What Is the Vaccine Court?

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 mild fever or a sore arm, but a very small percentage of people may experience a serious or even life-threatening reaction.

When this happens, individuals in the United States can seek compensation for such injuries through what is commonly referred to as the vaccine court.

Justice scales and books and wooden gavel
Witthaya Prasongsin / Getty Images 

What the Vaccine Court Does

The National Vaccine Injury Compensation Program (VICP) allows someone who thinks they have been injured by a vaccine to seek compensation through the U.S. Court of Federal Claims.

The program is overseen by the Office of Special Masters—a.k.a. "the vaccine court"—and is considered a no-fault alternative to filing a lawsuit with a vaccine manufacturer.

Compensation, when approved, is provided by the U.S. Department of Health and Human Services (HHS).

Why the Vaccine Court Was Created

Before the vaccine court was established in the United States, individuals injured by vaccines had to go through traditional civil courts to get compensation. It was a messy and expensive process for families and vaccine manufacturers alike.

Families were faced with a high burden of proof that many could not meet. On the flipside, there were virtually no limits to what vaccine manufacturers could be sued for.

In some cases, pharmaceutical companies would stop making vaccines altogether to avoid legal exposure. This, in turn, led to vaccine shortages as more and more manufacturers abandoning vaccine production.

Such was the case with the manufacturers of LYMErix, a Lyme disease vaccine that attracted multiple class-action lawsuits claiming that the shot caused chronic arthritis. Faced with compounding legal risks and waning sales, the manufacturer discontinued the vaccine in 1991—a mere three years after it was approved by the U.S. Food and Drug Administration (FDA).

The crisis of possible vaccine shortages led the U.S. Congress to pass the National Childhood Vaccine Injury Act (NCVIA) of 1986. VICP came out of this piece of legislation and judgments on petitions started in 1988.

The creation of the vaccine court addressed two related needs:

  • Give Americans means to successfully obtain compensation for legitimate vaccine injuries
  • Protect vaccine supplies by sheltering pharmaceutical companies from lawsuits that could disincentivize production

How the VICP Works

Vaccine court works a little like a traditional court. There are two parties who present their cases, as well as a special master who functions much like a judge.

The process by which compensation is sought follows standard steps:

  1. A petition is filed: A person who believes that they have been injured by a vaccine files a petition with the U.S. Court of Federal Claims. Specific instructions on how to do this are available on the Health Resources & Services Administration's website (part of HHS).
  2. The petition is reviewed: Medical staff at HHS review the file and make a recommendation based on specific medical criteria.
  3. A report is submitted to the court: 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.
  4. The petition is reviewed: A special master appointed by the U.S. Court of Federal Claims reviews the petition and decides whether compensation is warranted and, if so, how much.
  5. A hearing is scheduled (if needed): If there is any contention as to the validity of the claim, a hearing is scheduled in which a representative of the government and the individual who filed the petition (along with a legal representative, if desired) present their cases.
  6. A decision is made: If the vaccine court agrees with the petitioner, compensation is awarded by HHS. If the case is dismissed, the person who filed the petition can appeal or file a separate claim against the vaccine manufacturer in civil court.

If both parties want to avoid the time and expense of this process, a negotiated settlement can be made out of court. In fact, most compensations awarded by the VICP come from such settlements. In such cases, blame is not assigned and a determination of cause is not made.

Challenges and Limitations

The process of seeking compensation from the VICP has its challenges. Among them, the program doesn’t cover every vaccine in the United States (although it does cover all routinely recommended childhood vaccines, as well as some adult vaccines).

Vaccines for 16 different infectious diseases are covered by VICP:

The VICP does not cover Shingrix (the shingles vaccine) or the pneumococcal vaccine Pneumovax. Claims of injury from these vaccines need to be filed in civil court.

Another drawback to the VICP system is time. Petitions can often take years to be decided by the court, and petitioners are frequently burdened with demands to provide additional medical or corroborating evidence during the review process.

Qualifying Events and Compensation

Despite some considerable challenges, the VICP tends to give petitioners the benefit of the doubt as long as the injury is included in program's vaccine injury table.

This is a list of conditions presumed to be caused by vaccines. It outlines the specific adverse events associated with each vaccine, as well as the events or conditions that would have to have taken place in order for the court to presume the vaccine caused the injury.

If you have a condition or injury that meets the criteria, you do not have to prove that the vaccine caused the injury in order to be compensated.

The vaccine injury table defines compensable injuries based on three criteria:

  1. A specific list of vaccine types (including whether it a live vaccine, inactivated vaccine, etc.)
  2. A specific list of illnesses, disabilities, injuries, or conditions associated with each vaccine (such as anaphylaxis, chronic arthritis, Guillain-Barré syndrome, shoulder injury, etc.)
  3. The time during which the first symptoms appeared (this could be within days or months of the dose)

In addition to compensation amounts, the table outlines how much can be awarded for lawyers’ fees, loss of earnings, and pain and suffering.

The vaccine injury table is updated periodically by the Office of the Secretary of HHS, which can add conditions or injuries based on science or policy. When it does, HHS posts a notice and gives the public an opportunity to comment.

In addition, any new vaccine can be covered by VICP, at least in part, if it has been recommended for use by the Advisory Committee on Immunization Practices (ACIP), an independent group of experts within the Centers for Disease Control and Prevention (CDC).

Individuals can still be compensated for conditions not included in the vaccine injury table, but it is more challenging. The court won’t presume that the vaccine caused the injury, so it will be up to the petitioner to make a strong case to evidence their claim.

Informed Consent and Safety

The vaccine court wasn’t the only thing to emerge from the NCVIA. The act also put in motion several programs designed to improve informed consent and monitor vaccine safety.

Vaccine Information Statements (VIS)

Vaccine information statements (VIS) are two-page documents that describe what a vaccine is for, who should and shouldn’t get it, and the risks and benefits of use in easily understood terms.

When you get a vaccine in the United States, healthcare providers are legally obligated to give you a VIS specific to the vaccine you are receiving. The documents can also be viewed on the CDC website.

Vaccine Adverse Event Reporting System (VAERS)

The Vaccine Adverse Event Reporting System (VAERS) was set up by the CDC and FDA in 1990 to monitor the safety of vaccines.

If an adverse event occurs after receiving a vaccine dose, an individual or their doctor, guardian, or representative can report it to VAERS. Reports are welcome even if it is unclear whether the vaccine caused the adverse event or not.

The data collected by VAERS can help the CDC:

  • Spot new, unusual, or rare side effects that may not have come up during clinical trials
  • Monitor for increases in known adverse events
  • Identify factors that might increase a person's risk of an adverse event
  • Evaluate the safety of new vaccines
  • Determine whether a particular batch, type, or brand of vaccine is linked to a specific adverse event

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 “the number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.”

Even with these caveats, it doesn’t take much for the system to spot red flags.

In 1998, a rotavirus vaccine called RotaShield was pulled from the market after VAERS data showed that it could cause intussusception (a rare form of intestinal blockage) in small babies. While the risk was low (about one in 10,000), it was enough for the FDA to discontinue the vaccine's use. 

Common Questions

How many injury claims reach the vaccine court?
Fewer claims make their way to vaccine court than one might expect. Of the more than 3.7 billion doses of VICP-covered vaccines distributed in the United States from 2006 to 2018, only around 7,000 cases were taken up, and only 4,800 were awarded compensation.

Put another way, for every million doses of vaccine distributed, only around one results in compensation by vaccine court.

Where does the compensation money come from? 

The VICP is funded by the Vaccine Injury Compensation Trust Fund. Money in this fund comes from excise taxes collected from vaccine manufacturers. The tax is included in the price of the vaccine and comes to around $0.75 per vaccine dose, or disease that is prevented.

If a vaccine prevents more than one disease—such as with combination vaccines—the tax is multiplied accordingly. For example, a flu shot is taxed at $0.75 a dose because it treats a single disease, whereas the MMR (measles, mumps, and rubella) vaccine is taxed at $2.25 because it prevents three.

Does compensation mean the vaccine is to blame?

Not necessarily. In fact, in around 70% of compensated cases, the HHS made no determination as to whether the vaccine caused the injury or not.

Because of this, payouts should not be seen as proof that a vaccine caused a particular condition. Similarly, the number or size of compensations awarded should not be seen to reflect the size or scope of vaccine injuries in the United States.

Can individuals still sue pharmaceutical companies?

Individuals in the United States can directly sue pharmaceutical companies for vaccine injuries, but there are caveats.

If a person believes that their claim is valid and litigable, they still have to go through the process of filing a petition with the VICP first. It is only after their petition is dismissed or they reject the compensation that they can go through the civil courts to sue the vaccine manufacturer directly.

Does the U.S. government keep payouts secret?

Under the NCVIA, compensation statistics must be disclosed. Several government websites overseen by the Health Resources and Services Administration provide payout statistics and detail what is involved in determining vaccine injury compensation.

Individual payouts might not be widely covered in the media, but any claims that the federal government is "covering up" vaccine injuries are simply untrue.

A Word From Verywell 

The vaccine court is often referenced by vaccine opponents as a way to question the safety of vaccines or mislead people into thinking those injured have no recourse. The reality is quite the opposite. While the system is far from perfect, the VICP provides an easier way to obtain compensation than through civil courts.

This is important for those who may have been harmed by a vaccine. But thankfully, with only one dose per million leading to vaccine injury compensation, the U.S. vaccine supply has proven to be not only extremely effective, but safe.

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Article Sources
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