Class action lawsuits involving medical devices and pharmaceuticals present complex legal, regulatory, and procedural challenges. These cases often involve allegations of product defects, failure to warn, fraudulent misrepresentation, and mass patient harm, requiring legal expertise in multi-district litigation (MDL), scientific evidence, and corporate liability. This course provides an in-depth legal analysis of class action procedures, regulatory compliance, litigation strategies, settlement negotiations, and risk management for pharmaceutical companies, medical device manufacturers, and healthcare providers. Students will gain expertise in defending or prosecuting class action claims, navigating mass tort complexities, and ensuring compliance with federal and state regulatory frameworks.
Course Objectives
By the end of this course, students will:
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Understand the Legal and Regulatory Framework for Medical Device and Drug Class Actions – Analyze FDA regulations, state and federal consumer protection laws, and product liability doctrines.
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Examine the Requirements for Class Certification in Drug and Device Litigation – Study Rule 23 of the Federal Rules of Civil Procedure and state class action laws.
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Assess the Role of Multi-District Litigation (MDL) in Medical Class Actions – Learn how MDLs are structured and how they differ from traditional class actions.
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Analyze Scientific and Medical Evidence Used in Drug and Device Lawsuits – Explore how expert testimony, clinical studies, and regulatory findings shape litigation.
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Review Case Law on Landmark Class Actions Involving Medical Products – Study precedents that shaped pharmaceutical and medical device litigation.
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Evaluate Litigation Strategies for Plaintiffs and Defendants in Class Action Cases – Develop best practices for presenting, defending, and settling mass tort claims.
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Examine the Role of Government Investigations and Regulatory Actions in Class Actions – Investigate how the DOJ, FDA, and SEC influence litigation outcomes.
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Prepare for the Future of Medical Class Action Litigation – Examine emerging trends, AI-driven risk assessment, and evolving consumer protection laws.
