Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.
On May 4, 2020, the Securities and Exchange Commission (“SEC”) issued a temporary final rule easing some restrictions on small businesses seeking to raise capital pursuant to Regulation Crowdfunding (“Reg CF”). The SEC made the move in response to feedback from its Small Business Capital Formation Advisory Committee and other outreach conducted by SEC staff regarding the industry’s urgent need for expedited access to capital while maintaining investor protections as the COVID-19 pandemic persists. Continue Reading
On April 24, 2020, in Taylor Lohmeyer Law Firm PLLC v. United States, the United States Court of Appeals for the Fifth Circuit held that a Texas-based estate and tax-planning law firm (“Taylor Lohmeyer” or the “firm”) could not invoke the attorney-client privilege to quash a summons by the Internal Revenue Service (“IRS”) seeking the identities of firm clients. See No. 19-50506, Dkt. No. 00515394156 (5th Cir. Apr. 24, 2020). In affirming the District Court’s decision, the Court of Appeals ruled that Taylor Lohmeyer could not use the privilege as a “blanket” to circumvent compliance with the summons, but may have viable arguments to shield disclosure of specific documents through the use of a privilege log. Continue Reading
The devastating economic impact of the COVID-19 pandemic already has set in, with the future of thousands of businesses hanging in the balance. Big and small businesses alike are finding it difficult to cope with the downturn. The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) provisions related to small business loans provide a glimmer of hope. Among other forms of economic relief, the CARES Act created the $349 billion Paycheck Protection Program (“PPP”) to provide funding to assist small businesses impacted by the pandemic. After the initial allocation of PPP funds was exhausted the President signed a bill providing an additional $484 billion in relief, including $310 billion for the PPP, on April 24, 2020. It may turn out for some businesses, however, that these provisions will be nothing more than fool’s gold. The U.S. Small Business Administration (“SBA”) loan programs, including the PPP under the CARES Act, only are available to qualifying businesses that strictly comply with complex rules related to the size of the business, including its employee count, financial condition, affiliations, control and ownership, and industry classifications. Businesses that reflexively jumped at the SBA money grab without discipline or compliance are at risk of aggressive government enforcement that surely will follow.
All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in the public health response to COVID-19. The Secretary for the Department of Health and Human Services (“HHS”) issued an updated PREP Act declaration implementing this addition to the covered countermeasures eligible for PREP Act immunity, with retroactive effect to March 27, 2020. Continue Reading
The novel coronavirus (“COVID-19”) pandemic has given Department of Veterans Affairs (“VA”) contractors several powerful new tools in their toolbelts, and VA contractors should not leave available protections on the table. VA contractors, including those supplying medical devices under the MSPV-NG bridge contract and pharmaceuticals on a VA Federal Supply Schedule (“FSS”), now can negotiate for extraordinary limitations on liability (in addition to some provided by statute), among other opportunities. Particularly for contractors providing goods and services used in the COVID-19 pandemic response, it is crucial to understand both new protections available and other changes to the rules of VA contracting.
COVID-19 took the world by surprise and continues to spread across the globe in more than 210 countries and counting. The outbreak in the United States escalated rapidly, with over 585,000 confirmed cases as of April 14, 2020. The federal government and a number of hard-hit states were caught off guard, and soon learned that their inventories of personal protective equipment (“PPE”) and other life-saving equipment such as test kits and ventilators were insufficient to keep pace with the pandemic. The demand for equipment to fight COVID-19 skyrocketed and government and commercial entities have shifted into high gear to respond. Whether motivated by humanitarian concern or commercial enterprise, many state and local governments, companies and individuals are now looking abroad to procure critical supplies on an expedited basis. At the same time, many foreign industrial manufacturers are positioning themselves for the high demand of exports by adapting their facilities to produce PPE. For example, Chinese electric car maker BYD announced on March 13, 2020 it is now the largest face mask factory in the world—less than one month after converting its facilities in response to the pandemic. In the midst of these exigent circumstances, the global supply chain landscape is replete with Foreign Corrupt Practices Act landmines—and well-intentioned companies hoping to partner with foreign PPE manufacturers could become a casualty if they don’t watch their step. Continue Reading
As the Federal Government struggles to secure a sufficient volume of Personal Protective Equipment (“PPE”) – i.e., gloves, masks, gowns, face shields, etc. – for the nation’s health care workers and first responders, states and localities have begun taking it upon themselves to identify and protect the resources available within their geographic boundaries. These efforts have resulted in a growing number of state and local orders targeted at manufacturers, suppliers, and distributors of PPE and medical equipment. Continue Reading
To further assist the contractor community with the effects of the unprecedented Coronavirus Disease 2019 (COVID-19), the U.S. Department of Defense (DoD) issued on April 8, 2020 a Class Deviation authorizing contracting officers to use a new clause – DFARS 231.205-79, CARES Act Section 3610 Implementation – to address contractor reimbursement under Section 3610 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136). Section 3610 allows agencies to reimburse paid leave, including sick leave, that a contractor provides to keep its employees or subcontractors in a ready state, including to protect the life and safety of Government and contractor personnel, during the COVID-19 pandemic. Paid leave is reimbursable at the contractor’s minimum billing rates under its contracts, and may be allowed for up to an average of 40 hours per week. Continue Reading
There is more than $2 trillion on the line and the multi-trillion-dollar question is: Who’s minding the store? On March 27, 2020, in response to the financial set-back created by the novel COVID-19 pandemic, President Trump signed into law the more than $2 trillion Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) – by far the largest economic relief package in U.S. history. The CARES Act’s purpose is to keep the U.S. economy afloat and provide relief to struggling Americans, large corporate sectors, and small businesses while the nation battles this pandemic. With $500 billion allocated for big corporations, $377 billion for small businesses, and another $153.5 billion for healthcare, these relief moneys (like with most government funds) are sure to come with strings attached in the form of complex regulations and substantial oversight, with enforcement not far behind. Continue Reading