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
The Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), has generated more commentary than anyone could possibly read. Reed Smith alone has issued four Loper Bright alerts and established a resource center. Overall, we think that Loper Bright’s assertion that judges know better than administrative agencies how to interpret and apply those agencies’ organic statutes smacks of judicial triumphalism. However, it is what it is, and we’ll be living with it for some time.
Loper Bright essentially tells courts to ignore administrative interpretations and to give statutes “the reading the court would have reached if no agency were involved,” 144 S. Ct. at 2266 (citation and quotation marks omitted). One thing that we (and Mark Herrmann, who first suggested this topic) haven’t seen in any commentary on Loper Bright are the implications of that mandate on the FDA’s questionable basis for its ban on all “off-label promotion” – particularly truthful off-label speech – by the firms it regulates.Continue Reading Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?
The title is ridiculous, but unfortunately true.
Muldoon v. DePuy Orthopaedics, Inc., is a suit over “hip-replacement surgery conducted in 2007.” 2024 WL 1892907, at *1 (N.D. Cal. April 30, 2024) (“Muldoon II”). Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.Continue Reading 15 Years After the Fact, This MDL Remand Case Is Still at the Pleading Stage
It has been some time since we have discussed False Claims Act (“FCA”) litigation over alleged promotion of a prescription drug for off-label uses. And when we read United States ex rel. Hearrell v. Allergan, Inc., 2024 U.S. Dist. LEXIS 70888 (E.D. Tex. Apr. 18, 2024) we were reminded why. Off-label promotion is not
Bexis recently gave the keynote address at the Minnesota State Bar Association’s annual FDA Forum. In preparing his speech, which concerned recent challenges to FDA regulatory authority, Bexis had occasion to study Apter v. Dep’t of HHS, 80 F.4th 579 (5th Cir. 2023), which the blog previously discussed here. Since Bexis was discussing