Category: Featured

Empty hospital bed.

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

James W. Lytle Leave a comment

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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Baby shoes.

Infants Born Through Surrogacy Contracts Cannot Be Canceled or Returned

Katherine Drabiak Leave a comment

By Katherine Drabiak

Recently, media reported that Zheng Shuang, a popular Chinese actress, commissioned two surrogates with boyfriend Zhang Hang, and then allegedly decided, seven months into the pregnancies, that she did not want to become a parent and questioned the possibility of abortion or adoption.

Zhang asserts that he has been caring for the infants in the U.S. for more than a year after Zheng abandoned the infants. Zheng has not addressed the allegations directly, and multiple facts remain unclear.

This case, and other rare similar cases, raise the question: If intended parents initiate an agreement with a gestational surrogate to create a child, can they also terminate the agreement – and pregnancy – if they no longer want the resulting child?

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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.

It’s Time to Update the ACA’s Anti-Discrimination Protections

Jenna Becker Leave a comment

By Jenna Becker

Assuming that the Affordable Care Act (ACA) withstands its most recent challenge in California v. Texas, the Biden administration should prioritize as a future reform the codification of clearer nondiscrimination standards.

The ACA’s Section 1557, which provides anti-discrimination protections, has been fraught with challenges. Section 1557 incorporates nondiscrimination protections from four separate civil rights statutes. This vague language allows administrations to offer widely differing interpretations of healthcare anti-discrimination protections.

In a 2016 rule, the Obama administration interpreted Section 1557 broadly, including protections based on gender identity and sexual orientation, as well as specific language access requirements. Many of these protections were eliminated in a 2020 rule promulgated by the Trump administration.

It’s time to end these fluctuating standards. The Biden administration should work with Congress to add clearer nondiscrimination protections to the ACA.

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close up photo of U.S. currency.

When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims

Laura Karas Leave a comment

By Laura Karas

In June 2020, the U.S. District Court for the Northern District of Illinois dismissed state and federal antitrust claims against AbbVie, maker of Humira (adalimumab), for accruing more than 130 patents on the top-selling drug and asserting allegedly unmeritorious patent infringement claims against makers of adalimumab biosimilars. AbbVie then settled the patent infringement litigation by entering into agreements with eight drug makers to allow adalimumab biosimilars to enter the U.S. market in 2023 and the European market in 2018.

In my last post, I discussed the district court’s memorandum opinion finding that “the vast majority” of AbbVie’s conduct was not “objectively baseless petitioning” and was therefore immunized under the Noerr-Pennington doctrine. In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

The Consequences of Public Health Law Vacuums

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By Daniel Goldberg

Pandemic planning documents and materials from the early 2000s to the present anticipated a great deal of what the U.S. has been experiencing during the COVID-19 pandemic. The best of such plans documented exactly what be required to manage, respond, and control a pandemic spread by a highly communicable respiratory virus like SARS-CoV-2.

What the plans did not account for was what we are now experiencing: That governments would simply refuse to govern.

Few truly accounted for the possibility that the very entities charged with regulating for the health, safety, and welfare of their residents and citizens would simply decline to do so, choosing instead the public health law vacuums in which we find ourselves at the present time. Read More

USB drive

The False Dilemmas of the Fifth Circuit’s HIPAA Ruling

Leslie Francis Leave a comment

By Leslie Francis

In a caustic opinion issued on January 14, the Fifth Circuit vacated penalties assessed by the U.S. Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center for HIPAA security breaches.

As has happened to many other health care entities, M.D. Anderson had employees who were not careful with their laptops and thumb drives (and the data therein). A laptop with the unencrypted protected health care information of nearly 30,000 patients was stolen. Unencrypted thumb drives with information on another almost 6,000 patients were lost. M.D. Anderson disclosed the security breaches to HHS, which assessed civil monetary penalties for violation of HIPAA’s encryption and disclosure rules. M.D. Anderson then filed a petition for review, which resulted in the Fifth Circuit holding that the agency action was arbitrary and capricious for failure to consider an important aspect of the problem.

Commentators have already pointed out that this decision will reverberate throughout the HIPAA enforcement world. As it does, I hope it is met with scorn, for it trades on the informal logical fallacy of the false dilemma in two noteworthy ways.

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COVID-19 fake news concept illustration.

COVID-19 Vaccine Misinformation and the Anti-Vaccine Movement

Dorit Reiss 18 Comments

By Dorit Rubinstein Reiss

The anti-vaccine movement is aggressively working to promote misinformation about COVID-19 vaccines, up to and including promoting fake claims of deaths from vaccines. We need to be aware of its efforts, and be prepared to respond.

It’s worth emphasizing that this blog post is focused on the anti-vaccine movement, not people with concerns about vaccines (the “vaccine hesitant”).

In relation to COVID-19, anti-vaccine activists have aggressively promoted misinformation from the start of the pandemic.

In March 2020, anti-vaccine activists incorrectly alleged – by misrepresenting a study – that flu vaccines increase COVID-19 risks. In June, anti-vaccine activist Del Bigtree described COVID-19 as a “cold,” blamed those who died for their own deaths, and called on his followers to “catch that cold.”

And from the beginning, anti-vaccine activists were committed to the ideas that COVID-19 vaccines would not work, would be dangerous, and would be promoted by a nefarious global conspiracy. They continue to spread these allegations, for example, using the fact that there are liability protections for COVID-19 vaccines to imply the vaccines are dangerous. Liability protections for COVID-19 vaccine manufacturers are real; but they are not evidence that the vaccines are unsafe.

This post will focus on one type of misinformation: alleged deaths from COVID-19 vaccines.

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Empty classroom.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

The Petrie-Flom Center Staff Leave a comment

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

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Balancing Health Care Rationing and Disability Rights in a Pandemic

The Petrie-Flom Center Staff Leave a comment

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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