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 in a time of incomplete, conflicting, and shifting information, nursing home issues, as well as concerns about whether efforts to prevent or treat the disease…
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FDA’s Efforts to Monitor Manufacturers of COVID-19 Products

The Food and Drug Administration (FDA) provided an update on its efforts to combat the sale of fraudulent products during the COVID-19 pandemic through written testimony before the U.S. Senate Subcommittee on Manufacturing, Trade, and Consumer Protection on July 21, 2020. The FDA has uncovered more than 780 fraudulent COVID-19 products, including substandard personal protective equipment (PPE), diagnostic tests, and purported vaccines being offered for sale. The FDA found that the Internet is the primary mechanism for the sale of fraudulent COVID-19-related products, which presents…
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Pennsylvania Supreme Court Reaffirms Fealty to Frye Standard

Although our nation and our courts are still very much in the midst of addressing the acute aspects and effects of the COVID-19 pandemic, there will come a time when our courts return to more “normal” operations. It is likely that this will coincide with an influx of new litigation relating to COVID-19 claims of many kinds, including, of course, personal injury and, tragically, wrongful death claims. For many of those claims, the use of experts and expert testimony to address issues of causation will…
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FDA’s Website a Worthwhile Source of Information

A trip through the FDA’s website is worth the time spent both for those heavily invested in the development of COVID-related diagnostic and treatment endeavors, and those with a causal interest. In this time of the politicization of response to the pandemic and reliance on traditional or social media for their spin (informed, or otherwise), it is worthwhile to either peruse or dissect FDA’s statements and guidance. Surely there is some PR in these materials, but they are the primary source for the content –…
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As Temperatures Heat Up, Remember Litigation Will, Too

For many litigators, including those of us who handle pharmaceutical and medical device litigation, the past several months have seen various departures from how we might otherwise have pursued our pending cases. While effects varied in different parts of the country, and courts in different jurisdictions have adopted different plans for reopening and allowing cases to continue, everyone has likely seen at least some changes. Some attorneys have embraced virtual/remote depositions, while others have opted to wait to schedule and depose witnesses in the hopes…
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New York Governor Releases Report to Show His Nursing Home Admissions Policy Not Linked to Increased Nursing Homes Deaths

We have previously discussed the heightened criticism of New York Gov. Andrew Cuomo’s handling of the nursing homes during the COVID-19 pandemic. In response to that criticism, on, New York Commissioner of Health Dr. Howard Zucker released a report on July 6, 2020 by the New York State Department of Health entitled, “Factors Associated with Nursing Home Infections and Fatalities in New York State During the COVID-19 Global Health Crisis.” The full report is available here. The report states the March 25 admission policy…
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FDA Authorizes First COVID-19 At-Home Sample Collection Kit Authorized For Use With Multiple Tests

Diagnostic testing for SARS-CoV-2 is a key tool in the combat against the COVID-19 pandemic. Since the Secretary of Health and Human Services declared a public emergency on January 31, 2020, calling for the entire country to aid in response to the COVID-19 outbreak, the U.S. has had low diagnostic testing rates due to a lack of testing capabilities. In order to improve access to testing, the U.S. Food and Drug Administration (FDA) recently granted an emergency use authorization to Everlywell, Inc. for an at-home…
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