Ivy Sports Medicine, LLC v. Burwell

Ivy Sports Medicine, LLC (Ivy) (plaintiff), the successor in interest to ReGen, a medical device manufacturer, challenged the Food and Drug Administration’s (FDA) order forcing ReGen to withdraw its surgical mesh device for use in knee-replacement surgeries from the market. The FDA issued the order after reversing its earlier finding that the device met the substantial-equivalent standard under its premarket notification process in 21 U.S.C. § 360c(f). (In this process, if a product is found substantially equivalent to a proposed existing Class I or II device, the FDA allows it to be marketed; if the FDA disagrees with the proposed classification, the device remains in Class III and must go through a lengthier and more involved pre-market approval process.) Before its reversal, the FDA had thrice concluded that the device did not meet the substantial-equivalent standard in § 360c(f)—it was not until ReGen solicited the assistance of its congressional representatives that the FDA found that the device was as safe and effective as the predicate devices. Published allegations of inappropriate political pressure to skew the FDA’s approval process prompted the review. Although the FDA did not conclude that its previous process had been compromised, it ordered a new review that produced mixed findings but ultimately found that the device was not substantially equivalent to its claimed predicates, rendering it a Class III device. The district court granted summary judgment for the FDA, and Ivy appealed. Ivy argued that the FDA lacked authority to reverse its earlier decision under § 360c(f) and it was instead required to follow the procedures in § 360c(e) to correct its device classification error. The FDA argued that it had implicit authority to correct erroneous substantial equivalent decisions.