Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
As 2015 winds down, we reflected on some of the year’s most significant legal developments for drug and device manufacturers. In our opinion, the bench got it right (for the most part) this year. Here is a brief recap and...more
On April 13, 2015, in the case of Kathleen Hafer v. Medtronic, Inc., the United States District Court for the Western District of Tennessee issued a favorable opinion to a medical device manufacturer in the context of...more