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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

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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

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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?

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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