When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and capricious.” FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009), set the current APA standard for review of federal agency flipflops. While no “heightened standard” exists under the APA for reversals
These days there are two topics that dominate legal conferences, presentations, and CLEs: artificial intelligence (AI) and Loper Bright. You will doubtless see us frequently bloviate about the former, but today’s case – American Clinical Laboratory Ass’n v. Food and Drug Administration, 2025 U.S. Dist. LEXIS 59869, 2025 WL 964236 (E.D. Tex. March
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”
There is a new twist in the “Right to Try” movement: A doctor in Seattle sued the DEA trying to establish a statutory right to treat terminally ill patients with hallucinogenic drugs without the DEA’s registration or approval. It did not work.
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
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
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
We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.
Well here’s another one: Medtronic, Inc. v. Lohr, 518 U.S.
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?
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