tag:blogger.com,1999:blog-36762711.post7849574364625353448..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Defeating FDCA-Based Negligence Per Se On State-Law GroundsRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-36762711.post-84556076382558573382009-02-15T23:27:00.000-05:002009-02-15T23:27:00.000-05:00This comment has been removed by a blog administrator.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-26231221408126081182009-02-12T21:26:00.000-05:002009-02-12T21:26:00.000-05:00Interesting case from a regulatory perspective. T...Interesting case from a regulatory perspective. This court document https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2005cv2086-33 indicates that the injected substance was "a combination of Histoacryl and Lipiodal" intended to embolize (block blood flow into) a pathological vascular structure. Poking around on the internet a bit, it looks as if the Histoacryl is a cyanoacrylate glue of some sort, and the Lipiodal is a contrast agent. Individually these are probably a device and a drug, respectively; however, together they might be considered a device. Contrast agents are in sort of a gray area--they are not metabolized in their medical function, but are regulated as drugs, presumably because they are systemically administered. I suppose one might argue that together they are a combination product, but devices are commonly combined with opacifying agents and it seems most reasonable (to me) to consider it a device. The contrast portion really has no drug action, further supporting device status.Anonymousnoreply@blogger.com