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

QUESTION PRESENTED 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 public reporting of adverse events, and claims alleging defective manufacture of medical devices.