As the COVID-19 vaccine rollout continues nationwide, consumers are beginning to ask questions about what happens if something goes wrong with the vaccination process. In this article, we'll discuss:
Since Pfizer and Moderna released their COVID-19 vaccines in late 2020, reports of serious allergic reactions or other problems have been relatively rare. At the same time, while the results of vaccine administration have been promising, these medications haven't been subject to the standard timeline of robust clinical trials prior to their approval. This might leave some consumers weighing the risk of vaccination against their chance of contracting the coronavirus.
If you do decide to get the vaccine, what recourse do you have should you suffer an unexpected injury or illness? Because the COVID-19 vaccines were developed in response to a public health emergency, the personal injury liability landscape looks very different.
Because communicable diseases threaten the entire population, the federal government provides a safety net for those who choose to get recommended vaccines. Under normal circumstances, when someone is injured from a vaccination, the National Vaccine Injury Compensation Program (VICP), sometimes called “vaccine court,” provides benefits. The VICP is a no-fault program designed to compensate people injured by somewhat run-of-the-mill vaccines like childhood inoculations.
The purpose of VICP is to ensure an adequate supply of vaccines, stabilize costs, and provide an efficient forum for injury compensation. VICP is an efficient alternative to litigation because it's less formal than a typical lawsuit and pays attorneys' fees and expert fees for injured consumers.
Vaccines covered by the VICP are primarily standard-issue inoculations, like the flu shot, recommended for children and pregnant women by the Centers for Disease Control and Prevention. The VICP filing deadline for an injury is within 3 years after symptom onset. For death cases, survivors must file a VICP claim within 2 years of the death and 4 years of symptom onset.
To qualify for VICP benefits, claimants must also meet a certain threshold of injury severity:
From 2006 to 2018, VICP ruled in consumers' favor in 70% of cases. But when a public health emergency requires ramped up vaccine development with less stringent clinical trial protocols, the VICP safety net is limited by the Public Readiness and Emergency Preparedness Act (PREP Act).
As an incentive for pharmaceutical companies to meet urgent public health needs, vaccines developed in response to a public health emergency are excluded from the VICP. When the Department of Health and Human Services declared COVID-19 a public health emergency, anyone injured by the newly developed vaccine was automatically excluded from claiming compensation under VICP. Under the PREP Act, people injured by a vaccine developed in response to the emergency must bring claims under the Countermeasures Injury Compensation Program (CICP).
CICP provides blanket immunity to drug makers manufacturing the COVID-19 vaccine unless there's a showing of willful misconduct by the manufacturer. To prevail in the program, an injured consumer must present “compelling, reliable, valid, medical and scientific evidence” that the vaccine in question caused the injuries alleged, according to USA Today.
While vaccine injury compensation is available under CICP, the benefits are much less robust than those provided under the VICP. The claim filing deadline for CICP benefits is within 1 year of vaccination, even if symptoms have not yet manifested. CICP also limits benefits to medical bills and lost income. For example, damages available under CICP are limited to $50,000 per year for lost income and do not include compensation for "pain and suffering" or mental anguish.
Benefits under CICP are much more difficult to get as well. Over the last decade, of a total 499 claims made, CICP has paid a mere 29. CICP benefits include:
CICP has been criticized for its lack of transparency and a perceived stinginess when it comes to paying claims. Experts in the field have raised additional concerns about the program's ability to handle an influx of claims on the heels of the large swath of consumers expected to receive the COVID-19 vaccine. CICP does not pay attorneys' fees or expert witness fees, and doesn't hold hearings or allow for appeals.
A medical malpractice claim related to the COVID-19 vaccine would likely only be feasible if based on improper administration or storage. For example, if the health care provider gave the wrong dosage or reused a syringe, a patient might have a viable malpractice claim. But potential malpractice claims covered under CICP would likely be preempted by the federal government.
Another area of concern with COVID-19 vaccines is the ultra-cold temperatures at which they must be stored (the "cold chain"). Although the Moderna vaccine can be stored at normal freezer temperature, the Pfizer vaccine must be stored at -70 degrees Celsius. While Pfizer monitors in-transit vaccine temperatures, once the medication is delivered, the recipient is charged with temperature control. Pfizer's insistence that the government take responsibility for temperature monitoring after delivery will likely only promote the good public relations Pfizer has fostered with its quick vaccine rollout. Ultimately, legal liability for improperly handled vaccines is preempted by the PREP Act.
Consumer advocates are urging the government to direct COVID-19 vaccine claims to the VICP. Until the COVID-19 vaccine is approved for use in children and pregnant women, a move to vaccine court is unlikely.
For in-depth discussion of key legal issues related to the coronavirus pandemic, check out Nolo's special coverage: The Law and Your Legal Rights During the Coronavirus Outbreak.