Drug & Medical Device Litigation

2024 has been a pivotal year for drug and medical device litigation, marked by significant case law developments that have reshape the landscape. This opening panel will explore these critical changes, dissecting their real-world impacts and forecasting their influence on 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
• Coordinating within the defense bar to “level the playing field”

The landmark Loper Bright decision marks the end of Chevron deference, a foundational principle of administrative law. This ruling is poised to transform the regulatory landscape for drug and device manufacturers, lower courts, and federal agencies, and expose numerous statutes to potential legal challenges and significantly altering regulatory enforcement capabilities.

Join us for this critical and interactive town hall session as our panel of Supreme Court practitioners delve into the far-reaching implications of this ruling. Topics of discussion will include:

• Understanding how the decision will affect the strategic decisions and operations of drug and device manufacturers
• Examining the new legal landscape and its demand on outside counsel
• Predicting the potential for new and renewed legal challenges to longstanding federal regulations
• Analyzing the likelihood and scope of increased litigation as a result of the ruling

Before this session, AI and a law firm associate will independently analyze a legal complaint to formulate strategies. This session will compare their recommendations, allowing for attendees to cast their vote and discuss the effectiveness of AI versus human legal analysis. Topics of discussion will include:

• Summarizing the facts of the Complaint
• Exploring and examining the legal theories
• Developing timelines for the next steps and pleadings
• Crafting questions to pose to the “client”
• Reviewing the litigants’ drafts of an Answer and Motion to Dismiss

In this session, panelists will explore pivotal cases featuring non-traditional plaintiff theories, while dissecting significant rulings and their potential impact on future drug and medical device litigation. Topics of discussion will include:

• Examining and breaking down the “Duty to Innovate”, and the reduction or elimination of the requirement that there be a “design defect”
• Exploring the scope of a “Failure to Warn”, and identifying the characteristics of an adequate warning
• Reviewing the elements of alleged “Design Defects”, including:
  • “Pre-approval” Buckets
  • “Post-approval” Buckets

As massive 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 jurisprudence around utilizing bankruptcy as a mass tort exit strategy and forecasting how this strategy will play out in the future
• Overcoming the negative perceptions of companies utilizing bankruptcy to evade full responsibility

This session will explore how the plaintiff’s bar increasingly employs sophisticated methods to enhance their funding and expand their plaintiff pool. Panel leaders will emphasize the need for in-house counsel and their law firm counterparts to formulate strategies to counter these evolving tactics. Topics of discussion will include:

• Taking an aggressive stance against false or misleading messages delivered to the public through increasingly aggressive plaintiff advertising
• Mitigating the challenges created by third-party litigation funding to gain full disclosure and determine who really is making the settlement decisions
• Weeding out meritless claims with the data and analytics from initial census forms and registries
• Utilizing social media channels to recognize and eliminate claims that lack merit or actual injury

Reptilian strategy targets the defendant’s unsafe behavior form the outset, often subtly, making it crucial to recognize and counteract early. This session will discuss prompt case assessment and developing strong defense theories immediately. Topics of discussion will include:

• Identify the issues that indicate the presence of a reptile case
• Identify and approaching reptile theory through pleadings, written discovery and early motion practice
• Overcoming reptile attacks on the standard of care and other alleged “duties”
• Utilizing motions in limine to resolve issues outside the eyes and ears of the jury, and identify the evidence to be excluded
• Making use of voir dire to counteract plaintiff’s strategy

Verdicts are skyrocketing from $10 million to over $100 million, fueled by jury sympathy and societal trends favoring corporate accountability. This session will explore the factors fueling this thermonuclear verdicts, and offer strategies to present sound science in court to mitigate exposure. Topics of discussion will include:

• Preventing tactics that manipulate juror behavior and arbitrarily inflate damages
• Countering and blocking methods that plaintiff’s counsel often utilize to assess and calculate damages
• Reducing the effects of plaintiff advertising and third-party litigation funders that widen the gap for negotiating a reasonable settlement
• Requesting bifurcation of compensatory and punitive damages to prevent inflation of compensatory awards to punish defendants

Join this panel of esteemed General Counsel and Heads of Litigation from premier drug and medical device companies as they share critical perspectives on the strategic “big picture” challenges and trends set to define the industry in 2025, including:

• Aligning legal department activities with the strategic goals of the business – while striving to maintain an 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

During this highly anticipated panel, esteemed Members of the Bench will offer first-hand insights into the evolving landscape of Drug and Medical Device Litigation. 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

Rule 702’s landmark revision – the most significant in 25 years – 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 of discussion will include:

• Reviewing decisions in which courts have addressed, referenced or relied upon the new rule
• Identifying what defense counsel can do to ensure that judges are actually implementing and applying the new Rule 702 changes going forward
• 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
• Evaluating the tighter connection between experts’ opinions and the methods they use – to eliminate experts who exaggerate the conclusions

PFAS contaminants are driving aggressive class action litigation, posing significant risks to drug and medical device manufacturers. Join this breakout to explore the latest developments in this developing area of the law. Topics of discussion will include:

• Analyzing the impact of the historic 3M and Dupont settlements
• Examining the trends in PFAS litigation against “downstream” manufacturers, distributors and retailers of PFAS-containing products
• Understanding the legal nuances and plaintiff theories in contaminant litigations, with corresponding defense tactics to counter
• Examining how product testing/sourcing and recorded regulatory approval can yield additional strategies for class-action defense of PFAS, and other related trace chemical lawsuits
• Examining the latest trends in Prop 65 activity that the pharmaceutical and medical device industries should be paying attention to
• Understanding ways to mitigate initial exposure for PFAS risks through insurance

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

Data privacy laws impact drug and medical device development, with pixel technology, biometric devices, and online portals posing major risks. Join this breakout to explore strategies for limiting litigation risk and preventing data breaches. Topics of discussion will include:

• Implementing encryption, access controls and other security measures to prevent unauthorized access to patient data
• Prioritizing data protection when choosing a vendor for FDA compliance assistance to meet standards effectively
• Managing compliance documentation and audit trails from risk assessments and internal audits
• Fortifying Data Security in the Supply Chain and in online portals
• Emerging legal issues with wearable and 3D printed devices

Proposed 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 proposed rule’s impact and implications for procedures. Topics of discussion will include:

• Understanding how the new rule may 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 Proposed 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?

Effective DEI initiatives go beyond setting objectives – they must be ingrained in a company’s DNA and daily operations. This requires commitment and collaboration between life sciences companies and their law firms. Join this breakout to explore successful DEI strategies and tackle the latest challenges in creating lasting impacts. Topics of discussion will include:

• Exploring ways to implement policies and practices that will truly effect change and promote a diverse workplace
• Understanding what specific evidence of diversity in-house legal departments are seeking from outside counsel when vetting and choosing law firms to represent them
• Identifying best practices for evaluating a firm’s efforts in promoting diversity
• Understanding how life science companies and their outside firms can efficiently share tools, best practices and resources to create an effective DEI infrastructure and ecosystem
• Identifying how in-house and outside counsel can work together to successfully attract and keep diverse talent in our practices and on trial teams
• Determining what’s working, what’s not, and how you can do better

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

Winding down drug and device litigations like opioids, PPI, Zantac, and Roundup is a daunting task, but no company wants to be embroiled in massive litigation long term. This session will address best practices 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
  • Selection and engagement with mediator / settlement special master

This interactive session – led by drug and device litigators, will test your ethics skills with complex hypothetical scenarios. Compare your approach to ethical dilemmas with your peers and gain practical insights from the results. Topics of discussion will include:

• Determining what you would do in these hypothetical scenarios
• Deciding when you should take action (or not take action) for each example
• Encouraging and implementing inter-departmental cooperation for ethical concerns