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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Coronavirus
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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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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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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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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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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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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Recently, I was speaking with a plaintiff’s lawyer whom I like and respect about the potential impacts of COVID-19 on the concept of a reasonably prudent person—something we have written about before. He suggested to me that an even bigger impact—not necessarily tied solely to COVID but certainly exacerbated by it—could be with respect to jurors’ willingness to listen to and believe scientific testimony.
In many life sciences lawsuits, science and scientific evidence play important roles. Many defendants in life sciences cases—particularly product…
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We previously discussed whether Senate Republicans would propose federal liability immunity in the next COVID-19 relief bill. On July 27, 2020, Sen. John Cornyn (R- TX), introduced the SAFE TO WORK (Safeguarding America’s Frontline Employees to Offer Work Opportunities Required to Kickstart the Economy) Act, Section 4317, which would provide broad liability immunity for businesses, health care workers and facilities, educational institutions, and local governments. Sen. Cornyn claims that this bill “would protect those acting in good faith from being sued into oblivion while…
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On Monday, August 3, 2020, Governor Andrew Cuomo signed a bill (A.10840/S.8835 Kim/Sepulveda) recently enacted by the New York Legislature that revised the Emergency Disaster Treatment Protection Act (EDTPA). The EDTPA was enacted with the state budget in April and granted broad immunity to certain health care providers and facilities, including nursing homes, regarding good faith actions or omissions undertaken in response to the COVID-19 outbreak. The EDTPA applied retroactively to when Gov. Cuomo first declared a state of emergency in March 2020.
The new…
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