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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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 ant