We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute experimental drugs due to liability concerns, and these statutes don’t go far enough in removing that threat. Third, such statutes
As our guest post predicted in last Monday, even Hurricane Harvey could not delay the Fifth Circuit long in deciding the Pinnacle Hip MDL mandamus petition. Its decision, denying mandamus but mostly agreeing with the defendant’s substantive position, is available here. In re Depuy Orthopaedics, Inc., ___ F.3d ___, 2017 WL 3768923 (5th
The cases we typically write about focus on events after medical products have made their way through the applicable regulatory process and been marketed in the United States. The marketed product is used, people claim to have been injured by it, and they sue the manufacturer under various product liability theories. Often, in the course