The first really, really major post-Riegel preemption battle in the PMA device product litigation has been the Sprint Fidelis implantable cardiac defibrillator lead MDL, in which Medtronic moved to dismiss (that means on the pleadings – without discovery) against all claims on the strength of the express preemption clause as interpreted by Riegel.
In what will certainly be an early entry for one of the top ten decisions of 2009, Medtronic just won. The short of it:
Medtronic, the Defendant in this multidistrict litigation, asserts the same doctrine here, arguing that Plaintiffs’ claims – sounding in negligence and strict products liability – are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. Having carefully considered the parties’ voluminous submissions, the Court agrees.
On one ground or another, the court dismissed all 21 claims in the master complaint: (1) strict liability – failure to warn; (2) strict liability – manufacturing defect; (3) negligence; (4) negligence per se; (5) breach of implied warranty; (6) breach of express warranty; (7) negligent misrepresentation; (8) intentional misrepresentation; (9) fraud; (10) constructive fraud; (11) violation of the Minnesota False Statements in Advertising Act; (12) violation of the Minnesota Deceptive Trade Practice Act; (13) violation of the Minnesota Prevention of Consumer Fraud Act; (14) violation of the Minnesota Senior Citizen and Handicapped Person Consumer Fraud Act; (15) negligent infliction of emotional distress; (16) loss of consortium; (17) wrongful death; (18) survival action; (19) medical monitoring; (20) unjust enrichment; and (21) Medicare Secondary Payer Act.
That means that the entire master complaint – the entire MDL – is dismissed with prejudice. Slip op. at 34-37. It’s an appealable order and will make for a donnybrook of an appeal. Once again Medtronic leads the charge.
The court made the following significant rulings:
(1) The Class I FDA recall that the Medtronic leads underwent did not deprive the defendant of its preemption defense. Slip op. at 14-17. A recall does not invalidate an in-force PMA, and in any event the recall could not affect the status of devices implanted before the recall occurred.
(2) Claims asserting manufacturing defects are preempted. Slip op. at 18-22. These claims do not “parallel” FDA manufacturing requirements because manufacturers have to develop their own quality control systems under what are “flexible” regulations. The “level of fine detail” necessary to establish an actual violation does not exist. Plaintiffs’ claims are would impose a level of detail “different from or in addition to” the FDA’s regulations. “Violation” is not a “magic word” that defeats preemption. Twombly requires the factual basis of a violation claim to be pleaded.
(3) Warning claims, including post-sale duty to warn allegations, are preempted. Slip op. at 22-27. Preemption under the MDC is much broader than the Cigarette Act. Regulations that “permit” manufacturers to modify their warnings (the CBE regulations in the device context) do not save claims that would “require” such modifications without being “different from or in addition to” those regulations. The conditions of the PMA itself did not impose any greater warning or reporting requirements than the FDA regulations themselves. Plaintiffs reporting-based allegations amount to a prohibited attempt at enforcing the FDCA – which is a form of implied preemption based upon 21 U.S.C. §337(a), providing for exclusive federal enforcement of the Act. Remember the §337(a) point. That may turn out to be the most important single ruling in the opinion.
(4) Design defect claims are preempted. Slip op. at 27-29. The introduction of a new “safer” model does not create a duty requiring immediate withdrawal of prior versions, unless the FDA so requires. It did not, so there is no “parallel” federal requirement for the plaintiffs to hang their state-law claims on. “Adulteration” claims are either a restatement of preempted manufacturing defect claims or amount to prohibited private enforcement.
(5) Negligence per se claims are preempted for the same reasons that the manufacturing, warning and design claims are. Slip op. at 30-31. Negligence per se does not “magically” permit private rights of action where such rights do not exist, and in any event the underlying claims for which negligence per se would set a standard of care, are already preempted.
(6) Breach of warranty claims (express and implied) are preempted. Slip op. at 31-33. Implied warranty merely tracks preempted manufacturing/warning/design claims. The 21 C.F.R. §808.1(d)(1) argument was rejected in Riegel. An express warranty of “safety” would require a jury to find the devices unsafe, which is what Riegel prohibits.
(7) Miscellaneous claims are preempted. Slip op. at 33-34. Derivative claims (consortium, unjust enrichment, consumer fraud) fail for the same reason as the claims from which they derive. Medicare Secondary Payor Act cases fail for essentially the same reason. If the individual insureds have no claims, their insurers have no claims on their behalf.
As we’ve said before, preemption can be a very powerful defense.