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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Safe Assumption About EPA’S Safer Choice Labels

The U.S. Environmental Protection Agency (EPA) Safer Choice labeling program “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” The EPA offers lists of Safer Choice-Certified Products for different industries including all-purpose cleaners, car care products, dish soaps, floor cleaners, laundry products, and tub and tile cleaners. The Safer Choice Standard includes criteria for chemical ingredients and requirements for performance, packaging, pH, and VOCs (i.e., volatile organic compounds. Manufacturers, importers, and distributors of…
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New York DOH Fines Long-Term Care Facilities for COVID-19-Related Failures Raising Concerns Regarding Limitations of Immunity Statute

Recently, New York’s Department of Health (DOH) issued fines to multiple nursing homes in New York for infection control issues, including for providing COVID-19 care without gloves and adequate personal protective equipment (PPE) for their staff. Reports state that 77 nursing homes in the state were fined for similar infection control issues. The largest fine of $50,000 was to a facility in Buffalo, NY, where DOH inspectors found COVID-19-positive patients on the same floors with residents not known to have the virus. As discussed in…
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Should a Head-Spinning “Cure” and “Blessing From God” Abort Well-Established FDA Processes?

Whatever one’s political views, the COVID-19 diagnosis and treatment of the president, was certain to raise issues and questions. My original thoughts for this blog post were to discuss those. It is now focused on the potential effects and consequences due to the recovery of the president from his COVID-19 illness, if indeed that is what happened. As most people know, the president was given an investigational drug cocktail from Regeneron, an antiviral drug remdesivir, as well as steroids and perhaps other treatments unknown…
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State Law Negligence COVID-19-Related Claims Do Not Fall within PREPA’s Preemptive Scope; Do Not Mandate a Federal Forum

A New Jersey District Court has held that state law claims such as negligence, wrongful death, and medical malpractice are not preempted by the Public Readiness and Emergency Preparedness Act (PREPA) and does not create a basis for federal jurisdiction―resulting in a remand of two cases back to a New Jersey state court. We previously wrote about PREPA and the scope of the March 17, 2020, declaration by the Secretary of Health and Human Services providing civil liability immunity to manufacturers, distributors, and state-licensed health…
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Are You Going to Eat That?

We have written before about issues related to hand sanitizers and household cleaners, which have expectedly taken on increased importance as people look for ways to protect themselves and others from the spread of COVID-19. Recently, the FDA addressed another potential concern that it believed consumers and manufacturers should be aware of―the risk of misuse of hand sanitizers manufactured or packaged in a way that may mimic foods or beverages. As reported by the FDA, some manufacturers have packaged hand sanitizers in containers resembling beer…
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New York Relaxes COVID Restrictions at Nursing Homes to Allow More In-Person Visitation

After rallies were held outside New York Governor Andrew Cuomo’s Manhattan office earlier this month to bring attention to the restrictions on visitation at nursing homes, on September 15, 2020, the Cuomo administration announced it has relaxed COVID restrictions at nursing homes to allow family members to have more in-person visits with residents. The New York State Department of Health (NYSDOH) relaxed the requirements that a nursing home be free from any positive COVID results from 28 to 14 days, which was previously set by…
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