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Kelly Savage

This document discusses how the legal doctrine of preemption can provide a defense against product liability claims for generic drug manufacturers. Preemption arises when federal law supersedes state law, including when a state lawsuit would force a defendant to violate federal regulations. The document examines a recent case where preemption was used as a defense, noting that generic drug manufacturers cannot unilaterally change labeling approved by the FDA.

BusinessGesundheit & Medizin
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Preempting Products Liability Claims Against Generic Drug Manufacturers Kelly Savage, Esq.
Pharmaceutical manufacturers all face the prospect of tort litigation now and in the future.
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Today, you’ll learn more about the important defense of preemption and its potential impact on defending product liability claims brought against your company. ,[object Object],[object Object],[object Object],[object Object]
Preemption Fundamentals – What is Preemption? ,[object Object],[object Object],[object Object]
Types of Preemption ,[object Object],[object Object],[object Object]
Why Should Preemption Matter to You? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Recent example: Dennis Quaid and Baxter ,[object Object],[object Object],[object Object]
Baxter’s “Dear Doctor Letter” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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Baxter’s Motion to Dismiss ,[object Object],[object Object],[object Object],[object Object]
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NDA vs. ANDA Review Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],ANDA Requirements Labeling Pharm/Tox Chemistry Manufacturing Controls Inspection Testing Bioequivalence
What are the Basic Generic Drug Requirements? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Labeling ,[object Object],[object Object],[object Object]
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Generic Drugs and Preemption ,[object Object],[object Object],[object Object]
Preemption: A Case Study Gaeta v. Perrigo Pharmaceuticals Company
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Using Preemption to Your Advantage

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