7:00 am Registration & Welcome Breakfast

8:00 am Co-Chairs’ Opening Remarks

Catherine Kassenoff
Executive Counsel and Executive Director - Head of
U.S. Litigation and Government Investigation
Boehringer Ingelheim USA Corp (Ridgefield, CT)

Michael Parini
Senior Vice President & Chief Litigation Counsel
Pfizer Inc (New York, NY)

8:15 am Case Study from Mensing to Bartlett: Determining Whether Design Defects Claims are Preempted for Generic Manufacturers and the Potential Liabilities

Catherine Kassenoff
Executive Counsel and Executive Director - Head of
U.S. Litigation and Government Investigations
Boehringer Ingelheim USA Corp (Ridgefield, CT)

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

Jan Dodd
Norton Rose Fulbright (Los Angeles, CA)

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

  • Who is making the determination of a product’s efficacy?
    • FDA
    • plaintiff
    • branded manufacturer
    • juries
  • Ensuring products are accompanied by the proper labeling
  • Mirroring the safety label of the brand-name company and alerting the FDA whenever they learn of an adverse event related to their products
  • Clarifying the ‘failure to warn’ standard and its application to drug safety
  • Exploring the tension in the law where branded drugs are subject to certain product liability suits, but the generic versions are not
  • Analyzing efforts within the FDA and Congress to impose liability on generics
  • Crafting preemption arguments when there is no obvious comment from the FDA
  • Utilizing the novel legal theory of innovator liability
  • Pleading around preemption – how are negligent training/claims being defended?
  • Understanding the implications of the Stengel decision on device manufacturers’ preemption arguments
  • Defining the manufacturer’s duty with respect to safety and public communication
  • Addressing plaintiffs’ parallel claims
    • summary judgment motions
    • discovery challenges
    • examples of claims
  • Can branded manufacturers be liable for failure to publish in the PDR?

9:15 FDA Keynote Address

Kelsey A. Schaefer
Associate Chief Counsel for Enforcement
Office of Chief Counsel
U.S. Food and Drug Administration (Silver Spring, MD)

9:55 am Morning Coffee Break

Hosted by:

10:10 am Judicial Insights on Multidistrict Litigation

The Honorable John G. Heyburn II
Judicial Panel on Multidistrict Litigation

10:40 am Bolstering the Defense Position: Effectively Defeating Class Certification

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

Jennifer Quinn-Barabanov
Steptoe & Johnson LLP (Washington, DC)

Amy R. Fiterman
Faegre Baker Daniels (Minneapolis, MN)

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

  • Removing cases on the basis of the Class Action Fairness Act (CAFA)
  • Analyzing the growing trend of using Daubert motions to defeat class certification
    • plaintiff strategies for defending these challenges
  • Successfully removing a putative class case from state to federal court
  • Defeating plaintiff claims of numerosity, commonality, typicality, and adequacy-of-representation
  • Refuting a plaintiff’s proof of class wide liability tied to the drug or device
  • Understanding Courts’ commonality standard and the enforceability of class action waivers
  • Attacking class definition at the pleading stage – over breadth and ascertainability
  • Defense tactics for presenting favorable economic analysis in class action litigation
  • Using denial of class cert offensively

11:40 Crisis Management & Litigation Preparedness: How Drug and Device Manufacturers Can Minimize Risk and Maintain Consistency When Litigation Looms

Timothy Howard
Assistant Counsel
Merck & Co., Inc. (North Wales, PA)

Jonathan Wasserman
Vice President & Associate General Counsel,
Litigation & Government Investigations
Bristol-Myers Squibb Co. (New York, NY)

Kenneth F. Baum
Goldman Ismail Tomaselli Brennan & Baum LLP
(Santa Monica, CA)

Kevin Zielke
Dykema Gossett PLLC (Detroit, MI)

Sarah Heineman
Bayer Corporation

Moderated by:

Melissa A. Geist
Reed Smith LLP (Princeton, NJ)

  • Pre-Litigation Crisis Management – Developing a standard set of policies and procedures to counteract
    the silo mentality following a “signaling event”
  • Cultivating a media relations strategy to face an adverse event or government investigation head on
  • Training on good document creation and retention practices
  • Analyzing the impact on the attorney-client privilege, eDiscovery and document preservation
  • Assessing the Science – Frequently overlooked concepts that must be applied to assess the strengths and weaknesses of the scientific basis for criticisms and support of the product
  • Coordinating crisis management efforts between the legal and business sides of the business
  • Developing a crisis checklist – considerations before and after the manufacturer’s response
  • Responding once a medical journal tanks one of your products
    • FDA
    • talking to the press
    • talking to employees and shareholders
  • Preserving emails, drafts and other documents during the flurry of media and investigatory activity
  • Protecting documents that will be subject to discovery
  • Tools to prevent the litigation from overtaking business objectives
  • Assessing the business and reputational risks and consequences
  • Deciphering the science and working with sales and marketing teams to bring litigation sensitivity to the process
  • Bringing in outside counsel to gird yourself for the coming litigation

12:50 pm Networking Lunch for Speakers and Delegates Hosted by:

Breakout Session 1 | 2:00 pm - 3:15 pm (choose A or B)
A Conducting Successful Voir Dire and Selecting the Right Jury: Novel Strategies, Tactics and Ethical Considerations B In-House Round Table:
Best Practices for Case Management

Lori Cohen
Greenberg Traurig LLP (Atlanta, GA)

Sidney Kanazawa
McGuireWoods LLP (Los Angeles, CA)

With Commentary by:

The Honorable John Tunheim
District Judge
U.S. District Court, District of Minnesota

  • Understanding unique juror preconceptions in drug and device cases – how do these differ from traditional juror attitudes?
  • Identifying problem jurors – product specific approaches
  • Exploring different methodologies and lines of questioning for selecting a jury
  • Ethical considerations in selecting and dismissing specific jurors
  • Addressing biases against large manufacturers and minimizing the impact of negative media coverage
    • gauging what jurors will not like about the manufacturer
  • Effectively using jury questionnaires
  • Framing questions for maximum information and candor
  • Increasing the chance of selecting the right jury by knowing what to look for when retaining jury consultants
  • Predicting juror favorability through psychological techniques
  • Analyzing the impact of runaway juries on verdicts in pending cases
    • best practices for reigning in runaway juries
  • Managing unanticipated juror misconduct
  • Preventing jurors from accessing electronic information about the case
  • Conveying to jurors the importance of having a culture of compliance and patient safety

Debra L. Burns
Senior Counsel, Litigation/Investigations
GE Healthcare (Wauwatosa, WI)

Candice Ciresi
Senior Corporate Counsel, Vascular Therapies
Covidien (Plymouth, MN)

Jill Harrison
W.L. Gore & Associates, Inc. (Flagstaff, AZ)

Michael Howe
Associate General Counsel
Biogen Idec (Weston, MA)

Jason D. Maxwell
Vice President & Associate General Counsel–Litigation
Cardinal Health (McGaw Park, IL)

Moderated by:

Julie Hardin
Reed Smith LLP (Houston, TX)

  • Establishing an effective and beneficial relationship between
    in-house and outside counsel
  • Enhancing collaboration among the entire legal team, streamlining communications and sharing of key information
  • Balancing government investigations with decreased monetary resources
    • protecting both the company and individual employees
    • doing more internally
  • Assigning in-house attorneys to monitor individual law firms
    and managing those relationships
  • Retaining external lawyers that understand a drug or device’s application process as well as the epidemiology of the product in dispute
  • Bringing the e-discovery process in-house and creating a competent e-discovery team
  • Techniques for resolving cases expeditiously
  • When is it cost effective to use national counsel? Regional counsel?
    • maximizing contribution of local counsel
  • Setting limits on outside counsel
  • More effectively sharing resources among the defense team
  • Successful methods for discovery that have resulted in lower costs
  • Placing more effective emphasis on litigation avoidance
  • Specifying how matters are to be staffed
    • limits on usage of new associates
    • client consent for changes in assigned attorneys
    • setting diversity requirements

3:15 pm Afternoon Refreshment Break Hosted by:

Breakout Session 2 | 3:30 pm - 4:30 pm (Choose C or D)
C Controlling the Witness and the Testimony: Practical Strategies for Conducting a Direct Examination of the Company Witness D Combatting Claims Against Device Manufacturers for Failure to Adequately Train Physicians and Managing the Proliferation of Dear Doctor Letters

Alexander G. Calfo
Barnes & Thornburg LLP (Los Angeles, CA)

Ranjit S. Dhindsa
Hollingsworth LLP (Washington, DC)

Jeffrey B. Shapiro
Arnstein & Lehr LLP (Miami, FL)

With Commentary by:

The Honorable John Tunheim
District Judge
U.S. District Court, District of Minnesota

  • Selecting an effective expert witness: detailing the characteristics of a persuasive defense expert witness – what characteristics to look for and what to avoid
    • Structuring testimony for court – discussing potential subjects for direct and cross
  • Ensuring that the expert can explain the entire theory of the case in a clear concise fashion during his or her testimony – low tech and high tech approaches
  • Personalizing and humanizing the company
  • Utilizing repetition to help the issue sink in with the jury
    • strategic use of demonstratives and exhibits and court rules about pre-trial disclosure
  • Getting the expert to truthfully (and favorably) provide relevant history
  • Showing that the company endeavored to do what was best for patient safety and took immediate action in light of patient safety concerns
  • Using complex scientific evidence to persuade the jury
    that use of the product did not cause the plaintiff’s injury
  • Understanding when to use medical journal reports,
    noting evidentiary state court limitations
  • Establishing fertile ground for cross-examination
  • Keeping track of information that is communicated
    to the expert for privilege purposes
  • Ethical obligations of counsel when utilizing experts in drug and device litigation
  • Demonstrating that company did not act irresponsibly
    in putting the product on the market
  • How to show that adverse event results were not
    statistically significant

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

Brandee Kowalzyk
Nelson Mullins Riley & Scarborough LLP (Atlanta, GA)

James W. Huston
Morrison & Foerster LLP (San Diego, CA)

  • Understanding the liability implications surrounding
    Dear Doctor Letters
    • FDA draft guidance
    • communicating new information promptly to health care practitioners
  • Is a Dear Doctor letter within the scope of the defendant’s duty to warn?
    • causation evidence
  • Defending against plaintiffs’ “failure-to-communicate” claims
  • Addressing negligence claims at the outset of a potential lawsuit
  • Providing training on new and emerging medical devices and novel technologies
  • Determining what constitutes “adequate” training in the minds of the Court
    • taking affirmative action to train
  • Hiring a consultant surgeon to host training sessions and demonstrate a live procedure
  • Mitigating the liability risks of sales reps in the operating room
  • Disseminating a prep guide for physicians with different techniques to use, issues that they have seen with the product
  • Who is at the front line of communication when a physician has a specific targeted question about the device itself?

Breakout Session 3 | 4:30 pm - 5:30 pm (Choose E or F)
E Strategically Using Daubert in Cross-Examination to Establish Important Defense Themes
F Post-Government Investigation, Now What? Analyzing the Potential Litigation Ramifications for Pharmaceutical and Medical Device Manufacturers

Vincent A. Thomas, CPA, CFF, CVA, ABV
Senior Managing Director
Forensic & Litigation Consulting
Co-Leader, U.S. Intellectual Property Practice
FTI Consulting (Chicago, IL)

Sharon L. Caffrey
Duane Morris LLP (Philadelphia, PA)

Pamela J. Yates
Kaye Scholer LLP (Los Angeles, CA)

With Commentary by:

The Honorable John Tunheim
District Judge
U.S. District Court, District of Minnesota

  • Deciding when to file a Daubert motion
  • Utilizing the cross-examination to knock out the other side’s case law
  • Positioning the company from a discovery standpoint
    for summary judgment
  • Avoiding the trap of reinforcing injury/loss
  • Challenging methodology through an analysis of the underlying science
  • Focusing on assumed or inaccurate facts which the opposing expert may have relied on in forming his opinion
    • discrediting through lack of expertise and/or preparation
  • Challenging the foundation of the plaintiff’s expert testimony by asking “how did you arrive at that conclusion?”
  • Developing a cross-examination methodology that creates a compelling trial record on each and every Daubert factor that may call into question the technical or scientific reliability of the proffered opinions
  • Persuading the court that the proffered opinions do not amount to scientific knowledge because they are not scientifically reliable
  • Highlighting areas where opposing expert agrees with your own expert to bolster your expert’s credibility
  • Understanding how governing law should shape the way you present to an expert
  • Challenging the quality of the peer review – determining the acceptable industry standard
  • How to impeach witness credibility
    • diluting the plaintiff witness opinion
  • What level of proof is expected when challenging an expert?

Dwight O. Moxie
Senior Counsel - Legal Department
Allergan, Inc. (Irvine, CA)

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

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

  • Handling derivative lawsuits stemming from a government fine/settlement
    • demonstrating that the company did not breach its fiduciary duty to shareholders
  • Combatting ambitious plaintiffs filing follow-on class action suits
    • practical strategies for keeping these suits at bay
  • Minimizing the impact of a government investigation on a potential jury verdict
  • Dealing with the expanded use of investigative subpoenas, broadened theories of liability, and pronounced criminal and regulatory penalties
  • How does interagency coordination impact civil and
    government cases?
  • Defeating plaintiffs’ efforts to introduce evidence about government enforcement actions in product liability cases
  • Handling parallel civil and government investigations

5:30 pm Conference Adjourns to Day 2

5:30 pm Networking Cocktail Reception Hosted by:


7:15 Registration & Continental Breakfast

8:00 Co-Chairs’ Opening Remarks

8:15 United States v. Caronia One-Year Later:
The Impact of the First Amendment Argument on Off-Label Communication

Michael Hulka
General Counsel, Lilly Oncology & ImClone Systems
Senior Director, Assistant General Counsel
Eli Lilly and Company (Indianapolis, IN)

Paul Kaufman
Assistant U.S. Attorney
Chief of Civil Healthcare Fraud
U.S. Attorney’s Office, Eastern District of New York (Brooklyn, NY)

John J. Pease
Senior Counsel
Teva Pharmaceuticals (Horsham, PA)

  • Breaking down the Caronia decision and the current state of off-label communication practices
    • truthful, non-misleading off-label speech
  • Analyzing the increasing claims against sales reps and the causes of action alleged
  • Focusing on the ‘intent to misbrand’ rather than the ‘promotion of off-label use’
  • Defending against plaintiffs using the regulatory limitations on drug and device marketing as a springboard for tortious claims
  • Exploring the current relationship between FDA and the manufacturers in light of Caronia
  • Defining appropriate interactions between sales reps and physicians
  • Creating compliance protocols to reduce the risk of off-label communications
  • Developing appropriate product promotion policies and responses to physicians’ unsolicited requests for information
  • Reigning in rogue sales reps who engage in illegal off-label promotion
  • Illustrating potential consequences of failing to abide
    by company policies and standards

9:15 Exploring New Approaches to Bellwether Trial Selection Procedures and Emerging Best Practices for the Consolidation of Mass Torts

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

Charna Gerstenhaber
Vice President and Head of Litigation
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

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

Robert K. Woo, Jr.
King & Spalding LLP (Atlanta, GA)

Moderated By:

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

  • Determining factors for trying a case and how to select which case to try
  • Selecting issues that have the best chance of eliminating future claims
  • Understanding the purpose and benefits of a bellwether trial
  • Organizing your mass tort so that there is a fair and objective way of moving the case along
  • Ensuring that you have the right front-end logistics and procedural defense strategies in place
  • Implementing techniques for organizing and tracking a voluminous amount of data
  • When should tag alongs be transferred to an existing MDL?
  • Coordinating between state and federal court proceedings and implementing efficient processes for doing so
  • Minimizing the enormous costs involved and the gamesmanship that goes on for both sides
  • Analyzing what strategies are working well to move the MDL along more efficiently

10:25 Morning Coffee Break Hosted by:

10:45 View from the Bench: Current Judicial Views on Pharmaceutical and Medical Device Litigation

The Honorable William S. Duffey, Jr.
District Judge
U.S. District Court, N.D. Georgia

The Honorable David Herndon
Chief Judge
U.S. District Court, S.D. Illinois

The Honorable Richard Kramer
San Francisco Superior Court

The Honorable Theodore A. McKee
Chief Judge
U.S. Court of Appeals for the Third Circuit

The Honorable Cynthia M. Rufe
District Judge
U.S. District Court, E.D. Pennsylvania

The Honorable Kaymani D. West
Magistrate Judge
U.S. District Court, District of South Carolina

Moderated by:

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

In products liability cases, there are often parallel federal and state proceedings, with numerous depositions. When you have parallel cases addressing the same issues, which judge do you call? Which time limits apply? If the state court action is ahead of the federal action, do they defer? This session will offer a rare opportunity to hear the perspectives of renowned jurists from the state and federal bench, with an opportunity for attendees to ask questions. Gain valuable understanding of how members of the bench coordinate and manage state and federal proceedings in pharmaceutical and device mass tort actions.

12:00 Networking Luncheon for Speakers and Delegates

1:00 A Good Offense is the Best Defense: Effective Use of Social Media in Products Liability Litigation

Brennan Torregrossa
Assistant General Counsel
GlaxoSmithKline (Philadelphia, PA)

Jennifer Mingus Mountcastle
Thompson Hine LLP (Columbus, OH)

  • Uncovering inconsistencies in the plaintiff’s claim by perusing social media sites for photos and videos
  • Conducting a social media analysis of prospective jurors before committing to a specific jury
  • Understanding state laws regarding friending judges and government officials
  • Knowing when comments made online can become part of the evidentiary record
    • alerting employees to the ramifications of tweets, blogs and posts on potential litigation
    • establishing a corporate record retention policy applicable to social media
  • Meeting the requisite foundational elements of social media authentication
  • Making successful objections to keep out damaging posts and messages
  • Ensuring that uncovered information can be preserved, stored and date stamped
  • Sending a retention letter to plaintiff’s counsel to prevent deletion of information or profiles from social media websites

Ethical Considerations

  • Delineating between ethical and unethical social media research when learning more about a plaintiff or juror
  • Finding information without a formal discovery process
  • Avoiding conduct that could be considered “pretexting” or deceptive as proscribed by state rules of professional conduct

2:00 Afternoon Refreshment Break

2:15 Coordinating Litigation Efforts Across Borders: Analyzing Product Liability Trends Outside the U.S. and the Impact on U.S.-Based Litigation

Adam Deutsch
Vice President and Associate General Counsel -
Litigation, Investigations and Risk Management
Biomet, Inc. (Warsaw, IN)

Kaspar Stoffelmayr
Vice President & Associate General Counsel
Bayer Corporation (Pittsburgh, PA)

Christopher D’Angelo
Montgomery, McCracken, Walker & Rhoads, LLP
(Philadelphia, PA)

  • Assisting international legal teams with necessary product information and managing the cultural and language barriers
  • Identifying international jurisdictions that may be potentially problematic for the drug or device manufacturer
  • Finding local attorneys who really understand the laws and regulations of the country you are being sued in
  • Putting together defense packets that can be utilized in other countries
  • Developing effective strategies for managing unexpected product safety risks and issues arising from efforts to obtain discovery crossing international boundaries
    • depositions of foreign personnel
    • discovery of foreign labeling, regulatory, scientific, and corporate documents
  • What impact does evidence related to your drug or device in a foreign countries have in the U.S.?
    • determining what evidence is admissible and inadmissible
  • Analyzing the latest trends in the interplay between product liability and criminal liability in Europe
  • Using FDA approval as evidence of non-defectiveness outside the U.S.
    • educating non-U.S. judges and legislators
    • coordination between communication of FDA and FDA-like entities in other countries
  • Understanding foreign courts’ view on mass tort litigation

3:15 Main Conference Concludes

3:30 – 5:30 Post-Conference Business Development Master Class
on Selecting and Evaluating Outside Counsel