Topic Archives: Drug & Medical Device

November 22, 2021 - Coronavirus (COVID-19), Drug & Medical Device, Emergency Use Authorization (EUA), FDA, Pharmaceutical & Medical Devices

HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

By: Stacy Cline Amin, Bethany J. Hills, and Brigid DeCoursey Bondoc

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 …›

July 8, 2021 - Announcements & Press, Class Action, Consumer Products, Drug & Medical Device, Environmental Law, MDL, Mass Torts, Pharmaceutical & Medical Devices, Product Liability, Retail, Trials

Morrison & Foerster Is Recognized As Tier 1 Firm in Product Liability, Mass Torts, and Class Action for Consumer Products

Legal 500 US 2021 has named Erin Bosman, David Fioccola, Jessica Grant, Julie Park, James Schurz, William Tarantino, and Claudia Vetesi among their top product liability and class action practitioners nationwide. The publication also recognized Morrison & Foerster as a top Tier 1 Firm …›

November 24, 2020 - Announcements & Press, Class Action, Coronavirus (COVID-19), Drug & Medical Device, MDL, Product Liability, Public Readiness and Emergency Preparedness Act (PREP Act)

Join Us: Drug & Medical Device Litigation Conference

By: Erin M. Bosman and Julie Y. Park

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 …›

September 17, 2020 - Coronavirus (COVID-19), Drug & Medical Device, FDA, Product Liability

First Decisions Limit PREP Act Immunity in Coronavirus Context

By: Erin M. Bosman, Julie Y. Park, Bethany J. Hills, and Alexander A. Najarian

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 …›

June 30, 2020 - Antitrust, Arbitration, Consumer Products, Drug & Medical Device

Schein On: Supreme Court to Decide Key Arbitration Delegation Question

The Henry Schein arbitration battle is making its way to the Supreme Court again. The Court recently granted Henry Schein, Inc.’s certiorari petition to answer the question of “Whether a provision in an arbitration agreement that exempts certain claims from arbitration negates an otherwise …›

May 26, 2020 - Coronavirus (COVID-19), Drug & Medical Device, Emergency Use Authorization (EUA), FDA, Product Liability

FDA Signals Flexibility with COVID-19 Tests

By: Bethany J. Hills, Erin M. Bosman, and Julie Y. Park

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 …›

July 3, 2019 - Drug & Medical Device, FDA, Pharmaceutical & Medical Devices, Product Liability

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

By: Erin M. Bosman, Bethany J. Hills, and Julie Y. Park

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. …›

January 16, 2019 - Antitrust, Arbitration, Consumer Products, Drug & Medical Device

Leave Arbitration to the Arbitrator: No “Wholly Groundless” Exception Where Contract Delegates Arbitrability Determination to the Arbitrator

By: Penelope A. Preovolos

The United States Supreme Court continued the pro-arbitration trend in its jurisprudence, as well as its strict construction of the Federal Arbitration Act, in its unanimous decision in Henry Schein, Inc. v. Archer & White Sales, Inc., No. 17-1272, 2019 WL 122164 (U.S. Jan. …›

October 24, 2018 - Consumer Products, Drug & Medical Device, FDA, Privacy, Product Liability

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

By: Erin M. Bosman and Julie Y. Park

FDA is tackling cybersecurity threats head-on and expects industry to do the same.  Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices.  Industry should take note, as these developments …›

June 13, 2018 - Drug & Medical Device, Privacy

A New Era in FTC Data Security Oversight?

By: Julie O'Neill

The U.S. Court of Appeals for the Eleventh Circuit has issued a ruling that may drastically change the nature of the relief that the Federal Trade Commission (“FTC”) seeks to impose on companies it alleges to have had inadequate data security measures in place. …›