2026 Drug and Medical Device Seminar

Young Lawyers Blockbuster

• In-House Counsel Panel: Five Ways In-House Counsel Think Differently from You
• Recent Trends in Plaintiff’s Lawyer Tactics and How to Counter Them
• AI and Software as Products: Emerging Trends in Product Liability in the U.S. and EU

Young Lawyers Blockbuster
In-House Counsel Panel: Five Ways In-House Counsel Think Differently from You

Outside counsel and in-house teams often share the same goals but operate under very different pressures, incentives, and information constraints. In this candid discussion, in-house attorneys from major life sciences companies will share the internal realities, from risk tolerance and product timelines to cross-departmental coordination, that drive their decision-making. Understanding these differences will help outside counsel deliver advice that is strategic, efficient, and aligned with business priorities.

Young Lawyers Blockbuster
Recent Trends in Plaintiff’s Lawyer Tactics and How to Counter Them

Plaintiffs’ lawyers are increasingly using tactics such as social media shorts to warn consumers about products they would “never use,” often with inflammatory statements about the products designed to spark outrage among the public, and they are increasingly using litigation funding to support both these campaigns and their substantive litigation against these products, complicating resolution of these cases. This session would address these tactics and discuss practical solutions and ways to address them in litigation.

Angelique Ciliberti, Arnold & Porter, Washington, D.C.
Jenna Johnson, Barnes & Thornburg, Dallas, TX

Young Lawyers Blockbuster
AI and Software as Products: Emerging Trends in Product Liability in the U.S. and EU

As courts and regulators confront the rapid integration of AI and software into everyday life—from chatbots to ride‑sharing platforms to medical technologies—the legal landscape around product liability is shifting. Recent U.S. decisions, including the Middle District of Florida’s 2025 ruling treating an AI chatbot as a “product” and the Ohio Supreme Court’s analysis in Deditch v. Uber Technologies, Inc., signal a growing willingness to classify software and AI systems as products subject to traditional liability frameworks. At the same time, the EU’s new Product Liability Directive expands and modernizes product definitions to explicitly encompass digital and AI‑driven tools. This presentation will explore these developments, compare emerging U.S. and EU approaches, and discuss what companies deploying AI or software‑based services should consider as product liability law evolves.

Sebastian Ovalle, Hollingsworth LLP, Washington, D.C.

Dine-Arounds

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

Dine-Around details

Welcome and Introductions

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

The MAHA Impact: Regulators, Ingredients, and High-Stakes Litigation Risk

The Make America Healthy Again (MAHA) initiative aims to reshape the food and pharmaceutical regulation in several ways. The underlying premise of the initiative and related reports is that food we consume and the medicines we take have an outsized impact on the health and well-being of the country, particularly children. With respect to drugs, the MAHA initiative focuses on issues such as ingredient safety; potential overprescribing of certain categories of prescription drugs, especially for pediatric populations; so-called “corporate capture” and conflicts of interest; and Direct to Consumer (DTC) advertising practices. Hear from a former US Senator on the current regulatory landscape and what companies can be doing as Congress, agencies, and advocates push for new standards for pharmaceuticals consistent with the MAHA agenda.

Moderator
Sharon Mayl, DLA Piper, Washington, D.C.

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

DRI Insights Quick Hits
Recent Regulatory and Legal Trends in the Life Sciences Industry

This talk will discuss recent regulatory trends in the life sciences industry, including FDA’s new quality system inspection procedure and observations of overreliance on AI. In addition, this talk will discuss best practices and effective use of visualizations and graphics.

Marta Villarraga Ph.D., RAC, Exponent, Philadelphia, PA

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
Michael X. Imbroscio, Covington & Burling LLP, Washington, D.C.

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.

Jessica Grant, Shook Hardy & Bacon LLP, San Francisco, CA
Larry D. Ottoway, Foilart Huff Ottoway & Bottom, Oklahoma City, OK
Jennifer Saulino, Sidley Austin LLP, Washington, D.C.

From Start to Finish and the Influence/Impact of the Defense on Settlement Administration

Debra Forsythe, Epiq

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

• Freedom Trail: The Walk Into History Tour
• Tour of Fenway Park

View small group networking details

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

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

Welcome and Announcements

Eric Rumanek, Troutman Pepper Locke, Atlanta, GA
Charissa Walker, 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

Robin A. Walker, Lexington, MA
Heidy King-Jones, Spyre Therapeutics, Boston, MA

Ted-Style Talk (Non-CLE)

Jim Beck has spent the last forty years thinking about ways to improve the defense of prescription medical product liability litigation. In this quick-hitting talk, he describes his best and most impactful ideas.

Jim Beck, Reed Smith LLP, Philadelphia, PA

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.

Eva Canaan, King & Spalding LLP, Miami, FL
Daniel J. Brown, McCarter & English LLP, Wilmington, DE
Eric G. Lasker, Hollingsworth LLP, Washington, D.C.

Ted-Style Talk (Non-CLE)

Gail Rodgers, Axiom Law, New York, New York

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
Hon. J. Gavin Reardon, Jr., Boston, MA
April Little, Faegre Drinker Biddle & Reath LLP, Minneapolis, MN