Day 1 | Thursday, December 3, 2015

7:00 Registration and Welcome Breakfast

7:45 American Conference Institute Opening Remarks

8:00 Co-Chairs’ Opening Remarks

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



Max C. Heerman
Principal Litigation Counsel
Medtronic (Minneapolis, MN)



Sarah Heineman
Senior Counsel
Bayer Corporation (Pittsburgh, PA)



8:15 General Counsel and Chief Litigation Counsel Roundtable: Factoring in the Attendant Consequences of a Products Liability Action When Making Business and Settlement Decisions

Jean F. Holloway
Vice President, General Counsel & Secretary
CryoLife, Inc. (Kennesaw, GA)

Rita A. McConnell
Vice President and Chief Litigation Counsel
Medtronic, Inc. (Minneapolis, MN)

Richard W. Silbert
V.P., Assoc. General Counsel
Purdue Pharma L.P. (Stamford, CT)

Jack C. Silhavy
Executive Vice President & General Counsel
Fresenius Kabi USA (Lake Zurich, IL)

Anthony P. Tinari
Vice President and General Counsel
Bracco Diagnostics Inc. (Monroe Township, NJ)

Allen Waxman
Executive Vice President & General Counsel,
Market Access/Law & Government Affairs
Eisai Inc. (Woodcliff Lake, NJ)

Moderated by:

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

  • What keeps in-house products liability counsel up at night when faced with a potential products liability issue?
  • Creative management and resolution of mass tort scenarios before the cases are filed
  • Considerations for putting systems in place before products liability litigation happens based on a clear understanding
    of how these ancillary consequences drive and trigger each other
  • Tools for coordinating strategies with different in-house constituencies to cover the collateral consequences and form a bulletproof defense
  • Determining when to bring in law firm counsel
  • Early case evaluation and various approaches to settlement
    • Exploring the troubling steady increase in the size of drug and medical device products liability settlements and verdicts
    • Understanding the challenges inherent in executing a trial/settlement strategy in the face of an increasingly aggressive plaintiffs’ bar and ever-rising litigation costs
    • Positioning yourself from the outset to drive down the costs of settlement decision
    • Anticipating the consequences of settlement decisions: how do you resolve one side of a potential products liability issue without creating a monster on the other side?

9:45 Morning Coffee Break Hosted by:

10:00 Efficiently and Effectively Managing Large Scale Discovery: Best Practices for Preservation and Production and How to Avoid Discovery Being Used as a Blunt Tool Against the Defense

Candace Camarata
Assistant General Counsel, Litigation & Investigations
C.R. Bard, Inc. (New Providence, NJ)

Courtney Camp Enloe
Lead Counsel, Litigation
McKesson (San Francisco, CA)

Joanne R. Lane
Associate Director
Merck & Co., Inc. (Rahway, NJ)

Christopher D. Liwski
Senior Corporate Counsel, NA Litigation & Investigations
Sanofi US (Bridgewater, NJ)

Michael P. Panagrossi
Associate General Counsel
Purdue Pharma L.P. (Stamford, CT)

Patrick L. Oot
Shook, Hardy & Bacon L.L.P. (Washington, DC)

  • Reexamining company policies for document preservation in light of current e-discovery standards and expectations
    of U.S. Courts
    • What best practices and procedures should prudent companies have in place surrounding ESI to prevent million dollar mistakes?
    • Formulating internal policies and educating employees about the consequences of failure to comply with discovery and litigation holds to mitigate risk stemming from employees’ actions and email usage
    • Survey of the quickly evolving case law surrounding ESI protocols: updates on key federal and state decisions
    • Considerations for international companies: managing cumbersome global discovery demands in light of differing privacy rules internationally
    • Practical considerations: what is the projected growth of stored data and are the costs feasible given the exponentially large volume?
    • Acquiring and using the contents of private cell phones and text messages in litigation: considerations vis-à-vis company employees’ privacy rights and plaintiffs
  • Complying with litigation holds: Understanding what is expected in terms of deadlines and production and the consequences for failing to comply
    • Arguing for limited jury instructions and against adverse jury instructions regarding litigation holds in light of the risk of exorbitant punitive verdicts disproportionate to the actual harm
    • Analyzing where an attorney’s duty ethically begins and ends in light of recent strict case law about spoliation: law firm and in-house considerations
  • Understanding how the December 2015 implementation of the changes to Rule 37(e) of the Federal Rules of Civil Procedure in December will impact litigation strategy going forward
    • Practical implications: will the new good faith standard bring proportionality to discovery?
    • Examining whether Actos has created a feeding frenzy and emboldened the plaintiffs’ bar to pursue “discovery torts”
    • Anticipating ways some plaintiffs’ attorneys will still find ways to use discovery to drive up costs and force settlements and gain a tactical advantage
    • Exploring other approaches to discovery: how to get more and better information from plaintiffs

11:30 Getting Out Of Dodge — A Strategic Checklist For Getting Out of Unfriendly Jurisdictions and Practical Tips For Using Personal Jurisdiction, Forum Non Conveniens, Severance Motions, And CAFA And Other Removal Arguments

Sarah Heineman
Senior Counsel
Bayer Corporation (Pittsburgh, PA)

Alan S. Modlinger
Merck & Co., Inc. (Kenilworth, NJ)

Eric L. Alexander
Reed Smith LLP (Washington, DC)

Sean P. Fahey
Pepper Hamilton LLP (Philadelphia, PA)

  • Examining the disparate procedural mechanisms in your arsenal and considerations for using them in the knock-down drag-out battle for removal to federal court
    • CAFA removal provisions — diversity and mass actions
    • Federal question arguments and specific versus general jurisdiction post-Bristol-Myers Squibb Co. v. Superior Court of San Francisco County
    • Severing claims that fall short of removal pursuant to CAFA numbers based on personal jurisdiction in the wake of Daimler AG v. Bauman and Walden v. Fiore
    • Understanding how Mylan v. Astra Zeneca will affect the personal jurisdiction analysis
    • Transfers under 1404
    • Growing case law surrounding forum non conveniens: will this kill mass proceedings in certain states?
    • Fraudulent joinder/misjoinder
  • Update on plaintiffs’ efforts to manipulate venue and jurisdiction
    • Anticipating more cases in which plaintiffs attempt to defeat the CAFA removal provisions by filing no more than a hundred actions per complaint in state court
    • Multi-plaintiff filings with spoiler plaintiffs and defendants
    • Overview of some of the recent cases regarding removal between state and federal court: what is the defense scorecard?
  • Best practices for litigating in plaintiff friendly jurisdictions when manufacturers are unable to defeat remand to state court
    • How to improve your chances in unfriendly jurisdictions
    • Conducting discovery in full-discovery states
    • Litigating in multi-plaintiff cases

12:30 Networking Luncheon for Speakers and Delegates Hosted by:

1:30 Plaintiffs’ Lawyer Advertising and Lead Generation: Neutralizing the Efforts of Increasingly Aggressive Plaintiffs’ Tactics

Blaine R. Dart
Senior Corporate Counsel, Litigation, Investigations &
Risk Management
Zimmer Biomet (Warsaw, IN)

Michael W. King
Corporate Counsel
Novo Nordisk Inc. (Plainsboro, NJ)

Abigail M. Butler
Faegre Baker Daniels (Fort Wayne, IN)

Brooke Killian Kim
DLA Piper (San Diego, CA)

  • What can defense attorneys do to counterbalance the frustrating volume of plaintiffs’ lawyer advertising to
    create claims?
    • Creating a defense message focused on safety and desire to promote health and well-being
    • Getting the word out there about victories for pharma and medical device companies in products liability actions to counteract reputational risk when lawsuits are publically filed
  • Striking back: case studies of manufacturers who have taken an aggressive stance against false or misleading statements by law firms and 3rd party funding groups
    • Cease and desist letters
    • Countering free speech and lawsuits against public policy arguments
    • Factoring in relevant ethical rules surrounding attorney advertising
    • Understanding the business impact of going this route
  • Using plaintiffs’ advertising offensively
    • Monitoring new trends in plaintiffs’ advertising and gauging what’s coming down the pike in terms of exposure and liability
    • Focusing defense claims based on this analysis
    • Statute of limitations arguments: when does this begin to toll based on when ads are run?


2:30 Afternoon Breakout Sessions – Choose A or B
A - FDA’s Generic Drug Labeling Proposed Rule: Best Practices for Generic, Innovator, and Biosimilars Manufacturers to Combat Anticipated Plaintiffs’ Tactics

Andrew Calica
Mayer Brown LLP (New York, NY)

José A. Isasi, II
Jones Day (Chicago, IL)

Kevin C. Newsom
Bradley Arant Boult Cummings LLC (Birmingham, AL)

  • Updates on the status of FDA’s proposed generic labeling and preemption rule:
    deep-dive into the practical implications for both branded, generics, and biosimilars
    • Branded liability based on their ability to unilaterally change the label: which state Courts are rejecting and accepting Conte?
    • Utilizing an innovator liability theory when arguing for generic preemption
  • Survey of the new preemption landscape: Overview of the new Federal Court and lower Court decisions and pending significant appeals
    • Dissecting plaintiffs’ best arguments for pleading around preemption
    • Overview of successful defense strategies in recent cases regarding parallel claims
    • Forecasting the resurgence of the impossibility preemption defense in light of recent case law
    • Update on the status of the infamous “Footnote 4” exception cases winding their way through the Courts
B - Preserving the Medical Device Preemption Defense in Light of Contrary Court Decisions and a Resurgence of Off-Label Attacks

Max C. Heerman
Principal Litigation Counsel
(Minneapolis, MN)

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

James F. Murdica
Patterson Belknap Webb & Tyler LLP (New York, NY)

  • Putting a defense strategy in place in spite of the current subtle contradiction in case law surrounding state-law parallel claims: what is the state of play with the Circuit splits?
    • Understanding the significance of the Supreme Court’s denial of Cert in Stengel with respect to parallel state failure-to-warn claims
    • Avoiding express and implied preemption in cases regarding Class III medical devices
    • What are plaintiffs pleading to state their claims around preemption?
    • Which Courts are adopting or accepting the Solicitor General’s opinion?
    • Insights into recent allegations of off-label promotion on medical device manufacturers
    • Understanding how expressed and implied preemption will be affected
    • Special considerations surrounding preemption for PMA devices with combination or multiple parts including bone and hip grafts and infused products: what is the scope of pre-market approval?
    • Exploring the rise of FDA’s use of human factors experts and analysis
  • Insights from real arguments to best respond to the concerns on Judges’ minds surrounding preemption going forward

3:30 Afternoon Networking Break Hosted by:

3:45 Afternoon Breakout Sessions – Choose C or D
C - Enforcers’ Spotlight: Understanding Government’s Enforcement Priorities vis-à-vis Drug and Device Products Liability Matters

Jacob T. Elberg
Chief, Health Care& Government Fraud Unit
United States Attorney’s Office,
District of New Jersey (Newark, NJ)

Charlene Keller Fullmer
Assistant United States Attorney and Deputy Chief, Affirmative Litigation, United States Attorney’s Office, Eastern District of Pennsylvania (Philadelphia, PA)

Carmen M. Ortiz
United States Attorney
District of Massachusetts
(Boston, MA)

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


John J. Pease
Morgan Lewis & Bockius LLP
(Philadelphia, PA)

  • Preparing for increased criminal and civil enforcement actions stemming from drug and med device products liability
    • Off-label
    • Consumer Fraud
    • False Claims
    • Anti-kickback statute
    • FCPA for products distributed abroad
  • Is a billion the new million? Analyzing the steady trend of staggering penalties and fines for drug and device makers in these cases
  • The government’s perspective on when and why to prosecute: how do enforcers identify companies for investigations?
    • Recognizing behaviors which may raise a red flag for enforcers and cause an enforcement and products liability action to go hand-in-hand: alleged false statements and misleading statements to watch out for
    • Addressing the increased threat of individual liability for responsible corporate officers and in-house counsel stemming from alleged products liability
    • Examining the level of interaction between federal and state governments in investigations stemming from the same alleged misconduct
    • What is the nature of the state’s burden of proof in establishing harm?
    • What does the government expect and appreciate in how companies conduct discovery during an investigation?
  • Practical considerations for in-house and law firm counsel when faced with DOJ or AG action
    • Best practices for responding to a government investigation
    • Properly conducting and documenting internal investigations
    • Making the difficult choice to voluntarily disclose the results of internal investigation in return for cooperation credit
    • Factoring the effect of follow-on civil litigation into the decision to settle with the DOJ
    • Analyzing the best arguments for and against AG’s contingency fee arrangements with plaintiffs’ counsel
D - Controlling the Effects of Social Media on Products Liability Litigation: Practical Tips for Drug and Device Manufacturers

David M. Layfer
Abbvie (North Chicago, IL)

Erica L. Visokey
Legal Counsel
Stryker Corporation (Allendale, NJ)

Tariq M. Naeem
Tucker Ellis LLP (Cleveland, OH)

David B. Sudzus
Drinker Biddle & Reath LLP
(Chicago, IL)

  • Update on FDA’s social media guidelines for pharmaceutical and medical device manufacturers
    • Developing appropriate, risk-based protocols for social media presence to promote your products, in the absence of final guidance
    • Insights from recent warning letters of behavior that companies should avoid
    • Preparing and training employees about appropriate social media use
    • Alerting employees of the potential risks of tweets, blogs, and social media posts during litigation
    • Establishing a corporate record retention policy regarding social media
  • Examining how social media might become a catalyst to products liability action
    • Overview of the ways FDA is using social media to detect and monitor adverse effects of drugs
    • Understanding the scope manufacturer liability for posted comments involving alleged adverse events and off-label product use
    • What is a company’s duty to monitor the internet, beyond its own sponsored sites?
    • Beyond that, what is the duty to follow up?
  • Making successful objections to keep out damaging posts and messages

4:45 Continue to Next Session

5:00 Afternoon Breakout Sessions – Choose E or F
E - What Drug and Defense Counsel Need to Know About the Rapidly Evolving Off-Label Promotion Landscape Post-Amarin v. FDA

Patrick L. Gibson
Director, Government Investigations
Merck & Co., Inc. (North Wales, PA)

Michael J. Hulka
General Counsel and Senior Director, Strategy and Operations, Lilly Oncology
Eli Lilly and Company
(Indianapolis, IN)

Mark Crane
Segal McCambridge Singer & Mahoney, Ltd. (Chicago, IL)

Sean P. Wajert
Managing Partner –
Philadelphia Office
Shook, Hardy & Bacon L.L.P.
(Philadelphia, PA)

  • Going through the year’s biggest developments in the Legislatures and the Courts signaling that clarity surrounding permissible off-label usage might be on the horizon
  • Examining the import of the First Amendment ruling in Amarin v. FDA: how to interpret the rights of sales to promote in a truthful and non-misleading method for an off-label indication?
  • Status of the 21st Century Cures Act: will FDA be mandated to issue guidance?
  • Update on recent drug and device Court battles surrounding off-label: what are the new trends vis-à-vis off-label marketing and products liability?
  • Communicating to judges and juries that off-label does not necessarily equate unsafe
F - Recent Developments and Strategies for Strengthening Your Class Action Defense

Blaine R. Dart
Senior Corporate Counsel, Litigation, Investigations &
Risk Management
Zimmer Biomet (Warsaw, IN)

Donald R. Frederico
Pierce Atwood LLP (Boston, MA)

Brian A. Troyer
Thompson Hine LLP
(Cleveland, OH)

  • Survey of recent case law: strategies for success in defending against class actions against drug and device manufacturers
  • Rule 23(c)(4): understanding and defeating certification of issue classes
  • Using Daubert challenges in opposition to class certification
  • Developments and strategic considerations regarding overbreadth and ascertainability challenges
  • Understanding key issues in the use of statistics and econometrics in class actions
  • Developments in American Pipe tolling and mootness based on offers of judgment

6:00 Conference Adjourns to Cocktail Party Hosted by:


Continue to Day 2

Day 2 | Thursday, December 3, 2015

7:30 Registration and Continental Breakfast

8:00 Co-Chairs’ Opening Remarks and Recap of Day 1

8:15 Revisiting Bellwether Trials as the Go-To Choice for Mass Tort Litigation: A Close Look at the Benefits and Effectiveness of the Process

Cynthia J. Kretz
Vice President, General Counsel
Cook Group Incorporated (Bloomington, IN)

Christopher P. Gramling
Assistant General Counsel – Litigation and Legal Compliance
Eli Lilly and Company (Indianapolis, IN)

Alexander G. Calfo
King & Spalding (Los Angeles, CA)

John E. Galvin
Fox Galvin, LLC (St. Louis, MO)

Andrea Roberts Pierson
Faegre Baker Daniels (Indianapolis, IN)

  • Examining the benefits and drawbacks of going the bellwether trial route knowing that the case has the potential to shape the entire litigation
    • Lessons learned from the year’s biggest bellwether trials with a focus on both challenging rulings for the defense as well victories
    • Is it dangerous for corporate to defendants to put all their eggs in one basket or do that cost savings make it worthwhile?
  • Best practices when electing to go the bellwether route: Implementing smart front-end strategies and setting precedents to streamline future trials and minimize litigation risks going forward
    • Effectively using screening orders and Lone Pine orders in mass torts to narrow the claims before the bellwether trials: setting up the case and implementing the order
    • Strategically selecting issues which have the best chance of eliminating future claims
    • Lobbying for favorable forums
    • Securing desirable timing and case sequences
  • Overview of viable alternatives to the bellwether process: what are the relative strengths and weaknesses of each?
    • Allowing cases to go forward in state court
    • Groups of cases worked up in an MDL but tried in different District Courts
    • Sets of cases tried in front of a transferee judge

9:15 A View from the Bench: Judicial Insights into Drug and Medical Device Products Liability Litigation

The Honorable Ruben Castillo
Chief Judge, United States District Court,
Northern District of Illinois (Chicago, IL)

The Honorable Joy Flowers Conti
Chief Judge, United States District Court,
Western District of Pennsylvania (Pittsburgh, PA)

The Honorable Michael J. Davis
United States District Judge, District of Minnesota
(Minneapolis, MN)

The Honorable David R. Herndon
United States District Judge, Southern District of Illinois
(East St. Louis, IL)

The Honorable Leslie E. Kobayashi
United States District Judge, District of Hawaii
(Honolulu, HI)

The Honorable J. Frederick Motz
Senior Judge, United States District Court,
District of Maryland (Baltimore, MD)

The Honorable Arnold L. New
Supervising Judge, Court of Common Pleas,
Trial Division – Civil (Philadelphia, PA)

The Honorable Christopher A. Nuechterlein
United States Magistrate Judge,
Northern District of Indiana (South Bend, IN)


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

Hear what arguments and claims Courts find most effective and persuasive when presiding over a drug or medical device products liability case. Formulate your drug and med litigation strategies based upon the insights of renowned jurists experienced in products liability litigation who will share their thoughts on pressing issues within litigation, including discovery, science days, civility, and cooperation between state and federal proceedings.

10:45 Morning Coffee and Networking Break

11:00 The Globalization of Drug and Med Products Liability: A Checklist for Creating a Cost-Effective Approach to International Mass Tort Litigation

Jobina Jones-McDonnell
Senior Litigation Attorney
Endo Pharmaceuticals (Malvern, PA)

Lisbeth Warren
Assistant General Counsel
Johnson & Johnson (New Brunswick, NJ)

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

Robin Linley
Blake, Cassels & Graydon LLP (Toronto, ON)

12:00 Networking Luncheon Hosted by: 

1:00 Successfully Defending the Corporate Deposition: Concrete Examples of How to Prepare Witnesses for Reptile Questions

Jason Baranski
Head Counsel U.S. Commercial
Shire Pharmaceuticals (Wayne, PA)

D’Lesli M. Davis
Norton Rose Fulbright US LLP (Dallas, TX)

Michael B. Hewes
Butler Snow LLP (MS)

Old tricks, new name: familiarizing corporate witnesses with plaintiffs’ tactics to demonstrate danger to the community as a whole and tap into jurors’ “reptile brains”

2:00 Afternoon Networking Coffee Break

2:15 Hot Topics in Legal Ethics: Civility, Discovery, Privilege, Diversity, and More

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

Donald P. Bunnin
Senior Litigation Counsel
Allergan plc (Irvine, CA)

Brennan J. Torregrossa
Assistant General Counsel
GlaxoSmithKline (Philadelphia, PA)

Stephen J. McConnell
Reed Smith LLP (Philadelphia, PA)

Mary R. Pawelek
Executive Managing Partner
Bowman & Brooke LLP (Austin, TX)

In this CLE Ethics session, leading counsel will go through a series of hypotheticals and examine the relevant ethical rules at play.

3:15 Main Conference Concludes

Continue to Day 1

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