The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community.  Id. at 350.  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 n.5 (citation and quotation marks omitted). 

Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent:  Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998).  This article came to be cited twice by the United States

A long time ago in a law school relatively far away, we took torts as a first year law student.  Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice. 

It’s a unique relationship based largely on knowledge and trust.  Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient.  Knowledge that often develops overtime through trust.  Patients want and need to be able to trust their doctors.  Sometimes patients share information with

Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less.  As we pointed out in the prior post, this drug has serious potential side

We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products.  Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the