In Brief: COVID-19 vaccine development, rollout, and risks have dominated the news for a year now. Recent news stories attribute blood clots and serious side effects to these vaccines, including deaths. By all credible accounts, this involves a very minute percentage of the millions of doses. But people naturally have concerns, since these vaccines have not had the time to go through the years-long FDA-approval process and are being released under “Emergency Use Authorization.” Numerous people have asked me about whether people can sue the COVID vaccine manufacturers for serious side effects. The short answer is “no.” But a claim is possible; the HHS agency runs a restrictive, alternative program for seeking compensation for serious injuries or death from certain vaccines (including COVID vaccines), called CICP.

What laws prevent these lawsuits?

In the National Childhood Vaccine Injury Act of 1986, the United States banned lawsuits for side effects from any vaccine against the manufacturers. 42 U.S. Code § 300aa–22(b) provides in part: “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The Supreme Court has held that this law not only prevents federal lawsuits, but pre-empts state lawsuits (such as in a Virginia Circuit Court like Roanoke City or County) based upon defective product theories. See Bruesewitz et al. v. Wyeth LLC (2018).

People suffering serious injuries from standard vaccines (such as tetanus, measles, etc.) do have an alternative formal program for filing individual claims, called the National Vaccine Injury Compensation Program. This involves filing a claim or “petition” in the United States Court of Federal Claims. It is supposed to be a “no fault” standard that does not require proving defects in the vaccine. But this claims process limits damage categories in ways that constrain monetary recovery and discourage claims, unless the case involves truly serious injuries or death. Nonetheless, the US has paid out over $4 billion in the VICP since it began.

However, COVID-19 vaccines are not subject to the VICP and the Court of Federal Claims. As a pandemic vaccine, COVID vaccines are covered by the Public Readiness and Emergency Preparedness Act (PREP). That Act established a prohibitive standard to proving liability against pharmaceutical companies—a plaintiff must prove “willful misconduct” by the company. This level of intent is so much greater than negligence that it essentially grants blanket immunity for covered manufacturers. People injured by vaccines subject to this law also have an alternative program, but it is even more restrictive than the VICP.

What is the CICP?

As a result, people who suffer serious injuries (or death) by COVID vaccines have only one option to pursue compensation—an administrative (agency) claim with the Department of Health and Human Services under the “Countermeasures Injury Compensation Program” (CICP). The COVID vaccines are covered “countermeasures” for the pandemic.

Instead of filing a lawsuit, or even a petition in the Court of Federal Claims, people who pursue COVID vaccine-related claims must file an administrative claim for limited “benefits” with HHS, like a worker compensation-type claim. You must file a claim within one year of the date of injury—a very short statute of limitations. There is no trial, no jury, and if denied, no appeal. And claimants must surpass difficult standards of proof of both their injures and the direct causation of their injuries, making a skilled, written presentation of the supporting medical science very important.

The CICP limits recoverable damages: you can only recover out-of-pocket medical expenses (such as co-pays or unpaid balances) if determined to be reasonable and necessary, and lost employment income benefits (66.6% of an individual’s unreimbursed gross income, or 75% if the individual had dependents). There is a cap of $50,000 for lost employment income per year. In the case of a death, the CICP does have a provision for death benefits to certain survivors which as of 2020 is capped at $365,670. As a result, the CICP is really only an option when someone has died, or a living person has incurred significant medical bills unpaid by other insurance or Medicare, or have suffered significant lost income. There is no pain-and-suffering compensation in the CICP program, and no award for attorney fees and costs.

I will describe this CICP claims process and its evidentiary challenges, as well as the limited damages available when someone is successful, in Part Two of this article. The reality is that while an individual can file a claim on his or her own, the CICP has technical proof and procedures that justify hiring an attorney for guidance and preparation. If you or a loved one have suffered serious injuries requiring extensive medical treatment or lost income, or death, please do call us to discuss your case.