharmaceutical companies from abandoning production of new or existing vaccines.

In addition to establishing the vaccine court, the act also included a list of specific injuries possibly caused by vaccines that could be compensated under the new program and outlined how much could be given for lawyers’ fees, loss of earnings, and pain and suffering.

The vaccine court wasn’t the only thing to emerge from the NCVIA. The act also put in motion several programs and systems designed to improve informed consent and monitor vaccine safety. These include vaccine information statements (VIS) and the Vaccine Adverse Event Reporting System (VAERS).

Vaccine Information Statements (VIS)

VIS sheets are one-page documents that discuss in easily understood terms what a specific vaccine is for, who should and shouldn’t get it, and the risks and benefits research shows to be associated with that specific vaccine.

When you get a vaccine in the U.S., health care providers are legally obligated to give you a VIS sheet specific to the vaccine(s) you’re receiving , and they are also accessible to anyone online through the Centers for Disease Control and Prevention (CDC) website at any time.

Vaccine Adverse Event Reporting System (VAERS)

VAERS was set up by the CDC and Food and Drug Administration (FDA) in 1990 to monitor the safety of vaccines. If something unwanted happens after getting a vaccine dose, anyone can report it to VAERS, including parents and doctors—even if they aren’t sure the vaccine caused the adverse event.

The CDC uses the data to detect warning signs that can help the agency:

  • Spot new, unusual, or rare adverse events that might not have come up during earlier clinical trials.
  • Monitor upticks in known adverse events linked to vaccines.
  • Identify things that might make someone more likely to get an adverse event (also called risk factors).
  • Evaluate the safety of new vaccines.
  • Determine and address groups of reports that could signal safety problems, for example, signs that a particular batch of vaccines might be linked to specific adverse events. 

Some adverse events reported to VAERS have nothing to do with vaccines, and not all adverse events are reported to the system. For these reasons, the CDC warns that “[t]he number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.”

VAERS is meant to spot warning signs, and it should never be used as proof that vaccines cause a particular side effect or that vaccines are somehow inherently unsafe.

Even with these caveats, it doesn’t take much for the system to spot red flags. For example, in 1998 a now-discontinued vaccine was approved by the FDA to protect infants from rotavirus, a virus that causes diarrhea, vomiting, and (consequently) serious dehydration in young children. 

After the vaccine’s release, reports to VAERS signaled it could be causing intussusception (a rare form of intestinal blockage) in small babies. After less than a year on the market, the CDC suspended use of the vaccine to study the issue, and the vaccine manufacturer quickly pulled it from the market. The risk ended up to be rare (about one in 10,000), but it was enough for the U.S. to discontinue its use. It took just 15 VAERS reports to set the whole process in motion.

Common Questions

Many people are simply not familiar with the vaccine court nor how it works. There are several common questions that come up like, where does the money come from for payouts? And can pharmaceutical companies still be sued?

How Often Do Vaccine Doses Result in a Vaccine Court Payout?

Compensation by the VICP is extraordinarily rare. Of the more than 3.4 billion doses of VICP-covered vaccines distributed in the U.S. from 2006 to 2017, only around 6,400 cases were decided by the vaccine court, and only about 4,400 were awarded compensation. Put another way, for every million doses of vaccine, only about one has resulted in compensation by the court thus far.

Where Does the Money for Payouts Come From? 

The VICP is funded by the Vaccine Injury Compensation Trust Fund and paid for by an excise tax collected from the vaccine manufacturers and included in the price of the vaccine. Manufacturers pay $0.75 per vaccine dose.

If a vaccine prevents more than one disease—as is the case of combination vaccines—the tax is multiplied accordingly. For example, a flu shot is taxed at $0.75 a dose even though it protects against multiple strains because it prevents a single disease (influenza), whereas the MMR (measles, mumps, and rubella) vaccine is taxed at $2.25 because it prevents three.

Does Compensation Mean the Vaccine Caused the Injury?

Not necessarily. In fact, for the vast majority (roughly 70%) of cases compensated by the VICP, the HHS hadn’t concluded that the vaccine caused the injury. Cases are awarded compensation for a number of reasons.

Sometimes, a case is settled because both parties want to speed things along. In which case, a determination is never made whether the vaccine caused an injury or not. And in other instances, attorneys’ fees are paid out even if the case itself isn’t compensated by the court. 

Because of this, payouts shouldn’t be seen as proof that a vaccine caused a particular condition, and the number or amounts of compensation awarded shouldn’t be an indication of the size or scope of vaccine injuries in the U.S.

Can Individuals Still Sue Pharmaceutical Companies?

Yes, individuals in the U.S. can still sue pharmaceutical companies, but there are caveats. If they want to sue to get compensation for what they believe to be a vaccine injury, they have to go through the process of filing a petition with the VICP first. If their petition is dismissed or they reject the awarded compensation, they can then go through the civil courts to sue the vaccine manufacturer directly.

Individuals can also still sue pharmaceutical companies for reasons other than vaccine injury.

Does the Government Keep the Court or Its Payouts a Secret?

No. Several government websites outline the VICP in detail, including discussing how it works and what the payout statistics are. Individual payouts might not be widely covered in the media, but any claims that the U.S. government is “hiding” or “quietly” paying people for their alleged injuries are simply untrue.

A Word From Verywell 

The vaccine court is often referenced by vaccine opponents as a way to criticize the safety of vaccines or mislead people into thinking those injured by vaccines have no recourse. The reality is quite the opposite.

While an imperfect system, the VICP provides an easier method than civil courts for individuals with known vaccine injuries to get compensation, and with only one dose in a million leading to compensation, it demonstrates just how safe the U.S. vaccine supply really is.

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Article Sources

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