Changing Policies and Attitudes: Impacts on Medical Product Litigation

Attorneys Eric Alexander, Megan Mocho, Juliet McBride and Sara Klock presented a webinar with Medmarc breaking down changes in federal healthcare regulations and policy and their implications for medical product litigation. Ms. Klock, who focuses on digital health and life sciences, covered enforcement and administrative updates at the U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS), such as the increased use of warning letters and inspections. Ms. McBride, a member of the firm's Healthcare Regulatory & Enforcement Practice Group, explained shifts at the Centers for Medicare & Medicaid Services (CMS), from an uptick in HHS Office of Inspector General (OIG) and U.S. Department of Justice (DOJ) investigations of wound care and cell tissue products to program integrity audits to an overall focus on data reliability and relevance in product marketing. Ms. Mocho, a litigation attorney who co-chairs Holland & Knight's White Collar Defense and Investigations Team and False Claims Act Defense Team, spoke on DOJ and OIG enforcement policies and practices. She highlighted priority areas for government investigations, including kickbacks, materially defective medical devices and healthcare fraud, along with the DOJ's whistleblower pilot program. Finally, Mr. Alexander, leader of the Product Liability – Life Sciences Team, talked about changing attitudes at agencies and in the courtroom, such as increased juror skepticism of mainstream science, and what those changes spell for litigators. He also offered a big-picture look at how all of these developments affect product liability litigation. The program blended perspectives from multiple practice areas to give listeners a comprehensive look at the current state of medical device litigation and insightful predictions for what lies ahead.

Duration: 1:02:47