5060 Defenses and Regulatory Pre-emption in Drug Liability Cases
Price: $ 119.00 (USD)
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You will receive 1 credit (CE) upon completion of this course.
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Course Description
How does a major pharmaceutical company best defend itself in a mass torts case against one of its drug products? How does the FDA normally go about regulating drugs, and what is its role in regulating and withdrawing drugs with problems? An experienced drug and device defense lawyer discusses how and why the environment for mass torts has become more hostile to plaintiffs and more sympathetic to pharmaceutical companies in the past few years�and how this change may affect Vioxx litigation and the Merck defense strategy. With a similar eye on the Vioxx litigation, the president of a medical consulting company discusses how the FDA normally regulates drugs, and the exact role and responsibilities of the FDA, compared to the role and responsibilities of a pharmaceutical company, in attempting to make sure drugs are safe.
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Course Outline
Defenses and Regulatory Preemption in Drug Liability Cases
I. Defending a Pharmaceutical Company (Thomas Moore)
A. Introduction: Sacrificial Lamb for the Defense
B. Current Environment for Mass Torts
1. Pharmaceutical Company Defense Strategy
2. Shift in Media Attitude
3. Judicial Shakeups and Tort Reform
4. Shift in Juror Attitude
5. Role of the FDA
C. Vioxx in Current Environment for Mass Torts
1. Causation Theory
2. Regulatory Issues
3. Outrage of the Scientific Community
4. What Merck Did Right
5. The Players Are Key
II. Major Concerns for Plantiffs’ Bar
III. Regulation of Pharmaceuticals (Alan Donald)
A. Overview
B. U.S. Food and Drug Administration 101
1. What the FDA Does and Doesn’t Do
2. FDA Standards
3. Changing FDA Standards
4. Other FDA Regulatory Tools
5. Recall vs. Withdrawal
C. Vioxx and the FDA
1. Application Approval Process
2. Post-Approval Confusion
3. FDA Warnings
4. What to Watch For
AfterWordsSM
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I. Defending a Pharmaceutical Company (Thomas Moore)
A. Introduction: Sacrificial Lamb for the Defense
B. Current Environment for Mass Torts
1. Pharmaceutical Company Defense Strategy
2. Shift in Media Attitude
3. Judicial Shakeups and Tort Reform
4. Shift in Juror Attitude
5. Role of the FDA
C. Vioxx in Current Environment for Mass Torts
1. Causation Theory
2. Regulatory Issues
3. Outrage of the Scientific Community
4. What Merck Did Right
5. The Players Are Key
II. Major Concerns for Plantiffs’ Bar
III. Regulation of Pharmaceuticals (Alan Donald)
A. Overview
B. U.S. Food and Drug Administration 101
1. What the FDA Does and Doesn’t Do
2. FDA Standards
3. Changing FDA Standards
4. Other FDA Regulatory Tools
5. Recall vs. Withdrawal
C. Vioxx and the FDA
1. Application Approval Process
2. Post-Approval Confusion
3. FDA Warnings
4. What to Watch For
AfterWordsSM
More Information
| Language | English |
| Course Length | 1.17 hours |
| Duration of Access | for 3 months from day of enrollment |
| Continuing Education Credits | 1 |
| Instructor | Andy D. Birchfield, Alan Donald, Thomas M. Moore |
| 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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