HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations …›

A Return to Normalcy? Check Your Local Rules – An Update on Mask Litigation and Guidelines

Nine months ago, we discussed several issues that had been raised by COVID-19 face mask-related litigation.[1] Soon after, COVID-19 infection rates spiked to unprecedented levels. But with the emergency use authorization of three COVID-19 vaccines in the United States, the state of the pandemic …›

May 18, 2021 - Coronavirus (COVID-19), FDA

New Face Mask Performance Standard Has Consumers Covered

ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety …›

Ex-Tyson Employees’ COVID-19 Suit to Be Litigated in Federal Court

Court Rules the Federal Officer Removal Statute May Provide “Critical Infrastructure” Companies Additional Pathway to Litigate COVID-19 Claims in Federal Court The Eastern District of Texas ruled last week that Tyson, a “critical infrastructure” company, properly removed a COVID-19-related case to federal court under the …›

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 …›

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 …›