- Apparently the Minnesota Supreme Court has an appeal currently pending that presents the question whether to adopt the Twombly/Iqbal pleading standard. Slip op. at 16-17 n.9 (discussing Barr v. Capella University, No. A08-1367).
- Claims involving PMA supplements are preempted to the extent as claims involving an original device PMA. Slip op. at 20 n.11.
- A product recall does not invalidate either a device's pre-market approval or that approval's preemptive effect. Slip op. at 21-22.
- The changes being effected provisions for devices don't preclude express preemption, because for state law to mandate what is a voluntary process under state law would be "different from or in addition to" federal warning requirements. Slip op. at 26.
- Express warranty claims predicated on the safety or effectiveness of a PMA device are preempted. Slip op. at 30-31.
- Fraud, misrepresentation, and consumer fraud claims would "retroactively question the soundness" of the FDA's approval, and are therefore preempted. Slip op. at 31-32.
- "Derivative" claims for loss of consortium, medical monitoring, unjust enrichment, and Medicare Secondary Payer are preempted. Slip op. at 32-33.
- Plaintiffs haven't alleged any unpreempted "parallel" claims because: (1) they are disguised private attempts to enforce the FDCA, which are impliedly preempted under Buckman; (2) there is no parallel state law claim for failure to follow the conditions of an FDA PMA; (3) there is no federal requirement to submit a CBE (it's strictly voluntary); (4) claims challenging the sufficiency of a defendant's submissions to the FDA are disguised fraud-on-the-FDA claims; (5) plaintiffs' design claims would impose rigid specificity that FDA regulations do not; (6) nothing in the FDA's regulations requires withdrawal of a device because an allegedly "safer" model was later approved; (7) there is no obligation to submit a PMA supplement immediately after learning of problems with an existing device; (8) certain alleged violations were not causally connected to any plaintiff's injuries; (9) adulteration claims are disguised private attempts to enforce the FDCA; negligence per se claims are disguised private attempts to enforce the FDCA; (10) a statute that does not authorize a private cause of action cannot be the basis of a negligence per se claim under state law; and (11) the regulations subject to plaintiff's negligence per se claims are only administrative requirements and do not prescribe standards of care owed to any individual. Slip op. at 33-42.