7:00 Registration and Welcoming Breakfast

Hosted by:

8:00 ACI Opening Remarks and Awards Presentation

8:15 Co-Chairs’ Opening Remarks

Lisa M. Dunkin
Senior Litigation Counsel
Zimmer Biomet
(Warsaw, IN)

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

8:30 GC and CLO Roundtable: “What Keeps Me Up at Night When Faced With a Products Liability Action”

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

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

Bradley J. Tandy
Executive Vice President, General Counsel and Secretary

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

Jonathan A. Wasserman
Vice-President & Associate General Counsel
Bristol-Myers Squibb
(Plainsboro, NJ)

Moderated by:

Lori G. Cohen
Shareholder; Chair, Pharmaceutical, Medical Device &
Health Care Litigation Group; Chair, Trial Practice Group
Greenberg Traurig, LLP (Atlanta, GA)

In this exclusive session, attendees will have the unique opportunity to hear insights from leaders at biopharmaceutical and medical device companies about their greatest products liability challenges, including gamesmanship from an increasingly aggressive plaintiffs’ bar, controlling ever-rising litigation costs, and preparing for collateral consequences and follow-on actions stemming from products liability.

9:45 Morning Coffee Break

10:00 Striking Back Against Innovative Third Party Litigation Funding and Aggressive Attorney Advertising

Greg A. Dadika
Associate General Counsel, Litigation
C. R. Bard, Inc. (Murray Hill, NJ)

Daniel Healey
Corporate Counsel
Pfizer Inc. (New York, NY)

Leah L. Lorber
Assistant General Counsel
GlaxoSmithKline (Washington, DC)

Orlando R. Richmond, Sr.
Butler Snow LLP (Jackson, MS)

Katherine M. Swift
Bartlit Beck Herman Palenchar & Scott LLP (Chicago, IL)

  • The rise of third party litigation funding: Understanding how this phenomenon is fueling drug and med products liability litigation
  • Exploring the mechanics and following the money: how common is this and how are the cases being funded
  • Managing control when the funder is calling the shots and driving the litigation
  • Considerations for resolution and settlement in this increasingly complicated arena
  • Concrete strategies to neutralize the effects of increasingly aggressive plaintiffs’ advertising
  • Limiting plaintiff advertising: taking an aggressive stance against false or misleading messages to the public
  • Getting data regarding plaintiff attorney advertising spend into discovery
  • Uncovering third-party arrangements through discovery
  • Counterbalancing the volume of lawyer advertising with a well-crafted defense the me of safety and patient protection

11:00 A Practical Guide to Using Tools in the Defense Arsenal to Fight Litigation Tourism and Frivolous Litigation

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

Robert J. Bassett
Williams Venker & Sanders (St. Louis, MO)

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

Stephen J. McConnell
Reed Smith (Philadelphia, PA)

James F. Murdica
Barnes & Thornburg LLP (Chicago, IL)

  • Examining the latest and greatest procedural mechanisms and arguments plaintiffs are using to secure favorable venue in multi-plaintiff cases
  • Highlighting recent litigation successes: Court case updates relevant to defense counsel’s best tools for removal
    • Personal jurisdiction post-Daimler AG v. Bauman
    • Snap removals
    • Severance motions with fraudulent or misjoinder
    • CAFA procedures
    • The one year window
    • Burdens of proof
    • Securing appellate review
  • Anticipating what comes next in plaintiffs’ efforts to manipulate venue and jurisdiction
  • Exploring when plaintiffs’ conduct rises to a level of egregiousness where seeking sanctions is appropriate

12:15 Networking Luncheon

Hosted by:

1:30 Combating Plaintiffs’ Tactical Advantage in Discovery: Specific Strategies for Limiting Production and Cost-Effective Preservation Under the Amended FRCP Rules

Candace Camarata
Assistant General Counsel
C.R. Bard, Inc. (Murray Hill, NJ)

Lynn Reilly
Director, eDiscovery Client Services
Lighthouse eDiscovery (Seattle, WA)

Bart C. Sullivan
Fox Galvin, LLC (St. Louis, MO)

  • Changes to Rule 37(e) of the Federal Rules of Civil Procedure one year later: what have been the practical effects in terms of improving proportionality, efficiency, and costs?
  • Exploring defense advocacy efforts to preserving the spirit of the new rules and challenging any potential efforts to undermine the landmark rules
  • Leveling an asymmetrical playing field: opportunities under the new rules to prevent discovery from being used as a blunt weapon to leverage claims against the defense
  • Making meaningful objections to burdensome disproportionate preservation and discovery requests
  • Using favorable court opinions limiting the scope of document preservation and e-discovery in the past year: analysis of relevant cases by jurisdiction


2:30 Afternoon Breakout Sessions – Choose A or B
A - Preemption of Design-Defect and Warning Claims in Pharmaceutical Cases:
        A Cheat Sheet for Recent Developments in the Lower Courts

Paul J. (PJ) Cosgrove
Ulmer & Berne (Cincinnati, OH)

Geoffrey M. Drake
King & Spalding LLP
(Atlanta, GA)

Kathleen S. Hardway
Venable LLP
(Baltimore, MD)

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

  • Analyzing the continued evolution in the Circuit Courts of the Federal
    preemption doctrine post-Supreme Court trilogy of Wyeth, Mensing,
    and Bartlett
    • Celexa in the First Circuit
    • Yates in the 6th Circuit
    • Januvia in the 9th Circuit
    • Other cases to watch
  • Exploring some of the gray areas and lingering questions that may
    lead to the next wave of litigation
  • What qualifies as “newly acquired information” in terms of unilateral
    label changes?
  • Impossibility preemption in design defect claims
  • Updates on the status of FDA generic drug labeling rules post-2016
    presidential election: practical implications for the future of innovator
    liability and best practices for branded and generic companies going
B - Mock Medical Device Preemption Motion to Dismiss: Formulating a Robust Defense Strategy for Sales Reps in the OR, MDR-based claims, Off-Label, and More

The Honorable Richard Kramer (Ret.)
JAMS (San Francisco, CA)
(Judge, San Francisco County Superior Court,

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

Andrew Tauber
Mayer Brown LLP
(Washington, DC)

In this entertaining and interactive session, learn trial advocacy tips to preserve the medical device preemption defense in battles going forward as experienced trial counsel pretend to duke it out before a retired Judge, well-versed in the intricacies of device preemption. ACI will provide attendees a fact pattern featuring some of the most challenging plaintiffs’ preemption-avoidance arguments surrounding the role of sales reps in the operating room, off-label promotion allegations and more common real issues. The advocates will provide attendees with highlights from their mock brief and explain their goals for oral argument in advance. Learn how esteemed trial counsel counters the arguments against preemption in search of a favorable outcome.

3:30 Afternoon Networking Break

Hosted by:

3:45 Afternoon Breakout Sessions – Choose C or D
C - Exploring the Risks and Potential Products Liability Consequences for 3D Printing

Stephen G.A. Myers
Irwin Fritchie Urquhart & Moore LLC
(New Orleans, LA)

Raymond M. Williams
National Diversity and Inclusion Partner and Co-Chair,
Product Liability and Mass Torts Practice
DLA Piper (Philadelphia, PA)

Richard J. Underwood, Ph.D., CEng.
Manager, Biomedical Engineering
Exponent, Inc. (Philadelphia, PA)

  • What’s all the fuss about? Seeing how a 3D printer works and how it will change products liability going forward
  • Reviewing the specifics of FDA’s newly issued guidance on 3D printing for drugs and devices: what kind of products and materials are eligible for approval?
  • Understanding who the potential defendants in products liability matters are: Manufacturers? Hospitals? Program designers?
  • Exploring potential theories of litigation that plaintiffs will use and formulating defenses based on anticipated plaintiffs’ tactics
D - Avoiding Drug and Med Litigation Pitfalls Arising from Emergent Areas of the Law: Biosimilars, Personalized Medicine, Sunshine Act, and More

Jessica Benson Cox
Faegre Baker Daniels LLP
(Indianapolis, IN)

Steven M. Selna
Drinker Biddle & Reath LLP
(San Francisco, CA)

In this session, an esteemed panel of experts will highlight some of the biggest laws affecting the pharmaceutical and device industries which have downstream consequences for products liability litigation. Attendees will walk away with increased knowledge of these laws and the ability to effectively spot the most important issues impacting drug and med litigation down the road.

  • Biosimilars: preemption analysis and marketing and promotion
  • Personalized medicine and genetic testing: warnings and causation with tailored treatments
  • Sunshine Act: how will plaintiffs use the database against doctors and expert witnesses


E - International Mass Tort Litigation: Strategies for Handling the Increasing Interplay Between Domestic and Global Products Liability Actions

James W. A. Ladner
Deputy General Counsel – Litigation & Investigations
St. Jude Medical, Inc. (St. Paul, MN)

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

Gerry Lowry
Norton Rose Fulbright US LLP
(Houston, TX)

  • Creating a cost-effective approach to international mass torts: working within the nuances of different legal frameworks but with the same fact patterns and witnesses
  • Using expert witnesses in multiple foreign jurisdictions
  • Handling the nuances in foreign jurisdictions and mastering logistical coordination challenges
  • What are the new pressures to resolve claims in key jurisdictions?
  • Update on key recent ex-US legal developments which may affect products liability litigation outcomes
  • Understanding the interplay between USFDA and foreign regulatory bodies
F - Deep Dive into Women’s Health: Preparing for the Second Wave of Products Liability Litigation

Howard Cyr
Associate General Counsel
Teva Pharmaceuticals
(North Wales, PA)

Barbara R. Binis
Reed Smith LLP
(Philadelphia, PA)

Alicia J. Donahue
Shook, Hardy & Bacon L.L.P.
(San Francisco, CA)

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

Connie Matteo
Assistant General Counsel, Pfizer Inc, (New York, NY)

  • Exploring the uptick in cases focused on drug and device products for women: what are the drivers?
    • FDA’s launch of the Office of Women’s Health
    • History of emerging litigation aimed at drug and device products for women
  • Evolving theories and themes:
    • Lack of scrutiny for clinical trials for women
    • Distribution of products
    • Deceptive marketing targeted at women
    • Disproportionate adverse events affecting women
  • Putting practical, proactive defense strategies in place to undermine emotional arguments, counter issues and themes and litigation, and address them before litigation arises
  • What does the future of this litigation hold?

5:45 Conference Adjourns to Cocktail Party

Hosted by:

Continue to Day 2


7:30 Registration and Continental Breakfast

8:00 Countering Off-Label Promotion Claims: The Effect of Evolving First Amendment Jurisprudence

Steven E. Derringer
Bartlit Beck Herman Palenchar & Scott LLP
(Chicago, IL)

Nilda M. Isidro
Goodwin Procter LLP
(New York, NY)

  • 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?
  • How are tort claims being premised on off-label allegations throughout the country?
  • Review of the year’s biggest developments in the Legislatures and the Courts surrounding permissible off-label discussion post-Amarin

9:00 A View from the Bench: Judicial Insights into Drug and Medical Device Products Liability Litigation

The Honorable Timothy S. Black
Judge, United States District Court
Southern District of Ohio (Cincinnati, OH)

The Honorable Elaine Bucklo
Judge, United States District Court
Northern District of Illinois (Chicago, IL)

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

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

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


The Honorable John F. Keenan
Judge, United States District Court
Southern District of New York (New York, NY)

Moderated by:

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.

10:15 Morning Coffee Break

10:30 The Rebirth of Daubert and Frye: Recent Successful Expert Challenges

Julie E. Fink
Senior Corporate Counsel
Pfizer Inc. (New York, NY)

Robert T. Adams
Shook, Hardy & Bacon L.L.P. (Kansas City, MO)

Ted Mayer
Managing Partner
Hughes Hubbard & Reed (New York, NY)


Moderated by:

Brennan J. Torregrossa
Vice President and Associate General Counsel
GlaxoSmithKline (Philadelphia, PA)

  • Overview of recent Daubert and Frye rulings (Mirena, Zoloft, Lipitor and more) and the implications for the industry on successful defense arguments regarding evidentiary challenges
  • Battling for bellwethers: how to shut down litigation based on early favorable expert decisions regarding causation
  • Upsides and challenges of company witnesses in Daubert and Frye context
  • Practical tips for dealing with unreliable expert testimony.

11:30 Enforcers’ Spotlight: Recognizing Behaviors Which May Raise a Red Flag for Enforcers vis-à-vis Products Liability

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

Philip Ziperman
Director, Office of Consumer Protection
Attorney General for the District of Columbia
(Washington, DC)

The Honorable Leslie Rutledge
Attorney General, Arkansas
(Little Rock, Arkansas)

Eric W. Sitarchuk
Morgan, Lewis & Bockius LLP
(Philadelphia, PA)


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


  • 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
    • Fraud-on-the FDA
  • The government’s perspective on when and why to prosecute: how do enforcers identify companies for investigations?
  • Analyzing the steady trend of staggering penalties and fines for drug and device makers in these cases
  • Practical considerations for in-house and law firm counsel when faced with DOJ or AG action: Best practices for responding to a government investigation
  • Exploring the practical implications of AG’s contingency-fee arrangements with plaintiffs’ counsel in consumer protection actions
  • Deep-dive into the definition of “cooperation” in the context of a government investigation post-publication of the Yates memorandum: has the memo changed the dynamics of government / industry relationships?

12:30 Networking Luncheon

Hosted by:

1:30 Revisiting Lone Pine Orders in Drug and Medical Device Mass Torts: Never Say Never?

Lisa M. Dunkin
Senior Litigation Counsel
Zimmer Biomet (Warsaw, IN)

J. Stephen Bennett
Faegre Baker Daniels LLP (Fort Wayne, IN)

  • Do Lone Pine Orders have new life following In Re Zimmer NexGen Knee MDL 2240?
  • Changing perceptions of MDL effectiveness and the impact on requests for Lone Pine Orders
  • Does a Lone Pine order by any other name still smell as sweet? The screening order as a quasi-Lone Pine
  • Are Lone Pine Orders the only way to put plaintiffs to their proofs regarding science and expert declarations early on to protect time and judicial resources?
  • Best practices for setting up the defense to get to truly representative cases, define the issues, and streamline discovery


2:30 Diversity and Inclusion: Exploring the Challenges and Opportunities in Attracting and Retaining a Diverse Legal Team

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

Julie L. Hussey
Perkins Coie LLP (San Diego, CA)

  • How firms and companies can best implement policies that will truly effect change and promote a diverse workforce
  • Moving from an intellectual understanding of the need for diversity to measurable efforts showing recruitment, retention and advancement
  • Putting together a leadership team to develop and mentor diverse talent
  • Drilling down into the criteria that in-house counsel looks for when choosing diverse law firms

3:30 Main Conference Concludes

Continue to Day 1

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