5050 Vioxx on Trial: The Medicine and Context of the Case
Price: $ 119.00 (USD)
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You will receive 1.75 credits (CE) upon completion of this course.
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Course Description
Several experienced mass torts litigators present the case against Merck Pharmaceuticals, discussing the evidence that implies that Merck knew Vioxx caused cardiovascular problems years before they voluntarily withdrew it from the market. This course, intended for attorneys considering taking class-action cases against Merck, also presents a lawman�s medical overview of how Vioxx works and of the clinical trials that eventually proved Vioxx was dangerous.
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Course Outline
Vioxx on Trial: The Medicine and Context of the Case
I. Overview of the Vioxx Case (Birchfield)
A. Welcome and Overview
B. Failure of the FDA
C. Effectiveness of the FDA?
D. Effectiveness of Court and Jury System?
II. Medical Overview (Sizemore)
A. How Vioxx Works
B. Where the Problems Began
C. Out of Balance
D. Effect on Prostacyclin
E. Blood Clots
III. Clinical Trials for Vioxx (Buchanan)
A. VIGOR Trial (1)
B. VIGOR Trial (2)
C. Post-VIGOR Studies
D. APPROVe Trial (1)
E. APPROVe Trial (2)
IV. Timeline: What Happened, When, and Why (Arsenault & Andrus)
A. Timeline
B. New Drug Application
C. Aggressive Marketing
D. Criticism of Promotion
E. Spinning the VIGOR Data
F. Merck-FDA Dynamics
G. Warning Label
H. Increased Risk of Blood Clots
I. Merck Denies Safety Risk
J. Kaiser Study
K. Merck Reaction, FDA Silence
L. Merck and the APPROVe Study
M. Voluntary Withdrawal
N. FDA and the Public Health
O. Reaction
P. Lessons for Litigation
Q. Prediction: Final Outcome
AfterWordsSM
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I. Overview of the Vioxx Case (Birchfield)
A. Welcome and Overview
B. Failure of the FDA
C. Effectiveness of the FDA?
D. Effectiveness of Court and Jury System?
II. Medical Overview (Sizemore)
A. How Vioxx Works
B. Where the Problems Began
C. Out of Balance
D. Effect on Prostacyclin
E. Blood Clots
III. Clinical Trials for Vioxx (Buchanan)
A. VIGOR Trial (1)
B. VIGOR Trial (2)
C. Post-VIGOR Studies
D. APPROVe Trial (1)
E. APPROVe Trial (2)
IV. Timeline: What Happened, When, and Why (Arsenault & Andrus)
A. Timeline
B. New Drug Application
C. Aggressive Marketing
D. Criticism of Promotion
E. Spinning the VIGOR Data
F. Merck-FDA Dynamics
G. Warning Label
H. Increased Risk of Blood Clots
I. Merck Denies Safety Risk
J. Kaiser Study
K. Merck Reaction, FDA Silence
L. Merck and the APPROVe Study
M. Voluntary Withdrawal
N. FDA and the Public Health
O. Reaction
P. Lessons for Litigation
Q. Prediction: Final Outcome
AfterWordsSM
More Information
| Language | English |
| Course Length | 1.75 hours |
| Duration of Access | for 3 months from day of enrollment |
| Continuing Education Credits | 1.75 |
| Instructor | Vance R. Andrus, Richard J. Arsenault, Andy D. Birchfield, David R. Buchanan, J. Paul Sizemore |
| Vendor | Cognistar (Read more about Cognistar accreditation.) |
| Course Certification | CLE credit available, see details for each course for states where available |
| Prerequisites/Audience | intended for attorneys and law students |
| Requirements/Materials Included | computer with Internet access |
Price: $ 119.00 (USD)
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