Federal legislation largely protects healthcare organizations administering COVID-19 vaccines. The immunity can be voided by failing to comply with requirements.
The Public Readiness and Emergency Preparedness Act shields healthcare entities from most lawsuits.
Many types of licensed or certified employees may administer vaccines.
Carefully document compliance with vaccine storage and handling rules.
Healthcare organizations are afforded substantial protection from liability related to administering the COVID-19 vaccines, but there are ways to void that protection and create vulnerability for plaintiffs’ attorneys.
With more than 100 million people fully vaccinated in the United States, it is inevitable some will try to claim damages and sue the organization that administered the vaccine, says James R. Embrey, Jr., JD, partner with Hall Booth Smith in Nashville, TN.
“Any time you’re looking at those kinds of numbers, there have to be liability claims from some enterprising plaintiff’s lawyer,” he says. “If you have big damages, often a plaintiff will make a claim even if there is no real liability. They harp on the damages and hope that is dramatic enough to get some sort of settlement.”
The good news is that organizations providing the vaccines are largely shielded from liability by the Public Readiness and Emergency Preparedness (PREP) Act, which provides tort liability immunity to certain individuals and entities during a pandemic. On March 10, 2020, the Department of Health and Human Services (HHS) invoked the protections of the PREP Act for COVID-19. It has been used to protect healthcare organizations during outbreaks of avian flu, H1N1, and Ebola.
“The act provides immunity from legal liability for any type of claim or loss related to a number of things — development, testing, manufacturing, distribution, administration, or use of a countermeasure, which includes vaccine administration,” Embrey explains.
Vaccine administration is a “covered countermeasure,” but the PREP Act requires it to be administered by a “covered person,” Embrey says. A covered person includes a “qualified person,” as defined in the act.
A qualified person includes a licensed health professional and other individuals “authorized to prescribe, administer, or dispense vaccine,” according to the PREP Act. (More information is available at this link.)
Immunity from the PREP Act is broad and provides strong legal backing, but there are ways a hospital or other healthcare entity could be exposed to liability. “There are some cracks here, loopholes that could put you at risk,” Embrey says. “There is a seventh amendment to the PREP Act that lists the individuals who are qualified to administer vaccines. Risk managers need to be sure that the individuals administering the vaccine are on this list.”
The list includes nontraditional licensed or certified health professionals such as dentists, pharmacists, pharmacy technicians, podiatrists, paramedics, medical students, and veterinarians. The individual’s state certification must be up to date or active within the last five years. (The amendment is available here.)
“You want to make sure that whoever is sticking the syringe in someone’s arm fits in that CDC box of approved people. This includes most clinicians of all sorts, even recently retired clinicians whose licenses expired within the last five years,” Embrey says. “It does not include administrative employees. You want to make sure the individual giving the vaccine is authorized by the state in whatever capacity that makes them eligible to administer the vaccine.”
Embrey stresses the importance of documenting individuals’ eligibility to administer the vaccine. The PREP Act immunity could be lost if a plaintiff challenges the person’s qualifications and there is no evidence the employer verified it.
Willful Misconduct Not Protected
The PREP Act makes an exception for willful misconduct, Embrey notes. If the person administering the vaccine intentionally harms the patient, the immunity will not apply to the individual or the employer. But a plaintiff would be challenged to prove such a claim.
“If the person acted intentionally to achieve a wrongful purpose, the PREP Act is not going to help you. That’s a very tough thing to prove,” Embrey says. “It has to result in a serious injury or death to lose the immunity, so that’s also a high bar. This has to be proven by clear and convincing evidence — another high bar.”
Willful misconduct could be claimed if, for instance, the person administering the vaccine reused a syringe or intentionally administered too much vaccine to one person, Embrey says.
Show Government Approval
Another way to jeopardize PREP Act immunity is by failing to properly coordinate vaccine administration with federal, state, or local officials.
“They have to have government authorization and coordination. They have to have the fingerprint of the government on their administration of the vaccine,” Embrey says. “They should have that in writing, but it doesn’t have to be anything extravagant. It can be a letter from the state health department, the mayor, the governor discussing what the vaccine administrators are doing to further the state’s interest in vaccinating their citizens.”
The letter may be as simple as a statement from the city stating the healthcare organization can use a public space for vaccine administration.
Improper storage is another potential liability risk. Embrey says this might be the most common claim brought against healthcare organizations related to the COVID-19 vaccine in coming months.
“The claim will be that the vaccine was delivered to you, and you stored improperly at the wrong temperature, or you stacked it too close to the side of the freezer, or the freezer breaks down,” he explains. “Or, maybe the temperature indicator on the box is broken and your employee uses the vaccine anyway. As an attorney, I can see an argument there because storage isn’t really addressed very well in the PREP Act.”
Activist judges might try to find such loopholes for an injured party to get through the motion phase of the litigation and before a jury.
“I think storage is a weak point. The CDC has a lot of information on vaccine storage and handling, so make sure you are adhering to that exactly,” Embrey says. “Risk managers should develop a protocol that ensures proper storage, and document your adherence to that protocol.”
Chain of custody also is important. When receiving vaccine deliveries, ensure the chain of custody is valid. Do not accept delivery if the shipping company cannot show the vaccines were handled properly.
“Check the packaging and look for any problems right away. Were there broken vials? Any indication the package was mishandled in any way?” he asks. “It’s common sense-type stuff, but putting it in writing on a checklist or a protocol form gives you the extra confidence that you’re doing the right thing to stay under that immunity umbrella.”
Must Prove Serious Injury
For any claim regarding vaccine administration to have merit, the plaintiff must show he or she was seriously injured, meaning permanent impairment of a bodily function, permanent damage to a body structure, or requiring medical intervention to avoid permanency.
A woman recently told media outlets in Nashville that she could no longer walk after receiving the Pfizer vaccine, Embrey notes. She did not claim the administration of the vaccine caused the alleged injury — just that the vaccine itself was defective.
“But in litigation, the plaintiff’s attorney will bring in the vaccine manufacturer, and probably just to be safe they will bring in whatever organization administered the vaccine to her, too,” he says. “It’s an uphill battle for the plaintiff, but we probably will see more of these cases. As everyone in risk management knows, just being involved in a case like this will cost you money and time.”
Federal Program First to Assess
Such claims must first be presented to the Countermeasures Injury Compensation Program, a federal program that examines the case, determines if there is enough evidence for liability and damages, and if so, awards a certain sum, Embrey explains. If the program rejects the claim, the plaintiff can file a lawsuit with the United States District Court for the District of Columbia.
“If that happens, you go out with both barrels. You move to dismiss, citing the PREP Act immunity,” Embrey says. “If the court says no and wants discovery to occur first, then the vaccine administrator will have to show everything they did to comply with HHS guidelines, that you did comply with the CDC’s vaccine storage and handling toolkit, the protocols you used, all the signatures. There are a lot of defenses available to the administrator if they check all the boxes to make sure they remain under that umbrella of immunity.”
Embrey says he suspects most plaintiffs’ attorneys will find such vaccine lawsuits too challenging, and there will not be a huge wave of litigation. But there always will be some attorneys who will accept the challenge.
“Unless the pot of gold at the end of the rainbow gets very tempting because of some unforeseen circumstance and very serious injuries, the hill is too steep for most plaintiffs’ attorneys right now,” Embrey says. “But you still have to be ready to defend yourself and show you did the right thing.”
- James R. Embrey, Jr., JD, Partner, Hall Booth Smith, Nashville, TN. Phone: (615) 313-9911.