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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COVID-19 and Expert Believability

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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GOP Introduces Bill Creating Broad Civil Immunity for COVID-19 Lawsuits

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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FDA Announces Laboratory Testing Method for Hand Sanitizers

We have written before on some of the issues relating to hand sanitizers, including troubling information about how some people misuse hand sanitizers in dangerous ways and the FDA’s efforts to publicize information about various hand sanitizers identified by the FDA as being hazardous to users. The FDA has warned consumers not to use those hand sanitizers and has warned importers, consignees, distributors, retailers, and others not to distribute or sell those hand sanitizers, even if the corresponding manufacturers have not recalled them. Earlier this…
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New York Rolls Back Immunity to Nursing Homes and Health Care Service Providers

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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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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