Ninth Circuit Rules False Claims Act Suit Involving Off-Label Use of Medical Devices | Arnall Golden Gregory LLP
The Off-Label/Contraindicated-Use Theory The relator alleged “that Medtronic engaged in misbranding, mislabeling, and adulterating in violation of the Food, Drug, and Cosmetics Act (FDCA)” by marketing devices “without FDA approval or clearance for use in the cervical spine—an ‘off-label’ and indeed contraindicated use.” The Ninth Circuit rejected this theory because “the federal government does not distinguish between on-label and off-label uses in determining whether to pay for medical devices.” Thus, an allegation of off-label or contraindicated use was not enough. The re...
Source: jdsupra.com
