I’ve received a number of calls from doctors whose offices have slowed down. Elective cases have been cancelled. But these same doctors have years of experience. They want to help screen and inform patients about COVID-19. There’s a tsunami of misinformation circulating online about COVID-19. These same doctors have asked how to help and not be sued. No good deed goes unpunished. In helping our brothers and sisters on the front line, we don’t want to be a plaintiff’s lawyer’s next meal.
Well, you’re immune.
Not from COVID. But from litigation. Mostly.
I can’t say it much better than the federal government does itself.
When Congress focused on pandemics in 2005, it again combined tort immunity with no-fault compensation. Under the Public Readiness and Emergency Preparedness (PREP) Act (see Public Readiness and Emergency Preparedness Act), manufacturers, distributors, and health care providers administering vaccines and other pandemic countermeasures are granted total immunity (except in cases of willful misconduct) when the secretary of health and human services invokes such immunity while declaring a public health emergency. The PREP Act also authorizes limited no-fault compensation for persons harmed by covered countermeasures, but unlike NCVIA, it does not allow for judicial review or civil litigation. In June 2009, Secretary of Health and Human Services Kathleen Sebelius issued an emergency declaration for H1N1 influenza. The declaration has since been updated and reissued several times.
OK, we’re off to a good start here.
The first step was the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Alex Azar, the Secretary of Health and Human Services, published this Declaration on March 17, 2020. It covers the entire US. It will last until October 1, 2024 or the final day of the emergency, whichever comes first. Also, the Declaration was retroactive to February 4, 2020.
Persons who prescribe, administer, or dispense countermeasures such as healthcare providers may be afforded immunity from liability under a PREP Act Declaration.
What counts as a “countermeasure?”
A “covered countermeasure” may be:
An unapproved drug, biological product, or device, or an approved drug, biological product, or device intended for an unapproved use, that is intended for emergency use and shipped and held by a government agency or someone working on that agency’s behalf for use only when that use is authorized.
In general, these are products that are approved, cleared, or licensed by FDA; authorized for investigational use, i.e. an Investigational New Drug (“IND”) or Investigational Device Exemption (“IDE”), by FDA, authorized under an EUA by FDA, or otherwise permitted to be held or used for emergency use in accordance with Federal law. However, each has a specific legal definition. See the PREP Act Glossary for more information.
Well, that seems broad. How about in English?
In the Declaration, countermeasures are defined as:
Countermeasures — any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials.”
According to my reading, “any diagnostic or any other device” would include using telemedicine to ascertain whether a patient has a COVID-19 diagnosis.
It looks like a patient can still sue for willful misconduct. What’s that?
The bar would be quite high for proving willful misconduct. It’s more than ordinary negligence. It’s probably more than gross negligence (although gross negligence and willful misconduct are confusingly similar.). “Gross Negligence” is recklessness, or actions taken or omitted with conscious indifference to or the complete disregard of harmful, avoidable or foreseeable consequences. Willful misconduct would be an act done intentionally, knowingly, and generally in bad faith.
What remedy does a patient have if they do want to sue for negligence?
There’s a potentially limited no-fault compensation fund.
As a complement to the immunity protections, the PREP Act provides for a no-fault compensation program for eligible individuals for serious physical injuries or death directly caused by the administration or use of countermeasures identified in the declarations. Funds must be appropriated by Congress for this purpose.
The CARES stimulus package also includes protections.
Importantly, it protects volunteer healthcare workers from liability for treatment of COVID-19 in preemption of state laws, allowing healthcare providers to treat patients and work to contain outbreaks where they might otherwise not be licensed or face liability. The act also streamlines patient medical record information sharing for the epidemic and authorizes home delivery of medical nutrition services for patients who are self-isolating.
So, go ahead and jump in.
Finally, a Cornell intensivist produced a 45-minute video which provides actionable information to prevent spread of COVID-19. The video was also uplifting. If you did little more than share this, it would help the worldwide effort immensely.
What do you think? Let us know your thoughts in the comments below.
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Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.
Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.
Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.