Opinion ID: 4110875
Heading Depth: 2
Heading Rank: 4

Heading: Axium Design Defect Claims

Text: The proposed complaint also seeks to advance a design defect claim. To do so, it first asserts that Axium was modified and improved over time. It then calls defective all earlier versions of the device that predated such improvements. Even by their own conclusory terms, these allegations do not make all - 25 - devices defective; for example, any device featuring the most recent modifications when sold would not be defective. More importantly, we agree with the district court that a product (much less an FDA-approved medical device) cannot be called defective for purposes of establishing falsity in a qui tam case merely because new versions of the product contain design improvements. See D'Agostino, 153 F. Supp. 3d at 537. Indeed, by that standard, most every car sold to the government would be per se defective.