3rd Annual

Drug and Medical Device on Trial

Wednesday, June 24, 2009

About

2009 has been a whirlwind year for the drug and device industries – numerous developments in the industry are predicted to lead to increased product liability litigation in 2010.

With a final decision on FDA preemption still unannounced at press time, a newly-developing set of caselaw seeking to re-establish the limits of innovator vs. generic product liability and an unwavering initiative by the government to crackdown on off label promotion, plaintiff’s counsel will no doubt, continue to utilize poor juror perception, media bias and even government investigation as their motivation for continuing to bring high-profile, high-publicity litigation against the drug and device industries. With jury verdicts in the past two years totaling in the billions, there is no room for error in the courtroom.

Back in it’s 3rd installment, ACI’s Drug and Medical Device On Trial, offers participants a rare opportunity to witness tried and true litigation witness examination tactics, as well as opening and closing statement strategies, demonstrated live over the course of an intense, two-day mock trial.

Attend Drug and Device On Trial to Learn – From the Experts -
How to Most Effectively Defend Against Your Next Product Liability
Case When It Strikes

For the past 13 years, drug and device litigators from across the country have relied on ACI to provide them with the most cutting edge insights on issues currently being litigated, at our annual Drug and Medical Device Litigation event. In contrast to the annual event, Drug and Medical Device On Trial, provides the ultimate trial skills demonstration for pharmaceutical and device manufacturers and their counsel. Drawn from one central adverse event fact pattern (see page 6-7 infra), and updated this year to reflect emerging issues in drug and device product liability litigation, including off label promotion and DTC advertising, this event brings together the top defense litigators in the country, who are in the trenches, making news and setting precedent, defending the top drug and device manufacturers in the world.

Demonstrating and offering novel jury communication strategies on the most challenging aspects of drug and device product liability trials, this mock trial event will explore, by way of direct and cross examination, how to effectively:

  • connect with the jury during opening and closing statements
  • conduct a cross examination of key plaintiff witnesses including, the plaintiff; prescribing/treating physician; regulatory/FDA expert; cardiologist; marketing expert and pharmacologist
  • conduct a direct examination of the company witness; in-house scientist; company regulatory professional; defense cardiologist, FDA expert; and pharmacology expert

Also, to provide additional insight into how and what the process is for selecting the right company witness, an in-house roundtable discussion has been added to this year’s agenda as well. Featuring in-house co-chairs representing both the drug and device industries (Eli Lilly and Company and Medtronic), as well as commentary following each segment from renowned federal and state judges who are actively involved in these cases, Drug and Medical Device On Trial will be one of the most useful and innovative conferences you’ll attend in your career.

A unique opportunity for law firm litigators and in-house counsel to learn from the best drug and device litigators, while also obtaining firsthand insights by evaluating litigation tactics and approaches currently being used in high-stakes, high-profile drug and device litigation, there is no other event on the market to offer the intense benefit you will take away from this conference!

Contents & Contributors

About

2009 has been a whirlwind year for the drug and device industries – numerous developments in the industry are predicted to lead to increased product liability litigation in 2010.

With a final decision on FDA preemption still unannounced at press time, a newly-developing set of caselaw seeking to re-establish the limits of innovator vs. generic product liability and an unwavering initiative by the government to crackdown on off label promotion, plaintiff’s counsel will no doubt, continue to utilize poor juror perception, media bias and even government investigation as their motivation for continuing to bring high-profile, high-publicity litigation against the drug and device industries. With jury verdicts in the past two years totaling in the billions, there is no room for error in the courtroom.

Back in it’s 3rd installment, ACI’s Drug and Medical Device On Trial, offers participants a rare opportunity to witness tried and true litigation witness examination tactics, as well as opening and closing statement strategies, demonstrated live over the course of an intense, two-day mock trial.

Attend Drug and Device On Trial to Learn – From the Experts -
How to Most Effectively Defend Against Your Next Product Liability
Case When It Strikes

For the past 13 years, drug and device litigators from across the country have relied on ACI to provide them with the most cutting edge insights on issues currently being litigated, at our annual Drug and Medical Device Litigation event. In contrast to the annual event, Drug and Medical Device On Trial, provides the ultimate trial skills demonstration for pharmaceutical and device manufacturers and their counsel. Drawn from one central adverse event fact pattern (see page 6-7 infra), and updated this year to reflect emerging issues in drug and device product liability litigation, including off label promotion and DTC advertising, this event brings together the top defense litigators in the country, who are in the trenches, making news and setting precedent, defending the top drug and device manufacturers in the world.

Demonstrating and offering novel jury communication strategies on the most challenging aspects of drug and device product liability trials, this mock trial event will explore, by way of direct and cross examination, how to effectively:

  • connect with the jury during opening and closing statements
  • conduct a cross examination of key plaintiff witnesses including, the plaintiff; prescribing/treating physician; regulatory/FDA expert; cardiologist; marketing expert and pharmacologist
  • conduct a direct examination of the company witness; in-house scientist; company regulatory professional; defense cardiologist, FDA expert; and pharmacology expert

Also, to provide additional insight into how and what the process is for selecting the right company witness, an in-house roundtable discussion has been added to this year’s agenda as well. Featuring in-house co-chairs representing both the drug and device industries (Eli Lilly and Company and Medtronic), as well as commentary following each segment from renowned federal and state judges who are actively involved in these cases, Drug and Medical Device On Trial will be one of the most useful and innovative conferences you’ll attend in your career.

A unique opportunity for law firm litigators and in-house counsel to learn from the best drug and device litigators, while also obtaining firsthand insights by evaluating litigation tactics and approaches currently being used in high-stakes, high-profile drug and device litigation, there is no other event on the market to offer the intense benefit you will take away from this conference!

Contents & Contributors

Crafting a Compelling Opening Statement – Strategies for Engaging the Judge and Jury While Introducing the Court to Your Theory of the Case
Andrea Roberts, Partner, Baker & Daniels LLP (Indianapolis, IN)

Cross-Examination of the Plaintiff
Lori G. Cohen, Shareholder, Greenberg Traurig, LLP (Atlanta, GA)

Cross-Examination of the Prescribing/Treating Physician
Joseph P. McMenamin, Partner, McGuireWoods LLP (Richmond, VA)

Cross-Examination of the Plaintiff’s Cardiologist
Harvey L. Kaplan, Partner, Shook, Hardy & Bacon L.L.P. (Kansas City, MO)

Cross-Examination of the Plaintiff’s Regulatory/FDA Expert

Debra M. Perry, Partner, McCarter & English, LLP (Newark, NJ)

Cross-Examination of the Plaintiff’s Pharmacologist

Stephen A. Wood, Partner, Kelley Drye & Warren LLP (Chicago, IL)

Direct Examination of the Company Witness

Caryn M. Silverman, Partner, Sedgwick, Detert, Moran & Arnold LLP (New York, NY)

Direct Examination of the Company Regulatory Professional Responsible for FDA Submissions

John J. Sullivan, Partner, Dechert LLP (Princeton, NJ)

Direct Examination of the Defense FDA Expert

John Garde, Partner, McCarter & English LLP (Newark, NJ)

Direct Examination of the Defense Pharmacology Expert
Charles F. Morrow, Partner, Butler, Snow, O’Mara, Stevens, and Cannada, PLLC (Memphis, TN)

Persuading the Jury Through a Well-Crafted Closing Argument

Joseph J. Ortego, Partner, Nixon Peabody LLP (New York, NY)



DOCUMENT TYPES: PPTX PPT PRESENTATIONS AVAILABLE: 13

7:15
Registration and Continental Breakfast
7:45
Co-Chairs' Opening Remarks and Introduction of Judges
Monique Hunt McWilliams
Assistant General Counsel‚ Corporate Litigation
Eli Lilly and Company
Ms. Jean F. Holloway
Vice President & Deputy General Counsel
Medtronic‚ Inc.
8:00
Crafting a Compelling Opening Statement - Strategies for Engaging the Judge and Jury While Introducing the Court to Your Theory of the Case
Ms. Andrea Roberts
Partner
Baker & Daniels LLP
1 file
Crafting A Compelling Opening Statement:
5.8 MB 18 pages Presentation
PPTX - Crafting A Compelling  Opening Statement:
9:00
Cross-Examination of the Plaintiff
Moderator: Ms. Lori G. Cohen
Shareholder
Greenberg Traurig‚ LLP
2 files
ACI’S THIRD ANNUAL DRUG & MEDICAL DEVICE ON TRIAL
1.4 MB 17 pages Presentation
PPT - ACI’S THIRD ANNUAL 	DRUG & MEDICAL  	DEVICE ON TRIAL
June 3, 1994
2.7 MB 23 pages Presentation
PPT - June 3, 1994
10:00
Morning Coffee Break
10:15
Cross-Examination of the Prescribing/Treating Physician
Mr. Joseph P. McMenamin
Principal Consultant
Venebio Group
1 file
Cross-Examination of Plaintiff’s Treating Physician
9.8 MB 27 pages Presentation
PPT - Cross-Examination of Plaintiff’s Treating Physician
11:15
Cross-Examination of the Plaintiff's Marketing Expert
Mr. Walker W. Jones
Shareholder
Baker‚ Donelson‚ Bearman‚ Caldwell & Berkowitz‚ PC
12:15
Networking Luncheon
13:30
Cross-Examination of the Plaintiff's Cardiologist
Mr. Harvey L. Kaplan
Partner
Shook‚ Hardy & Bacon L.L.P.
1 file
Dogood v. Painkiller Pharmaceuticals, Inc. Cross–Examination of the Plaintiff’s Cardiologist
2.7 MB 25 pages Presentation
PPT - Dogood v. Painkiller Pharmaceuticals, Inc. Cross–Examination of the Plaintiff’s Cardiologist
14:30
Cross-Examination of the Plaintiff's Regulatory/FDA Expert
Ms. Debra M. Perry
Partner
McCarter & English LLP
1 file
Cross-Examination of the Plaintiff’s Regulatory/FDA Expert
140 KB 8 pages Presentation
PPT - Cross-Examination of the  Plaintiff’s Regulatory/FDA Expert
15:30
Afternoon Refreshment Break
15:45
Cross-Examination of the Plaintiff's Pharmacologist
Mr. Stephen A. Wood
Partner
Kelley Drye & Warren LLP
1 file
Cross-Examination of the Plaintiff’s Pharmacologist
969 KB 18 pages Presentation
PPT - Cross-Examination of the Plaintiff’s Pharmacologist
16:45
In-House Roundtable: The Company Witness - Preparing and Selecting the Right Witness to Testify at Trial
Mr. Perry S. Goldman
Vice President‚ Legal Affairs
Actelion Pharmaceuticals US‚ Inc.
Gary D. McConnell
Vice President & Associate General Counsel
Bayer Corporation
Ms. Malini Moorthy
Senior Corporate Counsel - Litigation‚ Legal Division
Pfizer Inc.
Mr. Jason Steinhart
Associate Vice President, Associate General Counsel
Sanofi US
Ms. Jean F. Holloway
Vice President & Deputy General Counsel
Medtronic‚ Inc.
17:30
Conference Adjourns to Day Two
7:30
Continental Breakfast
8:00
Co-Chairs' Remarks and Introduction of Day Two Judges
Monique Hunt McWilliams
Assistant General Counsel‚ Corporate Litigation
Eli Lilly and Company
Ms. Jean F. Holloway
Vice President & Deputy General Counsel
Medtronic‚ Inc.
8:15
Direct Examination of the Company Witness
Ms. Caryn M. Silverman
Partner
Sedgwick‚ Detert‚ Moran & Arnold LLP
1 file
Direct Examination of the Company Witness
625 KB 23 pages Presentation
PPT - Direct Examination of the Company Witness
9:15
Direct Examination of the In-House Scientist
Mr. Anand Agneshwar
Partner
Arnold & Porter LLP
1 file
Assessing Congressional And Political Influence On Product Liability Litigation
1.9 MB 20 pages Presentation
PPT - Assessing Congressional And Political Influence On Product Liability Litigation
10:15
Morning Coffee Break
10:30
Direct Examination of the Company Regulatory Professional Responsible for FDA Submissions
Mr. John J. Sullivan
Partner
Dechert LLP
1 file
DIRECT EXAMINATION OF COMPANY’S REGULATORY PROFESSIONAL
1.5 MB 23 pages Presentation
PPT - DIRECT EXAMINATIONOF COMPANY’S REGULATORY PROFESSIONAL
11:30
Direct Examination of the Defense Cardiologist
Mr. Loren H. Brown
Partner
DLA Piper
1 file
Direct Examination of the Defense Cardiologist
21.8 MB 38 pages Presentation
PPT - Direct Examination of the Defense Cardiologist
12:30
Networking Luncheon
13:45
Direct Examination of the Defense FDA Expert
Mr. John Garde
Partner
McCarter & English‚ LLP
1 file
Direct Examination of the Defense FDA Expert
247 KB 5 pages Presentation
PPT - Direct Examination of theDefense FDA Expert
14:45
Afternoon Refreshment Break
15:00
Direct Examination of the Defense Pharmacology Expert
Mr. Charles F. Morrow
Partner
Butler‚ Snow‚ O'Mara‚ Stevens‚ and Cannada‚ PLLC
1 file
Direct Examination of the Defense Pharmacology Expert
407 KB 15 pages Presentation
PPT - Direct Examination of the Defense  Pharmacology Expert
16:00
Persuading the Jury Through a Well-Crafted Closing Argument
-Mr. Joseph J. Ortego
Partner
Nixon Peabody LLP
17:00
Conference Concludes