Opinion ID: 177259
Heading Depth: 1
Heading Rank: 2

Heading: Parallel Claim Issues

Text: A. Failure to Warn and Related Claims. In the Master Consolidated Complaint, Plaintiffs alleged that Medtronic failed to adequately warn consumers of known defects and that the Sprint Fidelis Leads presented an unreasonably dangerous risk beyond what the ordinary consumer would reasonably expect. These claims are preempted by § 360k. The FDA's PMA approval includes specific language for Class III device labels and warnings. Plaintiffs did not allege that Medtronic modified or failed to include FDA-approved warnings. Rather, they alleged that, by reason of state law, Medtronic was required to give additional warnings, precisely the type of state requirement that is different from or in addition to the federal requirement and therefore preempted. See Riegel, 552 U.S. at 330, 128 S.Ct. 999. Even if federal law allowed Medtronic to provide additional warnings, as Plaintiffs alleged, any state law imposing an additional requirement is preempted by § 360k. Where a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is preempted. McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.2005), cert. denied, 547 U.S. 1003, 126 S.Ct. 1464, 164 L.Ed.2d 246 (2006). Plaintiffs' reliance on Wyeth v. Levine, ___ U.S. ___, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), for a contrary rule is unavailing. Wyeth turned on implied conflict preemption, not express preemption, because Congress did not extend the express preemption for medical devices in § 360k to prescription drugs. Id. at 1200. Plaintiffs further alleged that Medtronic was negligent in continuing to sell the original version of the Sprint Fidelis Lead after it had received FDA approval to sell a modified version. However, as the FDA did not prohibit Medtronic from continuing to sell the unmodified lead, a state requirement to that effect would be different from or in addition to the federal requirement and preempted under § 360k. Finally, Plaintiffs alleged that Medtronic failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations. As the district court concluded, 592 F.Supp.2d at 1161, these claims are simply an attempt by private parties to enforce the MDA, claims foreclosed by § 337(a) as construed in Buckman, 531 U.S. at 349, 353, 121 S.Ct. 1012. See Hughes v. Boston Scientific Corp., 669 F.Supp.2d 701, 710-12 (S.D.Miss.2009). B. Design Defect Claims. The Master Consolidated Complaint alleged that Medtronic designed the Sprint Fidelis Leads in a dangerous and defective condition and in a manner violative of the [MDA]. Absent concrete allegations that the product sold by Medtronic was not the product design approved in the PMA Supplement, these are not parallel claims. Rather, they are attacks on the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device. Such claims are expressly preempted by § 360k. See Mitchell v. Collagen Corp., 126 F.3d 902, 913-14 (7th Cir.1997), cert. denied, 523 U.S. 1020, 118 S.Ct. 1300, 140 L.Ed.2d 467 (1998). State tort law that requires a manufacturer's [Class III device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme. Riegel, 552 U.S. at 325, 128 S.Ct. 999. C. Manufacturing Defect Claims. Plaintiffs assert that the Sprint Fidelis Leads were defectively manufactured because Medtronic used unreliable direct resistance spot welding to affix the device's cables to electrodes. Count II of the Master Consolidated Complaint further alleged that facilities or controls used by [Medtronic] in the manufacture, packing, storage, or installation of the Sprint Fidelis Leads were not in conformity with applicable requirements of the MDA. In opposing Medtronic's motion to dismiss, Plaintiffs explained to the district court that the referenced applicable requirements were FDA Current Good Manufacturing Practices (CGMPs) found in the Quality System Regulations applicable to all medical devices. See 21 C.F.R. Part 820. The district court concluded that Plaintiffs' general allegations of failure to comply with CGMPs  practices that FDA has described as an umbrella quality system providing general objectives for all device manufacturers  do not save these claims from preemption under § 360k because Plaintiffs failed to identify any specific federal requirement in the PMA approval for the Sprint Fidelis Leads that forms the basis for an unpreempted parallel claim. By contrast, the court noted, the plaintiff in Rollins v. St. Jude Medical, 583 F.Supp.2d 790, 799-800 (W.D.La. 2008), alleged that the Class III device manufacturer failed to comply with the device's specific PMA requirements. As a result, the court concluded, 592 F.Supp.2d at 1157-59, Plaintiffs failed to allege a parallel manufacturing defect claim with the detail required by Twombly, 550 U.S. at 555, 127 S.Ct. 1955 ([A] plaintiff's obligation to provide the `grounds' of his `entitle[ment] to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.). Accord Ashcroft v. Iqbal, ___ U.S. ___, 129 S.Ct. 1937, 1951, 173 L.Ed.2d 868 (2009). On appeal, Plaintiffs primarily argue that the district court's application of Twombly in this case held them to an impossible pleading standard because the FDA's specific federal manufacturing requirements are set forth in the agency's PMA approval files that are accessible, without discovery, only to Medtronic and to the FDA. This argument  which focuses on the timing of the preemption ruling  would have considerable force in a case where a specific defective Class III device injured a consumer, and the plaintiff did not have access to the specific federal requirements in the PMA prior to commencing the lawsuit. Compare Braden v. Wal-Mart Stores, Inc., 588 F.3d 585, 598 (8th Cir.2009) (while plaintiffs must offer sufficient factual allegations to show that he or she is not merely engaged in a fishing expedition or strike suit, we must also take account of their limited access to crucial information.). [5] But that is not the case Plaintiffs presented to the district court. Plaintiffs alleged that state law entitles every person who has an implanted Sprint Fidelis Lead to damages (for emotional distress) and to equitable relief (monitoring or implanting of a replacement device) because all Sprint Fidelis Leads have an unreasonably high risk of fracture failure. In the district court, Plaintiffs conceded that the PMA Supplement doubtless authorized the use of spot welding, and they specifically disclaimed the need for discovery in opposing Medtronic's motion to dismiss. Thus, as pleaded and argued, the manufacturing defect claims are not parallel, they are a frontal assault on the FDA's decision to approve a PMA Supplement after weighing the product's benefits against its inherent risks. On this record, the district court properly concluded these claims are preempted. At oral argument, Plaintiffs posited a hypothetical case in which the plaintiffs could not know without discovery that every Class III device was defectively manufactured because the PMA approval required 400 degree welds but the manufacturer used a 300 degree welding process. This hypothetical well illustrates the care that courts must exercise in applying Riegel's parallel claim principle at the pleading stage, particularly to manufacturing defect claims. But here, Plaintiffs simply failed to adequately plead that Medtronic violated a federal requirement specific to the FDA's PMA approval of this Class III device. The district court did not abuse its discretion in denying Plaintiffs' motion to reconsider the dismissal order and grant their belated request for discovery to see if they could find such a requirement. Medtronic Leads, 2009 WL 294353 at  (D.Minn. Feb.5, 2009).