Program Details
2026-08-25 13:00:00
Over 1,000+ webinars
Course Overview
2026-08-25 13:00:00
2h CLE Credits
Intermediate
2
1:00 pm - 2:00 pm ESTThis session teaches attorneys how to read the March 2025 FDA Warning Letter to Dexcom (MARCS-CMS 700835) and the June 2025 and October 2025 Class I Recall Notices as a unified evidentiary package supporting both individual CGM personal injury claims and no-injury consumer refund class actions. This will also include 2026 updates. Attorneys will learn the intake workflow for hypoglycemia and hyperglycemia injury cases using FDA MAUDE adverse event data and recall serial-number matching for Dexcom G6, G7, and Abbott FreeStyle Libre 3 sensors, and will master the parallel-claim pleading framework required to survive express preemption under 21 U.S.C. § 360k(a) and implied preemption under Buckman. Attendees will leave with practical tools for pleading, class certification strategy under Fed. R. Civ. P. 23(b)(3), Article III standing after TransUnion, and the consumer-protection statutory framework across California, New York, and Florida.
This session examines how FDA warning letters and recall notices can be used together as key evidence, while exploring effective plaintiff intake strategies through MAUDE database searches, recall matching, preemption challenges, parallel-claim pleading, and leveraging FDA records to support consumer refund class actions.
Moze Cowper
Adam J. Levitt
David A. Simon 2:10 pm - 3:10 pm ESTThis session examines recent developments and emerging issues in medical device litigation, with a particular focus on the role of FDA regulatory processes in shaping litigation strategy and case outcomes. Participants will explore how FDA oversight influences liability through labeling decisions, current Good Manufacturing Practice (cGMP) regulation violations, warning letters, product recalls, and clinical trial regulations. The session will also examine how FDA pilot programs and enforcement discretion decisions may expand or limit potential liability for manufacturers, providing insight into the evolving regulatory landscape and its impact on medical device litigation.
Moze CowperAdam J. LevittDavid A. SimonMoze Cowper is the founding partner of Cowper Law in Los Angeles and is admitted to practice in both the United States and New South Wales, Australia. He brings twenty-five years of complex litigation experience, with particular depth in disputes involving pharmaceutical and medical device companies.
Adam J. Levitt co-founded DiCello Levitt and represents plaintiffs in complex, multidistrict, class action, public client, mass tort, and commercial litigation. Over his career, he has delivered more than $25 billion in recoveries for clients across biotechnology, financial services, securities, insurance coverage, consumer protection, automotive defect, agricultural, and antitrust disputes.
David A. Simon is an Associate Professor of Law at Northeastern University School of Law, where he teaches tort law, administrative law, and drug and device regulation. His scholarship focuses on innovation in healthcare, particularly the regulation and safety of drugs and medical devices. Professor Simon’s research has been published in leading legal, medical, and scientific journals, and he leads several major research initiatives dedicated to improving medical device safety and healthcare regulation.
Moze Cowper is the founding partner of Cowper Law in Los Angeles and is admitted to practice in both the United States and New South Wales, Australia. He brings twenty-five years of complex litigation experience, with particular depth in disputes involving pharmaceutical and medical device companies.
Adam J. Levitt co-founded DiCello Levitt and represents plaintiffs in complex, multidistrict, class action, public client, mass tort, and commercial litigation. Over his career, he has delivered more than $25 billion in recoveries for clients across biotechnology, financial services, securities, insurance coverage, consumer protection, automotive defect, agricultural, and antitrust disputes.
David A. Simon is an Associate Professor of Law at Northeastern University School of Law, where he teaches tort law, administrative law, and drug and device regulation. His scholarship focuses on innovation in healthcare, particularly the regulation and safety of drugs and medical devices. Professor Simon’s research has been published in leading legal, medical, and scientific journals, and he leads several major research initiatives dedicated to improving medical device safety and healthcare regulation.
Requirements
The Alabama State Bar MCLE Commission requires attorneys to complete 12 credits, including 1 ethics, by December 31 of each year. All credits must be reported by February 15 of the following year. A maximum of 12 credits, including 1 ethics credit, may be carried over for 1 year only.
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