Friday, October 23, 2009

Sprint Fidelis - Strike Two (State Court Dismissal)

In a decision that largely tracks the preemption rulings already reached (and currently on appeal) in the Sprint Fidelis MDL, see In re Medtronic Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), the court in the Minnesota State Court parallel proceedings has likewise dismissed all of the claims before it on preemption grounds. Here's the slip opinion.

Highlights:
  • 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.
Congratulations to Medtronic and its litigation counsel, Ken Geller at Mayer Brown. Keep those preemption wins coming.

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