Administrative Law

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We were promised “radical transparency” by the incoming Secretary of HHS.  We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.”  Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself.  For one thing, as we mentioned most recently here, the FDA takes notice and comment on guidance documents, such as those it issues that concern off-label speech.  As we’ve pointed out many times, guidance documents are not regulations with force of law.Continue Reading “Radical” but Not “Transparent”

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The federal government and the Fourth Circuit have ruled that a charitable patient assistant program conceived to increase access to cancer drugs for needy patients violated the federal Anti-Kickback Statute.  In an opinion long on canons of statutory interpretation and short on compassion for sick and dying patients, the Fourth Circuit upheld an HHS advisory…

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In our two prior posts, Loper Bright Likely Lays Lohr Low, and Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?, we focused on ways that Supreme Court’s holding in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), that courts were not to defer to administrative agency views in evaluating such agencies’ interpretations of their organic statutes, could be used by our clients in a positive fashion in the defense of prescription medical product liability.

Today we’re addressing the flip side.  How do we defend against the other side’s attempts to use Loper Bright for nefarious purposes?

Understanding the limitations of Loper Bright is a good start.Continue Reading Limits to Loper Bright

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United States v. Cal. STEM Cell Treatment Cntr., Inc., 2024 U.S. App. LEXIS 24525 (9th Cir. 2024), is not, strictly speaking, a product liability case at all.  But it hits several of our personal sweet spots.  For example, it is from the Ninth Circuit, where we clerked for Judge Norris.  It involves another…

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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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Standing should not be a political issue.  Ensuring that someone who initiates a lawsuit has enough of a connection to the alleged harm for which they seek redress from a court is a key part of the broader constitutional concept of justiciability.  Because federal courts are courts of limited jurisdiction, they cannot decide just any…

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We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”).Continue Reading A Couple of Thoughts about the Comstock Act

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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