Pre-Conference Workshops

Drug and Med Cross-Examination 101

Nov 28, 2018 9:00am – 12:00pm

Speakers

Sean K. Burke
Partner
Duane Morris (Washington, DC)

Peter J. Goss
Partner
Blackwell Burke P.A. (Minneapolis, MN)

Defense Counsel Only War Room

Nov 28, 2018 2:30pm – 5:00pm

Speakers

Max Heerman
Principal Litigation Counsel
Medtronic (Washington, DC)

Day 1 - Thursday, November 29, 2018

7:00
Registration and Welcoming Breakfast
HOSTED BY:
8:00
Co-Chairs’ Opening Remarks
8:15
GC and CLO Roundtable: What Keeps Them Up at Night
9:30
MDLs: Their Intended Purpose, What Attempts Have Been Made at Improving the MDL System, and Effective Ways for Wrapping Them Up
10:15
Morning Coffee Break
10:45
A View from the Bench: Judicial Insights into Drug and Medical Device Products Liability Litigation
12:00
Networking Luncheon
HOSTED BY:
1:00
Practical Ways for Incorporating Diversity and Inclusion into Your Trial Team and Litigation Strategy
1:45
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)
2:30
Afternoon Networking Break
3:00
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)
3:45
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)
4:30
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)
5:30
Conference Adjourns to Cocktail Party
HOSTED BY:

Day 2 - Friday, November 30, 2018

7:15
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
A View from the Bench: Judicial Insights into Drug and Medical Device Products Liability Litigation
9:30
Enforcers’ Roundtable: Priorities with Respect to Consumer Fraud, False Claims, Anti-Kick-Back, and Off-Label
10:30
Morning Coffee Break
10:45
Hiring the Right Regional Counsel
11:30
Engaging the Courts in the Right Way: What Does It Mean to Be an Innovative Thinker as an Outside Counsel
12:00
Networking Lunch
1:30
Lay of the Land with Respect to Regulatory Trends, Pricing Transparency, and Patent Litigation
2:30
Opioid Enforcement and Litigation Landscape
3:30
Conference Ends

Day 1 - Thursday, November 29, 2018

7:00
Registration and Welcoming Breakfast
HOSTED BY:
8:00
Co-Chairs’ Opening Remarks

Kailee Goold
Senior Counsel
Cardinal Health (Columbus, OH)

Carolyn M. Hazard
Senior Vice President, Associate General Counsel – Litigation
Endo Pharmaceuticals Inc. (Malvern, PA)

8:15
GC and CLO Roundtable: What Keeps Them Up at Night

Ragan E. Cheney
Sr. Vice President, General Counsel Corporate Secretary
Titan Spine (Mequon, WI)

Elizabeth Howard
Executive VP and General Counsel
Arbutus Biopharma (Warminster, PA)

Maureen A. Ruane
Vice President & Head of U.S. Litigation
Novartis (East Hanover, NJ)

Richard W. Silbert
Vice President, Chief Legal Strategist
Purdue Pharma L.P. (Stamford, CT)

Jonathan Wasserman
Vice President and Associate General Counsel, Litigation & Government Investigations
Bristol-Myers Squibb Company (Lawrenceville, NJ)

Moderator:

Lori G. Cohen
Co-Chair, Global Litigation; Chair, Pharmaceutical, Medical Device & Health Care Litigation Group; Chair, Trial Practice Group Greenberg Traurig,
Greenberg Traurig, LLP

In this exclusive session, attendees will have the unique opportunity to hear directly from leading counsel at pharmaceutical and device companies about their greatest products liability challenges. Gain critical insights into the thinking and mindset of key legal decision makers on such topics as:

  • Conducting litigation and compliance audits to determine key areas of risk
    • Factoring in litigation trends and recent product liability law suits and enforcement activity against life sciences companies
    • Analyzing areas of risk for your company based on internal audits and forecasting the likelihood of a potential lawsuit or enforcement action
    • Assessing costs of potential litigation
  • Communicating areas of potential risk to company’s senior executives
  • Weighing options to manage an MDL when settlement is not feasible
  • Exploring the latest fee arrangement and alternate payment structures with outside counsel
  • Balancing the litigation environment with business demands/realities
  • How to best address/respond to media scrutiny and attack as well as other public relations issues

9:30
MDLs: Their Intended Purpose, What Attempts Have Been Made at Improving the MDL System, and Effective Ways for Wrapping Them Up

John Galvin
Partner
Fox Galvin (St. Louis, MO)

Lana K. Varney
Partner
King & Spalding (Austin, TX)

  • What is the intended purpose behind MDLs and has that purpose been obscured by practicalities of courts’ needing to manage the case dockets?
  • What attempts have been made at improving the MDL system?
  • Early judicial analysis of inventories in MDLs: Looking at the issue of meritless cases hiding within the MDLs, can any strategies be suggested to the courts as to how to address it?
  Getting closure: How to wrap up an MDL?
  • Ideas and strategies as to how to manage whatever is left after the settlement (e.g., unpaid claims)
  • How to negotiate and convince Plaintiff’s counsel?
  • How to manage client’s expectations?
  • What kind of assurances can be had?

10:15
Morning Coffee Break
10:45
A View from the Bench: Judicial Insights into Drug and Medical Device Products Liability Litigation

Hon. Rex M. Burlison
Circuit Judge
22nd Judicial Circuit (St. Louis, MO)

Hon. Michael J. Davis
Senior Judge
U.S. District Court, D. Minn. (Minneapolis, MN)

Hon. David R. Herndon
Judge
U.S. District Court, S.D. Ill. (East St. Louis, IL)

Moderator:

Andrew T. Bayman (Andy)
Partner
King & Spalding (Atlanta, GA)

12:00
Networking Luncheon
HOSTED BY:
1:00
Practical Ways for Incorporating Diversity and Inclusion into Your Trial Team and Litigation Strategy

Sonia Chen Arnold
Assistant General Counsel – Litigation and Legal Compliance
Eli Lilly and Company (Indianapolis, IN)

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

Kim M. Schmid
Firm Vice Chair and Executive Managing Partner
Bowman and Brooke LLP (Minneapolis, MN)

Robert R. Simpson
Partner
Shipman & Goodwin LLP

Having a diverse group of attorneys comprised of individuals of different races, genders, sexual orientations, and generations, which is reflective of the community in which cases are tried, makes for a stronger litigation team with a wealth of perspectives and personal experience. In addition to this common sense rationale for diversity, in-house counsel have espoused a commitment to diversity within their law departments and have made it clear that diversity matters to them when vetting and choosing law firms to represent them. In this session, points of discussion will include:  

  • Making sure all understand why it makes good business sense to have a diverse litigation team within both companies and law firms
  • Moving from an intellectual understanding of the need for diversity to measurable efforts showing recruitment, retention, and advancement
    • Discussing what diversity initiatives are working and designing sustainable diversity program for life sciences companies and outside law firms representing them
  • How law firms and companies can best implement policies that will truly effect change and promote a diverse workforce
    • What specific evidence of diversity are companies seeking from outside counsel
      • Firm composition overall
      • Partners
      • Breakdowns within teams
  • Evaluating a firm’s efforts in promoting diversity
    • Having a written plan and timeline in place to measure diversity efforts
    • Targeting specific deficiencies within the firm’s composition
    • Putting together a leadership team to develop and mentor diverse talent

1:45
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)

A – The Future of Personal Jurisdiction: Decisions of Note and Interpretations Around the Country

Halli D. Cohn
Partner
Troutman Sanders LLP (Atlanta, GA)

Sarah Heineman
Counsel, Corporate Litigation
Bayer Corporation

John P. Lavelle Jr.
Partner
Morgan, Lewis & Bockius LLP (Philadelphia, PA)


B – Gaining Control Over Third-Party Financing of Litigation: How are Third-Party Funding Deals Structured and What Efforts Have Been Made to Combat the Trend

John H. Beisner
Partner
Skadden, Arps, Slate, Meagher & Flom LLP (Washington, D.C.)

Christopher Guth
Senior Counsel
Bayer U.S. (Pittsburgh, PA)

Kelley S. Olah
Partner
Barnes & Thornburg LLP (Los Angeles, CA)

2:30
Afternoon Networking Break
3:00
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)

A – Best Strategies for Moving Forward When Faced with an Actual Multi-Plaintiff Trial

Amanda T. Perez
Assistant General Counsel
Pfizer Inc. (New York, NY)

Hildy Sastre
Partner
Shook Hardy & Bacon L.L.P. (Miami, FL)

David B. Sudzus
Partner
Drinker Biddle (Chicago, IL)


B – Has Proportionality Changed Anything? Impact of Recent Decisions and New Technologies on the Scope of Discovery

Julie Y. Park
Partner
Morrison & Foerster LLP (San Diego, CA)

Patrick Reilly
Partner
Faegre Baker Daniels LLP (Indianapolis, IN)

Munjot Sahu
Counsel – Litigation and Legal Compliance
Eli Lilly and Company (Indianapolis IN)

3:45
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)

A – State of the Union on Preemption

Paul J. Cosgrove
Partner
Ulmer & Berne LLP (Cincinnati, Ohio)

David W. O’Quinn
Member
Irwin Fritchie Urquhart & Moore LLC (New Orleans, LA)

Erica Valenti Visokey
Legal Counsel
Stryker Corporation (Stamford, CT)

Moderator:

Terrence J. Dee
Partner
McDermott Will & Emery (Chicago, IL)


B – Strategies for Minimizing the Effects of Innovator Liability

Henninger S. Bullock
Partner
Mayer Brown LLP (New York, NY)

Sean Fahey
Partner
Pepper Hamilton LLP (Philadelphia, PA)

Janet H. Kwuon
Partner
Reed Smith LLP (Los Angeles, CA)

Moderator:

Brennan Torregrossa
Vice President and Associate General Counsel Head of Global External Legal Relations Team (GELRT)
GSK (Philadelphia, PA)

4:30
AFTERNOON BREAKOUT SESSIONS (CHOOSE A OR B)

A – Training the Future Generations of Life Sciences Attorneys to Become the Next Deans of the Products Liability Bar

Nina Dillon
Senior Counsel
Boehringer Ingelheim (Ridgefield, CT)

Heidi Levine
Partner
Sidley Austin LLP (New York, NY)

Sara K. Thompson
Shareholder
Greenberg Traurig LLP (Atlanta, GA)

 

B – Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health and 3D Printing

James M. Beck
Senior Life Sciences Policy Analyst
Reed Smith LLP (Philadelphia, PA)

Erin M. Bosman
Partner
Morrison & Foerster LLP (San Diego, CA)

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

Vernessa T. Pollard
Partner
McDermott Will & Emery LLP (Washington, DC)

5:30
Conference Adjourns to Cocktail Party
HOSTED BY:

Day 2 - Friday, November 30, 2018

7:15
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
A View from the Bench: Judicial Insights into Drug and Medical Device Products Liability Litigation

Hon. Ann D. Montgomery
Senior Judge
U.S. District Court, D. Minn. (Minneapolis, MN)

Hon. Arnold L. New
Coordinating Judge/Complex Litigation Center
Philadelphia Court of Common Pleas (Philadelphia, PA)

Hon. Leda Dunn Wettre
Magistrate Judge
U.S. District Court, D.N.J. (Newark, NJ)

Hon. Susan D. Wigenton
Judge
U.S. District Court, D.N.J. (Newark, NJ)

Moderator:

Andrea Roberts Pierson
Partner
Faegre Baker Daniels LLP (Indianapolis, IN)

9:30
Enforcers’ Roundtable: Priorities with Respect to Consumer Fraud, False Claims, Anti-Kick-Back, and Off-Label

Lisa D. Kutlin
U.S. Attorney’s Office, Assistant U.S. Attorney
Eastern District of New York (Brooklyn, NY)

Gregg Shapiro
Chief, Affirmative Civil Enforcement
U.S. Attorney’s Office, District of Massachusetts (Boston, MA)

Pat Stein
Senior Asst. Attorney General for Health Fraud Consumer Protection Division
The Attorney General’s Office for the State of Texas (Dallas, TX)

Moderators:

Carolyn M. Hazard
Senior Vice President, Associate General Counsel – Litigation
Endo Pharmaceuticals Inc. (Malvern, PA)

Sarah M. Padgitt
Senior Counsel / Litigation
Baxter International Inc. (Deerfield, IL)

  • The government’s perspective on when and why to prosecute: how do enforcers identify companies for investigations?
    • What techniques are enforcers using these days to investigate manufacturers?
    • What specific information are enforcers focusing on?
  • Practical considerations for in-house and law firm counsel when faced with DOJ or AG action: best practices for responding to a government investigation

10:30
Morning Coffee Break
10:45
Hiring the Right Regional Counsel

Adam C. Bassing
Associate General Counsel
UCB, Inc. (Smyrna, GA)

David L. Ferrera
Partner & Chair, Product Liability Practice Group
Nutter McClennen & Fish LLP (Boston, MA)

Andrew D. Kaplan
Partner
Crowell & Moring (Washington, DC)

It is critically important for lead counsel as well as their in-house clients to ensure that they are working with the best regional counsel. At the same time, as a regional counsel, it is important to ensure that you know how to communicate to the lead as well as in-house counsel your skill-set and what you can contribute to the litigation. In this session, attendees will have an opportunity to develop best strategies for evaluating regional counsel, including what questions to ask and what to look for to make sure that any particular regional counsel is the best fit. The session will also include a discussion of what regional counsel can do to make sure they are answering the needs of their potential clients.

11:30
Engaging the Courts in the Right Way: What Does It Mean to Be an Innovative Thinker as an Outside Counsel

Greg A. Dadika
Associate General Counsel, Litigation
Becton, Dickinson and Company (Murray Hill, NJ)

Jan Dodd
Partner
Norton Rose Fulbright US LLP (Los Angeles, CA)

Kailee Goold
Senior Counsel
Cardinal Health (Columbus, OH)

Stephen E. Marshall
Partner
Venable LLP (Baltimore, MD)

Drug and device companies are changing the face of healthcare in a challenging environment every day. Sharing these companies’ values around creativity and advancement is going to become critical in order for outside counsel to distinguish themselves. This session will look to illuminate what lawyers/law firms/in-house counsel can do differently to really add value. Among topics to be discussed are:  

  • Fostering an environment of creativity
    • How to think about things differently
    • Questions to ask yourself/client/team
    • Rewarding and not punishing outside the box thinking
    • How to advance these ideas with the business
  • Improving communication skills
  • Candid feedback during and after the matter
    • Practical tips for doing this

12:00
Networking Lunch
1:30
Lay of the Land with Respect to Regulatory Trends, Pricing Transparency, and Patent Litigation

Gina Gencarelli
Senior Director, Intellectual Property
Par Pharmaceutical (Chestnut Ridge, NY)

Julia Post
Attorney
Covington & Burling LLP (Washington, DC)

As an in-house counsel, staying abreast of the key rulings and positions government takes as well as what government enforcers plan to do is crucial when looking to assess the risk for a company. In this session, we will look to extrapolate biggest trends and developments with respect to pricing transparency, patent litigation, and most recent regulation within the past year.

2:30
Opioid Enforcement and Litigation Landscape

Patricia A. Barbieri
SVP, General Counsel and Secretary
Daiichi Sankyo, Inc. (Parsippany, NJ)

Terry M. Henry
Partner
Blank Rome LLP (Philadelphia, PA)

Wendy West Feinstein
Partner
Morgan Lewis & Bockius LLP (Pittsburgh, PA)

  • Enforcement and litigation update
  • How is opioid MDL different from a typical MDL?
  • Interplay of state consumer protection laws with product liability actions
  • New theories of tort liability being advanced and how these expansions of traditional confines of tort law may impact other areas of products tort litigation

3:30
Conference Ends

Drug and Med Cross-Examination 101

Nov 28, 2018 9:00am – 12:00pm

Sean K. Burke
Partner
Duane Morris (Washington, DC)

Peter J. Goss
Partner
Blackwell Burke P.A. (Minneapolis, MN)

What is it about?

Because a drug or device trial often hinges on the expert witness testimony, knowing how to conduct an effective cross-examination of an expert is crucial in determining the direction of the litigation. Designed for those who are new to this type of litigation, this intensive 3-hour class will arm you with strategies on how to effectively use key case milestones, such as Daubert/Frye motions, as well as how to cross-examine a science and a regulatory/FDA expert. Points of discussion will include:  
  • Conveying easy to understand scientific concepts to the jury
  • Exacting jury-friendly concessions from the opposing expert
  • Highlighting the expert’s misuse of statistical data and methodology
  • How to undercut attempts to confuse principles of burden of proof with principles of statistical significance
  • Using the expert to establish the expertise of the FDA and pervasiveness of FDA review and oversight
  • Successfully showing — through cross — that the regulatory/FDA expert lacks sufficient qualifications in the area of proposed testimony
  • Using prior reports and testimony to demonstrate that the expert’s opinions are boilerplate and full of biases
  • Following the money: Using the total dollar figures the expert has made providing testimony against him/her

Defense Counsel Only War Room

Nov 28, 2018 2:30pm – 5:00pm

Max Heerman
Principal Litigation Counsel
Medtronic (Washington, DC)

What is it about?

Open to defense counsel only — Join your peers for a state-of-the-industry analysis and candid discussion about the latest and greatest in plaintiffs’ tactics. In-house and law firm defense counsel are encouraged to participate in this unique, interactive networking session that will set the stage for the topics discussed in-depth throughout the event and provide you with valuable takeaways about what your peers from around the country are seeing from the plaintiffs’ bar. Discussion will include:  
  • Jurisdictional issues
  • Discovery, including cross-border discovery
  • Successful motions to dismiss and other dispositive motions
  • Litigation tactics in aggregated cases: multiple plaintiff trials
  • Defending against junk science and using good science/literature to bolster your defense
  • Punitive damages: to bifurcate or not bifurcate?
  • In-house counsel: how can your clients better serve you? Outside counsel: how can your clients be better partners?
  • Analysis of the recent wave of cases in device litigation where courts have been excluding evidence of the 510k clearance process
  • A survey of the less known but important decisions impacting the drug and device space