2023 Agenda
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Conference Day 1
December 5, 2023
Co-Chairs’ Opening Remarks
Drug and Medical Device Year in Review
Shining a Light on the Top 10 Court Cases Impacting the Life Sciences Product Liability Sphere in 2023
Mary-Alice BarrettAssociate General CounselGenentech
Lisa A. DunkinVice President & Associate General Counsel, LitigationZimmer Biomet
Ashley GarrySenior CounselViatris
Rachel GallagherAssociate General CounselTeleflex
Sarah H. RichardsonSenior Litigation CounselW.L. Gore & Associates
Sara ThompsonShareholderGreenberg Traurig LLP
Our opening session will deliver insights from key biopharmaceutical and medical device in-house counsel on the most important case law developments of the past year. They will explore their real-life impact on drug and medical device litigation practice as well as their implications and influence on future decisions, trends, and strategies in this arena.
Points of discussion will include:
- A survey of the year’s most significant and influential court decisions involving drug and medical device claims
- Pending decisions that may have the most foreseeable future impact
- How practitioners can update their practice and litigation strategies in response to the latest developments
Harley RatliffPartnerShook Hardy & Bacon
Janet KwuonPartner, Co-Chair of Life Sciences Industry GroupReed Smith LLP
John BeisnerPartnerSkadden, Arps, Slate, Meagher & Flom LLP
- Assessing newly proposed FRCP 16.1 and the status of its approval
- Analyzing how the new rule will impact early case management procedures in MDLs
- “Just, Speedy and Inexpensive” – examining how the newly proposed MDL rule reforms may restore life to Rule 1 in MDLs and mass torts
- Understanding how the new rule may be applied differently in different case settings and in different MDL proceedings
Morning Coffee Break
Spotlight on Artificial Intelligence
Uncovering the Product Liability Risks Associated with AI in Drug Development and Medical Device Usage
Ashley CarrPartnerDLA Piper
Erin BosmanPartner, Co-Chair, Class Actions and Mass Torts Practice GroupMorrison & Foerster LLP
Daniel LazaroCounselBuchanan Ingersoll & Rooney PC
Lora SpencerPrincipal Litigation & Investigations CounselMedtronic
AI is rapidly transforming the Life Sciences industry, with applications being used in both drug development and in diagnostics which allow for greater predictability of disease. While these groundbreaking developments are cause for excitement, concerns abound as to the accuracy of these AI applications, the associated risks and the potential product liability implications. This panel will delve into topics including:
- Examining the current legal and regulatory landscape governing AI use in the pharmaceutical and medical device space
- Analyzing the FDA’s most recent April 2023 guidance on AI/ML-Enabled Device Software Functions
- What potential product liability risks does this new guidance flag for life science companies?
- Taking a look at existing case law which sheds light on how the legal system will treat product liability claims made against an AI-enabled medical device
- What are the theories of liability involved?
- What precedent exists suggesting that AI-driven software programs do constitute “products” subjectable to PL claims?
- Evaluating liability for AI-enabled drug development
- Understanding how companies can issue spot areas of potential PL risk associated with the use of AI, and address them up front
Michelle KitchenGlobal eDiscovery Lead, IP and Legal CounselNovartis
Anita Modak-TruranPartnerButler Snow LLP
Davis WalshPartnerMcGuireWoods LLP
- 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 Sponsored by: 
Key Takeaways from Three of This Year’s MDLs: Impactful Rulings and Hot Opinions from the Acetaminophen, Zantac and Exactech MDLs
Andrew KaplanPartner, Chair of Mass Tort, Product, and Consumer Litigation GroupCrowell & Moring LLP
Steven BoranianPartnerReed Smith LLP
Emily Van TuylPartnerDechert LLP
Join us for a deep dive into three MDLs – Acetaminophen, Zantac, and Exactech. Our panelists will analyze significant orders in these three MDLs and provide insights on how recent developments in these MDLs may impact the future of prescription and OTC pharmaceuticals. Tune for analysis of each of these MDL’s:
- Significant rulings on preemption, Daubert, and more
- Distinctive litigation approaches and macro issues
- Analysis of common issues – and some not so common
- Lessons learned
Bankruptcy As a Mass Tort Resolution Vehicle: Weighing the Benefits and Risks of this Growing Litigation Strategy
Rachel A. FarnsworthSenior Counsel | Litigation & Government InvestigationsBristol Myers Squibb
Daniel PariserPartnerArnold & Porter
Patrick CorrPartnerFaegre Drinker Biddle & Reath LLP
- Analyzing the recent trend of drug and device manufacturer defendants attempting to exit multidistrict litigation by filing for bankruptcy
- Exploring the benefits and risks associated with using bankruptcy strategies to exit mass tort litigation
- 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
Afternoon Break
BREAKOUT SESSIONS (Choose A or B)
A — Daubert in Doubt: Devising a Plan for New Rule 702 Implementation and Working With Experts After the Recent Amendments
Leah LorberAssistant General CounselGlaxoSmithKline
Wendy West FeinsteinPartnerMorgan, Lewis & Bockius LLP
JT LarsonPartnerBarnes & Thornburg LLP
- Understanding what defense counsel can do to ensure that judges are actually implementing and applying the new Rule 702 changes going forward
- Navigating states that adopt a hybrid version of the new rule
- What should practitioners now focus on when offering expert testimony under the new amendments?
- Analyzing recent decisions in which courts have addressed, referenced or relied upon the new rule
- Practice pointers for relying on the right Rule 702 cases in your arguments now that many of them will no longer be applicable
- Best practices for hiring, working with and preparing expert witnesses following the new rule amendments
Lawrence CookePartnerVenable LLP
Anne GrunerAttorneyDuane Morris LLP
- Examining scenarios when it is beneficial to seek out FDA involvement in your case
- Assessing when and how to solicit FDA support in your defense (e.g. through the court, FDA subpoenas, back channels, etc.)
- Developing a strategic plan for obtaining evidence (documents and testimony) from FDA
- Understanding how to get the court involved in obtaining that evidence
- Analyzing the use of FDA based evidence in your case, including 510k clearances, letters to file, warning letters and integrity holds
- Considering the public narrative and plaintiff’s portrayal of the FDA and how that can impact the issues in your case
BREAKOUT SESSIONS (Choose A or B)
A — Innovative Tactics for Persuading Juries That Pharma and Med Device Companies Are Not Bad Actors
Jean PattersonAssistant General CounselBecton Dickinson
Zane RiesterSenior CounselJohnson & Johnson
Eric RumanekPartnerTroutman Pepper
Jennifer SaulinoPartnerSidley Austin LLP
- Strategies for motions in limine: how to convince the court that your client should not be viewed the same as other defendants without negatively impacting your co-defendants’ cases?
- Trial presentation strategies for framing your narrative to reach today’s jurors
- Overcoming juror biases and predispositions about life sciences companies in today’s social and political climate
- Decreasing risks of extreme verdicts by changing the narrative
B — Spotlight on PFAS: Addressing Emerging Threats of Litigation Arising from So-Called “Forever Chemicals”
Libretta (Libby) StennesShareholderGreenberg Traurig LLP
Matt HolianPartner; Co-Chair, Global Life Sciences SectorDLA Piper LLP
Joseph PetrosinelliPartnerWilliams & Connolly LLP
- Contaminant class actions: what every defense attorney for a drug or medical device company needs to know about PFAS and other emerging contaminants
- Understanding the legal nuances of contaminant litigations
- What theories are plaintiffs relying on in these claims, and what defense strategies are proving to withstand the latest plaintiff challenges?
- 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
Conference Adjourns
Cocktail Reception Sponsored by: 
Conference Day 2
December 6, 2023
Co-Chairs’ Opening Remarks
Coffee and Q+A With Our Esteemed Judges: Judicial Perspectives on Managing Life Sciences Mass Tort Proceedings
Honorable Karen K. CaldwellChief JudgeU.S. District Court, E.D. Kentucky
Chair
Judicial Panel on Multidistrict Litigation (JPML)
Honorable Brian R. MartinottiDistrict JudgeU.S. District Court, District of New Jersey
Honorable John R. TunheimChief JudgeU.S. District Court, D. Minnesota (Minneapolis, MN)
Honorable Kristine BakerDistrict Judge U.S. District CourtDistrict of Arkansas
Honorable Abbe F. FletmanJudgePhiladelphia Court of Common Pleas
Honorable Brian H. MayCircuit Judge, Division 1St. Louis County Circuit Court
Andrew T. (Andy) BaymanPartnerKing & Spalding LLP
A panel of distinguished jurists with some of the liveliest drug and medical device litigation dockets in the country will:
- Provide valuable insights on how they manage MDLs and coordinated proceedings
- Identify the challenges of resolving mass tort proceedings from their perspective
- Shed light on what arguments and litigation practices have worked and not worked in their courtrooms, as well as areas for improvement by counsel who appear before them
Morning Coffee Break
BREAKOUT SESSIONS (Choose A or B)
Larissa A. EusticeSenior Assistant General CounselBayer
Katherine Unger DavisPartnerDechert LLP
Michael LeardPartnerNutter McClennen & Fish LLP
Colleen BaimePartnerBaker & McKenzie LLP
- Examining the recent trend of plaintiffs dismissing MDL claims mid-trial and moving them to state courts in unfavorable jurisdictions (e.g Zantac MDL)
- What efforts can drug and device companies (and their counsel) make to prevent this from happening?
- Understanding how you can best deal with the aftermath if/when this does happen
- Tools and strategies for effective coordination between the federal and state courts regarding
- Scheduling hearings
- Conducting and completing discovery
- Avoiding inconsistent federal and state rulings
- Accomplishing resolution of all cases nationwide
Paul (P.J.) CosgrovePartner Ulmer & Berne LLP
Judge Booker ShawPartnerThompson Coburn LLP
Bill ChildsAssistant General Counsel, Litigation3M
Keith C. Pounds, PhDSenior Jury ConsultantIMS
Jessica DavidsonPartnerSkadden, Arps, Slate, Meagher & Flom LLP
- Developing effective strategies for combatting reptile theory from the earliest phases of litigation
- Diffusing plaintiff counsel attempts to utilize reptile approach before it gains traction
- Tactics for responding to plaintiff counsel questions aimed at rattling even the most seasoned corporate witnesses
- Asking questions on redirect which combat reptile approach
- Creating your own evidence to be used in negotiations for deposition designations
BREAKOUT SESSIONS (Choose A or B)
A — FDA in the Crosshairs: What Recent Court Activity and State Litigation Over Mifepristone Means for the Future of Agency Deference
Sarah PadgittAssociate General CounselBaxter
Thomas KurlandPartner, Litigation, Products Liability and Brand ProtectionPatterson Belknap Webb and Tyler LLP
Dan TroyManaging DirectorBerkeley Research Group
Following the Supreme Court’s decision in Dobbs, we saw a recent groundbreaking ruling by the Northern District of Texas when it suspended FDA’s longtime approval of the abortion pill, mifepristone. This is also set against the backdrop of both red and blue states suing FDA regarding the drug. This panel will engage in an exploration of:
- The rising appetite of courts to revoke agency authorities
- What this may mean for the role and discretion of judges in future drug and medical device product liability cases
- The fallout of the overturning of Roe and how courts are looking at preemption battles involving state attempts to ban FDA-approved drugs
- What this year’s activity could potentially mean for the future of FDA deference
B — Crafting Successful Jurisdiction, Standing and Preemption Arguments at the Motion to Dismiss Stage
Jonathan JungGeneral CounselPrinston Pharmaceutical
John LavellePartnerMorgan Lewis & Bockius LLP
Steven WeisburdShareholderCarlton Fields, P.A.
Jessica DavidsonPartnerSkadden, Arps, Slate, Meagher & Flom LLP
- Identifying primary jurisdiction and standing arguments which may be effective in eliminating or narrowing a class at the motion to dismiss stage
- Understanding the primary jurisdiction challenges which are most prevalent in drug and device product liability class actions, as well as how to manage and overcome them
- Incorporating takeaways from the latest preemption rulings into your class action litigation practices and strategies
BREAKOUT SESSIONS (Choose A or B)
A — Examining the Rise in “Non-Traditional” Liability Theories in Drug and Medical Device Product Liability Cases
Justin WitzmannDirector, Legal Affairs - Global LitigationNuvasive
Julie ParkPartnerMorrison Foerster LLP
Christopher KaufmanPartnerShook, Hardy & Bacon LLP
- How the defense bar can prepare for the latest plaintiff bar attempts to circumvent traditional liability theories in drug and medical device claims
- Examining the latest ways plaintiffs are manipulating the following theories and how to combat them:
- Public nuisance
- Misbranding
- Failure to warn/failure to report
Russell “Chip” GaudreauPartnerKing & Spalding LLP
Greg DadikaVice-President, Litigation, Governmental Investigations, and Risk ManagementBoehringer Ingelheim
Terri ReiskinPartnerNelson Mullins Riley & Scarborough
Elizabeth MitchellAssociate General Counsel, Global LitigationSmith & Nephew
Ethan GreeneManaging PartnerReisman Greene Theis LLP
- Identifying common challenges arising in drug and device product liability class settlements as well as key strategies for tackling those challenges
- Comparing class settlement trends by jurisdiction
- Identifying favorable jurisdictions to settle in, as well as jurisdictions to avoid settlement in
- Proven defense strategies for drafting settlement agreements, structuring the settlement benefit and noticing the class
- Best practices for dealing with more than one judge when a class action is filed in multiple jurisdictions
- Working with a settlement administrator to ensure the settlement is implemented with efficiency and accuracy
- Understanding how to make the decision of whether to settle or go to trial
- Structuring your settlement agreement so you don’t leave yourself exposed to future lawsuits
Networking Luncheon
Exploring Critical International Developments Impacting Drug and Device Product Liability Litigation in Foreign Jurisdictions
Grant WordenPartnerTorys LLP
Jill LawriePartnerBlake, Cassels & Graydon LLP
Patrick ReillyPartnerFaegre Drinker Biddle & Reath LLP
- Examining the advent and implementation of the EU Collective Redress Directive
- What impact will this have on the future of drug and medical device product liability class actions in Europe?
- What are the perceived risks of this Directive for US drug and device manufacturers?
- Preparing to combat the rise in collective actions that drug and device companies will face in Europe as the plaintiffs’ bar sets up new overseas firms to take advantage of the new directive
- Analyzing recent developments in Canada which have changed how product liability cases are being handled there
- What US in-house counsel and their law firm partners need to know about coordinating litigations in Canadian jurisdictions
- Exploring cross-border concerns for US and Canadian counsel who work in tandem on a product liability litigation
Where the Rules Meet the Road: Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps
Celeste Coco-EwingPartnerIrwin Fritchie Urquhart Moore & Daniels LLC
Jobina Jones-McDonnellVice President, Assistant General Counsel - Litigation and RiskEndo Pharmaceuticals