Conference Agenda
Day 1, Friday, January 14, 2011
7:45 a.m. - 8:45 a.m.
Continental Breakfast & Registration
8:45 a.m. - 9:00 a.m.
Introduction & Overview by Chairperson
Richard J. Arsenault, Neblett, Beard & Arsenault
9:00 a.m. - 10:00 a.m.
Recent Interest
- Circumstances Surrounding Its Removal From the Market
- International Recall History and Recent FDA Action
- Prior FDA Action and Warnings
- Action by Xanodyne and other Generic Manufacturers
James T. Capretz, Capretz & Associates, Newport Beach, CA
Stacy K. Hauer, Zimmerman Reed, Minneapolis
Chad Cook, Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., Montgomery, Ala.
10:00 a.m. - 11:00 a.m.
Product Overview
- Brand Names and Their Differences: Darvon vs. Darvocet
- Popoxyphene, Dextropopoxyphene and other Preparations
- Number of Prescriptions and Patient Demographics
Gale D. Pearson, Pearson, Randall, Schumacher & LaBore, PA, Minneapolis
Matthew J. McCauley, Parker Waichman Alonso LLP, New York
11:00 a.m. - 11:15 a.m.
Refreshment Break
11:15 a.m. - 12:15 p.m.
Manufacturer Information
- Xanodyne Company History
- Manufacturing History: From Eli Lilly to Xanodyne
- The Generics: Identifying/Locating Generic Manufacturers
- Gauging the Profitability of the Drugs
B. Kristian W. Rasmussen III, Cory, Watson, Crowder & DeGaris, Birmingham, AL
John R. Climaco, Climaco, Wilcox, Peca, Tarantino & Garofoli Co., L.P.A., Cleveland
12:15 p.m. - 1:15 p.m.
Lunch
1:15 p.m. - 2:15 p.m.
The Science
- Heart Risks and Cardiotoxicity
- Studies and Evidence of Adverse Effects on the Heart
- Other Available Evidence of Adverse Heart Risks
- Foreign Regulatory Action
- Public Citizen Petitions and Outcomes
- Florida Medical Examiner's Death Data
- Post Hoc Analysis of Adverse Event Reports
- Data Point Surveys from Various State Medicade Programs
Dawn M. Chmielewski, Climaco, Wilcox, Peca, Tarantino & Garofoli Co., L.P.A., Cleveland
Chris Coffin, Pendley, Baudin & Coffin, LLP, Plaquemine, LA
Hunter J. Shkolnik, Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP, New York
2:15 p.m. - 2:30 p.m.
Refreshment Break
2:30 p.m. - 3:15 p.m.
Other Injuries
- Studies and Evidence of Causing Hip Fracture
- Efficacy and Conclusion and Overall Risk Benefit Profile
- How to Use and Qualify a Regulatory Expert to Pass a Daubert Challenge
Joseph H. Saunders, Saunders & Walker, P.A., Pinellas Park, FL
3:15 p.m. - 4:15 p.m.
Past Claims and Pending Litigation
- Porter v. Xanodyne Pharmaceuticals Inc. (D. Minn.).
- Differences/Similarities to Other Pharmaceutical Torts
- Rulings on the Liability of Generic Drug Manufacturers
Nicholas J. Drakulich, The Drakulich Firm, San Diego
Mark E. Burton Jr., Hersh & Hersh, San Francisco
Karen Barth Menzies, Robinson, Calcagnie & Robinson, Newport Beach, CA
4:15 p.m. - 5:15 p.m.
Potential Litigation and Potential Defenses
- Case Criteria
- Assessing the Injury
- Determining the Date of Injury
- Establishing and Challenging Proof of Use and Causation
- Automatic Exclusion Criteria
- Where to File: Filings in State and Federal Court
- MDL Considerations
Ervin A. Gonzalez, Colson Hicks Eidson, Coral Gables, FL
Neil D. Overholtz, Aylstock, Witkin, Kreis & Overholtz, PLLC, Pensacola, FL
Daniel Becnel, Becnel Law Firm, LLC, Reserve, LA