Mealey's Pharmaceutical Litigation

SuperConference

 

Mealey’s™ Pharmaceutical

 

 Litigation SuperConference

 

 

A Plaintiff’s Bar Discussion

 

June 23 -25, 2008 • Embassy Suites Chicago - Downtown / Lakefront, Chicago

Chair:

Ramon Lopez, Esq., Lopez McHugh, LLP, Newport Beach, CA

 

Agenda and Networking Events

View updates to the agenda at www.lexisnexis.com/conferences

Monday, June 23, 2008

8:00 Registration & Continental Breakfast

 

9:00 Welcome & Introductory Remarks

Ramon Lopez, Esq., Lopez McHugh, LLP, Newport Beach, CA

 

9:15 Bextra® Litigation

• Litigation update

• Latest studies and reports

• MDL — individual, medical monitoring and third-party complaints

• Future of the litigation — catalysts that may propel litigation forward / obstacles that stand in the way

Jayne Conroy, Esq., Hanly Conroy Bierstein & Sheridan LLP, New York City

Clinton Fisher, Esq., Hanly Conroy Bierstein & Sheridan LLP, New York City

 

10:15 Morning Break

 

10:30 Gadolinium

• Gadolinium — what it is and what it does

• The categories of agents available

• Relationship to reported cases of NSF

• The role of the chelate in the renal-impaired patient

• The thermodynamic and kinetic properties of the contrast agents

• Transmetallation

• Dissociation

• The liability picture: What was known/what was knowable and when?

John Restaino, Esq., Burg Simpson Eldredge Hersh & Jardine, P.C., Denver, CO

 

11:30 Accutane®

• Factual overview

• History & use of the drug

• The science & the studies

• Alleged health effects and treatment alternatives

• Theories of liability & defenses

• FDA warnings & restrictions

• Status of the litigation to date

Speaker to be announced

 

12:00 Networking Luncheon

 

1:15 Seroquel®

• Factual overview

• History & use of the drug

• The science & the studies

• Alleged health effects and treatment alternatives

• Theories of liability & defenses

• FDA warnings & restrictions

• Status of the litigation to date

Speaker to be announced

 

2:15 Afternoon Break

 

2:30 Contact Lens Solution

• Claimant pool

• Update on recent recalls — manufacturing/design defect

• Failure to warn, labeling & advertising issues

• Consumer expectations and ineffectiveness of contact lens solution as a disinfectant

Jason Ochs, Esq., Lopez McHugh, LLP, Newport Beach, CA

 

3:15 Update on the Fosamax® Litigation: The Critical Details

• What is osteonecrosis of the jaw and what do the medical reports say about the alleged link between Fosamax and this disease?

• Status report on the cases being filed, including petitions for class actions and MDL

• Analysis of the causation debate: Is there evidence that Fosamax actually causes osteonecrosis of the jaw?

• Adequacy and timing of the warnings

• Risk/benefit (What is the risk? How great is the benefit?)

Shelly Sanford, Esq., Sanford Pinedo, LLP, Houston

 

4:00 Avandia®

• FDA labeling

• The science and medicine

• Liability update, case selection & criteria

• Venue and the MDL filings

W. Mark Lanier, Esq., Lanier Law Firm, PLLC, Houston

 

5:00 Networking Reception

 

Tuesday, June 24, 2008

8:30 Continental Breakfast

 

9:00 Ketek

• Factual overview

• History & use of the drug

• The science & the studies

• Alleged health effects and treatment alternatives

• Theories of liability & defenses

• FDA warnings & restrictions

• Status of the litigation to date

Ramon Lopez, Esq., Lopez McHugh, LLP, Newport Beach, CA

 

10:00 Morning Break

 

10:15 Chantix (varinicline) Litigation

• Efficiency and safety according to published scientific literature

• Determining the risk associated with Chantix

• Regulatory action and labeling

• Intake criteria for cases

Kristian Rasmussen III, Esq., Cory Watson Crowder & DeGaris, Birmingham, AL

 

11:15 Trasylol (aprotinin) Litigation

• Factual overview

• History & use of the drug

• The science & the studies

• Alleged health effects and treatment alternatives

• Impact of Bayer pulling from the market at the request of FDA

• Status of the litigation to date

James Ronca, Esq., Anapol Schwartz, Philadelphia

 

12:15 Networking Lunch

keynote speaker: Hon. Daniel S. Pratt (Ret.), JAMS, Los Angeles

 

1:30 VIOXX—the Status of the Settlement

• First round of claim filings

• Issues regarding opt-outs

• Challenges to the settlement

Thomas Girardi, Esq., Girardi & Keese, Los Angeles

 

2:00 Consumer Fraud Act Cases

• Zyprexa® — the impact of the Alaska settlement

• Federal claims and attorney general involvement

• Third-party fraud claims

Robert Salim, Esq., Salim Law Firm, Natchitoches, LA

 

3:00 Afternoon Break

 

3:15 Zelnorm

• History of the drug and side effects — increased risk of heart attack, stroke and severe chest pain

• Were the signals missed and was the FDA mislead?

• How many prescriptions used and how many cases can be expected?

Neil Overholtz, Esq., Aylstock, Witkin, Kreis & Overholtz, P.L.C., Pensacola, FL

 

4:00 How to Effectively Present Your Case in Today’s World of Complex Litigation

• Using jury research to uncover case themes & develop trial strategy

• Successful approaches for working with key witnesses

• Jury de-selection beyond demographics

• At-trial presentations that educate & persuade

Joanna Gallant, Ph.D., Vice President, Jury Research & Trial Services, Precision Trial Solutions, Inc., A Subsidiary of Golkow Technologies, New York City

 

5:00 Networking Reception

 

Wednesday, June 25, 2008

8:00 Continental Breakfast

 

8:30 HRT Litigation—Ortho Evra

• What does the first Prempro MDL ruling mean for plaintiffs?

• Arlene Rowatt, et al. v. Wyeth

• Analysis of the current medical issues

• What did the manufacturer know and when? An in-depth look at failure-to-warn arguments and theories of liability against Wyeth and Upjohn (Pfizer)

• Dealing with the FDA defense

• How to correctly examine the prescribing physician

James Morris Jr., Esq., Brent Coon & Associates, Austin, TX

Rainey Booth, Esq., Littlepage Booth, Houston

 

9:45 NuvaRing

• Brief history and controversy surrounding Third Generation Contraceptives

• Comparison of NuvaRing to other methods of contraception — oral and transdermal (Ortho Evra) — as well as “traditional” (non third-generation) contraceptives

• Organon/Schering Plough’s mixed marketing messages

• Case Screening — Blood clot cases and Toxic Shock Syndrome cases

• Mechanism of action of vaginal ring contraceptives

• Litigation Update

Carmen Scott, Esq., Motley Rice, LLP, Mount Pleasant, SC

 

10:30 Morning Break

 

10:45 Preemption: The Effect of the FDA’s Final Rule on Pharmaceutical Drug Litigation

• FDA’s Final Rule: analysis of the FDA’s position

• Background of preemption in pharmaceutical litigation

• Update on the judicial interpretation of preemption since the June 30 deadline — is a trend developing?

• Allowing state claims to stand — innovation, public health, drug availability and price concerns

• The politics of the FDA’s decision to amend the code

• Areas of litigation affected by preemption — what does the future hold?

Arnold Levin, Esq., Levin, Fishbein, Sedran & Berman, Philadelphia

 

12:00 Adjourn