Can I Sue Vaccine Manufacturers?

Vaccines are an essential part of modern life. We have eradicated diseases such as polio, tetanus, and smallpox through vaccines. Vaccines are not risk-free, however. Everyone reacts differently to a vaccine. Some people sustain injuries or adverse reactions from vaccination.

Despite this, we cannot sue vaccine manufacturers for any harm that results from inoculation. This does not mean there are no remedies in case of an injury or death. The federal government has two programs to compensate anyone who sustains vaccine-related injuries. The first is the Vaccine Injury Compensation Program. The second is the countermeasures injury compensation program (CICP). This article will explore both programs.

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

When most drugs cause harm, pharmaceutical companies face product liability lawsuits. But that isn't the case with vaccines. In 1986, Congress passed a law protecting vaccine manufacturers from civil personal injury and wrongful death lawsuits resulting from vaccine injuries. That law is the National Childhood Vaccine Injury Act of 1986 (the Vaccine Act).

Drugmakers and federal government officials admit that although vaccines help keep the public safe, they can cause rare, serious, and sometimes fatal side effects.

In the 1970s and '80s, drugmakers paid millions to plaintiffs in hundreds of vaccine-related injury lawsuits. The litigation was complex and expensive because it was challenging 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. They worried about sustaining existing vaccines and developing new vaccines.

The National Childhood Vaccine Injury Act

Congress stepped in with the Vaccine Act to ensure the injured would receive compensation. It also protects drugmakers from open liability. In 2011, the United States Supreme Court clarified the type of lawsuits the Vaccine Act protects. The Court ruled that the federal law protects drugmakers from design-defect claims as long as the vaccine was properly manufactured and carried adequate warning 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 is its own "court" created to compensate those who claim to have suffered vaccine side effects caused by vaccines.

Since the program's creation in the late 1980s, it has paid more than $4 billion to those who said vaccines harmed them. The average payment per injured party from 2013 to 2017 was about $430,000, an average of $229 million annually.

How Does the Vaccine Injury Compensation Act Work?

Because the program is not fault-based, people claiming vaccine injuries do not have to prove that the vaccine caused the damage. Instead, they only have to show that the injury occurred within a certain time period, depending on the vaccine, after vaccine administration.

The Vaccine Injury Table covers possible vaccine-related injuries and side effects. The program must also cover the vaccine involved. All routinely administered vaccines include:

• 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)

Filing A Claim (VICP)

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

File a Petition

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

HHS Reviews the Petition

In the second step, an HHS healthcare provider reviews the petition. The provider determines if the claim meets the medical standards for compensation and then gives a recommendation to the DOJ. The DOJ then submits the government's position to the Court.

Special Master Makes a Decision

A "special master" is a person appointed by the Court. They decide whether to grant compensation after reviewing the report submitted by the DOJ.

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

Injured Party Files an Appeal, Accepts the Decision, or Rejects the Decision

After the special master issues a decision, the claimant can accept the decision, decide to file an appeal, or reject the decision and file a claim in civil state court. A party can file a regular lawsuit in civil court against the vaccine manufacturer under certain circumstances. For example:

• The vaccine was not appropriately manufactured (e.g., not following the FDA-approved design); or

• The manufacturer failed to provide the proper directions and warnings with the vaccine.

• Negligence — file a tort claim against the healthcare provider.

Countermeasures Injury Compensation Program (CICP)

The CICP differs from the VICP in one notable way: It addresses public health emergencies and national security threats. The government will support developing countermeasures to address the threat in a public health emergency, such as the recent coronavirus (COVID-19) pandemic. Any vaccines, medications, or devices used to prevent or treat a public health emergency are a countermeasure.

The CICP and the public readiness and emergency preparedness act (PREP Act) work together. Under the PREP Act, the Secretary of Health can issue a declaration. This declaration shields drug manufacturers and healthcare providers from liability related to a countermeasure. The order will identify the public health emergency and the recommended countermeasures.

The COVID-19 vaccine is the most recent countermeasure developed in response to a public health emergency. Drug manufacturers, like Pfizer and Moderna, developed COVID vaccines in record time. Anyone who sustained a severe injury or died after the administration of a COVID vaccine is eligible for compensation under the CICP. This includes medical expenses, lost employment, and a death benefit for survivors. Injured parties have one year after receiving the vaccine to file a claim under the CICP. The injured person or their estate must file a Request for Benefits package. That package must include the following:

• Request for Benefits form or a letter of intent

• Proof of vaccine administration

• Medical records

• Proof of injury

Who Can File a Vaccine Injury Petition?

Anyone who has sustained an injury can file a claim with either program. Parents or legal guardians can file on behalf of their children. Legal representatives can file on behalf of the disabled and deceased. If you have questions about the process or your situation, contact an experienced local healthcare attorney.

Other Helpful Resources:

• Vaccination Laws

• What Is Vaccine Injury Compensation?

• School Vaccine Exemption Laws by State