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’s COVID-19 Product Regulation Enforcement Roadmap

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA …›

Join Us: Drug & Medical Device Litigation Conference

MoFo is a proud sponsor of the American Conference Institute’s Drug & Medical Device Litigation Conference, the premier products liability litigation event for the pharmaceutical and medical device industries for the past 24 years, to be held virtually on December 8 – 9, 2020. Erin …›

First Decisions Limit PREP Act Immunity in Coronavirus Context

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act …›

Cancellations and Refunds Under California’s Consumer Protection Statutes in an Evolving COVID-19 Landscape

Several months into the widespread business closures and event cancellations resulting from the COVID 19 pandemic, we have seen businesses adopt a range of strategies to respond. Those strategies, in addition to the closures and cancellations themselves, have sparked a surge in class action …›

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 …›