Physical therapist helps person in wheelchair.

Balancing Patient Rights and Costs in Medical Malpractice Claims

By John Tingle and Amanda Cattini

The issue of the high and increasing costs of clinical negligence (medical malpractice) in the National Health Service (NHS) in England has long been a contentious one. There are common themes in the debate. The economic arguments supporting reform explain that the NHS is spending a considerable amount of money out of its health budget on malpractice claims, which otherwise could be put into front line health care services.  While the economic arguments are important, others contend that the patient’s voice must be heard more widely in the reform debate. They emphasize that it is important to look deeper as to what compensation means to victims of clinical negligence, and caution against unnecessarily fettering patients’ reasonable pursuit of claims.

Two recently published reports provide several key perspectives on these issues.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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Top view of white cubicles in modern office with white walls and carpeted floor. 3d rendering.

Managing Cognitive Decline Concerns in the Workplace

By Sharona Hoffman

As the American population ages, employers must contend with the growing challenge of cognitive decline in the workplace.

Cognitive decline becomes more common as individuals age. The risk of Alzheimer’s disease doubles every five years after age 65, and almost one-third of people over 85 have the disease. And, as detailed in my book, Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow, the American population is aging. By 2034, about 77 million people will be seniors, accounting for 21% of U.S. residents.

Additionally, many professionals work past retirement age. For example, over 31% of physicians are over 60, and 15% of attorneys are over 65. The average age of federal judges is 69.

Considered together, these trends substantiate concerns about the increasing prevalence of cognitive decline in the workplace. Recent research provides further support: when Yale New Haven Hospital tested clinicians on staff who were seventy and older, it found that almost 13% had significant cognitive deficits.

Older employees often bring a wealth of experience and highly refined skills to their jobs. They can therefore add great strength to the workforce. Yet, employees with cognitive decline can cause a multitude of complex challenges in the workplace. They can threaten workplace productivity, workforce morale, and even public safety.

How might employers address cognitive decline concerns? As I argue in my article “Cognitive Decline and the Workplace” (forthcoming in the Wake Forest Law Review), there are several options, but many are legally and ethically problematic.

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Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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Kirkland, WA / USA - circa March 2020: Street view of the Life Care Center of Kirkland building, ground zero of the coronavirus outbreak in Kirkland.

The PREP Act and Nursing Homes’ Fight to Move COVID Claims to Federal Court

By Kaitlynn Milvert

As nursing homes face wrongful death claims amid the COVID-19 pandemic, they increasingly have pursued a common litigation strategy: attempting to reroute state tort lawsuits to federal court.

A recent ruling in the Third Circuit Court of Appeals rejected this tactic. As the first court of appeals ruling on this issue, the decision avoids extending a federal statute limiting pandemic liability into unprecedented areas and defines at least some limits on the statute’s effect on state tort suits. Read More

Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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Finger pressing Apple Maps button on the Apple CarPlay main screen in modern car dashboard.

Addressing Distracted Driving: The Problem is Bigger than Texting

By Jack Becker

Distracted driving is deadly.

In 2019, 8.7% of all motor vehicle traffic fatalities involved a distracted driver, totaling 3,142 fatalities. And hundreds of thousands more are injured due to distracted drivers each year.

So, what are the solutions? Anti-drunk driving initiatives may provide some valuable insights.

The share of motor vehicle fatalities involving alcohol impairment has declined from 41% in 1985 to 28% in 2019.

Much of this decrease is attributable to laws and law enforcement. When the FY 2001 Transportation Appropriations bill included a provision setting the national impaired driving standard at .08 BAC, it was touted as saving an estimated 500 lives per year. Every state has some form of drunk driving law, and 38 states have open container laws, and these laws seem to impact fatalities.

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Doctor in white coat neck down

Buzzwords in Patient Safety: Some Preliminary Thoughts

By John Tingle and Amanda Cattini

Every profession, service, or industry maintains what can be termed, “buzzwords.” A “buzzword” can be defined as transient, flavor-of-the-month-type word, which describes a concept than can be seen to direct policy and practice until it becomes less topical and eventually fades away from general use. These terms come and go and are often refined and come back into use. In the National Health Service (NHS) in England, we have seen such pervading terms as clinical governance, patient empowerment, controls assurance, and patient advocacy.

Today there is what can arguably be called a new buzzword, “decolonization.” This word seems very much to be the term of the day. It pervades vast areas of academic and professional life and discourse. In terms of health law and patient safety research, the decolonization of national and global patient safety systems and structures seems an interesting perspective to further peruse.

One benefit of adopting decolonization perspectives to patient safety is that we can utilize the concept as a disrupter of established thinking and seek to establish new foundations of knowledge.

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