Field hospital in NY during COVID-19 pandemic.

Ethical and Legal Challenges Faced by Hospitals in New York’s First COVID-19 Surge

By Zachary E. Shapiro

After COVID-19 reached the United States, New York City quickly became the epicenter of the pandemic. Clinicians at New York Presbyterian Hospital-Weill Cornell Medical Center turned to the Clinical Ethics Consultation Service to help meet the ethical challenges that arose. During the surge, the Ethics Team saw a marked increase in the volume of consultations for individual patients in the hospital, and took part in over 2,500 informal consultations with caregivers. Discussions centered around a wide range of ethical issues distinct from those that come up in routine practice. As one of the only lawyers in the Division of Medical Ethics at Weill Cornell Medical College, I encountered a myriad of legal concerns presented by the pandemic.

During the height of the surge in New York, there was no formal legal guidance available to clinicians concerning medical practice during a pandemic. Questions about legal immunity abounded, as unclear state and federal guidance left many doctors worried that they were taking personal and professional risks by providing care to COVID-19 patients.

The pandemic forced doctors to shift away from traditional standards of care in terms of resuscitation, patient care, and surrogate decision-making. The ethics team had to take new dynamics into account, such as the risk of infection to doctors and staff, and balance these factors in the risk/benefit calculations for treatments and interventions. Undertaking these shifts without federal or state guidance caused significant distress and concern. It often seemed that the law was not only not helpful, but an active hindrance to medical practice, as many health care workers were consumed by worry about the prospect of future liability. This concern persisted, even though the deviations in the standard of practice were necessitated by the realities of the pandemic overwhelming our health care system.

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NHS building

Health Care Providers’ Legal Duty to Be Open and Honest with Patients

By John Tingle

Last September, the first ever prosecution of a National Health Service (NHS) trust for failure to comply with the regulation concerning duty of candor was adjudicated.

University Hospitals Plymouth NHS Trust was ordered to pay a total of £12,565 after admitting it failed to disclose details relating to a surgical procedure and to apologize following the death of a 91-year-old woman.

Duties of candor require that patients be informed of adverse events as soon as possible after they occur. These duties serve as mechanisms to help balance power dynamics in health care and to advance patient rights. In England, duties of candor are contained in the professional codes of ethics of doctors and nurses, and in statutory regulations.

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Russia, Saint-Petersburg, village of Telman - August 2015: a plant for the production of meat products. a worker walks down the hall of meat production in Russia, the village of Telman.

Performance Analysis of OSHA During COVID-19

By Zoey Binder

The United States Occupational Safety and Health Administration (OSHA) was highly criticized this year for an alleged lack of enforcement and failure to protect workers from unsafe working conditions related to COVID-19.

Of particular concern has been its failure to exert authority over the meatpacking industry, whose workers have been disproportionately harmed by the pandemic.

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Empty hospital bed.

New Data Reignites Concerns over COVID-19 and Nursing Homes in New York State

By James W. Lytle 

Concerns over New York State’s response to the COVID-19 pandemic, particularly with respect to its treatment of nursing homes, have recently re-emerged in light of a new report and court ruling related to the matter.

Almost from the outset of the pandemic, the State faced scrutiny as to whether it was accurately reporting deaths of nursing home patients.

After nursing homes complained in April about the lack of PPE and other resources to combat the pandemic, Governor Andrew Cuomo responded that it was not the state’s responsibility, and asked the Department of Health and the Attorney General to launch investigations into nursing homes’ response to the pandemic.

Nine months later, in late January 2021, the report by New York State Attorney General Letitia James of the nursing home investigation was released.

Among the report’s headlines, the Attorney General’s preliminary analysis found that the Department of Health had undercounted deaths of nursing home residents due to COVID-19 by about 50%, largely because of the failure of the State to count the deaths of those residents who were transferred to hospitals immediately prior to their deaths. No other state excluded patients who had been transferred before death to hospitals from their nursing home fatality reports.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Weaknesses in Medical Device Regulation Worsened by Trump Administration

By Jacob Howard

In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.

Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.

As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.

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Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

HHS Recognizes Key Role of Telehealth in Amended PREP Act Declaration

By Vrushab Gowda

On December 3rd, the Department of Health and Human Services (HHS) extended its provisions to cover telehealth services in amending its Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID–19.

This represents the first time HHS has covered telehealth services under the authority of the PREP Act. Telehealth providers are now permitted to deliver a range of COVID-related care across the country, including states in which they do not hold professional licenses. The Declaration, moreover, offers them expansive liability protection, effectively immunizing them against a host of claims in connection to their administration of designated countermeasures.

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Pill bottles.

During the COVID-19 Pandemic, the Opioid Epidemic Continues

By Laura Karas

“The boy’s first outcry was a rueful laugh,

As he swung toward them holding up the hand

Half in appeal, but half as if to keep

The life from spilling. Then the boy saw all—

Since he was old enough to know, big boy

Doing a man’s work, though a child at heart—

He saw all spoiled. . . .

He lay and puffed his lips out with his breath.

And then—the watcher at his pulse took fright.

No one believed. They listened at his heart.

Little—less—nothing!—and that ended it.

No more to build on there. And they, since they

Were not the one dead, turned to their affairs.”

This except from Robert Frost’s 1916 poem “Out, Out—,” which portrays the sudden death of a young boy after a woodcutting accident and the onlookers’ casual acceptance of his tragic death, is particularly apropos today, more than one hundred years later, in an America that looks very different than that of Frost’s time. Between the opioid crisis and the COVID-19 pandemic, America now suffers from a surplus of needless, untimely deaths.

Just as the protagonist of Frost’s poem became the casualty of a tragic accident, so too do the many victims of the opioid epidemic become casualties in a losing battle — lives “spoiled” by substance use disorder and cut short by tragic overdose. In this post I explore the status of the opioid epidemic in light of the COVID-19 pandemic and ongoing initiatives to address opioid use disorder (OUD).

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NHS building

COVID-19 and the State of Health and Social Care in England

By John Tingle

The COVID-19 pandemic has exacerbated challenges facing the provision of health and social care in England, a recent report from the Care Quality Commission (CQC) finds.

The CQC is the independent regulator of health and social care in England. Every year they produce an assessment of the state of the country’s health and social care. The yearly lookbacks include information on trends, challenges, successes, failures and opportunities.

The most recent report analyzes service provision both pre- and post COVID-19, and draws key conclusions from this information. From a patient safety perspective, the report contains important lessons about issues the COVID-19 pandemic has brought into sharp focus. The report also highlights trailing patient safety problems that existed before the pandemic, and are still present as England grapples with the pandemic’s second wave.

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