Drug and Device Forum on

Defending Consumer Fraud Economic Injury Claims

Advanced Strategies for Defeating State Consumer Protection Act Claims, Defending Against Government-Initiated Consumer Fraud Litigation, and Minimizing Future Litigation Risk

Tuesday, September 23, 2008

About

“No Injury” Consumer Fraud Claims Brought As Class Actions Against Drug and Device Manufacturers Have Never Been More Prevalent

A faculty of drug and device litigators will provide you with the special skills needed to defend against these novel and complex claims in today’s unrelenting litigious environment. Attorneys speaking at this conference have been involved in medical monitoring claims, consumer fraud litigation by state Attorneys General, civil fraud claims by putative consumer and insurer classes filed under state consumer fraud statutes and RICO, and the defense of other laws and theories concerning Prozac® , Stadol NS, PPA, Baycol, Vioxx, Fen-Phen, Neurontin, OxyContin, OTC medications, implantable drug delivery systems, ventilators, surgical closure devices, surgical instruments and equipment, orthopedic fixation devices, intrauterine contraceptive device (IUD), weight-loss medications, antidepressants, hormone replacement therapy, cough and cold medicines, surgical equipment and instruments, medical device implants, cholesterol medication and many others.

Cost reimbursement litigation, monetary restitution, consumer fraud – all aliases for what drug and device counsel have come to know as the troublesome “no injury” case. The number of these cases currently being brought against drug and device manufacturers is staggering and the threat can come from state attorneys general and/or plaintiff’s attorneys who quickly follow suit. Alleging no personal injury per se, but rather some sort of economic harm caused by alleged fraudulent or deceptive practices, these cases present unique challenges for drug and device companies to overcome.

Negative post-approval study results or other “incidents” that take place while the product is on the market, exposure to negative publicity, multi-jurisdictional class complications, and the threat of simultaneous or follow-on government investigation only serve to complicate the "no injury" case. Moreover, defense counsel are forced to defend these claims at a time when it is still unsettled how the courts will receive the assertion of the learned intermediary doctrine in the context of drug and device consumer fraud claims and what the true impact of recent and expected decisions on federal preemption will be on the viability of consumer fraud claims.

In this unsettled, high-risk and high-stakes environment, drug and device litigators must have an in-depth and complete understanding of the developments affecting consumer fraud claims in the industry today. ACI’s Drug and Device Forum on Defending Consumer Fraud Economic Injury Claims publication will provide you with the latest information on how to successfully tackle the “no injury” case delivered by your colleagues who are on the forefront of the current consumer fraud landscape. Learn what warning signs you should be on the lookout for and what you can do to minimize collateral damage to your company, without conceding to a claim that could be worth millions to your company in restitution, reimbursement or medical monitoring expenses.

Contents & Contributors

About

“No Injury” Consumer Fraud Claims Brought As Class Actions Against Drug and Device Manufacturers Have Never Been More Prevalent

A faculty of drug and device litigators will provide you with the special skills needed to defend against these novel and complex claims in today’s unrelenting litigious environment. Attorneys speaking at this conference have been involved in medical monitoring claims, consumer fraud litigation by state Attorneys General, civil fraud claims by putative consumer and insurer classes filed under state consumer fraud statutes and RICO, and the defense of other laws and theories concerning Prozac® , Stadol NS, PPA, Baycol, Vioxx, Fen-Phen, Neurontin, OxyContin, OTC medications, implantable drug delivery systems, ventilators, surgical closure devices, surgical instruments and equipment, orthopedic fixation devices, intrauterine contraceptive device (IUD), weight-loss medications, antidepressants, hormone replacement therapy, cough and cold medicines, surgical equipment and instruments, medical device implants, cholesterol medication and many others.

Cost reimbursement litigation, monetary restitution, consumer fraud – all aliases for what drug and device counsel have come to know as the troublesome “no injury” case. The number of these cases currently being brought against drug and device manufacturers is staggering and the threat can come from state attorneys general and/or plaintiff’s attorneys who quickly follow suit. Alleging no personal injury per se, but rather some sort of economic harm caused by alleged fraudulent or deceptive practices, these cases present unique challenges for drug and device companies to overcome.

Negative post-approval study results or other “incidents” that take place while the product is on the market, exposure to negative publicity, multi-jurisdictional class complications, and the threat of simultaneous or follow-on government investigation only serve to complicate the "no injury" case. Moreover, defense counsel are forced to defend these claims at a time when it is still unsettled how the courts will receive the assertion of the learned intermediary doctrine in the context of drug and device consumer fraud claims and what the true impact of recent and expected decisions on federal preemption will be on the viability of consumer fraud claims.

In this unsettled, high-risk and high-stakes environment, drug and device litigators must have an in-depth and complete understanding of the developments affecting consumer fraud claims in the industry today. ACI’s Drug and Device Forum on Defending Consumer Fraud Economic Injury Claims publication will provide you with the latest information on how to successfully tackle the “no injury” case delivered by your colleagues who are on the forefront of the current consumer fraud landscape. Learn what warning signs you should be on the lookout for and what you can do to minimize collateral damage to your company, without conceding to a claim that could be worth millions to your company in restitution, reimbursement or medical monitoring expenses.

Contents & Contributors

ANALYZING THE PROVISIONS OF AND DIFFERENCES BETWEEN STATE CONSUMER PROTECTION STATUES TO DEVELOP AN AGGRESSIVE DEFENSE STRATEGY
James P. Muehlberger, Shook, Hardy & Bacon L.L.P. (Kansas City, MO)

CLASS ACTIONS AND ARBITRATIONS LITIGATION HOTBEDS & SOME ENFORCEMENT TRENDS
J. Gordon Cooney, Jr., Morgan, Lewis & Bockius LLP (Philadelphia, PA)

PREEMPTION AND LEARNED INTERMEDIARY DEFENSES
Dwight J. Davis, King & Spalding (Atlanta, GA)

REFUTING EMERGING THEORIES OF CONSUMER FRAUD IN PRESCRIPTION DRUGS AND MEDICAL DEVICES
Debra S. Dunne, Stradley Ronon Steven s& Young, LLP (Philadelphia, PA)

IDENTIFYING THE “CONSUMER” IN “NO INJURY” CONSUMER FRAUD CLAIMS
Christopher C. Palermo, Kelley Drye & Warren LLP (New York, NY)

THE “CONSUMER” IN CONSUMER FRAUD LITIGATION
Thomas P. Hanrahan, Sidley Austin LLP (Los Angeles, CA)

AN INTRODUCTION TO MEDICAL MONITORING
Amy Payne, Jones Day (Dallas, TX)

MEDICAL MONITORING CLASS ACTIONS: FROM FEN-PHEN TO VIOXX – EXAMINING THE DECLINING VIABILITY OF PHARMACEUTICAL AND MEDICAL DEVICE MEDICAL MONITORING CLASS ACTIONS
Debra M. Perry, McCarter & English, LLP (Newark, NJ)

EVALUATING THE INTERSECTION OF REGULATORY OVERSIGHT AND CONSUMER FRAUD LITIGATION: INCORPORATING RECENT CHANGES TO FDA REGULATIONS AND INCREASED GOVERNMENT INTEREST INTO YOUR DEFENSE STRATEGY
Linda A. Willett, Sedgwick Detert Moran & Arnold LLP (New York, NY)
José A. Isasi, II, Greenberg Traurig, LLP (Chicago, IL)

THE EFFECT OF RECENT PREEMPTION DECISIONS ON THE DEFENSE OF CONSUMER FRAUD CLAIMS IN DRUG AND DEVICE LITIGATION
Jennifer Cairns, McGuire Woods LLP (Richmond, VA)
Patricia E. Lowry, Squire, Sanders & Dempsey L.L.P. (West Palm Beach, FL)
Julie Coletti, Bayer Corporation (Pittsburgh, PA)

MARY SHELLEY WOULD BE PROUD: CONSUMER FRAUD AND THE NEW FRANKENSTEIN’S MONSTER
Gavin J. Rooney, Lowenstein Sandler PC (Roseland, NJ)
George G. Gordon, Dechert LLP (Princeton, NJ)



DOCUMENT TYPES: PPT PRESENTATIONS AVAILABLE: 13

9:30
Registration and Continental Breakfast
9:45
Co-Chairs' Opening Remarks
Mr. Dan S. Dunham
Vice President, Chief Compliance and Privacy Officer
Aptalis Pharma US, Inc.
Mr. Ezra D. Rosenberg
Partner
Dechert LLP
10:00
Analyzing the Provisions Of and Differences Between State Consumer Protection Statues to Develop an Aggressive Defense Strategy
Mr. James P. Muehlberger
Partner
Shook Hardy & Bacon LLP
1 file
MuehlbergerJ.Updated
2.5 MB 26 pages Presentation
PPT - MuehlbergerJ.Updated
Mr. J. Gordon Cooney, Jr.
Partner
Morgan‚ Lewis & Bockius LLP
1 file
CooneyJ
1.3 MB 46 pages Presentation
PPT - CooneyJ
11:15
Morning Refreshment Break
11:30
More Than Just the U.S. Department of Justice: Coordinating Multiple Government Investigations and Lawsuits Against the Pharmaceutical Industry
Mr. Dan S. Dunham
Vice President, Chief Compliance and Privacy Officer
Aptalis Pharma US, Inc.
Mr. Frederick G. Herold
Partner
Dechert LLP
1 file
HeroldF.DunhamD
197.5 KB 19 pages Presentation
PPT - HeroldF.DunhamD
12:30
Networking Lunch
13:45
Refuting Emerging Theories of Consumer Fraud Liability Relating to Product Assertions and Promotional Activity
Mr. Dwight J. Davis
Partner
King & Spalding
1 file
DavisD
317 KB 16 pages Presentation
PPT - DavisD
Ms. Debra S. Dunne
Partner
Stradley Ronon Stevens & Young‚ LLP
1 file
DunneD.revised
212 KB 22 pages Presentation
PPT - DunneD.revised
14:45
Who is the Consumer? Redefining the Consumer in an Era of "No Injury" Claims
Mr. Christopher C. Palermo
Partner
Kelley Drye & Warren LLP
1 file
PalermoC3
1.1 MB 19 pages Presentation
PPT - PalermoC3
Mr. Thomas P. Hanrahan
Partner
Sidley Austin LLP
1 file
HanrahanT.revised
1.2 MB 24 pages Presentation
PPT - HanrahanT.revised
15:45
Afternoon Coffee Break
16:00
Forward Thinking: Preparing for Tag-a-Long Claims By Crafting Defense Strategies In a Manner That Will Minimize Exposure to Follow-On Litigation
Mr. Gavin J. Rooney
Member
Lowenstein Sandler PC
Mr. George G. Gordon
Partner
Dechert LLP
1 file
RooneyG.GordonG
373.5 KB 25 pages Presentation
PPT - RooneyG.GordonG
17:00
Conference Adjourns to Day Two
9:30
Continental Breakfast
9:45
Co-Chairs' Opening Remarks
10:00
Preventative Medicine: Uncovering Business Practices That Are Warning Signs To Consumer Fraud Litigation And What You Can Do To Stop It
Ms. Phoebe Wilkinson
Partner
Chadbourne & Parke LLP
Mr. Mike Moore
Partner
SNR Denton (Dallas, TX)
11:00
Morning Refreshment Break
11:15
Tactics for Defeating Class Certification in the "No Injury" Drug and Device Case
Mr. John Beisner
Partner
O'Melveny & Myers LLP
Mr. Ezra D. Rosenberg
Partner
Dechert LLP
1 file
RosenbergE
1.7 MB 64 pages Presentation
PPT - RosenbergE
12:30
Networking Lunch
13:45
Medical Monitoring: Assessing the Use and Allowance of Non-Monetary Recovery Theories in Drug and Device Consumer Fraud Claims
Ms. Amy Payne
Associate
Jones Day
1 file
PayneA
221 KB 19 pages Presentation
PPT - PayneA
Ms. Debra M. Perry
Partner
McCarter & English LLP
1 file
PerryD
799 KB 24 pages Presentation
PPT - PerryD
14:45
Afternoon Coffee Break
15:00
Exploring the Intersection of Regulatory Oversight and Consumer Fraud Litigation: Incorporating Recent Changes to FDA Regulations and Increased Government Interest into Your Defense Strategy
Ms. Linda Willett
Partner
Sedgwick Detert Moran & Arnold LLP
Mr. Jose A. Isasi, II
Shareholder
Greenberg Traurig‚ LLP
1 file
WillettL.IsasiJ
199.5 KB 23 pages Presentation
PPT - WillettL.IsasiJ
15:45
Evaluating the Effect of Recent Preemption Decisions on the Defense of Consumer Fraud Claims in Drug and Device Litigation
Ms. Jennifer Cairns
Associate
McGuire Woods LLP
1 file
LowryP.ColettiJ.CairnsJ.Revised
1.8 MB 58 pages Presentation
PPT - LowryP.ColettiJ.CairnsJ.Revised
Patricia E. Lowry
Partner
Squire Sanders & Dempsey
Ms. Julie Coletti
Director and Senior Counsel
Bayer Corporation
1 file
LowryP.ColettiJ.CairnsJ.Revised
1.8 MB 58 pages Presentation
PPT - LowryP.ColettiJ.CairnsJ.Revised
17:00
Conference Concludes