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
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
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