Today’s post is about one of our favorite topics, off-label use. This time, it isn’t about what manufacturers can say about unapproved uses. It’s about whether the DOJ can wield the FDCA’s misbranding provisions to criminally investigate hospitals whose physicians prescribe FDA-approved drugs for off-label purposes.
In In re Administrative Subpoena 25-1431-032 to Rhode
At the DDL blog we unashamedly confess our biases. Foremost among those biases is that we walk the defense side of the street. Another inescapable bias, at least for this particular scribbler, is that we know and like many of the Philly judges. In the City of Brotherly Love, familiarity breeds respect.
Over the past
Some of us are old enough to remember when the Kessler-led FDA attacked off-label use of prescription medical products by using archaic language in the agency’s “intended use” regulations (21 C.F.R. §§201.128, 801.4) to claim that a regulated entity’s mere knowledge that its products were being used off-label by physicians meant that those products were
In his latest off-label use-related law review article in 2021, Bexis pointed out:
[A]lthough states have traditionally been recognized to have broad authority to regulate the practice of medicine, aside from occasional attempts to restrict use of abortifacients, state-law interventions restricting the off-label uses of prescription medical products have been infrequent.
James M. Beck, “Off-Label
You can find useful legal precedents in surprising places. For example, Schmidt v. Schmidt, 2025 Pa. LEXIS 389 (Pa. March 20, 2025), is an interesting off-label use decision coming in a context that that most litigants of such cases will miss: a workers’ compensation case. But if you have been following this blog, Schmidt
Sometime last year, one of our esteemed bloggers wrote: “The qui tam provision of the FCA, which permits private plaintiffs – sorry, relators – to steer FCA claims presents marvelous opportunities for mischief.” We couldn’t have said it any better, so we won’t try. Moreover, mischief makes us think of the Marauder’s Map (Harry
United States v. Jackson, 2025 U.S. App. LEXIS 1261, 2025 WL 249109 (4th Cir. Jan. 21, 2025), is a criminal case involving off-label use of a medical device. The Fourth Circuit affirmed the conviction of a doctor for violating the Food, Drug, and Cosmetic Act, aggravated identity theft, and related offenses. The court sentenced
“Off label use” is a bit of an odd thing. The FDA does not regulate the practice of medicine, but it does get involved in the labeling of medical devices and pharmaceuticals through the applicable pre-marketing review processes, and those labels identify the use (or uses) intended for that medical product. That use (or
We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject. Not surprisingly, we follow medical malpractice decisions that address off label use. Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.
Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care
This is the second time in the last couple of weeks that we’ve written on a case brought under the False Claims Act (FCA). That is no accident. We are about to start a FCA trial, and have been studying all things FCA. Guess what we learned? Most FCA claims are even more bogus than