BREAKOUT SESSIONS (CHOOSE A OR B)

TRACK A: The Practice of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Today’s Products Liability Landscape

TRACK B: The Business of Drug and Medical Device Litigation: Understanding the True Costs of the New Products Liability Environment

December 8, 2020 4:15pm

Track A: State of the Union on Preemption: Examining the Continued Aftermath of Albrecht and the Latest Developments in Medical Device Preemption Efforts

Michelle M. Bufano
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

Marcela Kirberger
General Counsel, Corporate Secretary and Chief Compliance Officer
Roche Diagnostics Corporation (Indianapolis, IN)

Alan E. Rothman
Counsel
Sidley Austin LLP (New York, NY)

Track B: LIVE POLLING: Product Recall Do's and Don'ts: Identifying Best Practices for Effectively Managing a Product Recall

Mollie Benedict
Partner
Tucker Ellis LLP

Howard M. Cyr
Assistant General Counsel
Teleflex (Wayne, PA)

Rachel Gallagher
Director, Legal Counsel
Teva Pharmaceuticals (Horsham, PA)

Track A:
State of the Union on Preemption: Examining the Continued Aftermath of Albrecht and the Latest Developments in Medical Device Preemption Efforts
  • Examining the latest preemption rulings and emerging theories and defenses
  • Assessing the current status of Albrecht and how it has been being interpreted and applied by the lower courts
    • What successes have the plaintiffs’ bar been seeing in avoiding the preemption defense?
    • Which defense arguments work and which don’t?
    • Examining the latest 510(k) preemption efforts and strategies for navigating preemption motions for PMA devices
Track B:
LIVE POLLING: Product Recall Do’s and Don’ts: Identifying Best Practices for Effectively Managing a Product Recall
  • Identifying best practices for coordinating your team and minimizing damage to your company in the face of a nationwide product recall
  • Tips for identifying early warning signs and getting out in front of a recall early
  • Key actions to consider when conducting a product recall and how to execute them carefully and thoroughly
  • Understanding the different roles of in-house counsel, outside counsel, company witnesses, investigators, etc; and how everyone should work together to manage the recall and its effects
  • Best practices for
    • Conducting a health-hazard assessment
    • Planning your course of action
    • Contacting the FDA
    • Getting the word out/ crafting your recall communication
    • Talking to third-party vendors