It was late December when the first cases of COVID-19 were reported in China. Since then, the disease has spread across the world in a global pandemic. In response, countries have instituted various measures in an effort to slow its spread. One common measure has been to order non-essential businesses to suspend operations. Another common measure has been to limit domestic and foreign travel. But as the economic toll increases and the pandemic begins to abate in certain regions, governments are starting to think about how they will restart their economies.

Yesterday, April 15, 2020, for example, Chancellor Angela Merkel announced a plan to begin reopening the shuttered portions of Germany’s economy starting next week. The day before, US President Donald Trump signaled his desire to reopen American businesses by May 1 if not earlier.

Although the process of reopening businesses is still in its early stages even where the pandemic’s apex has apparently passed, this much is clear already: the process will be gradual, vary from jurisdiction to jurisdiction, and confront business with myriad issues.

Continue Reading As Pandemic-Related Shut-Downs Continue, the United States, Like Countries Across Global Regions, Begins To Consider How To Restart Business

Over the past month, in response to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) has invoked its statutory authority to issue a series of Emergency Use Authorizations (“EUAs”) that allow the distribution of certain products for use in the diagnosis, prevention, and treatment of COVID-19 that could not otherwise be distributed for those purposes. Manufacturers and distributors of such products should be aware of the (sporadically updated) EUAs and their limits.

In general, products that are intended to diagnose and treat disease may not be distributed in the United States absent FDA authorization. Although authorization to distribute drugs and medical devices may be obtained via various regulatory routes depending on the product in question, obtaining such authorization is usually a time-consuming endeavor, as the manufacturer must demonstrate the product’s safety and efficacy under the conditions stated in the product’s proposed labelling.

Continue Reading US FDA Emergency Use Authorizations In Response to the COVID-19 Pandemic

On Thursday, April 2, 2020, President Trump issued two memoranda directing use of the Defense Production Act (“DPA”) to (i) facilitate the supply of materials for production of ventilators and (ii) acquire N-95 respirators. Making the determination necessary to trigger the president’s powers under DPA section 101, 50 U.S.C. § 4511, the presidential memoranda determined

Pursuant to his powers under the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. § 247d-6d, the United States Secretary of Health and Human Services has issued a declaration that significantly limits potential legal liability arising from the design, testing, manufacture, labeling, distribution, administration, and provision of medical products intended to diagnose and treat COVID-19.

The declaration means that, subject to certain limitations, persons covered by its terms “shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered” product. 42 U.S.C. § 247d-6d(a)(1).

The scope of the immunity granted is broad. It “applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered” product, “including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such” a product. 42 U.S.C. § 247d-6d(a)(2)(B).

Continue Reading HHS Declaration Limiting Legal Liability Arising From Medical Products and Services Intended To Diagnose and Treat COVID-19