On Monday, United States District Court Judge, Kyle entered an order dismissing all claims asserted in the Medtronic Sprint Fidelis Leads Mulitdistrict Litigation based upon the doctrine of preemption.   

 In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 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.  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.

 
(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 modifiications 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.
(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.

(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.

The Court was clear that the Plaintiffs had been wronged, but under the law as it exists now, Plaintiffs have no remedy.  Our firm will particpate in working with Congress in order to ensure that individuals who are injured or killed due to defective medical devices will have a remedy.