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Can I Sue Vaccine Manufacturers?

Close-up medical syringe with a vaccine.

If you believe that your child has been injured as a result of vaccination, can you sue the manufacturer of the vaccine for damages?

The short answer is, no, you likely cannot sue the vaccine manufacturer. However, you may still be able to be compensated for your child's injuries through another process called the Vaccine Injury Compensation Program.

Why Can't Drug Companies Be Sued for Vaccine Injuries?

When most drugs cause harm, the pharmaceutical companies that make them can be sued in product liability lawsuits. But that isn't the case with vaccines. In 1986, Congress passed a law that protects vaccine manufacturers from being sued in civil personal injury and wrongful death lawsuits resulting from vaccine injuries.

Both drugmakers and federal government officials admit that although vaccines are created with the purpose of keeping the public safe, they can cause rare but serious, and sometimes fatal, side effects.

In the 1970s and 80s, drugmakers paid out millions to plaintiffs in hundreds of vaccine-related injury lawsuits. The litigation was complex and expensive because of how difficult it is to show epidemiological cause and effect in these cases.

Eventually, some drugmakers decided to stop making vaccines altogether. This drew alarm from public health officials, who worried about sustaining existing vaccines and also the development of new vaccines.

The National Childhood Vaccine Injury Act

Congress stepped in with the National Childhood Vaccine Injury Act of 1986 (the Vaccine Act) as a way to ensure that the injured would receive compensation, but also to protect drugmakers from open-ended liability.

In 2011, an important United States Supreme Court ruling clarified the type of lawsuits vaccine manufacturers are protected from under the Vaccine Act. In a 6-2 decision, the Court ruled that the federal law protects drugmakers from design-defect claims as long as the vaccine was properly manufactured and carried adequate warnings labels.

The National Vaccine Injury Compensation Program

When Congress granted drug companies immunity in regular court with the Vaccine Act, it established the Vaccine Injury Compensation Program. The no-fault compensation program was created as its own "court" to compensate those who claim to have suffered side effects caused by vaccines.

Since the program was created in the late 1980s, it has paid out more than $4 billion to those who said they were harmed by vaccines. The average payment per injured party from 2013 to 2017 was about $430,000, with an average of $229 million per year in total.

How Does the Vaccine Injury Compensation Program Work?

Because the program is not fault-based, people claiming vaccine injuries do not have to prove that the vaccine actually caused the injury. Instead, they only have to show that the injury occurred immediately after the vaccine was given.

Additionally, the vaccine-related injury has to be included on the vaccine court's list of side effects, called the Vaccine Injury Table. The vaccine involved must also be covered by the program. All routinely administered vaccines are included:

  • Diphtheria and Tetanus vaccines (e.g., DTaP, DTP, DT, Td, or TT)
  • Pertussis vaccines (e.g., DTP, DTaP, P, Tdap, DTP-Hib)
  • Measles, Mumps, and Rubella vaccines (e.g., MMR, MR, M, R)
  • Polio vaccines (e.g., OPV or IPV)
  • Hepatitis A vaccines (e.g., HAV)
  • Hepatitis B vaccines (e.g., HBV)
  • Haemophilus influenza type b vaccines (e.g., Hib)
  • Varicella vaccines (e.g., VZV) [herpes zoster (shingles) vaccine is not covered]
  • Rotavirus vaccines (e.g., RV)
  • Pneumococcal conjugate vaccines (e.g., PCV)
  • Seasonal flu vaccines (e.g., IIV3 standard dose, IIV3 high dose, IIV4, RIV3, LAIV3, LAIV4)
  • Human Papillomavirus vaccines (e.g., HPV)
  • Meningococcal vaccines (e.g., MCV4, MPSV4, recombinant)

When parents believe their child has been injured by a vaccine and the above requirements have been met, they can file a claim with the Vaccine Injury Compensation Program. The process typically looks like this:

1. Injured Party Files a Petition

The first step in filing a claim with the Vaccine Injury Compensation Program is to file a petition with the U.S. Court of Federal Claims, the court that handles vaccine injury claims. The court then notifies the Department of Health and Human Services (HHS) and the Department of Justice (DOJ), which represent HHS in the vaccine court process.

2. HHS Reviews the Petition

In the second step, a healthcare provider with the HHS reviews the petition. The provider determines if the claim meets the medical standards for compensation through the program and then makes a recommendation to the DOJ. The DOJ then submits the government's position to the court.

3. Special Master Makes Decision

A "special master" is appointed by the court. They make a decision on whether compensation should be granted in the case after reviewing the report submitted by the DOJ.

The decision to award compensation doesn't necessarily mean that the HHS determined that the vaccine caused the injury. Instead, it could represent a negotiated settlement aimed at reaching a quick resolution or avoiding expensive litigation.

4. Injured Party Files an Appeal, Accepts Decision, or Rejects Decision

After the special master's decision has been issued, the claimant can accept the decision, decide to file an appeal, or reject the decision and file a claim in civil state court.

Wait — state court? Hasn't this whole article been about how drug companies can't be sued? Yes, but it may be possible to file a regular lawsuit in civil court against the vaccine manufacturer for non-preempted reasons (reasons not covered by the Vaccine Act). For example:

  1. You believe that the vaccine was not manufactured properly (e.g., not in accordance with the FDA-approved design); or
  2. You believe the manufacturer failed to provide the proper directions and warnings with the vaccine.

Finally, it may be possible to file a regular tort claim against the healthcare provider who administered the vaccine if you believe negligence was involved.

Do You Need a Lawyer to File a Claim With Vaccine Court?

No, you do not need a lawyer to file a petition with the Vaccine Injury Compensation Program; however, most people do use a lawyer because the process is a legal proceeding and can be confusing and overwhelming to nonlawyers.

For example, there are strict timelines that have to be met, evidence that has to be provided, and a number of requirements that have to be satisfied before the petition will be accepted. Settlement negotiations may also take place.

Generally, the program will pay for lawyer's fees and legal costs related to filing the petition, even if the claim is ultimately denied.

HPV Vaccine Lawsuit: Can I Sue Gardasil?

The United States has voluntarily discontinued the use of the Gardasil HPV vaccine, though other parts of the world still may use it. There have also been voluntary recalls of batches of the vaccine. The Centers for Disease Control and Prevention (CDC) still recommends Gardasil injection for HPV prevention

The Gardasil vaccine was manufactured by Merck & Co. and approved by the U.S. Food and Drug Administration (FDA) in 2006. The vaccine is used to prevent some strains of the human papillomavirus (HPV). There are currently hundreds of strains of HPV. The vaccine was recommended to help prevent cervical cancer and numerous Gardasil lawsuits have been brought for adverse reactions, serious side effects, blood clots, and postural orthostatic tachycardia syndrome (POTS).

Who Can File a Vaccine Injury Petition?

Anyone who has received a covered vaccine and believes they have been injured as a result can file a claim with the program. Parents or legal guardians can file on behalf of their children. Legal representatives are permitted to file on behalf of the disabled and deceased.

However, all claims (with limited exceptions) must be filed within three years of the first symptoms, or within two years of death and within four years of the first symptoms that resulted in death.

If you have questions about the process or your situation, contact an experienced health care attorney in your area.

Other Helpful Resources:

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