Possible Federal Investigation of New York Governor over Misreporting of Nursing-Home Deaths

Earlier this month, we wrote about New York Governor Andrew Cuomo’s defense against claims of a cover-up regarding COVID deaths at nursing homes, following the New York Attorney General’s January 28, 2021 report. Since then, the criticism of Gov. Cuomo’s handling of the nursing homes during the pandemic has only increased. New York Assemblyman Ron Kim has alleged that Gov. Cuomo called him at home and threatened to “destroy” his political career unless he helped mitigate the damage from the scandal. Assemblyman Kim has since…
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New York’s Gov. Cuomo Continues to Defend Claims of Cover-up Regarding COVID-19 Nursing Home Deaths

On January 28, 2021, New York’s Attorney General Letitia James released a report on her office’s investigation into nursing home responses to the COVID-19 pandemic. The investigation found that more nursing home residents died from COVID than the New York State Department of Health (DOH) had made public. It found nursing home deaths from COVID may be undercounted by New York’s DOH by as much as 50 percent and found the DOH misstated in-facility deaths at many nursing homes as well. A complete copy of…
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New Year, New Administration, New Issues?

Much of the nation is watching the transfer of power from the outgoing Trump administration to the incoming Biden administration. Each new administration brings many things, but one constant is change. Obviously, COVID-19 has been the dominant issue for nearly all of 2020, impacting everything, from the drug and medical device industries to our legal system. We expect that while the new Biden administration will continue some of the policies and programs from the Trump administration relating to COVID-19, others will change or be modified,…
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A Farewell to 2020 and a Look Ahead at Life Sciences in 2021

What a year 2020 has been. The COVID-19 pandemic has been spewing death and economic destruction, and as scientists predicted, is now resurrecting itself in a second wave―just as it seemed there was light at the end of the tunnel. Now, we have news from the United Kingdom and elsewhere that the virus is mutating in a way that makes it more contagious. Yet, for the life sciences field, 2020 was a year of breathtaking achievement and innovation (e.g., ventilators, changes in standards of medical…
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New York Nursing Home Residents May Receive COVID-19 Vaccine Before End of Year

On December 6, 2020, the Trump administration provided a timetable for the rollout of the COVID-19 vaccine. Dr. Moncef Slaoui, chief science adviser of Operation Warp Speed, announced the administration’s program for distribution and deployment of the COVID-19 vaccine and advised that residents of long-term-care facilities will receive the first round of vaccinations by mid-January, perhaps even by the end of December. Speaking on ABC’s “This Week” on Sunday, Health and Human Services Secretary Alex Azar said: “If things are on track the advisory committee…
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HHS Issues Guidance on Vaccine-related COVID-19 Countermeasures

The Department of Health and Human Services (HHS) recently issued Advisory Opinion 20-03 addressing vaccination-related issues and the Public Readiness and Emergency Preparedness (PREP) Act. The opinion is significant because we are moving toward approval of COVID-19 vaccines over the upcoming months. In its opinion, HSS believes that the PREP Act preempts state law in three specified circumstances to the extent that state law may be more stringent than activities authorized by the HHS secretary under the PREP Act. “Covered countermeasures” under the PREP Act…
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New York Bans Visitation at Nursing Homes, Hospitals, and Other Facilities in COVID-19 Hot Spots

On October 23, 2020, New York State issued a health advisory banning visits at nursing homes, hospitals, adult-care facilities, residential treatment centers, facilities for individuals with developmental disabilities, and other facilities seeing clusters of COVID-19 positive results. In July, NYS Health Commissioner Howard Zucker announced that nursing homes and long-term-care facilities in New York would be allowed to resume limited visitations subject to guidelines issued by the NYS Department of Health effective July 15, 2020. The new advisory reinstates the ban on visitation at these…
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FDA Approves First COVID-19 Drug: Veklury

The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older. Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial…
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FDA Issues Warning Letter for Off-Label Promotion of Drug to Treat COVID-19

The Food and Drug Administration (FDA) recently issued a warning letter to the manufacturer of an approved prescription drug for an off-label use to treat COVID-19 symptoms. Off-label use is defined as an approved prescription drug for unapproved conditions, patient groups, or dosages. While the FDA has previously pursued hundreds of fraudulent COVID-19 products, this appears to be the first warning letter addressing the unapproved use of an FDA-approved drug to treat patients with COVID-19. Currently, there are no FDA-approved COVID-19 products on the…
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Take-home Exposure Claims May Lead to COVID-19 Litigation

Anyone familiar with asbestos litigation over the past several decades is well-aware of the so-called “take-home exposure” claim, in which the injured plaintiff claims to have been exposed to and injured by asbestos that another household member brought home on their person or clothing. This type of claim often arises out of an alleged workplace exposure to asbestos. In that scenario, the injured plaintiff does not claim to have been personally exposed to asbestos at the workplace, but instead asserts that a family member was…
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