American and European regulators recently paused the use of the Johnson & Johnson COVID-19 vaccine when a small number of women developed a severe blood-clotting disorder after receiving their shot. Although there is no proof of a direct link between the J&J vaccine and the blood clots, it raises the question of whether people have any legal recourse if they experience severe side effects after getting a COVID-19 vaccine.
Legal options are extremely limited. The federal government has granted companies like J&J, Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their vaccines. The Food and Drug Administration also cannot be sued for authorizing a vaccine for emergency use.
In February, then-Health and Human Services (HHS) Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness (PREP) Act of 2005 to cover the COVID-19 vaccines. PREP gives the federal government the power to shield drug companies from liability when deploying "medical countermeasures" during emergencies like the coronavirus pandemic. As a result, companies cannot be sued for monetary damages over injuries related to the administration or use of products to treat or protect against COVID. These protections last until 2024, and drug companies claim this is critical to ongoing innovation and keeping costs down.
However, the federal government has established a way for people to recover some damages should something go wrong following immunization. The PREP Act also created the Countermeasures Injury Compensation Program (CICP), which compensates individuals who suffer serious injury or death as a result of a covered vaccine. Compensation for medical expenses, lost wages and survivors' benefits is limited to $50,000 per year or a death benefit of $370,376.
However, the CICP typically only deals with vaccines the average person rarely gets, like the H1N1 and anthrax vaccines. In addition, the program is difficult to navigate and proving an injury is directly related to receiving a vaccine is not easy. In fact, the government has rejected the vast majority of claims made since the program began 10 years ago.
It may be possible to pursue claims related to COVID vaccine injuries through another program under the HHS called the National Vaccine Injury Compensation Program (NVICP). Established in 1988, the NVICP is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions. It typically covers routine immunization vaccines as well as some adult vaccines (COVID-19 vaccines are currently not on the list.)
Any individual who received a covered vaccine, and believes he or she was injured as a result, can file a petition. The program allows for recovery of pain and suffering and attorney’s fees, along with medical expenses and lost wages. Those claiming a vaccine injury cannot sue a vaccine manufacturer without first filing a claim with the U.S. Court of Federal Claims. The claimant can only file a civil lawsuit if their claim is denied or if it is approved and the compensation is rejected.
While there are questions around the extent of an employers’ liability, employees who are required to get the COVID-19 vaccine in order to return to work may have some legal recourse if they suffer debilitating side effects. Claims would most likely be made through worker’s compensation programs and treated as an on-the-job injury. However, proving there is a link between the vaccine and the injury can be difficult, and there are significant caps on the damages an employee can recover.
Although vaccines are designed to protect from disease, they can cause side effects that range from mild to serious. If you have received a COVID-19 or other vaccine and believe you have been injured as a result, we are here to help. Please contact us at 973‑707-3322 or LFarber@LFarberLaw.com.