The question presented is whether preemption
under the Medical Device Amendments to the Food,
Drug, and Cosmetic Act supports Rule 12(b)(6)
dismissal of state common law claims alleging failure
to warn by virtue of inaccurate post-approval, post
sale public reporting of adverse events, and claims
alleging defective manufacture of medical devices.

Whether preemption under the Medical Device Amendments supports dismissal of state common law claims alleging failure to warn and defective manufacture