Among the many concerns arising from rampant spread of COVID-19, are provider concerns regarding potential liability for care provided during the pandemic due to limited medical resources. Providers and policy makers have discussed such concerns particularly given the currently limited number of available ventilators and qualified technicians as compared to the numbers of patients who may need access to such equipment.[1] Congress and states have provided varying levels of liability protection, though such protections are themselves limited.

Under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), Congress provided liability protection to volunteer health care professionals providing health care services during the current public health emergency. [2] Specifically, the CARES Act exempts volunteer health care professionals from liability under federal or state law for any harm caused by an act or omission, unless the harm was caused by willful or criminal misconduct, gross negligence, reckless misconduct, conscious flagrant indifference, or under the influence of alcohol or intoxicating drugs, in providing health care services during the public health emergency with respect to the coronavirus. This provision preempts state or local laws that provide such volunteers with lesser protection from liability.

Notably, Congress chose not to extend liability protection to non-volunteer health care professionals, affording no wide-spread federal protection to those employed or contracted professionals treating patients during the emergency. Certain states, however, have extended liability protection to employed or contracted health care professionals through state orders. For example, Governor Cuomo of New York, through executive order, waived certain state laws to provide immunity from civil liability to certain health care professionals for any injury or death alleged to have been sustained directly as a result of an act or omission by such professional in providing medical services during the pandemic, unless such injury or death was caused by the professional’s gross negligence.[3]


Continue Reading Legal Liability of Healthcare Providers for Care Provided During COVID-19 Pandemic

On March 11, 2020, the World Health Organization declared that COVID-19 is now a pandemic.  The effects continue to be felt in the United States, which now has well over 1,000 confirmed novel Coronavirus disease (COVID-19) cases.  As of March 12, 2020, nineteen states have declared a state of emergency to ensure there are resources to address the Coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020.  Given the prevalence of the Coronavirus in the U.S. and the growing numbers of cases globally, health care providers should take extra precaution with their patients, employees, and visitors.  As all public health communications are making clear, efforts to limit the spread of COVID-19 will not only prevent illness, but they will also reduce the pandemic’s potential to overwhelm critical health care resources.

This advisory provides guidance for health care providers in responding to the COVID-19 pandemic.  Our best practices for all employers can be found here and here, and all businesses should visit our Coronavirus Resource Center.


Continue Reading Recommendations for Health Care Providers in Managing COVID-19

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written

Epstein Becker Green’s slides from the “Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers” webinar is featured on the American Hospital Association’s Ebola Preparedness Resourcesclick here.

The November 17 webinar addressed the professional and business challenges encountered by health

In response to the ongoing threat of the Ebola Virus Disease (“EVD” or “Ebola”) and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to