How 2020 Changed Product Liability — And What's Next

Erin Bosman, Julie Park, and Alexandra Preece authored an article for Law360 discussing how product liability regulation and litigation changed in 2020 due to the impact of the COVID-19 pandemic, as well as upcoming trends. “In a year dominated by the pandemic and political gridlock …›

FDA Signals Flexibility with COVID-19 Tests

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps to accelerate the …›

COVID-19 Update: FDA Authorizes First At-Home Collection Kit

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more …›

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort liability …›

FDA Inspires Modifications and Quick Authorizations for Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Ventilator Modification Enforcement Policy On …›

FDA Warns Against At-Home COVID-19 Testing Kits

A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included:  Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell, a company that offers food sensitivity and various other home health tests, and …›