Topic Archives: Product Liability + Class Action

July 2, 2019 - Medical Devices + Diagnostics, Product Liability + Class Action, Regulatory

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.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) …›

June 5, 2019 - Litigation, Pharma, Product Liability + Class Action, United States

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

By: Erin M. Bosman, Julie Y. Park, and Benjamin S. Kagel

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck …›