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Food and Drug Law

Michigan Telecommunications & Technology Law Review

2009

Generic drugs

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Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray Jan 2009

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …