Opinion ID: 175410
Heading Depth: 1
Heading Rank: 10

Heading: motion for leave to amend the complaint[1]

Text: We ordinarily review the denial of leave to amend a complaint for abuse of discretion, but when the district court denies leave on the basis of futility we review the underlying legal conclusions de novo. In re NVE Corp. Sec. Litig., 527 F.3d 749, 752 (8th Cir.2008). DGRS argues it could have cured the problems which resulted in dismissal by amending its complaint to allege Medtronic failed to disclose that there were actually four, instead of two, ways in which the devices had been reported to fracture. However, even if this is true, multiple fracture sites in a device would not cause a recall if the overall failure rate were within normal limits. This information has no bearing on the material question, which is whether Fidelis devices were known to exceed acceptable failure rates overall. The district court did not err in denying DGRS permission to amend the complaint to add this allegation. DGRS also requested leave to amend the complaint to include the allegation that 40% of the fractures in Medtronic's returned products data involved a hardware malfunction resulting in a break that could affect electrical performance of the lead. Again, this allegation would have absolutely no bearing on the relevant analysis. The returned products database only provides information on the devices that failed. A certain number of devices are expected to fail. The number of expected failures that result from mechanical problems is not relevant to the overall performance of the device. Even if 100% of the returned devices were mechanical failures, Fidelis would still be a viable product as long as the number of returned devices were within the acceptable failure rate. The district court did not err in refusing to allow DGRS to amend the complaint on this basis. DGRS then attempted to add allegations that Medtronic requested permission from the FDA to modify the design of the Fidelis leads during the class period. The type of modification requested addresses one of the four fracture points discovered in the course of reviewing the physician complaints. While we do not agree with the district court's conclusion that the modification was irrelevant to the analysis, even if relevant, amendment on that basis would still be futile. Medtronic had identified a problem that was causing fractures and moved to remedy it. The other allegations in the complaint already establish Medtronic was aware of fractures due to physical failure. What is missing from the complaint is any allegation Medtronic was aware that the physical failure was causing fractures in higher than acceptable numbers across the market. This allegation would not solve the fatal defect in the complaint and the district court did not err in so determining.