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Notes Feb 13 Preemption

Notes Feb 13 Preemption - regulation Used to milk the...

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Preemption Science is not necessarily all good Precautionary principle Regulation fails from time to time tort law – possibility for compensation Tort law: 1. Who owes the duty of care 2. What constitutes a breach of this duty? 3. How do we prove that the defendant cuased the plantiff’s harm 4. What injuries are recognized by the law as compensable You get fired, you cause the accident, you deserve compensation ? WTF? - Religious values - Perception of the body - “total justice”- paramount Clash between regulation and tort Pharmaceutical companies should get protection from tort litigation if they get FDA approval Tort law supposed to pick up where regulation ended The supreme court will approve preemption for some cases The science that is involved is unsubstantiated- eg breast implants- best we have for
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Unformatted text preview: regulation Used to milk the companies – need some instrunment to protect the companies FDA – The amendment also contain a preemption provision specifying that no state may establish any requirement that is different from or contrary to those of the FDA 2 kinds of FDA approvals – pre-market approval – full scale, demand and cost Pre-market notification- if a slight improved on a device pre 1976 then no need to do the whole shebang Companies will likely to go through the full scale approval in order to gain preemption making a new regime in which pre-market approval brings preemption could encourage manufactures to channel to that process those devices that are most likely to prompt tort litigation....
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