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Regulatory Focus™ > News Articles > The Preemption Defense: Limited in Scope or Broadly Embraced

The Preemption Defense: Limited in Scope or Broadly Embraced

Posted 01 May 2008

Pharmaceutical and medical device companies exist in a tightly controlled regulatory environment. The US Food and Drug Administration (FDA) directs, in varying degrees, how products must be designed, manufactured and labeled. The comprehensive regulatory process that governs the premarket approval of these products-when placed against the backdrop of an injured plaintiff and the skillful and emotional advocacy of the plaintiff's trial lawyer-is often obscured in the eyes of a jury deciding a product liability case. Because the Federal Food, Drug, and Cosmetic Act (FD&C Act) makes no provision for damage suits against device or drug manufacturers, injured patients frequently turn to state law to pursue claims against those manufacturers. Many cases have resulted in substantial damage awards, even though FDA had approved the product for marketing.


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