We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases. Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use. In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care. As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really attempts to turn off-label use itself into a tort.
The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously. Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw. We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost. But nothing was on the blog itself that could qualify as useful research.
We rectify that today.