In a December 2016 event at the National Press Club, Leslie Caldwell, Assistant Attorney General for the U.S. Department of Justice Criminal Division, acknowledged that “there are cases that get filed that shouldn’t be filed.” With U.S. Attorneys’ offices scattered across 94 federal judicial districts, “there are districts where the oversight is not where it should be, the experience level is not where it should be.”
Arguably, one case that should not have been filed was filed against medical-device maker Vascular Solutions and its CEO, Howard Root. In the first part of this half-day symposium, Root will explain how he spent $25 million on more than 100 lawyers in 14 different law firms over the course of a five-year criminal investigation to contest an ill-fated government indictment concerning off-label promotion allegations of a cleared medical device.
In the second part of the symposium, we hear from two former federal prosecutors and a law professor, to better understand whether this and similar cases are legitimate enforcement or government overreach. Tom Beimers, now a partner at Hogan Lovells, served senior counsel for HHS OIG and as a Special Assistant U.S. Attorney. Peter Leininger, now counsel at King & Spalding, previously served as Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel. Joan Krause is the Dan K. Moore Distinguished Professor of Law at UNC School of Law and a leading national expert on healthcare fraud and abuse.
Finally, in the third part of the symposium, all four presenters will participate in an interactive discussion with participants.
Agenda
8:30 – 9:00 Coffee and bagels
9:00 – 9:05 Welcome
9:05 – 10:00 Howard Root, JD
Retired CEO of Vascular Solutions, Inc.
10:00 – 10:15 Break
10:15 – 10:35 Thomas Beimers, JD
Partner, Hogan Lovells
10:35 – 10:55 Peter Leininger, JD
Counsel, King & Spalding
10:55 – 11:15 Joan H. Krause, JD
Professor, UNC Law School
11:15 – 12:00 Panel Discussion with all Presenters
12:00 – 12:45 Networking Lunch (included)
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