Photograph of a gavel in front of a British flag

A New Litigation Crisis on the Horizon: Negligent Delays for Non-COVID-19 Patients

By John Tingle

As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.

Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.

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Main Entrance Of Modern Hospital Building With Signs.

To Address COVID-19 Disparities, 340B Hospitals Need More Flexibility

By Sravya Chary

Many racial minorities and low-income individuals rely on 340B hospitals and associated child sites for access to discounted drugs and charity care.

In 1992, Congress enacted the 340B program as an avenue of access to prescription medication for “the nation’s most vulnerable patient populations.” Hospital savings incurred from purchasing 340B drugs at a steep discount are invested in charity care programs to enhance patient services and access to care.

The 340B program is an essential component of the COVID-19 response. Increased flexibility for 340B covered entities is necessary to address disparities faced by marginalized communities.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

What the Supreme Court’s LGBT Discrimination Decision Means for Health Care

By Elizabeth Sepper

On Monday, the Supreme Court held in Bostock v. Clayton County that LGBT discrimination is sex discrimination under Title VII, the federal workplace protection of the Civil Rights Act of 1964.

The ruling comes in stark contrast to a recent action taken by the Department of Health and Human Services (HHS). Just last Friday, HHS issued a new rule interpreting Section 1557 of the Affordable Care Act so as to strip LGBT people of rights to nondiscrimination.

Since it was enacted in 2010, Section 1557 of the Affordable Care Act has prohibited federally funded health programs, including insurers and health care providers, from discriminating based on the sex of patients. In 2016, the Obama Administration issued a rule making clear that transgender people and, to a lesser extent, LGB people were protected.

But under the Agency’s new interpretation, discrimination based on gender identity or sexual orientation is not sex discrimination.

In light of Monday’s Supreme Court decision, many are now wondering whether—and how—the new HHS rule interpreting Section 1557 of the ACA might be affected.

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empty hospital bed

COVID-19 Underscores Racial Disparity in Advance Directives

Cross-posted from The Hastings Center Bioethics Forum, where it originally appeared on May 26, 2020. 

By Stephen P. Wood

During a recent shift, I was the primary provider for a man in his 70s who was brought in by ambulance with respiratory failure. He had been sick for two days with a fever and a cough, weak and short of breath. The chest x-ray performed at his bedside revealed the diffuse, fluffy markings that are familiar signs of pneumonitis from COVID-19.

After giving him oxygen to improve his breathing, treating his fever, and running tests that are standard for COVID-19 patients, I clicked the admission button to cue him up for a bed. My patient and I then discussed goals of care and had a frank discussion about advance directives. He did not have an advance directive, but he knew he did not want to be resuscitated. He did not want to be put on a ventilator, go on dialysis, or receive artificial nutrition. He was quite clear and did not hesitate about these decisions. We signed the advance directive and filed it away in his chart.

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Pile of colorful pills in blister packs

Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation

By Blake N. Shultz and Gregory Curfman

Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.

The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.

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WHO flag.

WHO and Global Patient Safety: A View from Across the Pond

By John Tingle

After months of heavy criticism of the World Health Organization, President Donald Trump announced on Friday that the United States would end its relationship with the WHO.

As the organization shoulders sustained disparagement from President Trump, it is worth highlighting the critical work the WHO has done over the years. This post will focus on the role the WHO has played in promoting patient safety around the world and in the United Kingdom National Health Service (NHS) through useful materials and key initiatives.

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Hands close-up of surgeons holding medical instruments.

COVID-19 and Organ Transplantation

By James W. Lytle

After a banner year for organ transplantation in the United States in 2019, the success became a tattered memory by April 2020, when the COVID-19 pandemic hit major cities in the U.S. with its full fury.

A record number of 39,178 organs were donated in 2019, including 7,397 organs from living donors, also an all-time high.  After several years of adverse media and regulatory scrutiny, LiveOn NY, the organ procurement organization (OPO) that serves the Metropolitan New York City region, proudly reported that a total of 938 organs had been transplanted in 2019, another record that represented more than a fifty percent increase over the transplant total in 2015.

By late April 2020, however, organ transplantation activity in New York State had reportedly declined by ninety percent.

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Busy Nurse's Station In Modern Hospital

Hospital Administration and the COVID-19 Pandemic (Part II)

By Chloe Reichel

This post is the second in a series of question and answer pieces with Rina Spence about hospital administration and the COVID-19 pandemic.

The COVID-19 pandemic has brought numerous challenges to hospitals and hospital administrators: equipment shortages for both patients and health care workers; steep declines in revenue; and attendant staffing concerns.

Rina K. Spence served as the president and CEO of Emerson Hospital in Concord, MA from 1984 through 1994. Currently, Spence is an advisor to the Precision Medicine, Artificial Intelligence, and the Law Project at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Spence spoke with the Petrie-Flom Center to offer her perspective on the challenges hospitals are facing amid the COVID-19 pandemic. The conversation touched on: the basics of hospital administration; the business-like model by which many hospitals are run; unpopular decisions hospitals are making during the pandemic, like furloughing some staff and slashing retirement benefits; and steps forward in addressing the COVID-19 crisis at the hospital-level.

We’ve lightly edited and condensed the interview, which is running as a series of question and answer pieces. This second installment provides an overview of the administrative decisions hospitals are making during the COVID-19 pandemic, including cutting benefits for employees and furloughing staff.

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Doctors and patients sit and talk. At the table near the window in the hospital.

When and How to Resume Non-Urgent Care During COVID-19

By Louise P. King, MD, JD and Sigal Klipstein, MD

In recent days, we have seen our efforts at physical distancing flatten curves to mesas and begun to discuss re-opening for “elective” –- more commonly referred to as non-urgent -– medical care.

At some fundamental level, almost all care is essential to the individual seeking it, just as all lives have intrinsic value. The question then is not what is “essential,” because in trying to create such a list we will invariably wish to include so many conditions that we will list much of the breadth of medicine.

Instead, the question must be: can we accommodate non-emergent/non-urgent care safely or not, and if yes, which care do we address first as we re-open? While we cannot address all the issues raised by these questions in this short piece, we will highlight some considerations below.

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