Can I Sue a Vaccine Manufacturer for Side Effects?

Probably not. Pharmaceutical companies are generally immune from most vaccine-related personal injury lawsuits. That includes suits relating to the coronavirus (COVID-19) vaccines.

Depending on the particular vaccine, you may be able to recover at least some money from a federal program.

What Is a Vaccine?

Vaccination is an effective way of protecting yourself from harmful diseases before you become infected. Vaccines teach your immune system to create antibodies to a disease, just as if you have been exposed so that your own body can fight off an infection.

As long as the vast majority of people are vaccinated, it is much more difficult for an outbreak of disease to occur, let alone spread. This saves lives.

Vaccines Have Improved Lives

To say the least, vaccines have been a game-changer. In fact, some believe them to be the greatest life-saving innovation in the history of medicine.

A great example is the smallpox vaccine. Smallpox used to be a deadly disease. Between 1900 and 1920, it killed around 300 million people, but the development and introduction of a vaccine essentially eliminated the disease.

Vaccines have also worked for other diseases. For example, according to the U.S. Centers for Disease Control and Prevention (CDC), the flu vaccine has dramatically reduced the number of flu-related hospitalizations and doctor visits. Other diseases, such as measles, mumps, pertussis, diphtheria, and tetanus, are far less common than they used to be because of widespread childhood vaccination programs.

Vaccines Can Have Side Effects

Vaccines do carry some risks. Some people experience side effects. The United States Food and Drug Administration (FDA), which is the regulator of vaccine manufacturers, calls these adverse events, but they're better known as side effects.

For some, side effects can be mild, such as headaches or nausea. Serious side effects are rare. Sometimes vaccines are associated with deaths, but the data is often anecdotal at best.

Side Effects of COVID-19 Vaccines

The FDA has approved three COVID-19 vaccines in the United States for emergency use. Pfizer, Moderna, and Janssen/Johnson & Johnson make them.

COVID-19 vaccines have been associated with certain, mostly mild, side effects. They include:

• Fever
• Headaches
• Nausea and vomiting
• Pain in or near the injection site
• Fatigue
• Joint pain
• Swollen lymph nodes

Most side effects show up within the first three days after vaccination and in general last one or two days.

There have also been rare reports of heart inflammation, particularly in young men, after vaccination with the Pfizer and Moderna vaccines. The CDC is investigating these reports.

There have been serious side effects of the Janssen/Johnson & Johnson COVID-19 vaccine. They can occur within three weeks of vaccination. They include:

• Shortness of breath
• Persistent stomach pain
• Severe headaches
• Blurred vision
• Chest pain
• Leg swelling
• Easy bruising
• Red spots on the skin beyond the injection site

There have also been rare reports of people developing a nerve disorder or severe blood clotting after getting the Janssen/Johnson & Johnson vaccine. We discuss these reports and possible legal relief here.

Most Vaccine Manufacturers Cannot Be Sued for Side Effects

To encourage the development and use of new vaccines, including the COVID-19 vaccine, the federal government granted drugmakers substantial immunity from personal injury and product liability lawsuits involving vaccines. Let's focus on two contexts and federal statutes.

The Public Readiness and Emergency Preparedness Act

As we have described elsewhere, the first involves the Public Readiness and Emergency Preparedness Act (the PREP Act).

The PREP Act empowers the Secretary of the Department of Health and Human Services (HHS) to immunize “covered persons," including pharmaceutical companies and healthcare providers, that make what are called countermeasures including vaccines from liability in a declared public health emergency.

On March 17, 2020 (effective February 4, 2020), the Secretary of HHS declared the coronavirus pandemic to be such an emergency.

The manufacturers of COVID-19 vaccines such as Pfizer and Moderna enjoy sweeping liability protection from personal injury or product liability suits. The sole exception is for death or serious physical injury caused by willful misconduct.

The Willful Misconduct Claim

This claim can be difficult to prove, so if you do choose to sue it's recommended that you get a lawyer, because you will need one. The rules that apply to these cases are very specific, and it is easy to make mistakes that could hurt and even ruin any chances of recovery.

Some of the applicable rules include:

• Before even filing a lawsuit, you must first seek money from the Countermeasures Injury Compensation Program (CICP) 
• You cannot sue if you choose to accept compensation through CICP
• If you do sue, you must bring your case in one specific court (or the U.S. District Court if you are in the District of Columbia)
• You face stricter procedural requirements that will favor the vaccine manufacturers
• You have to prove willful misconduct by what lawyers call clear and convincing evidence, a harder standard to prove than you typically have to meet in a civil case
• You must have suffered serious injury or death
• Your recovery for noneconomic damages like pain and suffering is limited
• You cannot recover attorneys' fees
• You cannot recover at all if the pharmaceutical company can show that it complied with federal regulations
• You cannot recover unless either the Secretary of HHS or the U.S. Attorney General has taken enforcement action against the manufacturer and imposed penalties

As you can see, these willful and wanton misconduct claims are extremely complicated and hard to win. An experienced personal injury or product liability lawyer who knows the ins and outs of vaccine injury cases is essential.

The Countermeasures Injury Compensation Program (CICP)

If you experience a side effect from the COVID-19 vaccine, your legal situation isn't hopeless. If you follow the procedural hoops, for which a lawyer's help is recommended, you may be able to recover at least some money through CICP.

CICP is an administrative program administered by HHS that is funded by emergency federal appropriations. To be eligible, you must be able to prove that:

• You suffered death or serious physical injury limited to injuries resulting in hospitalization, significant loss of function, or disability
• Your injuries were directly caused by the use of a covered countermeasure, including a COVID-19 vaccine

If you can prove this, you (or, if you die, those who survive you) may be reimbursed for reasonable medical expenses, loss of employment income, and, if you die, survivor benefits.

You only have one year from the date of vaccination in which to bring a CICP claim. If you disagree with the determination, you need to bring it up with HHS, as you cannot get a judge to review it.

The National Childhood Vaccine Injury Act of 1986

The second context involves the National Childhood Vaccine Injury Act of 1986. This law protects the manufacturers of vaccines, including those routinely administered in the United States, such as childhood and flu vaccines, from liability for vaccine side effects.

It sets up a different compensation program in which you do not have to prove fault on the part of the manufacturer.

The National Vaccine Injury Compensation Program (VICP)

As we have discussed elsewhere, this no-fault program is the National Vaccine Injury Compensation Program (VICP).

Unlike CICP, the manufacturers of the vaccines fund VICP through an excise tax on licensed vaccines the CDC recommends for routine use in childhood and pregnant women.

If you follow the process, and the special master appointed by the U.S. Court of Federal Claims who reviews your claim approves it, you can recover:

• Medical expenses
• Special education expenses
• Diminished earning capacity (the amount of loss of your ability to make money)
• Pain and suffering
• Survivor benefits

As long as your claim is not frivolous, you can recover reasonable attorneys' fees. Keep in mind the filing deadlines:

• For an injury, your claim must be filed within three years after the first symptom of the side effect.
• For a death, your claim must be filed within two years of the death and no later than four years after the start of the first symptom of the side effect that caused the death.

If You Want Compensation, Consider Getting a Lawyer's Help

The bottom line? Suing a vaccine manufacturer is very difficult to do. Any recovery, if at all, is limited. Depending upon the vaccine, you may be able to receive at least some compensation from the federal government.

To better understand your legal rights, you should consider speaking to a personal injury attorney who specializes in vaccine-injury cases. Don't forget the time limits!