Legal Vaccine Against COVID-19 - Will Health Care Providers See Legal Protections?

By Trent Gill, Taylor Knight, Christine Gilliam and Robert Ott

Federal Law

On March 17, 2020, the Department of Health and Human Services (HHS) released a declaration under the Public Readiness and Emergency Preparedness Act (PREP) regarding medical countermeasures against COVID-19. Retroactively, the declaration became effective February 4, 2020.

The HHS declaration provides broad immunity from tort. Specifically, liability immunity is granted to “certain individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures except, for claims involving ‘willful misconduct’ as defined in the PREP Act.” Therefore, the declaration precludes, for example, negligence claims against manufacturers in creating a vaccine and against health care workers in prescribing a vaccine. The declaration also precludes negligence claims related to the management and distribution of countermeasures. Thus, a person at a distribution site who slips and falls or collides with another vehicle cannot sue if they came to the distribution site to receive the countermeasure.

Limited Waiver of HIPAA Sanctions and Penalties[1]

Generally, even during a nationwide emergency, the HIPAA Privacy Rule is not suspended. However, the Secretary of the U.S. Department of Health and Human Services (HHS) can waive certain provisions of the Privacy Rule once a national or public health emergency has been declared. Effective March 15, 2020, in response to COVID-19 pandemic, the HHS Secretary, Alex M. Azar, waived the following provisions of the HIPAA Privacy Rule for any hospital that has activated disaster protocol:

• the requirements to obtain a patient's agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
• the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
• the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
• the patient's right to request privacy restrictions. See 45 CFR 164.522(a).
• the patient's right to request confidential communications. See 45 CFR 164.522(b).

The waiver, however, only applies: (1) in the emergency area during the emergency period; (2) to hospitals with disaster protocol in place; and (3) for up to 72 hours from the time the hospital implements its disaster protocol.

Notably, outside of the waiver, the HIPAA Privacy Rule includes some permissive disclosures in emergent situations, including disclosures necessary to provide treatment to a patient and disclosures necessary to promote public health.

Facilitating Innovation to Fight Coronavirus Act

On April 2, 2020, U.S. Senator Ben Sasse introduced the Facilitating Innovation to Fight Coronavirus Act. The emergency legislation would limit liability for healthcare professionals who are fighting coronavirus. The bill would limit liability for healthcare providers for: (1) Using or modifying a medical device for an unapproved use or indication; (2) Practicing without a license or outside of an area of specialty if instructed to do so by an individual with such a license or within such an area of specialty; or (3) Conducting the testing of, or the provision of treatment to, a patient outside of the premises of standard health care facilities.

The Facilitating Innovation to Fight Coronavirus Act has not yet been addressed by Congress.  It is anticipated it will be part of the next round of COVID-19 relief legislation. 

State Declarations or Existing Law

The HHS’s declaration under the PREP Act is a federal initiative. Individual states may also offer liability protections and immunities. For example, states may also issue executive orders that grant civil immunity.[2] For example, in New York, Governor Andrew Cuomo promptly issued an executive order that provided broad civil liability immunity (with exception for gross negligence) for health care workers working to respond to the COVID-19 outbreak. Indiana and Ohio have both declared a state of emergency, but their governors have not issued orders discussing civil liability immunity for health care workers. Still, existing laws in Indiana and Ohio may already provide protections.  Similar to New York, Kentucky’s governor recently issued an order providing immunity from civil liability for ordinary negligence to health care workers treating COVID-19 patients.

Indiana Law

Indiana already has protections in place that can cover COVID-19 liability. Facilities and individuals providing health care services in response to a declared disaster emergency, such as the one declared because of COVID-19, may not be held civilly liable for care provided in response to that emergency event unless the care resulted from gross negligence or willful misconduct. Indiana Code 34-30-13.5 sets forth the details of this immunity.

“Health care providers (individuals),” “facilities,” and “Health care services” are defined broadly for purposes of immunity. Health care providers  (which can include volunteers) are granted civil immunity if they (1) have a license (even unlicensed providers can now be included so long as they are at least registered with the relevant board) to provide health care services under Indiana law or the law of another state and (2) provide health care services within the provider’s scope of practice at a location where health care services are provided during the state of emergency. See Ind. Code § 34-30-13.5. Facilities can include permanent structures and mobile hospitals in response to the emergency. Services include “any other services or goods furnished for the purpose of preventing, alleviating, curing, or healing human illness, physical disability, or injury.”  

Thus, existing Indiana law likely already provides civil immunity.

Ohio Law

Prior to the COVID-19 crisis, Ohio law provided “disaster immunity” to health care providers under certain circumstances. In that regard, a health care provider that provides emergency medical services, first-aid treatment, or other emergency professional care as a result of a disaster cannot be held liable for injury, death, or loss to person or property that allegedly arises from an act or omission of the health care provider in the provision of those services/treatment unless the act or omission constitutes reckless disregard for health and safety of the patient. See R.C. 2305.2311

Under the law, “Disaster” is defined as “any occurrence of widespread personal injury or loss of life that results from any natural or technological phenomenon or act of a human, or an epidemic and is declared to be a disaster by the federal government, the state government, or a political subdivision of this state.” However, “emergency medical services” is not defined.

While the COVID-19 epidemic likely falls within the definition of “disaster” under R.C. 2305.2311, only those services that fall within “emergency medical services” are given immunity.  Because “emergency medical services” is not defined, it is unclear as to what type of medical services or care – outside of care provided by paramedics, EMTs, and in emergency rooms – are covered by the statute.

R.C. 2305.2311 was first enacted in March 2019 in the Medical Malpractice Improvement Act and has not yet been interpreted by the Ohio Supreme Court.

Thus, Ohio’s brand new law without broad definitions, may not provide civil immunity.

Kentucky Law

During the state of emergency declared by Governor Beshear in response to COVID-19 on March 6, 2020, by Executive Order 2020-215, a health care provider who in good faith renders care or treatment of a COVID-19 patient has a defense to civil liability for ordinary negligence for personal injury resulting from such care or treatment if the health care provider acted as an ordinary, reasonable and prudent health care provider would under the same or similar circumstances.  This defense extends to health care providers who prescribe or dispense medicine for off-label use, who provide health care services outside of his or her professional scope of practice, and who use equipment or supplies outside of his or her normal use for medical practice. SB 150(5)(b) (signed by Governor Beshear March 30, 2020).

If you have any questions regarding the civil liability of health care workers, please call any member of Reminger’s Health Care Law or Medical Malpractice Liability Practice Groups.

_{This has been prepared for informational purposes only. It does not contain legal advice or legal opinion and should not be relied upon for individual situations. Nothing herein creates an attorney-client relationship between the Reader and Reminger. The information in this document is subject to change and the Reader should not rely on the statements in this document without first consulting legal counsel.}

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[1] See COVID-19 & HIPAA Bulletin Limited Waiver of HIPAA Sanctions and Penalties During a Nationwide Public Health Emergency, Dept. Health & Hum. Servs. (Mar. 2020), https://www.hhs.gov/sites/default/files/hipaa-and-covid-19-limited-hipaa-waiver-bulletin-508.pdf.

[2] See Executive Orders, Council St. Gov’ts, https://web.csg.org/covid19/executive-orders/ (last visited Apr. 6, 2020).