2026 Drug and Medical Device Seminar

Young Lawyers Blockbuster

Dine-Arounds

Join colleagues and friends at selected restaurants for dinner (on your own).

Welcome and Introductions

Ted J. McDonald III, McDonald Law Group, Kansas City, MO
Eric Rumanek, Troutman Pepper Locke, Atlanta, GA

MAHA and “Clean” Pharma: Regulators, Ingredients, and High-Stakes Litigation Risk

A growing “Make America Healthy Again” (MAHA) movement is pushing regulators and industry alike to re-evaluate long-standing pharmaceutical ingredients, with talc at the center of the debate. The FDA and other health agencies have already signaled heightened scrutiny of talc in drug products, and the ripple effects could extend to other ingredients, including PFAS. These regulatory shifts not only raise compliance challenges but also open the door to new product liability theories, with plaintiffs’ counsel seizing on ingredient safety debates to drive litigation. Hear from a former US Senator discuss the current regulatory landscape, the science and policy driving ingredient removal, and the parallel litigation risks facing manufacturers as agencies and advocates push for a new standard of “clean” pharmaceuticals.

Sharon Mayl, DLA Piper, Washington, D.C.
Richard Burr, DLA Piper, Washington, D.C.

Mass Torts Without Borders: Latest Strategies for Global Drug & Device Litigation

This international panel will discuss global coordination of mass torts and class action litigation, and emerging challenges involving cross-border drug and medical device litigation. With the globalization of communication and litigation, including increasing global coordination by plaintiff lawyer and third-party litigation funders, this topic continues to grow in importance. The speakers include counsel from four different countries, all with extensive experience handling cross border litigation in this space. Their discussion will focus on differences between jurisdictions that impact defense strategies, including differences in substantive and regulatory laws, discovery, expert and trial procedures, and how US and foreign counsel can best work together to achieve the best and most cost-effective result for clients.

Moderator
Peter Pliszka, Fasken, Toronto, Canada

Sophie Tatot, AbbVie, Paris, Île-de-France, France
Alexandre Einsfeld, Fialdini Einsfeld Advogados, São Paulo, Brazil

Inside the War Room: Trial Tested Tactics from Star Drug & Device Trial Lawyers

Hear long-term, well-known lawyers present on trial strategy issues for drug and device attorneys. They will share what has worked for them and what has not worked.

Larry D. Ottoway, Foilart Huff Ottoway & Bottom, Oklahoma City, OK

DRI Networking Lunch

Beyond Traditional Product Claims: Ethylene Oxide, PFAS, and the Next Wave of “Drug & Device Litigation”

Join us for an insightful panel discussion featuring leading legal experts as they delve into the evolving landscape of litigation against drug and medical device manufacturers. This session will focus on the latest claims involving ethylene oxide and PFAS (per- and polyfluoroalkyl substances), two critical areas of concern in the pharmaceutical and medical device industries. Ethylene oxide, a chemical used in sterilizing medical equipment, has come under scrutiny due to its potential health risks, leading to increased litigation. Similarly, PFAS, often referred to as "forever chemicals," have been linked to various health issues, prompting a surge in legal actions against manufacturers. Our panel of seasoned attorneys will explore the complexities of these cases, including regulatory challenges, scientific evidence, and strategic considerations.

Carla Karp, Becton, Dickinson, and Company, Franklin Lakes, NJ
Brian P. Cadigan, Reed Smith LLP, Los Angeles, CA
Dennis L. Murphy, Jones Day, Cleveland, OH

Small Group Networking

Networking Reception
Sponsored by: Barnes & Thornburg, Borden Ladner Gervais, Faegre Drinker, Nelson Mullins, Shook Hardy & Bacon, Tucker Ellis, UB Greensfelder

Join fellow seminar attendees at our Networking Reception. More details to come.

Dine-Arounds

Join colleagues and friends at selected restaurants for dinner (on your own).

Welcome and Announcements

Eric Rumanek, Troutman Pepper Locke, Atlanta, GA
Charissa Walkers, Tucker Ellis LLP, Cleveland, OH

Heavy Hitters in the C-Suite: What Keeps Drug & Device General Counsel Up at Night

Come hear from this dynamic panel of General Counsel from pharmaceutical and medical device companies. They will share valuable insights on less commonly known factors impacting strategic legal decisions, expectations for outside counsel, and the legal issues keeping them up at night.

Moderator
Sheila S. Boston, Arnold & Porter, New York, NY

Jamie Haney, Sanofi, West Newton, MA

Raising the Bar on Experts: Litigating Under Amended Rule 702 in Drug & Device Cases

This panel will explore the evolving landscape of expert admissibility under Federal Rule of Evidence 702. Speakers will review recent federal and state court decisions where courts excluded expert testimony, highlighting the reasoning and strategies that led to successful challenges. The discussion will also examine how state courts are beginning to amend their evidentiary rules to align with the federal standard, signaling a nationwide shift toward closer judicial scrutiny of expert qualifications and methodologies. Panelists will provide practical tips and litigation strategies for using Rule 702 to disqualify unreliable or unqualified experts, equipping attendees with concrete tools to strengthen their own motions and trial practice.

Daniel J. Brown, McCarter & English, LLP, Wilmington, DE

Promise and Peril: Judicial and Defense Perspectives on the Ethics of AI Assisted Advocacy

Artificial intelligence has quickly moved from novelty to necessity in legal practice, raising profound ethical questions for both advocates and judges. Lawyers face clear duties of candor to the court and compliance with Rule 11, yet recent cases illustrate the dangers of overreliance on unverified AI outputs—including “hallucinated” caselaw. Courts around the country have sanctioned attorneys for these missteps, and in one instance, a judge even withdrew an opinion after realizing it contained AI-generated inaccuracies. But the story of AI in the courtroom is not solely cautionary. The potential benefits of AI are substantial, including enhanced efficiency in research and drafting, improved access to justice for under-resourced litigants, and even the ability to streamline court administration. Join us to hear first-hand insight from local judges into how the bench views both the promise and perils of AI-assisted advocacy. Together with experienced practitioners, the panel will examine recent pitfalls, clarify lawyers’ ethical obligations, and offer practical best practices for leveraging AI responsibly—ensuring that innovation strengthens, rather than undermines, the integrity of the judicial process.

Mike Leard, Nutter, Boston, MA
Hon. Debra A. Squires-Lee, Boston, MA