Valerie Gutmann Koch

Unique Proposals for Limiting Legal Liability and Encouraging Adherence to Ventilator Allocation Guidelines in an Influenza Pandemic

In a severe influenza pandemic, many more patients would require the use of mechanical ventilators than can be accommodated with current supplies. In order to proactively confront the rationing of resources in preparation for the possibility of severe ventilator scarcity, in 2007, the New York State Task Force on Life and the Law and the New York State Department of Health released a draft guidance document entitled Allocation of Ventilators in an Influenza Pandemic, laying out a comprehensive clinical and ethical framework to guide distribution of ventilators in the event of a severe public health emergency using objective medical criteria, with the ultimate goal of saving the most lives. However, adhering to the Guidelines – despite the significant public health goals contained therein – may expose health care providers and entities to considerable costs and burdens, including the risk of jail time and/or financial penalties, the time and costs of discovery and preparing a case, higher medical malpractice insurance rates, and damage to one’s reputation, unless proper and adequate legal protections are in place. This article addresses the issue of liability for health care workers and entities who adhere to the recommended clinical protocol contained in the Ventilator Guidelines while rendering care in a disaster emergency. We consider the “trigger” for implementing emergency plans – a declaration of a public health or disaster emergency, explore current federal and State law that might offer immunity, defense, or indemnification to certain individuals or entities who provide care in response to that declaration, and offer several unique alternative approaches to mitigate clinicians’ and other entities’ burdens in the event of a lawsuit. The article culminates in recommendations for legislation granting adequate civil and criminal liability protections to health care workers and entities who adhere to the State’s Ventilator Guidelines in a pandemic.

Under Attack: Reconceptualizing Informed Consent

In 2014, the American Bar Association (ABA) Special Committee on Bioethics and the Law (“Special Committee”) sponsored a presidential showcase at the ABA Annual Meeting entitled Forging New Frontiers: The Intersection of Bioethics and Biotechnology Law. The showcase explored the bioethical and legal issues that arise with the development of cutting edge technologies, addressing genomics, stem cell research, and nanotechnology. Despite its technological focus, however, one of the most provocative statements was made about one of the most established processes in medicine and ethics – informed consent. George Annas, our first author in this special issue of JLME, stated that “informed consent is under attack.” He argued that written consent should be dispensed with when doing clinical research. Because of the ever changing nature, purpose and process of informed consent, in its current form it no longer serves the goal of protecting patients and ensuring autonomous, informed decision-making.