Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons learned following Medtronic’s 2015 consent decree related to its SynchroMed II infusion pump at the Food and Drug Law Institute’s (FDLI) annual enforcement meeting. Experts also predicted that the number of consent decrees in the sector will increase going forward.
Mark Levy, an attorney with Eckert, Seamans Cherin & Mellot LLC said he « doesn’t think there is any more challenging moment for an outside counsel to a company than to learn that there’s been outreach by the Department of Justice and that the outreach involves a possible injunction action.” He added that injunctions are “a powerful enforcement tool.”…
