FDA Moves to Stop Subpar KN95 Respirators from Being Sold in the U.S.

The Food and Drug Administration (FDA) is warning health care workers and other medical first responders about defective KN95 respirators imported from China for failing to meet a minimum particulate filtration efficiency of 95 percent in National Institute for Occupational Safety and Health (NIOSH) testing. This move is a part of the broader effort by the FDA to combat the sale of fraudulent COVID-19 products. The FDA first allowed the import of Chinese-made KN95 respirators on April 3, 2020, by issuing an emergency use
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Hands Off for More Sanitizers

Recently we posted about the FDA’s warnings regarding various potential dangers and harmful effects from hand sanitizers. Notwithstanding FDA’s efforts, reports continue of consumers using – or misusing – hand sanitizers and being injured. For example, on August 5, CNN reported about multiple significant injuries caused by people drinking hand sanitizers. But on the same day that we posted, the FDA released a further update and warned consumers and users of hand sanitizers about a different potential problem: the use of hand sanitizers that contain…
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COVID-19 Immunity for Health Care Services and Nursing Homes May Change Soon in New York

In previous blog posts, we discussed New York’s Emergency Disaster Treatment Protection Act (EDTPA), which was enacted on April 6, 2020 as part of the state budget. The Act provides immunity to hospitals, nursing homes and other health care professionals that arises from alleged decisions, actions and/or omissions related to the care of individuals with COVID-19 from the initial emergency declaration on March 7, 2020 through its expiration. The EDTPA does not provide immunity for intentional criminal conduct, recklessness or gross negligence by a facility…
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FDA Warns: Hands Off for Some Sanitizers

The COVID-19 pandemic continues to raise a multitude of legal and practical issues in the midst of a terrible health crisis. The legal issues related to potential legal liability for actions during unprecedented public health crisis will continue to grow. This space has addressed product fraud issues, product immunity issues, immunity issues for reasonable actions taken