DAY 1 | TUESDAY, DECEMBER 9, 2014

7:00 Registration & Welcome Breakfast

8:00 Co-Chairs’ Opening Remarks

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




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




Malini Moorthy
Vice President & Associate General Counsel
Bayer Corporation (Pittsburgh, PA)



8:15 Discovery Best Practices post-Actos: Minimizing the Risk of Harsh Defense Sanctions in an MDL

Gloria Y. Lee
Lead Counsel
McKesson Corporation (San Francisco, CA)

 

Ben Barnett
Partner and Co-Chair,
Complex Commercial Litigation Practice
Dechert LLP (Philadelphia, PA)


James W. Huston
Partner and Chair, Trial Practice Group
Morrison & Foerster LLP (San Diego, CA)

 


Walter “Pete” Swayze, III
Shareholder
Segal McCambridge Singer & Mahoney, Ltd.
(Philadelphia, PA)

 

  • Reexamining document preservation policies and practices in light of current e-discovery standards and judicial expectations
    • What best practices and procedures should prudent companies have in place to prevent million dollar mistakes?
    • What are your ethical obligations in light of recent decisions regarding spoliation?
  • Preservation and Production: Case studies from the Actos and Pradaxa litigation
    • Arguing for limited adverse jury instructions regarding litigation holds in light of the risk of exorbitant punitive verdicts disproportionate to the actual harm (i.e., State Farm)
    • Managing document production and production deadlines to avoid consequences for failure to comply
    • Educating and protecting international companies facing global discovery demands
  • Understanding how the proposed changes to Rule 37(e) of the Federal Rules of Civil Procedure will impact litigation strategy going forward
    • Practical implications: will the new good faith standard bring some needed balance to discovery and sanctions practice?
    • Do the proposed changes offer any relief from discovery being used as a blunt instrument to drive up costs and force settlements?

9:15 FDA Keynote Address: Update on Generic Drug Labeling and Preemption of State Law Products Liability Claims

Kelsey Schaefer (Invited)
Associate Chief Counsel for Enforcement,
Office of Chief Counsel
United States Food and Drug Administration (FDA)
(Silver Spring, MD)


9:45 am Morning Networking and Coffee Break Sponsored by:

10:00 Chief Litigation Counsel Round Table: Proactively Spotting Litigation Red Flags Based on Current Hot Button Issues in Products Liability

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

 



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



Michael Parini
Seni Arnold or Vice President and Chief Litigation Counsel
Pfizer Inc. (New York, NY)



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



Moderated by:

Elizabeth B. Wright
Partner
Thompson Hine (Cleveland, OH)

 

 

  • Fighting an uphill battle against an aggressive plaintiffs’ bar adept at advancing novel and innovative theories of liability
    • Analyzing the drivers of hundred-million dollar verdicts in this space
    • Factoring in the increase in plaintiffs’ firms advertisements and the ensuing increase in mass tort litigation
    • Preparing for increased litigation (and a knockout battle during discovery) going forward post-Actos
    • Positioning yourself from the outset to drive down the cost of settlements
  • Developing winning trial themes and defenses to combat excessive damages and neutralize jurors’ biases
    • Defense playbook: utilizing new decisions and legal developments to your advantage in an increasingly litigious field
    • Case studies: success stories of defense techniques that providers have used when being slammed in a mass torts case
  • Proactively identifying drugs or devices which may be ripe for mass tort litigation in light of adverse event reports and social media postings
    • Having a litigation plan in place to cope with troubling plaintiffs’ tactics

11:15 MDL Insider Strategies: Implementing Best Practices for Bellwether Trial Selection in Mass Tort Litigation

Nicole D. Bearce
Partner
Lowenstein Sandler LLP (New York, NY and Roseland, NJ)

 


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

 

 

James D. Pagliaro
Partner
Morgan, Lewis & Bockius LLP (Philadelphia, PA)

 

 

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

 

 

  • For better or for worse: Weighing the benefits and drawbacks of going the bellwether trial route knowing that the case
    has the potential to shape the entire litigation
    • Minimizing the enormous costs involved and the gamesmanship from both sides
    • Recognizing outliers which can cause major issues down the road
    • Revisiting bellwethers as a go-to choice: when can the shepherd lead the flock over the precipice?
  • Determining which cases to try which are truly reflective of the overall pool of cases and working closely with the coordinating judge to formulate practical and fair selection procedures
    • Overview of competing bellwether selection processes: what are the relative strengths and weaknesses of each?
    • Is random best based on the cases we have seen to date?
  • Implementing smart front-end strategies and setting precedents to streamline future trials and minimize litigation risks going forward
    • Strategically selecting issues which have the best chance of eliminating future claims
    • Lobbying for favorable forums
    • Securing desirable timing and case sequences
  • Analyzing the strategies which work to move the MDL on fairly and effectively
    • Best practices for bellwether trial discovery in light of evolving case law and changes to 37(e)
    • Coordinating between state and federal court proceedings and implementing efficient processes for doing so
  • Realistically valuing the cases and coming to a resolution based on the strengths and weaknesses of each party’s position as it played out in trial

12:30 Networking Lunch for Speakers and Delegates Sponsored by:

1:45 - Afternoon Breakout Sessions - (Choose A or B)
A Fighting Back Against Overbroad or No Injury Class Actions: Strategies for Drug and Medical Device Defense Counsel to Effectively Defeat Certification B Social Media as a Catalyst to Products Liability Litigation? Delineating the Scope of Manufacturers’ Duty vis-à-vis Internet Marketing and Presence

William M. Gage
Partner and Chair
Litigation Department
Butler Snow LLP (Ridgeland, MS)

 

Jon Garside
Partner
Fox Galvin, LLC (St. Louis, MO)

 

 

Anthony Vale
Partner
Pepper Hamilton LLP
(Philadelphia, PA)

 

  • Analysis of case law post-Walmart: what is the practical impact on class certification for drug and device manufactures?
  • Limited issue class certifications post-Comcast: arguments against certifying part of a class and leaving individual issues for later
  • Removing cases under the Class Action Fairness Act (CAFA)
    • Using Daubert to defeat class certification
    • Attacking class definition at the pleading stage for overbreadth and ascertainability or lack of commonality
  • Defense tactics for presenting favorable economic analysis
  • Using denial of class certification offensively
  • Effect of Rule 23 decisions on aggregate litigation by State AGs

Elizabeth J. Asali
Assistant General Counsel
GlaxoSmithKline
(Philadelphia, PA)


Blaine R. Dart
Corporate Counsel
Litigation and Risk Management
Biomet (Warsaw, IN)

 

George E. McDavid
Partner
Reed Smith LLP (Princeton, NJ))

 

 

Erik Snapp
Partner
Dechert 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, including mobile medical applications
    • Grasping manufacturer liability for posted comments involving alleged adverse events and off-label product use
    • Knowing when comments made online can become part of the evidentiary record
    • Alerting employees of the potential risks of tweets, blogs, and social media posts during litigation
    • Establishing a corporate record retention policy regarding social media
    • Managing discovery requests for social media posts
    • o Making successful objections to keep out damaging posts nd messages
  • Understanding the significance of FDA monitoring social media for adverse events
    • What is a company’s duty to monitor the internet, beyond sponsored sites?
  • Preserving the learned intermediary defense in light of increased direct-to-consumer
    and internet advertising

2:45 Afternoon Refreshment Break Sponsored by:

3:00 - Afternoon Breakout Sessions - (Choose C or D)
C Litigating in Difficult Jurisdictions: Winning the Knock Down Drag Out Battle Over Removal D Defending Against State Attorney General Actions: Practical Considerations for Drug and Device Manufacturers Faced with AG Litigation

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

 

Halli D. Cohn
Partner
King & Spalding LLP
(Atlanta, GA)

 

Danielle Weksler
Counsel, Law Department
Roche Diagnostics Corporation
(Indianapolis, IN)

 

  • Overview of some of the recent cases regarding removal between state and federal court
  • Strategies for removal of multi-plaintiff cases structured to defeat diversity while avoiding the 100-plaintiff threshold for CAFA’s mass action provision
    • Establishing mass action jurisdiction by showing implicit proposals for joint trials
    • The challenges to fraudulent misjoinder as a basis for removal
    • Avoiding discovery in state court actions filed as part of plaintiffs’ efforts to open up multiple battlefronts in mass tort litigation
    • Threshold jurisdictional arguments, post Daimler Benz, as a strategy for avoiding multi-plaintiff cases in difficult jurisdictions
  • Best practices for litigating in plaintiff friendly jurisdictions when manufacturers are unable to defeat remand to state court

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

 

Stephen D. Brody
Partner
O’Melveny & Myers LLP
(Washington, DC)



J. Gordon Cooney, Jr.
Partner
Morgan, Lewis & Bockius LLP (Philadelphia, PA)

 

 

Kenneth A. Murphy
Partner and Vice-chair, Products
Liability and Mass Tort Practice Group
Drinker Biddle & Reath LLP (Philadelphia, PA)

 

 

  • Case study: Overview of the Risperdal litigation and recap of the procedural history to date vis-à-vis the state attorneys general
  • Preparing for an increasing volume of litigation prosecuted by state attorneys general and aggressive enforcement against life sciences companies
    • How do state AGs identify targets and proceed?
  • Practical steps for manufacturers to take when faced with an AG action:
    • Removal to federal court under federal question jurisdiction?
    • Motions to dismiss for lack of individualized proof or pure economic harm?
    • Arguments against government outsourcing the cases to private counsel
  • What is the nature of the state’s burden of proof in establishing harm?
  • How do you connect the size of the penalty to the harm?


4:00 - Afternoon Breakout Sessions - (Choose E or F)
E Mock Voir Dire: Strategically Selecting the Right Jury and Communicating Effectively From the Outset F Strategically Addressing Alarming Trends in Drug and Med Litigation: Third Party Funding of Claims and Subrogation Actions By Health Insurers

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



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

John LaDue
Principal
LaDue Curran & Kuehn LLC
(South Bend, IN)

 

As jury verdicts in products liability litigation continue to skyrocket and the “runaway jury” becomes frighteningly commonplace, it is more crucial than
ever to hone your trial advocacy skills and litigation techniques based on
current public perception of the pharmaceutical and medical device
industries. In this highly insightful session, leading defense counsel will
discuss and demonstrate in a mock voir dire session questioning techniques for discovering and “de-selecting” potential jurors who may be biased
against your client and lead your jury to an excessive verdict. This
presentation will cover the following topics:

  • Understanding how jurors make decisions
  • Preparing for voir dire
  • Selecting and working with jury consultants, focus groups, and mock and shadow juries
  • Drafting and effectively using juror questionnaires
  • Techniques for introducing yourself, your client, and your case themes — making a good first impression
  • Techniques for identifying potential leaders in the venire
  • Techniques for discovering biases, prejudices, and preconceptions
  • Understanding and discovering unique juror preconceptions in drug and device cases and addressing implicit and explicit juror biases against Big Pharma and Device
  • Minimizing the impact of negative media coverage surrounding the life sciences industry
  • Using social media — pros/cons, risks/benefits

Jennifer E. Dubas
Vice President, Litigation & Risk
Endo Pharmaceuticals
(Malvern, PA)

 

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



Third Party Funding of Products Liability Litigation

  • Understanding the creative ways plaintiffs firms are using third parties to generate cases and further develop volume in litigation
    • Third party funding companies
    • Overseas call centers
    • Medical insurance companies
  • Uncovering, identifying and responding to financial interests other then the allegedly injured plaintiffs: Determining whether this is going on in your litigation
    • Issuing subpoenas and conducting strategic discovery aimed at exposing the new volume of claims
    • Propounding discovery to ensure disclosure of contractual relationships between the respective parties

Subrogation Actions by Health Insurers Against Drug and Med Companies for Products Liability

  • Overview of recent cases involving claims from third party payors seeking to recoup the cost of medical bills for alleged victims during products liability litigation
    • Spotlight on Blue Cross and the Actos litigation
    • Under the Affordable Care Act, can we expect to see more cases like this?
  • Lessons learned from over a decade of subrogation claims in Canada: how are biopharmaceutical and medical device manufacturers successfully defending themselves there?

5:00 Conference Adjourns to Cocktail Party Sponsored by:

DAY 2 | WEDNESDAY, DECEMBER 10, 2014

7:30 Registration and Continental Breakfast

8:00 Co-Chairs’ Opening Remarks

8:15 Developing a Crisis Checklist: Strategies for Pharmaceutical Companies and Medical Device Companies to Counteract Negative Press and Potential Juror Bias

Michael R. Smith
Associate Counsel
Olympus Corporation of the Americas (Center Valley, PA)



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


 

Kevin M. Zielke
Member and Leader of Pharmaceutical Team
Dykema Gossett PLLC (Detroit, MI)

 


  • Protecting the blockbuster product: what should companies be doing before, during, and after products liability litigation?
    • How the potential for litigation should affect how prudent companies conduct themselves in the regulatory environment
    • Identifying a “signaling event” for impending litigation
    • Bringing the team together once there is potential litigation: science experts, regulatory lawyers, commercial/products support lawyers, and outside counsel
    • How can outside counsel best help?
    • Special considerations for products still on the market during litigation: preventing the litigation from tanking the product
  • Developing a proactive media relations policy as part of your overall crisis management plan
    • Maintaining good relations and effectively communicating with your shareholders during litigation
    • Assessing and combating reputational risk as a result of the litigation
  • Training employees on the significance of litigation holds and good document retention practices
  • Identifying and locking in potential expert witnesses early, particularly in the case of multiple defendants

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

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

 



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

 


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

 


The Honorable Mildred “Mimi” Methvin (Invited)
Judge ProTempore, 27th Judicial District Court of Louisiana (St. Landry Parish, LA)
United States Magistrate Judge for the Western District
of Louisiana (1983 – 2009)



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

 

 

The Honorable Joel A. Pisano
United States District Judge, District of New Jersey
(Trenton, NJ)

 

 

The Honorable John Tunheim
United States District Judge, District of Minnesota (Minneapolis, MN)

 


Moderated By:

Andrew T. Bayman
Partner
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, motion practice, and parallel state and federal proceedings.

10:25 Morning Coffee and Networking Break

10:45 – 12:15 A Practical Guide to Fighting the Continued Battle Over Preemption

Defending Against Plaintiffs’ Strongest Arguments Against Generic Preemption

Bridget M. Ahmann
Partner
Faegre Baker Daniels LLP (Minneapolis, MN)

 


Erin M. Bosman
Partner and Chair, Product Liability Practice Group
Morrison & Foerster LLP (San Diego, CA)

 

 

Glenn S. Kerner
Partner
Goodwin Procter LLP (New York, NY)

 

  • Asserting a successful preemption defense and managing parallel claims in a post-Bartlett world
    • Overview of successful defense strategies in recent cases regarding parallel claims
    • Defending against parallel claims that aren’t deemed to be preempted
    • Understanding the significance of the “Footnote 4” potential exemption cases currently working their way through the Circuit Courts
    • Pleading standards post In re: Darvocet
  • Dissecting plaintiffs’ best arguments for getting around preemption and how the courts treated these arguments
  • Updates on legislative and FDA developments regarding generic labeling: what are the practical implications for both branded and generics based on Congress’ and FDA’s positions to date
    • What should prudent companies do in the years leading up to a potential change in preemption doctrine?
  • Utilizing an innovator liability theory when arguing for generic preemption

Strategies for Preserving the Medical Device Preemption Defense post-Stengel

Andrew L. Campbell
Partner
Faegre Baker Daniels LLP (Indianapolis, IN)

 


John D. Winter
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

 

 

  • Understanding the significance of the Supreme Court’s denial of Cert in Stengel with respect to parallel state
    failure-to-warn claims
    • Overview of the procedural history to date and of the Ninth Circuit’s controversial decision in the case
    • Examining the competing judicial opinions defining the circumstances when a parallel state law claim can avoid express and implied preemption in cases regarding Class III medical devices
    • Comprehending the subtle contradictions in the lower Courts regarding and putting a defense strategy in place in spite of the patchwork of case law surrounding state-law parallel claims
    • Special considerations for PMA approved devices
  • Preparing for a surge in state law failure-to-warn claims premised on the Ninth Circuit’s opinion and the trend towards relaxed pleading requirements for plaintiffs under state law
    • Where are the holes in the argument for defense to build future cases around?
  • Factoring in the significance of the recent Lanham Act cases supporting private litigation under the FDCA including POM v. Coca Cola: how will these cases play out for other manufacturers of FDA regulated products?

12:15 Networking Luncheon

1:15 Enforcers’ Spotlight: Understanding Government’s Enforcement Priorities vis-à-vis Drug and Device Products Liability Matters

David A. Degnan
Assistant U.S. Attorney
U.S. Attorney’s Office, Eastern District of Pennsylvania (Philadelphia, PA)

 

David Hart
Assistant Attorney in Charge, Financial Fraud/Consumer Protection Section
Oregon Department of Justice (Salem, OR)

 

Joseph Mack
Deputy Chief, Health Care and Government Fraud Unit
U.S. Attorney’s Office, District of New Jersey (Newark, NJ))

 

Deborah A. Logan
Senior Counsel, Branded Pharmaceuticals
Endo Pharmaceuticals (Malvern, PA)

 

Moderated by:

Lesley Carol Reynolds
Partner
Norton Rose Fulbright (Washington, DC)

 

 

  • Preparing for increased enforcement actions stemming from drug and med device products liability
    • Off-label
    • Consumer Fraud
    • False Claims
    • Anti-kickback statute
    • FCPA for products distributed abroad
    • cGMP violations
    • FDA warning letters
  • The government’s perspective on when and why to prosecute: how do enforcers select 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
    • Individual responsibility: under what circumstances might corporate wrongdoing lead to criminal liability
      for in-house attorneys?
  • Best practices for responding to a government investigation
  • Spotlight on false claims: understanding emerging theories for civil false claims liability related to failure to warn

2:00 Afternoon Refreshment Break

2:15 Ethics and Products Liability Litigation: Maintaining Civility While Defending Against an Increasingly Aggressive Plaintiffs’ Bar

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

 

 

Catharine E. Gillespie
Corporate Counsel
E.I. du Pont de Nemours and Company
(Wilmington, Delaware)


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

 

 

Adam L. Hoeflich
Partner
Bartlit Beck Herman Palenchar & Scott LLP (Chicago, IL)

 

 

  • “Permitted gamesmanship v. prohibited conduct”:
    when do you cross the line in a spirited products liability defense against an aggressive plaintiffs’ bar?
    • Going through some of the real world issues which come up in products liability litigation and understanding the ethical rules implicated
    • Counterbalancing the increasing volume of lawyer advertising by plaintiffs looking to amass a class
    • Understanding the ethical issues implicit in third party funding of products liability claims

3:15 Main Conference Adjourns

3:30 – 5:30 Post-Conference Workshop
Ethics: Inclusion and Diversity and the Products Liability Bar: Exploring the Challenges and Opportunities in Attracting and Retaining Diverse Trial Counsel