2025 Drug and Medical Device Seminar

Name: 2025 Drug and Medical Device Seminar | DRI
Start: 2025-05-07T12:00
End: 2025-05-09T12:25
Location: Renaissance Nashville Hotel

May 7–9, 2025
Renaissance Nashville | Nashville, Tennessee

The Drug and Medical Device Committee Is Heading to the Music City!

Join us in Nashville for the 2025 Drug and Medical Device Seminar. Enjoy numerous opportunities to network with clients, potential referral sources, and colleagues and to learn about the latest developments in drug and medical device litigation. Hear a jury consultant and lawyers provide the latest insight into jury selection in a post-pandemic world. Learn from experienced in-house and outside counsel what the Loper Bright decision may mean for drug and medical device litigation as we head into the post-Chevron world. Participate in practical discussions concerning the latest on the effective use and management of remote testimony at trial and data driven Multi-District Litigations (MDL) management. This seminar is an amazing opportunity to hear from in-house counsel, outside counsel, and industry experts as it continues to be the go-to event for lawyers working in this field of litigation.

What You Will Learn:

A panel of in-house counsel will provide insight into what is keeping them up at night.
How to analyze the potential pitfalls at the intersection of FDA regulation, science, and off-label use.
Current privilege law on dual use communications.
Cutting edge practice pointers relating to the most effective ways to use remote depositions and trial testimony in the courtroom.

Expand Your Network By:

Attending an evening of food, drink, and fellowship at Fogg Street Lawn Club.
Joining corporate counsel who will gather to discuss issues unique challenges they are facing.
Participating in various small group networking activities to explore the great city of Nashville.

Counsel Meetings with Major Companies
Take advantage of the opportunity to engage with key industry companies* including:

Boston Scientific
GlaxoSmithKline (GSK)
Medtronic
Sanofi
Stryker

*Subject to change

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Thank You to DRI's Drug and Medical Device Committee Leadership

**Archibald T. Reeves, IV**
Program Chair

**Jennifer Snyder Heis**
Committee Vice Chair

Join the Drug and Medical Device Committee

Registration Information

In registering for this seminar, I attest that I devote a substantial portion of my professional time to defending the interests of individuals, business, associations, or governmental entities in civil litigation. I understand that DRI reserves the right, at its sole discretion, to cancel my registration, without a refund, if I do not meet the criteria described above.

	Member Pricing	Non-Member Pricing	Non-Member Bundle ^
Onsite Registration*	$1,695	$2,095	$2,015
Group Registration (Non-Sponsored)	Group registration is for registering four or more attendees. Members and non-members receive a 15% discount off the member and non-member rates respective to the time the group registration is initiated (i.e. Early Bird, Regular or On-Site registration periods). There is one free registration with every 10 paid registrations. If you want to register for the group pricing, fill out the form here. Please note that online registration is not available for this offer.
Government	Government members will receive the applicable government rate for the seminar upon login. If the government rate does not appear after logging in, please call DRI directly at (312) 795-1101 to receive the discounted rate. Invoices can be sent after purchase upon request.

Not a DRI Member? Select the Non-Member Bundle and Save!

^ Not a DRI Member and new to DRI? Take advantage of the Non-Member / Trial Membership Bundle and receive up to 9 months of membership when you register for the seminar. You’ll be able to add this special offer to your cart at check out. Note: Trial membership processing can take up to 30 days from the date of purchase, please contact DRI Customer Service with any questions. Please note renewing members and members with recently lapsed memberships are not eligible for a Non-Member Bundle.

Learn more about membership at DRI and get started on your DRI journey today!

*If your membership recently lapsed, please renew your membership prior to registering to ensure you receive your discounted member rate. If you would like to join DRI to receive the member pricing and see the benefits of becoming a member, click here to go to the Application page.

Networking Events

Premier Networking Reception at the Fogg Street Lawn Club
Sponsored by: ABC

Date: Thursday, May 8 from 6:00–8:00 p.m.
Pricing: Free when you register for the seminar
Location: Fogg Street Lawn Club, 648 Fogg St, Nashville, TN 37203

Get ready for an unforgettable evening at the DRI Premier Networking Reception! After a day of learning, join us at the one-of-a-kind Fogg Street Lawn Club for a truly unique experience. Picture this: you're sipping cocktails on Nashville's first rooftop lawn bowling green, chatting with fellow attendees, and soaking in the British-inspired atmosphere. It's like bocce ball with a twist! Unwind with light bites, an open bar, and the chance to forge lasting connections. Trust me, this isn't your average networking event – it's a night you won't want to miss!

Hotel Information

The seminar will take place at Renaissance Nashville Hotel, 611 Commerce Street, Nashville, TN 37203.
To contact the hotel directly, call 615.225.8400.

The DRI room block at the Renaissance Nashville Hotel is now sold out. Please use the link below to reserve a room at a nearby available hotel.

Alternative Hotels

If you are planning on attending the conference and have not secured a hotel reservation, search for hotel availability via our trusted partner aRes Travel**. Book online or call 800.559.3186 for assistance; for International callers 619.546.5773.

**aRes Travel is a third-party travel planner. Rates, deposits, and cancellation policies may vary and are the responsibility of the guest. Questions on hotel policies or payments made on aRes website should be directed to the aRes Reservation Center or to the hotel directly.

Full Agenda

*Schedule and Speakers subject to change

Wednesday, May 7, 2025

Time (Central)	Session
12:00 p.m.	Registration
3:05–5:00 p.m.	Young Lawyer Breakout
3:05–3:30 p.m.	Protecting Company Witnesses Andrew Jackson, Faegre Drinker Michelle Tessier, Medtronic Ethan York, Stryker
3:35–4:00 p.m.	Defending Against Plaintiffs’ Playbook – Combatting Plaintiff-Preferred Jurisdictions and Preference Trials and Advancing Key Defenses Tommy Huyn, Arnold & Porter Aleksandra Rybicki, Hollingsworth
4:05–4:30 p.m.	Managing the Relationship with Local Counsel and Identifying Expert Witnesses Peter Estall, Norton Rose Fulbright Bebe Thomas, Shook, Hardy, & Bacon
4:35–5:00 p.m.	U.S. Regulatory Frameworks for the Use of Artificial Intelligence in the Pharmaceutical and Medical Device Industries—Key Developments in 2025 and Beyond Precious Johnson, Greenberg Traurig Barrett Tenbarge (General Counsel)
3:00 p.m.	The Long View on Loper Bright For almost four decades and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. However, in June of 2024, that all changed when the U.S. Supreme Court issued the Loper Bright Enterprises v. Raimondo decision which overruled the long-standing Chevron precedent. Consequently, the deference to federal agencies such as the FDA has been narrowed, and courts now have discretion to determine whether an agency’s actions are consistent with the words of the statute and intent of Congress. Our panel will explain the import of the Supreme Court’s Lopez decision for the pharmaceutical and medical device industry and provide insights regarding the way in which litigants and lower courts are now treating agency interpretations in this new post-Chevron era. Margaret O’Neill, Merck, Philadelphia, PA Katlin McKelvie, Gibson Dunn, Washington, D.C. Abeba Habtemariam, Arnold & Porter, Washington, D.C.
4:00 p.m.	Jury Selection in a Post-Pandemic World In product liability lawsuits, trials are often won or lost at jury selection before the presentation of any evidence. Post-pandemic, juror views have shifted and factors that were once important in assessing whether a juror is undesirable are no longer as relevant to weeding them out. Join this panel for an interactive discussion of the latest data on juror perceptions of life sciences companies, how to deal with the impact of the current political and social landscape when it comes to juror biases, best practices through voir dire questioning and cause challenges for eliminating undesirable jurors and identifying stealth jurors who have negative perceptions toward your client, and the strategic use of juror questionnaires. Jill Leibold, Ph.D., IMS Legal Strategies, Los Angeles, CA Ursula Henninger, King & Spalding, Miami, FL Lucy Savorgnan, J&J, New Brunswick, NJ Rob Simpson, Shook Hardy & Bacon, Hartford, CT
5:00 p.m.	Adjourn
6:00 p.m.	Networking / Cocktail Hour
7:30 p.m.	Dine-Arounds Join colleagues and friends at selected restaurants for dinner (on your own). Sign up for Dine-Arounds

Thursday, May 8, 2025

Time (Central)	Session
7:00 a.m.	Fun Run Join us for a 3-mile fun run down to and along the Cumberland River greenway. Please feel free to run or walk at your own pace. You will feel great the rest of the day! Meet in lobby at 7:00, depart at 7:10.
8:30 a.m.	Registration & Coffee Service Get to know the early risers in our group over a cup of coffee.
9:00 a.m.	Welcome and Introductions Ted McDonald, McDonald Veon, Kansas City, MO Archie Reeves, McDowell Knight Roedder & Sledge, Mobile, AL
9:15–10:15 a.m.	What is Keeping In-House Counsel up at Night? Substantive discussion will revolve around what are essentially “hot-topics” for in-house counsel. Topics will include government actions impacting the pharmaceutical industry, global products liability and aggregate litigation trends, changes to the federal rules, and managing risk and expectation in the age of nuclear verdicts. Topics subject to change as current events evolve. Moderator Caroline Power, Kirkland & Ellis LLP, Philadelphia, PA Lisa Floro, Coloplast, Pittsburgh, PA Allison DeLaurentis, Bristol Myers Squibb, Princeton, NJ
9:30 a.m.–12:30 p.m.	DRI Cares \| Blessings in a Backpack Click here for details on DRI Cares project.
10:15 a.m.	Coffee Break
10:45 a.m.	DRI Insights Quick Hits
10:45–11:00 a.m.	Sponsored by: ESi Scary, Dirty, and Misunderstood Words in Medical Device Litigation Many terms related to the medical device industry and regulations are often misunderstood or erroneously given a negative connotation and used to fabricate a non-existent danger. This presentation will provide quick insights into understanding the proper nuance for terms such as, off-label use, recalls, and risk, and strategies to mitigate the impact of these terms in the context of litigation. Felicia L. Svedlund, Ph.D., ESi, Irvine, CA Kimberly K. Cameron, Ph.D., P.E., ESi, Sunnyvale CA Nikita Pak, Ph.D., P.E., ESi, Menlo Park, CA
11:00–11:15 a.m.	Sponsored by: Exponent Innovation and Recent Regulatory Trends in the Life Sciences Industry The presenters will offer insight into recent innovation and regulatory trends that the FDA has emphasized over the past year and leading into 2025, in an effort to continue to support the advancement of safe and effective medical products. Brad James, Ph.D., P.E., FASM, Exponent, Menlo Park, CA Kevin Ong, Ph.D., P.E., Exponent, Philadelphia, PA Marta Villarraga, Ph.D., RAC, Exponent, Philadelphia, PA
11:15 a.m.–12:15 p.m.	Data Driven MDL Management This panel will explore strategies for early vetting and the use of Lone Pine orders in Multi-District Litigations (MDLs), focusing on the role of data analysis in identifying no-injury cases. Panelists will discuss the timing and effectiveness of presenting data at various stages, including bellwether trials and Lone Pine motions, drawing from successful examples like the Taxotere litigation. The session will highlight key tactics, emphasizing the importance of early and repeated data presentation. We will also address the impact of the newly adopted Rule 16.1 of the Federal Rules of Civil Procedure. A demonstration of a data analysis technology tool will also be incorporated, showcasing how these tools can support case vetting and decision-making. Cami Capodice, Irwin Fritchie, New Orleans, LA Kip McDonald, Faegre Drinker, Indianapolis, IN Elizabeth Hanke, KCIC, Washington, D.C.
12:30 p.m.	DRI Networking Lunch
1:30–3:00 p.m.	Corporate Counsel Breakout
2:00 p.m.	Liability at the Intersection of FDA Regulation, Science, and Off-Label Use When scientific evidence outpaces FDA approvals, companies face a unique dilemma: how to effectively communicate the risks and benefits of off-label uses to the medical community, while navigating the complexities of regulatory restrictions. FDA prohibits off-label promotion, but some courts have imposed liability of manufacturers for failing to disclose risk information related to unapproved uses. This disconnect between medical practice, scientific publications, and regulatory constricts raises important questions about duty and transparency. This panel will dive into real-world and hypothetical examples, explore strategic communication approaches, and critically examine the legal implications and litigation risks at play. Sonali Gunawardhana, Becton Dickinson, Franklin Lakes, NJ Megan Krebs, Novo Nordisk, Philadelphia, PA Chris Campbell, DLA Piper, Atlanta, GA Molly Flynn, Barnes & Thornburg, Philadelphia, PA
3:00 p.m.	Drug and Medical Device Committee Business Meeting
3:30–5:45 p.m.	Small Group Networking -Bourbon Tasting: Available either 3:30–4:30 p.m. or 4:45–5:45 p.m. -Ryman Auditorium: 3:30–5:30 p.m. -National Museum of African American Music: 3:45–5:45 p.m. Click on "Small Group Networking" tab below for details and to RSVP.
6:00 p.m.	Premier Networking Reception \| Fogg Street Lawn Club Click here for details on the reception.

Friday, May 9, 2025

Time (Central)	Session
7:00 a.m.	Fun Walk A 2-mile fun walk down to and along the Cumberland River greenway. We will meet in the lobby at 7:00a.m., and leave at 7:10a.m. Everyone is welcome!
8:30 a.m.	Registration and Coffee Service
9:00 a.m.	Welcome and Announcements Eric Rumanek, Troutman Pepper, Atlanta, GA
9:10 a.m.	Zoom Depositions: Early Trial Strategy, Offensive and Defensive Positioning, and Improving Technology This panel will discuss the “new world” of Zoom depositions and trial strategy. Topics will include the increasing ease of use at trials, with upsides and downsides for defendants; jurisdictions with preferred practices and what those mean for trial; implications for “discovery” versus “trial” depositions; and demonstration of technological advancements that can make the most of a Zoom deposition. Brett Mason, Troutman, Atlanta, GA Travis Swearingen, Butler Snow, Nashville, TN Larissa Eustice, Bayer, Whippany, NJ
10:10 a.m.	Coffee Break
10:25 a.m.	In-House Privilege (Ethics) In-house and outside counsel often serve multiple roles when providing advice to their corporate clients. Their communications cover a broad range of topics, some of which are purely legal, but others are more nuanced, involving both legal and non-legal purposes. In the United States, the question of the extent to which those dual-purpose communications are protected by the attorney-client privilege and/or attorney work product doctrine varies. Some courts have adopted a “primary” or “predominant” purpose test which shields only those communications for which the principal purpose is to seek or offer legal advice. Other courts apply a more practical “significant legal purpose” test which protects communications whenever the seeking or giving of legal advice is “one of the significant purposes” of the communication. This issue becomes even more complicated when multi-national corporations are involved because of the varying laws of privilege in other jurisdictions. This presentation will focus on the current state of the law on attorney-client privilege as related to such dual-purpose communications, including an update on recent notable Circuit Court and Supreme Court rulings. The presenter(s) will offer insight both on post-communication privilege reviews and pre-communication guidelines [best practices] to ensure that communications seeking and providing legal advice are protected. Professor Kristi Arth, Belmont University, Nashville, TN Edona Vila, Borden Ladner Gervais LLP, Toronto, CA
11:25 a.m.	Hot Topics Join us for an engaging panel presentation where industry experts will delve into the latest hot topics in the drug and medical device space. The discussion will cover the latest issues, cases and trends in drug and device litigation, in the US and abroad. Attendees will gain valuable insights into the challenges and opportunities facing the industry today. Bradley Matta, Viatris, Pittsburgh, PA Gordon McKee, Blake, Cassels & Graydon LLP, Toronto, Ontario, Canada Sharon L. Caffrey, Duane Morris, Philadelphia, PA
12:25 p.m.	Adjourn

Small Group Networking

Bourbon Tasting
Date: Thursday, May 8 from 3:30–4:30 p.m. OR 4:45–5:45 p.m.
Pricing: $85/person - can be added when you register for the seminar*
Location: Onsite at Renaissance Nashville hotel

Are you ready to discover the perfect way to cap off your seminar day? Join us for a cozy and intimate small group bourbon tasting featuring the exquisite Belle Meade Bourbon. Gather with fellow attendees and let our beverage navigator guide you through a delightful exploration of this local icon. Discover the nuances of this smooth and flavorful spirit through interactive tastings and engaging conversation. Don't miss out on this unique chance to indulge your senses and make meaningful connections.
*Space is limited and offered on a first-come, first-served basis (25 max). Tickets are non-refundable unless DRI cancels the event due to not meeting the minimum attendance requirement.

Ryman Tour
Date: Thursday, May 8 from 3:30–5:30 p.m.
Pricing: Starting at $25.95/person
Location: Ryman Auditorium, 116 5th Ave N, Nashville, TN 37219

The Ryman’s self-guided tour features the “Soul of Nashville” immersive theater experience, historic exhibits, original pews from its church days, and a chance to step on the world-famous stage. You'll also see memorabilia from country music legends and vintage concert posters from Hatch Show Print. Meet in the lobby of the Renaissance Nashville Hotel at 3:30 p.m. before walking over together.

If you're planning to attend, please RSVP to the Ryman tour.
Tickets can be purchased them upon arrival at the Ryman box office or online in advance. Booking ahead is recommended to ensure availability.

African American Museum of Music Visit
Date: Thursday, May 8 from 3:45–5:45 p.m.
Pricing: $26.95/person
Location: National Museum of African American Music, 510 Broadway, Nashville, TN 37203

Join colleagues and friends for a self-guided tour of the National Museum of African American Music (NMAAM). Home to six distinct galleries, the NMAAM features artifacts, objects, memorabilia, clothing, and state-of-the-art technology designed to share a different narrative and a unique perspective on African American music and history. Each gallery illustrates the evolution of African American culture through time and its impact, on genres including blues, jazz, gospel, R&B and hip hop, through history. Attendees staying at the Renaissance Nashville Hotel may either walk to the museum (it is about a 10-minute stroll), or arrange shared transportation. The museum is centrally located in downtown Nashville, close to many dining and entertainment options, and accessible parking is available nearby. The group will meet at the front entrance of the museum; look for the main doors facing Broadway street!

If you're planning to attend, please RSVP to NMAAM tour.
Tickets can be purchased upon arrival at the box office. To enhance the experience, an RFID wristband can be purchased for an additional $5, that allows visitors to save interactive content as they explore the museum.

CLE Information

Earn up to 9.75 hours of continuing legal education hours (CLE), including 1.00 hour of Ethics from this seminar.

View CLE Credit by State

In some states that charge late CLE submission fees, there will be a $100 late fee to report CLE credits submitted more than 30 days after a seminar/virtual event. Click here for details on CLE late fees.

Thank You to Our Sponsors

DRI's Drug and Medical Device Seminar is proudly supported by:

Irwin Fritchie Urquhart & Moore LLC Counselors at Law

ReedSmith Driving Progress Through Partnership

If you would like to contact DRI about seminar sponsorship opportunities (including pricing) or to reserve a spot, please visit the sponsorship page.

DRI Cares

Blessings in a Backpack

Please join us in supporting Blessings in a Backpack, an organization that mobilizes communities, individuals, and resources to provide food on the weekends for school-aged children across America who might otherwise go hungry. Seminar attendees will have the opportunity to fill bags of food on the way to the joint networking lunch on Thursday, May 8. Feeding a child before you feed yourself is a wonderful way to support children and families in the Nashville community.

Donate to Blessings in a Backpack

Additional Resources

If you have any questions or concerns regarding DRI programs, please contact DRI Customer Service at 312.795.1101 or custservice@dri.org.