What would be the legal action that could take place if a healthcare professional misdiagnoses a patient or commits any mistakes when giving treatment and what responsibilities do pharmaceuticals have when giving vaccines?
The answer is that the professional status as an employee has to be evaluated since most protections are for people who offer voluntary services.
Due to how fast the virus spread, the need for healthcare professionals increased drastically, that’s why on March 27 of 2020, President Trump signed the "Coronavirus Aid, Relief and Economic Security Act", known as the CARES Act. This law included a "Good Samaritan" doctrine that provides federal liability protections for volunteer health care professionals during the pandemic. It states that physicians and all other healthcare professionals that provide volunteer medical service cannot be liable for providing such services. These called "services" include and are related to assessment, care, diagnosis, prevention, or treatment of a person suspected to have the virus.
Exceptions for this type of liability include gross negligence, criminal misconduct, or providing health care while intoxicated.
It is imperative to consider that these protections preempt state laws inconsistent with the Act but, if state laws provide greater protections CARES Act is not preempted.
Another law for volunteer healthcare professionals we have to consider is the “Volunteer Protection Act”, signed in 1997, this law also provides protections for liability to healthcare professionals that volunteer for nonprofit organizations or government entities. Volunteers need to be licensed or certified by the proper authorities required by law in the state where the harm occurs.
Also, in December 2005, President George W. Bush signed the “Public Readiness and Emergency Preparedness Act”, also called the PREPA. This law authorizes the Secretary of the Department of Health and Human Services to issue a PREP Act declaration which will provide immunity from liability for claims of "loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions, determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures".
This Act was amended on March 27th, 2020, and adopted wider protections to those who provide medical treatment for COVID-19. By treatment, it includes the administration or use of antiviral medications, drugs, biologics, vaccines, or devices to treat, cure, mitigate, or prevent the transmission.
In addition, in 2013 was signed the “Pandemic and All-Hazards Preparedness Reauthorization Act”, this law is known as PAHPRA, and added sections in which the “Federal Food, Drug and Cosmetic Act” (FD & C) to provide new authorities for the use of approved emergency products.
PAHPRA amended the provisions of the PREP Act that defined “countermeasures” and “qualified products in pandemics and epidemics” so that the products could be used within the authorities of PREP Act. PAHPRA also extended the definition of qualified products of pandemics and epidemics to include technological products whose intentions are to improve the use or effect of drugs, biological products or devices used to avoid pandemics or epidemics or against adverse events from these products.
In December 3rd of 2020, there was a new amendment to the PREP Act in which, among other things, permits healthcare professionals to use “telehealth” services to order or administer countermeasures covered by the law -like providing referrals for tests- to provide diagnostics authorized by the “Food and Drug Administration” to patients that are outside the State where the physician has license to operate. It also extends immunity to medical providers that can administer the covid-19 vaccine and other vaccines and it states required certifications for pharmacists, pharmacy interns and pharmacy technicians to administer the COVID-19 vaccine to children in conformity to PREP Act.
In march 24, 2020, Health and Human Services Secretary, sent a letter to governors of each state and territories where it included a declaration regarding responsibility immunities to healthcare providers during the COVID-19 emergency: “for healthcare professionals to feel comfortable serving to extend capacities on the front line in the face of the COVID-19 emergency, it is imperative that they feel protected from medical tort.” The letter recommended that “states should issue guidelines that summarize the statutory scope of the protections offered under their laws and processes necessary to adhere those protections to professionals who offer health services. Secretary Azar also noted that “it is particularly important for states to publish a public guide describing the protections available during the COVID-19 emergency” and commented in first person “I don’t want variations in liability protections to be confused or deteriorate health professionals in this emergency. I ask your office to quickly develop a list of health professional liability protections and exemptions during a state of national emergency.”
In conclusion, healthcare professionals that provide services voluntarily have certain protections and immunities, as long as they don’t act with intentional error or contrary to the law.
In case of pharmacies or authorized personnel to administer the vaccines, they have immunities as established in mentioned laws, the same way as any other healthcare professional, as long as they don’t act with intentional error or contrary to the law.
These protections and immunities are not total or absolute.
Every situation needs to be evaluated on a case to case basis and it needs to be determined if the professional is offering services voluntarily or if it is an employee of a medical institution.
In the other hand, and how Secretary Azar requested, every state needs to provide the protections for professional responsibility to the healthcare professionals that provide services during the emergency.
NOTE: If you have experienced malpractice or negligence you should consider talking to an attorney.
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