Agenda
Day 1
December 3, 2025
Registration and Breakfast
Amy Todd KlugGeneral Counsel and Secretary, Head of Legal and Corporate AffairsDaiichi Sankyo, Inc.
Greg DadikaVice-President, Litigation, Governmental Investigations & Risk ManagementBoehringer Ingelheim
Lora SpencerSenior Global Litigation & Investigations CounselMedtronic
Janet KwuonVice President, Global Head of Litigation and InvestigationsGilead Sciences
In celebration of three decades of industry leadership, we’re debuting an in-house roundtable series designed to foster intimate, high-impact discussions among legal peers.
Join fellow in-house counsel and their trusted law firm partners in a rotating roundtable format built for real talk, rapid idea exchange, and strategic benchmarking on today’s most urgent challenges in drug and medical device litigation.
Bring your toughest questions, boldest insights, and lessons learned. This is your best chance to connect, collaborate, and get candid at the start of this milestone event.
Each speaker will rotate tables every 30 minutes to maximize networking opportunities and idea-sharing on the following topics:
- PFAS and Product Liability Convergence: What Drug and Device Counsel Need to Know About the Rising Contaminant Litigation Risk
- Reclaiming the Narrative: Shutting Down Misleading Public Messaging and Expanded Liability Tactics Commonly Utilized by Plaintiffs’ Counsel
- The Future of Products Liability: Interpreting Game-Changing Rulings and Novel Legal Theories
Roundtable Recap
Extended Networking Break
This has been another pivotal year in life sciences product liability, marked by updated case law developments that have reshaped the landscape. Our 30th anniversary opening session will deliver insights from key in-house and outside counsel on the most important case law developments of the past year. We will explore critical changes, dissect real-world implications, and forecast future litigation trends and strategies. Topics of discussion will include:
- Surveying the year’s most significant and influential court decisions involving drug and medical device claims
- Analyzing pending decisions that may have the most foreseeable future impact
- Updating practice and litigation strategies in response to the latest case law development
- Assessing the impact of the EU Product Liability Directive and cross-border mass tort coordination
- Coordinating within the defense bar to “level the playing field”
As AI and accompanying tools continue to rapidly transform the life sciences sector, its influence is being felt across the spectrum of drug and device development, regulation, and litigation. The influence of AI on litigation strategy, case management, and evidentiary standards is becoming increasingly profound, and is reshaping legal research, document review, predictive analytics, and even courtroom advocacy. Join us in this informative session as we examine how litigators, judges, and clients are adapting to the increased use of AI in drug and device litigation – and what in-house and outside counsel must do to remain ahead of the curve. Topics for discussion include:
- Examining the latest ways that AI tools are being used in legal representation and trial practice in drug and device product liability litigation
- Document review
- Chronologizing medical records
- Motion/brief development
- Creating demonstratives at trial
- Addressing the obvious and not-so-obvious risks associated with AI-assisted legal representation
- Navigating judicial oversight of AI usage in litigation and trial prep
- Addressing the recent trend of judges ordering lawyers to sign AI pledges disclosing their usage
- Understanding how litigators can use the latest AI tools practically and effectively while avoiding ethical and compliance pain points and pitfalls
Networking Luncheon
SPECIAL 30th ANNIVERSARY PANEL
30 Years of Drug & Device Litigation: What’s Changed, What Hasn’t, and What’s Coming Next
Don’t miss this landmark session featuring some of the most seasoned and respected voices in drug and medical device litigation. Drawing on three decades of hard-fought lessons, this panel of thought-leaders will reflect on the defining challenges, pivotal shifts, and enduring truths that have shaped the defense bard, and where the next era is headed. Topics of discussion will include:
- Examining how multiple judicial and regulatory efforts over the last thirty years have left us to conclude that: the more things change, the more they stay the same
- Reviewing how the Defense Bar is working to “level the playing field” with the Plaintiffs Bar
- Detailing how to give your clients what they really need throughout the course of litigation
- Translating 30 years of lessons into practical advice for the next generation of litigators
- Tracing how HHS and FDA interventions have altered the litigation landscape
BREAKOUT SESSIONS A
TRACK 1
Trump 2.0/RFK 1.0: How the Administration Will Impact Pricing, Product Liability, Preemption and Labeling
The second Trump administration is expected to impact drug and device litigation in several ways, primarily through its emphasis on lowering prescription drug prices, promoting domestic manufacturing, and potentially influencing FDA regulatory oversight.
The administration’s policies may indeed lead to an increase in litigation as companies and interest groups challenge or defend the administration’s actions. Join us in this session as we discuss:
- Reviewing EOs on pricing and anticipating litigation fallout
- IRA
- 340B
- MFN
- Tracking proposed federal and state legislation impacting access, labeling, and approval pathways
- Challenging or defending policies targeting anticompetitive practices and rebate structures
- Navigating legal exposure tied to domestic manufacturing incentives and mandates
- Preparing for shifts in FDA leadership, enforcement, and rulemaking
TRACK 2
HRSA and the 340B Saga: Preventing Covered Entity Abuse and Curbing Diversion to Ineligible Patients
The 340B Program provides “covered entities” with access to discounted outpatient drugs from manufacturers. Some manufacturers worked to impose limits on the number of contract pharmacies to which a manufacturer will ship 340B drugs.
However, HHS declared in an advisory opinion that the 340B statute unambiguously requires manufacturers to deliver covered drugs to an unlimited number of contract pharmacies, and several states have enacted laws prohibiting manufacturers from placing conditions on covered entities’ use of contract pharmacies – resulting in drugs being significantly underpriced.
Join us in this session as our panelists explore the path to preventing this pattern from continuing. Topics for discussion include:
- Challenging the legal basis of HHS’s advisory opinion and HRSA enforcement actions
- Asserting preemption, vagueness, and Commerce Clause arguments in court
- Analyzing key rulings from the Third Circuit in AstraZeneca, Novo Nordisk, and Sanofi
- Contesting the expansion of state-level contract pharmacy protection laws
- Examining the likelihood of success with motions for preliminary injunctions
Networking Break
BREAKOUT SESSIONS B
TRACK 1
State Court Surge: Managing the Fallout of MDL Dismissals and the Rise of Parallel State and Municipal Actions
As drug and device litigation continues to grow, in-house and outside counsel are confronted with the complexities of navigating parallel proceedings in both state and municipal courts. These overlapping cases – often involving different procedural rules, discovery obligations, and judicial philosophies – can create significant strategic and logistical challenges.
Our panelists will examine the role of local government actions, forum-shopping concerns, and the interplay with MDLs. Topics for discussion include:
- Analyzing the implications of case law driving MDL claims into state and municipal courts
- Managing overlapping timelines, discovery burdens, and inconsistent rulings across jurisdictions
- Anticipating jurisdictional and venue challenges
- Weighing early resolution options under diverging procedural standards
TRACK 2
The Evolution of Runaway Verdicts and Jury Awards: Defending Against Massive Damages and Shifting Public Sentiment
Verdict and settlement amounts in drug and device liability cases are skyrocketing and can be fueled by jury sympathy and societal trends favoring corporate accountability. This session will explore the factors leading to these massive verdicts and offer strategies to mitigate exposure. Topics for discussion will include:
- Preventing emotional appeals and courtroom strategies that manipulate juror behavior
- Countering and blocking methods that plaintiff’s counsel often utilize to shift public perception and increase the distrust of drug and device manufacturers
- Developing proactive risk management and strategic litigation defense strategies
- Reducing the effects of plaintiff advertising and third-party litigation funders that normalize high monetary amounts
- Requesting bifurcation of punitive damages to prevent inflation of compensatory awards
As litigation risks evolve at an unprecedented rate, hear directly from senior leaders at the helm of major drug and device companies. This exclusive roundtable will deliver unfiltered insights into how top legal departments are staying agile, proactive, and aligned with the business amid mounting pressure from plaintiffs, regulators, and shareholders. Topics for discussion will include:
- Aligning legal department activities with the strategic goals of the business – while striving to maintain effective legal and litigation programs
- Evaluating and prioritizing risks for 2025
- Implementing cost-containment strategies that won’t diminish program effectiveness
- Examining the scope of legal exposure amid the increased risks associated with new product development and MDL/class action exposure
- Ensuring that all litigation matters are managed efficiently, with clear timelines, objectives, and resource allocation
- Identifying potential legal risks and implementing strategies to mitigate them through:
- Settlement negotiations
- Alternative dispute resolution
- Vigorous defense strategies
Conference Adjourns, Cocktail Reception
Day 2
December 4, 2025
Networking Breakfast
Amy Todd KlugGeneral Counsel and Secretary, Head of Legal and Corporate AffairsDaiichi Sankyo, Inc.
Greg DadikaVice-President, Litigation, Governmental Investigations & Risk ManagementBoehringer Ingelheim
Lora SpencerSenior Global Litigation & Investigations CounselMedtronic
Janet KwuonVice President, Global Head of Litigation and InvestigationsGilead Sciences
A View From the Bench: Judicial Perspectives on Navigating Drug and Medical Device Products Liability Litigation
During this highly anticipated judicial panel, distinguished members of the bench will offer candid, first-hand insights on how the litigation landscape is shifting, and what it means for drug and medical cases moving forward. Topics of discussion will include:
- Identifying the arguments they have found most effective and persuasive when presiding over a drug or medical device products liability case?
- Highlighting suggestions for speeding up the litigation process for lingering MDLs, class action and mass tort cases
- Offering thoughts and feedback on the new Rule 702 – and the consistency of the “gatekeeper” role
- Pinpointing what works and doesn’t work in their courtroom regarding jury instructions, voir dire and opening/closing statements?
- Describing actual accounts of effective (and poor) witness examination, tips and tactics related to effective jury selection, and good vs. bad lawyering
Third-Party Litigation Financing Under the Microscope: Managing Risk and Reclaiming Control Amid Rapid Expansion and Limited Transparency
As third-party litigation funding surges, often behind the scenes, drug and device manufacturers are exposed to risks that are difficult to predict and even harder to counter. This session will explore the evolving dynamics of third-party litigation funding, its influence on settlement strategy, and the growing regulatory response. Topics of discussion will include:
- Tracking the proliferation of foreign-backed funders in drug and device MDLs
- Examining the age-old question: who is really driving settlement discussions – the parties or the funders?
- Monitoring the creation of a federal subcommittee to address mandatory disclosure of funders and funding terms
- Responding to the growing number of states requiring disclosure of litigation funding arrangements and contracts
Networking Break
BREAKOUT SESSIONS C
TRACK 1
Navigating Rule 702 Amendments: Strategies for Expert Testimony in Drug and Medical Device Litigation
Rule 702’s recent revision transforms how expert testimony is assessed, reinforcing the judicial gatekeeper role and providing new tools to exclude unreliable opinions. This change aims to raise the admissibility standards, ensuring that only well-founded expert testimony reaches the jury. During this session, attendees will learn winning strategies for leveraging Rule 702’s amendments to enhance their litigation strategy and secure more favorable outcomes. Topics for discussion will include:
- Reviewing recent court decisions influenced by the Rule
- Identifying mechanisms that defense counsel can utilize in order to ensure that judges are actually implementing and applying the Rule 702 changes going forward
- Evaluating the tighter connection between experts’ opinions and the methods they use – to eliminate experts who exaggerate the conclusions
- Examining the new rule clarification stating that the proponent of expert testimony has the burden of establishing all criteria by a preponderance of the evidence
- Determining what practitioners should be focusing on when offering expert testimony under the new amendments
TRACK 2
AI in Pharma and Device Innovation: Navigating Regulatory Minefields and Emerging Liability Risks
AI is revolutionizing drug development and diagnostics by predicting diseases and identifying therapies from large-scale biometric data. However, this invites increased risks and potential product liability. Join this breakout as our session leaders explore:
- Investigating the legal and regulatory landscape governing AI use in the pharmaceutical and medical device space
- Reviewing the recent guidance on AI/ML-Enabled Device Software Functions and the potential product liability risks
- Evaluating liability for AI-enabled drug development
- Calibrating the approach to implementing and monitoring healthcare AI tools based on a careful assessment of the liability risk of each tool
- Examining case law on physical injury caused by AI or the malfunctioning of software embedded in medical devices
- Understanding how companies can issue spot areas of potential product liability risk associated with the use of AI, and address the risks up front
BREAKOUT SESSIONS D
As pharmaceutical and medical device litigation grows more complex and costly, stakeholders are increasingly weighing arbitration and other alternative dispute resolution mechanisms against traditional courtroom litigation.
Many see arbitration as worthy of consideration for product liability and MDL cases, and there is no policy that would per se exclude personal injury and wrongful death claims from the scope of arbitration.
Join us in this session as we explore the strategic, procedural, and practical considerations surrounding arbitration and litigation in the context of drug and device disputes. Topics for consideration include:
- Arbitration advantages such as:
- Speed of resolution
- Confidentiality
- Cost-efficiency
- Arbitration challenges such as:
- Enforceability challenges
- Potential limitations on appeal rights
- Discovery limitations
- Litigation pros such as:
- Legel precedent
- Structure
- Opportunities for appeal
- Litigation cons such as:
- Cost
- Public exposure
- Time consumption for matters to be resolved through expensive, protracted litigation
- The lingering question of whether the sale of prescription medical products qualifies as a “transaction” or “contract”
Winding down drug and device litigations is a daunting task, but no company wants to be embroiled in massive litigation long term. This session will address real world strategies for developing and implementing an effective exit strategy and identify common challenges in product liability settlements. Topics of discussion will include:
- Conducting an early assessment of risk and exposure:
- Engaging key consulting experts early
- Aligning exit strategy with business goals
- Developing a case management schedule to limit claims and claimants:
- Instituting an effective and targeted motion practice
- Coordinating with parallel proceedings
- Building and maintaining working relationships among plaintiffs’ leadership:
- Looking at the pros and cons of separate settlement and litigation teams
- Examining the role of census registry (and PFS process) in facilitating discussions
- Creative mediation and settlement strategies
Networking Luncheon
BREAKOUT SESSIONS E
TRACK 1
Bankruptcy as a Resolution Vehicle in Mass Tort Litigation: Calculating Legal, Financial, and Reputational Trade-Offs
As huge verdicts and settlements become more common, bankruptcy emerges as a strategic solution for managing overwhelming liabilities. This interactive breakout will consider how drug and device manufacturers are using bankruptcy to resolve mass tort claims. Topics of discussion will include:
- Streamlining the handling of claims, which may lead to faster resolutions
- Establishing trusts to quickly and accurately dispose of the cases and compensate victims
- Understanding the risks for future post-bankruptcy product liability plaintiffs
- Examining the advantages of utilizing bankruptcy as a mass tort exit strategy
- Forecasting how this strategy will play out in the future
- Overcoming the negative perceptions of companies utilizing bankruptcy to evade full responsibility
- Addressing public and legislative scrutiny, ethical considerations, and how bankruptcy intersects with traditional litigation strategies
TRACK 2
Mastering Jury Selection in the Current Drug & Device Litigation Climate: Winning Strategies to Identify Bias, Build Trust, and Select an Impartial Jury
Jury selection is crucial in drug and device product liability cases, with much at stake beyond just asking the right questions. Join this panel for an interactive, practical session featuring polling exercises to uncover best practices in jury selection. Topics of discussion will include:
- Identifying and “weeding out” potential jurors that appear to have a negative perception of large drug and device manufacturers
- Developing ways to get “undesirable” jurors removed for cause – versus peremptory challenges
- Determining how to identify “stealth” jurors that appear to be neutral but are actually plaintiff friendly
- Developing innovative tactics for overcoming juror biases and predispositions in today’s social and political climate
- Utilizing juror questionnaires to cut through barriers created by the courtroom setting and allow for the determination of juror biases on critical issues
- Tackling the tough issues in voir dire and questionnaires to weed out any predispositions
- Reviewing best practices for developing cause challenges
Networking Break
Rule 16.1 attempts to guide early case management in MDLs, impacting litigation pace and costs. Permissive language like “should” instead of “must”, could lead to inconsistent applications. Join this breakout to explore the rule’s anticipated impact and implications for procedures. Topics of discussion will include:
- Understanding how the new rule will be applied in different case settings and MDL proceedings
- Exploring the permissive, rather than mandatory language: does it eliminate the current uncertainty of MDL processes and procedures?
- Determining if the Rule limits or expands the discretion that District Judges have?
- Deciding if the Rule can help stem the tide of mass filings of meritless claims
- Reviewing the nonbinding language to determine if it only serves to perpetuate the uncertainty that exists in the world of MDLs?
Step into this fast-paced, interactive ethics lab where real-world scenarios will challenge your instincts and decision-making in high-stakes litigation. Using live polling and group discussion, compare your responses to those of your peers, and see how seasoned litigators would navigate the gray areas of the law. Topics of discussion will include:
- Responding to ethically ambiguous scenarios in discovery, witness prep, and settlement negotiations
- Deciding when to act, and when to escalate ethical concerns in complex litigation
- Collaborating across departments to build a culture of ethical accountability and risk mitigation