Yite John Lu (Yale University - Law School) has posted The Change in Knowledge Requirement: Repairing Preemption Doctrine in Medical Products Liability (Yale Law Journal, Vol. 121, 2012) on SSRN. Here is the abstract:
-
This note proposes a new rule, the change in requirement, that allows the FDA to achieve a better balance of medical product availability and safety without interference from tort law when the Agency has adequately reviewed the safety science. Capitalizing on the switch in FDA competency and manufacturer interest pre and post-market, the change in knowledge rule would require that plaintiffs show a change in the state of safety knowledge from the time of FDA approval to the time of the injury.
An interesting student note.
