Employers implementing Covid-19 workplace vaccination programs are rightfully concerned that sponsored vaccination clinics could give rise to legal liability. The question remains whether employers may be held liable to workers for injuries sustained from an emergency use authorized (EUA) vaccine administered at an employer-sponsored clinic.
Vaccine Program Immunity Under the PREP Act
The federal Public Readiness and Emergency Preparedness Act (PREP Act) provides broad, though not absolute, immunity. The PREP Act applies to covered persons against claims for loss arising from the distribution, administration, or use of certain covered countermeasures if the secretary of the Department of Health and Human Services issues an emergency declaration invoking the PREP Act’s protections for those measures. PREP Act protections are broad, not only because they apply to state and federal lawsuits against a covered person, but also because they apply to claims for loss that have a causal relationship with the administration or use of a covered countermeasure—including the distribution, dispensing, administration, or use of a vaccine.
The two Covid-19 vaccines currently in the marketplace under emergency use authorization are covered countermeasures under an HHS declaration, so they fall within the PREP Act’s protections against potential tort claims against those who administer the vaccine.
The PREP Act and HHS’s Covid-19 declarations extend to program planners, which include persons who supervise or administer a program for an EUA Covid-19 vaccine. However, there is the question of whether a private employer that sponsors or provides an immunization clinic for its employees would be subject to those same PREP Act liability protections as a program planner.
A private employer would presumably qualify as a program planner if it supervised or administered an immunization clinic, or if it distributes or administers the two authorized Covid-19 vaccines. The HHS’s declaration says that a “private sector employer” can be a “program planner” when it distributes or administers Covid-19 vaccines. Practically speaking, though, most private employers sponsoring vaccination clinics lack the necessary licenses or capabilities to deliver a vaccine and would use third-party vendors to supervise, administer, and operate the clinic. In that event, the PREP Act might not immunize the employer from liability.
But the specific facts and circumstances of an employer’s immunization clinic will determine whether PREP Act immunity applies. Because the PREP Act is a defense in litigation, employers should assess the structure of proposed vaccination programs, design them to meet the requirements of the PREP Act and HHS’s declaration, and document those efforts with an eye toward defending litigation.
If employers use clinic vendors, the employers should include provisions in their vendor contracts to limit the employer’s liability. Ironically, because a vaccination clinic operator is likely immune from liability under the PREP Act, that immunity could encourage litigants to pursue the sponsoring employer for any claimed vaccination-related injuries.
Other Potential Workplace Liability for Vaccine Clinics
Workers’ Compensation Statutes
While the PREP Act provides statutory “program administrator” immunity, employers facing claims from sponsored vaccination clinics may be able to seek other immunity under workers’ compensation schemes, which protect employers from liability for employee injuries sustained during employment.
Workers’ compensation statutes are creatures of state law, and therefore differ from state to state. However, most programs shield employers from liability for negligence-related injuries unless the employer’s conduct is reckless, grossly negligent, or is the product of intentional acts or fraud. Sponsoring a vaccination program that utilizes vaccines marketed under an EUA would seem to be a valid exception to liability.
But if, for example, an employer’s worker administered a vaccine without asking the necessary health questions that the EUA requires (as well as giving the opt-out warnings), the employer could face a claim for gross negligence.
Most non-health-care employers considering implementing vaccination programs would not use their own staff to actually administer the vaccines, but would as noted above, likely engage a vendor, much in the same way employer-sponsored flu clinics are operated. In this case, liability could be premised on recklessness or the grossly negligent failure to properly vet or engage a third- party vaccination vendor.
This liability could be addressed by ensuring that only state-licensed health-care companies or facilities are used for the program (and with appropriate indemnification and insurance provisions).
Disclosure of Personal Health Information
Another basis for employer liability arises from the disclosure of employee personal health information (PHI) that is required as a vaccination condition.
For example, if a vendor accidentally left PHI in the employer premises or was otherwise careless in disclosing that information, the employer could face liability for, among other things, violation of an employee’s privacy rights. If the disclosure were data-based, it could be a violation of state data privacy laws or regulations.
In addition, federal and state antidiscrimination laws protect against the disclosure of medical information to employers to prevent employers from using that information in employment decisions.
Again, these potential liabilities could be addressed, in part, through the selection of an appropriate vendor and contract indemnities.
Private employers need to know that PREP Act immunity is not absolute. Any workplace vaccination program must be carefully implemented and managed in order to avoid potential liability.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Brian P. Dunphy is a member of the Health Care Enforcement Defense group at Mintz. He defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act and similar state laws. He also defends pharmaceutical and biotechnology companies in national product liability cases and represents life sciences and technology companies in complex business disputes.
Joanne S. Hawana is member at Mintz counseling global clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, and medical devices.
Jen Rubin is a member at Mintz practicing employment law and is also a member of the firm’s ESG Practice group. She advises clients across various industries on issues such as wage and hour compliance and maintains a robust trial practice, with a focus on class actions, trade secrets, and employment mobility disputes, and the defense of discrimination, retaliation, and other disputes arising from the employment relationship.
To read more articles log in.