a pro-Defense bar, post-Escobar decision
handed down shortly before the holidays, the First Circuit held that a relator
could not proceed with an FCA claim based on alleged fraud in the inducement on
the Food and Drug Administration because the FDA had not withdrawn or suspended
its approval of the defendants’ medical device in response to relator’s allegations. D’Agostino v. ev3, Inc., No.
16-1126, 2016 WL 7422943 (1st Cir. Dec. 23, 2016). The opinion also doubles down on the First
Circuit’s Cyberonics decision that we
wrote about here,
again rejecting as insufficiently particular under Rule 9(b), allegations that identify a fraudulent scheme but fail to show that false
claims actually were submitted to the government as a result.