Vaccine injuries and your options for receiving compensation
The vast majority of vaccines are safe and effective.
The vast majority of people who receive vaccines don’t experience any problems or side effects. However, a small number of people experience minor side effects, such as a sore arm or low-grade fever, and an even smaller number of people experience serious side effects, such as an intestinal blockage or a life-threatening allergic reaction.
Product liability is an area of law that focuses on injuries caused by defective products. If you’re injured by a product, whether it’s a pharmaceutical drug or a child’s toy, you typically file a product liability lawsuit against the manufacturer to recover damages.
However, if you’re harmed by a vaccine, you might be forced to file a claim with the National Vaccine Injury Compensation Program instead. (We’ll talk more about this below.)
First, let’s take a look at injuries caused by vaccines and your options for recovery.
What is a defective vaccine?
Most vaccines are safe and work as intended. But every once in awhile a defective vaccine is administered. There are 3 types of defects:
- Manufacturing defect. A defectively manufactured vaccine is one that—though properly designed—left the manufacturer in a condition other than the one intended. In other words, some error occurred during the manufacturing process that caused the vaccine to become unsafe.
- Defective design. A vaccine is defectively designed if you can show that it failed to perform as safely as a reasonable person would expect, even when used as intended. To put it another way, nothing went wrong in the manufacturing process, the vaccine is simply inherently dangerous.
- Failure to warn. Manufacturers have a duty to warn users of the reasonably anticipated dangers inherent in their products. In the case of vaccines, this means warning users about potential side effects.
Does the FDA ever recall defective vaccines?
The United States Food and Drug Administration (FDA) is a branch of the federal government that oversees regulation and safety concerns for everything from cosmetics to vaccines. Since the formation of the FDA in 1906, there have only been a few vaccines recalled due to safety concerns.
Vaccine recalls are almost always initiated voluntarily by the vaccine manufacturer. For example, 13 lots of a vaccine that protects against the bacteria that causes meningitis, pneumonia, and other bloodstream infections were voluntarily recalled by Merck in 2007 because, during a routine inspection, the manufacturer discovered that the machines that made the vaccines had been contaminated with a harmless bacteria called Bacillus cereus.
When a recall is initiated, the manufacturer generally contacts vaccine distributors and healthcare facilities who might have purchased the vaccine to inform them of the suspected problem. The FDA’s role is to oversee a manufacturer’s recall strategy and help ensure the recall goes well.
If a vaccine given to you or your child is recalled, you’ll likely hear from your healthcare professional. Additionally, all recalls are listed in the FDA’s weekly Enforcement Reports. Information on vaccines that have been recalled over the past few years can be found at the FDA’s Recalled Vaccines webpage.
Types of vaccine injuries
An enormous amount of research has focused on the safety of vaccines. You can find lots of this research collected here and here.
Fortunately, the overwhelming conclusion is that vaccines are very safe. This is particularly true when compared to the risks of not getting vaccinated.
For example, research shows that a tetanus vaccine causes a life-threatening allergic reaction in at most 0.0006% of people who get the shot. On the other hand, the national fatality rate from tetanus is 13.2%.
Though rare, the most common vaccine injuries include:
- Guillain-Barre syndrome (a neurological malady associated with some influenza vaccines)
- Anaphylaxis (a life-threatening allergic reaction)
- Intussusception (an intestinal blockage associated with the rotavirus vaccine)
- Brachial neuritis (painful inflammation of the nerves that supply the hand and arm associated with tetanus vaccines)
- Febrile seizures (a harmless convulsion in a child)
- Minor injuries, such as a low-grade fever or sore arm
What about autism?
A couple of decades ago, parents began to sue vaccine manufacturers claiming that vaccines were responsible for causing autism in children. The surge in lawsuits was, as many speculated, caused by a 12-person study that linked autism to MMR vaccines. The study was later debunked, retracted, and widely condemned by the medical community.
The alleged link between autism and vaccines nevertheless became the subject of numerous scientific investigations, none of which found any causal relationship.
What’s more, because there were so many legal cases claiming that vaccines cause autism, the U.S. Court of Federal Claims chose 6 representative cases to examine the allegation. As part of the proceeding (deemed the Omnibus Autism Proceeding), the Court listened to numerous experts and reviewed all the relevant studies. Ultimately, the Court found NO causal relationship between vaccines and autism.
How to receive compensation for a defective vaccine injury
If you suffer an injury as a result of a defective vaccine, there are 2 possibilities for receiving compensation depending on the legal theory you pursue:
- File a claim with the National Vaccine Injury Compensation Program (VICP)
- File a product liability lawsuit
Let’s take a look at both options.
The National Vaccine Injury Compensation Program (VICP)
You MUST file a claim with the VICP (rather than a product liability lawsuit) if:
- The vaccine is a covered vaccine, and
- You’re claiming the vaccine caused your injury because of a defective design (rather than a manufacturing defect or failure to warn).
There are 5 steps to receiving compensation through the VICP:
- You file a petition with the U.S. Court of Federal Claims.
- The U.S. Department of Health and Human Services medical staff reviews your petition and determines if it meets the medical criteria for compensation and makes a preliminary recommendation to the U.S. Department of Justice.
- The Department of Justice develops a report that includes the medical recommendation and legal analysis and submits it to the Court of Federal Claims.
- The report is presented to a court-appointed special master who decides whether you should be compensated after presiding over a hearing in which you and the manufacturer can present evidence.
- If the court-appointed special master decides you should be compensated, the Court of Federal Claims orders the Department of Health and Human Services to award compensation.
There are a couple of benefits to filing a VICP claim:
- Claims are generally addressed more quickly when filed with the VICP than when filed in the traditional court system.
- VICP is a no-fault system. This means you don’t need to prove the manufacturer was negligent to receive compensation. Rather, you simply need to prove that the vaccine caused your injury. What’s more, if your injury is listed in the Vaccine Injury Table, you receive a presumption of causation. In other words, it’s assumed that the vaccine caused your injury and the burden is on the manufacturer to prove otherwise.
Product liability lawsuit
A product liability claim can be brought under a theory of negligence or strict liability. Typically, a plaintiff will use the theory of strict liability because it’s easier to prove. Let’s take a quick look at both theories.
Negligence
In a product liability case based on negligence, the plaintiff must prove that:
- The defendant owed the plaintiff a duty of reasonable care (manufacturers owe a duty of care to all potential users of their vaccines)
- The defendant breached the duty of reasonable care owed to the plaintiff
- The defendant’s breach was the proximate cause of the plaintiff’s injuries
Strict liability
In a product liability case based on strict liability, the plaintiff doesn’t need to prove that the defendant breached any sort of duty. Rather, the plaintiff only needs to show that:
- A vaccine was sold in an “unreasonably dangerous” condition
- The unreasonably dangerous condition existed at the time the product left the defendant’s control
- The dangerous condition was the proximate cause of the plaintiff’s injuries
Receiving compensation for a vaccine injury is an uphill battle. The defendant is often a powerful pharmaceutical company with deep pockets that is highly motivated to prove their vaccine is safe. What’s more, it’s not always clear whether your claim should be filed with the VICP or filed in the traditional court system.
Fortunately, there are experienced attorneys ready to help you get the compensation you deserve. Find an attorney near you using our free online directory.
Connect to top-rated lawyers in seconds using our comprehensive national directory
See our guide Choosing a personal injury attorney.