The Dexcom Three-Track Template for Medical Device Litigation

Moze Cowper, Founding Partner | Cowper Law

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.

• Education & Credentials

Mr. Cowper earned his J.D. from Rutgers University School of Law (Camden) in 2000, where he served as Articles Editor of the Rutgers Law Review and was a finalist in moot court. He received his B.A. in History from the University of New Hampshire in 1997, graduating Phi Beta Kappa. He is admitted in California, New Jersey, Texas, and Washington, D.C., as well as New South Wales, Australia, and practices before numerous federal district courts, the United States Court of Appeals for the Ninth Circuit, and the United States Supreme Court.

• Recognition & Leadership

Law360 has recognized Mr. Cowper as one of the most innovative attorneys in the United States for his work at the intersection of litigation and technology. Chambers USA describes him as “exceptional,” and Chambers Global recognizes his strength in disputes involving pharmaceutical and medical device companies. In 2012, the Association of Corporate Counsel recognized him as a rising star under the age of forty. He serves as co-lead counsel in the Medtronic MiniMed insulin pump litigation and in the Allergan Breast Implant litigation (JCCP 5104), both in Los Angeles Superior Court, and sits on the Plaintiff Steering Committee in MDL 2921, the Allergan Biocell Textured Breast Implant Litigation. He previously served on the Plaintiff Steering Committees in the Essure Litigation and the Argon/Rex IVC Litigation.

• Professional Involvement

Mr. Cowper is a member of The Sedona Conference Working Group 1 on Electronic Document Retention and Production and Working Group 6 on International Electronic Information Management, Discovery and Disclosure. He has served on the faculty of Georgetown Law’s Advanced E-Discovery Institute, is part of the speaker’s program at the Federal Judicial College, and has authored numerous articles on litigation, e-discovery, and privacy.

• Experience

Before founding his own firm, Mr. Cowper spent more than ten years at Amgen Inc., where he managed products liability, consumer fraud, securities, and derivative litigation for the company and developed a broad understanding of clinical trials, drug labeling, safety reporting, and the FDA. Earlier in his career, he practiced product liability and class action law at Drinker Biddle & Reath and clerked for the Honorable Marina Corodemus in the New Jersey Superior Court’s mass tort division, working on national diet drug, breast implant, defective tire, and tobacco litigation.

Adam J. Levitt, Co-Founding Partner | DiCello Levitt

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.

• Education & Credentials

Mr. Levitt earned his J.D. from Northwestern University School of Law and his A.B., magna cum laude, from Columbia College, Columbia University.

• Recognition & Leadership

Chambers USA has ranked Mr. Levitt Band 1 for Mainly Plaintiffs Litigation in Illinois for four consecutive years and ranks him nationwide for Product Liability: Plaintiffs, describing him as the “go-to plaintiffs’ attorney in the class actions space.” The National Law Journal has described him as a “pioneer” in technology litigation. Benchmark Litigation has named him a National Litigation Star, and Lawdragon lists him among the 500 Leading Lawyers in America, the 500 Leading Plaintiff Financial Lawyers, and the 500 Leading Plaintiff Consumer Lawyers in the United States.

• Professional Involvement

Mr. Levitt writes “Arguing Class Actions,” a monthly column in The National Law Journal, has testified before the Illinois Supreme Court Rules Committee on class action practice, and chairs an annual class action litigation conference in Chicago. He is an elected member of the American Law Institute and the Economic Club of Chicago.

• Experience

Mr. Levitt has served as co-lead counsel in three of the largest biotechnology class actions in U.S. history, helping recover more than $1.7 billion. He served on the Plaintiffs’ Steering Committee in the Volkswagen “Clean Diesel” litigation, which produced a $16 billion settlement, and with his fellow co-lead counsel secured a $102.6 million jury verdict against General Motors. His medical device leadership includes chairing the Plaintiffs’ Executive Committee in the Stryker Rejuvenate and ABG II Hip Implant Litigation. He also represents multiple State Attorneys General in PFAS environmental contamination litigation and the City of Baltimore in litigation arising from the Francis Scott Key Bridge collapse.

David A. Simon, Associate Professor of Law | Northeastern University School of Law

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.

• Education & Credentials

David A. Simon holds a Juris Doctor (J.D.), a Master of Laws (LL.M.), and a Doctor of Philosophy (Ph.D.). He is a practicing member of the Illinois and Massachusetts Bars and currently serves as a faculty member at Northeastern University School of Law, where he teaches courses on tort law, administrative law, and drug and device regulation.

• Recognition & Leadership

Professor Simon serves as the Principal Investigator for The Project on Medical Device Safety and is Co-Director of the Amy J. Reed Collaborative for Medical Device Safety, a research initiative funded by Arnold Ventures. He previously led a three-year research project at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics on the ethical, legal, and regulatory challenges of digital home healthcare, supported by the Gordon and Betty Moore Foundation. He has also served on the faculties of Harvard Law School, George Washington University Law School, and University of Kansas School of Law.

• Professional Involvement

Professor Simon is an active researcher and leader in health law and medical device regulation. His work has appeared in numerous leading legal, medical, and scientific publications, including the Texas Law Review, Boston College Law Review, Emory Law Journal, Georgia Law Review, Oxford Journal of Legal Studies, Journal of Law & the Biosciences, JAMA, Nature Biotechnology, NEJM AI, Neurology, Annals of Surgery, and the Journal of Law, Medicine & Ethics. He also founded two nonprofit organizations—Harmed Americans for Reform in Medical-Device Safety and Project TCF20—to advance medical device safety and related public policy initiatives.

• Experience

Professor Simon’s work centers on healthcare innovation, drug and medical device regulation, administrative law, and tort law. In addition to his teaching and scholarship, he directs major research initiatives focused on medical device safety, has participated in internationally funded research projects, including the European Union-funded UIUC CLASSICA research team, and has led interdisciplinary research examining the legal and regulatory implications of digital home healthcare technologies. His

SESSION 1 – Dexcom CGM Litigation: Personal Injury, Consumer Class Actions, and Preemption Strategy | 1:00pm – 2:00pm

This 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.

BREAK | 2:00pm – 2:10pm

SESSION 2 – Current and Emerging Issues in Medical Device Litigation | 2:10pm – 3:10pm

This 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.