Steven Vahidi

All articles by Steven Vahidi

 

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…  

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  

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…  

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…  

Will Lawmakers Provide Immunity to Businesses from COVID-19 Lawsuits?

As state and local governments take steps toward reopening the economy, business owners are rallying around the issue of liability immunity from COVID-19 lawsuits and organizing efforts aimed at pressuring federal and state lawmakers to enact legislation limiting liability from lawsuits filed by workers and customers infected by COVID-19. The stakes are high. Because the complete clinical picture regarding COVID-19 is not fully understood, big and small businesses alike are targets for opportunistic lawsuits. When symptoms may not develop for days after the fact, just…  

PREPA Extends Liability Immunity to Manufacturers of Component Parts and Suppliers of Raw Material Suppliers Used in COVID-19 Countermeasures

With the COVID-19 outbreak spreading across the globe, there is a shortage of critical medical supplies such as ventilators, test kits, and personal protective equipment (PPE). Component part manufacturers and raw material suppliers have scaled up production to help medical device and pharmaceutical manufacturers eliminate critical shortages. Components and raw materials are also being supplied to non-medical companies like General Motors, Tesla, and Dyson, who have repurposed their factories to make unfamiliar products like ventilators and face shields. To head off the inevitable wave of…  

Liability Immunity Now Extended to Manufacturers of Any NIOSH-Approved Respirator Used as a COVID-19 Countermeasure, Including Those Not Intended for Medical Applications

As the COVID-19 pandemic stresses the U.S. health care system, personal protective equipment such as personal respirators are in desperately short supply. Healthcare providers are repurposing respirators originally designed for non-medical use to combat the COVID-19 pandemic. This practice raises the question as to whether manufacturers of non-medical respirators qualify for liability immunity under the Public Readiness and Emergency Preparedness Act (PREPA). We previously wrote about PREPA and the March 17, 2020 declaration by the Secretary of Health and Human Services providing liability immunity to…