Our Fourth Annual!
We developed the Drug & Device Defense Forum because is imperative that, in order to offer the best internal and external services, in-house counsel and outside counsel in the pharmaceutical and medical device space must stay current on new liability risks, as well as new opportunities. We are pleased to welcome back Megan Grossman of Segal McCambridge Singer & Mahoney and Michelle Hart Yeary of Dechert as co-chairs. We are excited to announce that James Frederick of Goodell DeVries has joined this hard-working leadership panel.  This program gets great reviews every year. People value the relatively intimate size of the program, so they can interact with the faculty and other members of the audience. They value the number of in-house counsel who attend and the defense-only requirement.

Agenda and faculty subject to change. 

Tuesday, Oct. 24, 2017

7:30 am | Registration & Breakfast

9:00 am | Welcome & Opening Remarks

Tom Hagy, Managing Director, HB Litigation Conferences LLC
Megan Grossman, 
Shareholder, Segal McCambridge Singer & Mahoney Ltd.
Michelle Hart Yeary, Counsel, Dechert LLP
James A. Frederick, Partner, Goodell DeVries Leech & Dann LLP

9:15 a.m. | Personal Jurisdiction in Mass Torts: Will Decades of Precedent Be Reversed?

  • Review of Supreme Court argument in Bristol-Myers Squibb v. Superior Court
  • Non-residents vs. non-residents
  • Pendent jurisdiction
  • Federalism, predictability, and fairness
  • Impact of due process in MDLs and class actions
  • “Exorbitant” and “grasping” scope of jurisdiction
  • Non-mutual offensive collateral estoppel

Anand Agneshwar, Arnold & Porter Kaye Scholer LLP
Dan H. Ball, Bryan Cave LLP
Jonathan Wasserman, Vice President & Associate General Counsel, Litigation & Government Investigations, Bristol-Myers Squibb

10:00 am |  Third-Party Litigation Funding: Developments, Issues and Strategies for Product Liability Defendants

  • TPLF Overview – understanding how TPLF is driving drug and device products liability litigation through outside investment and advertising
  • History of TPLF – background on champerty and maintenance law, rise of TPLF in Australia and Europe, and emergence in U.S., including recent high-profile cases
  • Recent Trends in TPLF – TPLF industry consolidation, increases in DTC advertising, legal specialization, crowd-sourced funding, etc.
  • Potential Legal and Ethical Issues – lack of transparency, ethical conflicts / lack of plaintiff control, privilege concerns, lack of pre-filing merits evaluation, complications for resolution and settlement, etc.
  • Strategies for Striking Back – forcing disclosure of arrangements, enforcing ethical rules, combatting misleading plaintiff advertising, legislative and rules efforts, raising awareness with judges and the public, etc.

Daniel Healey, Corporate Counsel, Pfizer Inc.
Invited: Tripp Haston, Partner, Bradley Arant Boult Cummings LLP


11:00 am | Break

11:15 am | Cyber Security: Are Medical Devices at Risk?

  • What is the risk?
  • What is the FDA saying?
  • Relevance of the Supreme Courts’ 2013 Clapper v. Amnesty International
  • Analysis of the “injury in fact” requirement
  • Review of FDA and DHS security standards
  • What are the potential theories of liability?

Ernest F. Koschineg, Partner, Cipriani & Werner PC
Abby L. Sacunas, Member, Cozen O’Connor

12:00 pm | Lunch

1:15 pm | Effectively Presenting Scientific Evidence to Juries

  • Explaining research methods to a lay audience
  • Insights gathered study of 460 mock jurors
  • What jurors likely know about control groups, placebos, confidence intervals and more

Dr. Christina Marinakis, Litigation Insights

2:00 pm | Navigating the FDA Drug Approval Process

  • Standards of Evidence
  • Confounding Variables
  • Evidence-Based Observations
  • Natural History vs. Drug Effect
  • Unknown Genomic Variations
  • Right Drug, Right Patient, Right Dose, Right Time, Right Duration
  • Important Baseline Considerations
  • The Meaning of Effective
  • Clinical Trials
  • Alternative Proof
  • Statistical Significance

Dr. Robert Kane, MD, FACP | Formerly with Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation & Research, FDA

3:00 pm | Break

3:15 pm | Online Mass Tort Databases: Collaboration Among Litigants is Being Revolutionized

  • What is a mass tort case management system?
  • Core operational challenges presented by consolidated litigation
  • Using technology to effectively represent clients, accurately respond to opposing counsel, and successfully interact with the court
  • When should you implement a case management system?

Jennifer Alpert, Managing Director, Ankura Consulting
Edward Bell, Senior Managing Director, Ankura Consulting

3:45 pm | Effective & Ethical Applications of Social Media in the Legal Profession

Legal professionals have embraced social media not just for personal use but also professionally. According to the ABA’s 2016 Legal Technology Survey Report (Volume IV: Web and Communication Technology), over 62% of respondents report that their firms maintain a presence in a social network while over 85% use Facebook for personal reasons. But there are risks for legal professionals using social media for both professional and personal reasons. This session will explore how social media is impacting the legal profession and how attorneys can use social media effectively while avoiding ethical pitfalls. It will also discuss tips for effectively obtaining and preserving social media for discovery. The session will be relevant to in-house counsel as well, since social media is now an integral part of corporate public relations and marketing campaigns.

Caren Silverman Safra, Client Relations Specialist, LexisNexis

4:45 pm | Adjourn