JurisdictionUnited States

In a conventional tort case, a person injured by a healthcare product could raise several potential claims, depending on the mechanism of injury and the applicable state law. These points are generally discussed below, as are the potential defendants, common defenses, and available damages.

Potential Tort Claims

There are two primary types of vaccine injury: injury due to the physical injection itself (not the components of the vaccine) and injury due to the vaccine's components. Injury due to the physical injection itself results from unintentional trauma from the needle and/or unintentional injection of the vaccine into tissues or structures it was not meant to be injected into. For example, many vaccines are meant to be administered into the deltoid muscle of the arm. If, however, the vaccine is given too high on or too deep into the arm, the needle could go into other structures in the arm, such as the bursa (fluid filled sack that cushions the shoulder) or into a nerve, causing injury.1 As injuries due to the physical injection itself are usually due to improper administration of the vaccine by a medical professional, these injuries can be the basis for a medical malpractice claim against the medical professional who administered the vaccine, as discussed below.

In contrast, injury due to the vaccine's components are generally injuries caused by what is in the syringe, not by how the vaccine was administered. For example, if the vaccine itself was contaminated with a cancer-causing agent and the person who received the vaccine developed cancer, the subsequent cancer could be related to the vaccine, but not to its administration. Another potential injury due to the vaccine's components occurs when the person who receives the vaccine has an atypical immune response to the vaccine. For example, anaphylaxis—a potentially life-threatening allergic reaction—is an overreaction of the immune system to the presence of a particular substance. Vaccines for hepatitis B, polio, seasonal flu, meningococcal, human papillomavirus, and varicella have been associated with anaphylaxis. Similarly, Guillain-Barré syndrome (GBS) is a rare, potentially fatal disorder where the immune system overreacts to a substance such that it attacks not only the foreign substance but portions the person's nervous system.2 GBS has been associated with the influenza virus and influenza vaccine.3

As injuries due to the contents of the vaccine are not related to how the vaccine was administered, a medical malpractice claim is typically inappropriate. However, depending on the injured person's jurisdiction, various theories of product liability may be available.

Medical Malpractice

A plaintiff who is injured by the administration of the vaccine, and not the vaccine itself, can potentially bring a medical malpractice case against the person who administered it. To succeed, the plaintiff in such a case would generally need to prove: the medical provider who administered the vaccine owed a duty to the plaintiff; the medical provider who administered the vaccine breached his or her duty to the plaintiff by not exercising the degree of care or medical skill that a reasonably prudent healthcare provider would have used in the same or similar circumstances; plaintiff suffered damages while in the care of the medical provider and the medical provider's breach of duty caused plaintiff's damages.4

To prove that a duty exists, generally one needs only to establish that a professional relationship existed between the healthcare provider and the plaintiff. In most jurisdictions, breach of duty must be established through testimony of a medical expert that practices in the same or similar specialty as the provider who administered the vaccine. Causation is generally established by a medical expert as well since knowledge of the mechanism of the injury is generally beyond the general knowledge of a jury.

Damages are proven through documents and the testimony of multiple people. In terms of economic damages (e.g., lost wages and medical expenses), receipts and pay stubs are generally all that is required in cases where the plaintiff has fully recovered. If, however, the plaintiff suffered a severe injury that will require ongoing care and/or resulted in lost future earning capacity, additional experts may be required to establish economic damages. These potential experts are discussed in below.

Product Liability

When a person has been injured by a vaccine (not its administration), that person may have a claim based on one or more theories of product liability law. Unfortunately, the various theories of product liability (e.g., negligence, strict liability, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, breach of express warranty, and/or misrepresentation) are not uniform from state to state. For example, in Oregon, by statute there is only one product liability cause of action.5 In Indiana, breach of implied warranty in tort was subsumed by that state's adoption of Section 402A of the Restatement (Second) of Torts.6 New York, on the other hand, recognizes the theories of strict product liability, negligence, breach of express warranty, and breach of implied warranty.7


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