Administrative Law

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Photo of Eric Hudson

We’re not bashful about our affinity for real science. It underpins our clients’ ability to develop life-saving drugs and devices, supports Rule 702’s role in keeping junk science out of courtrooms, and reflects the skeptical habits of mind that should matter to everyone. Shortly before his death in 1996, Carl Sagan discussed with Charlie Rose the dangers of a society where fundamental understandings of science and technology continue to diminish:

There [are] two kinds of dangers. One is . . . [t]hat we’ve arranged a society based on science and technology in which nobody understands anything about science and technology, and this combustible mixture of ignorance and power, sooner or later, is going to blow up in our faces. I mean, who is running the science and technology in a democracy if the people don’t know anything about it? And the second reason that I’m worried about this is that science is more than a body of knowledge. It’s a way of thinking. A way of skeptically interrogating the universe with a fine understanding of human fallibility. If we are not able to ask skeptical questions, to interrogate those who tell us that something is true, to be skeptical of those in authority, then we’re up for grabs for the next charlatan political or religious who comes ambling along. It’s a thing that Jefferson laid great stress on. It wasn’t enough, he said, to enshrine some rights in a Constitution or a Bill of Rights. The people had to be educated, and they had to practice their skepticism and their education.

Carl Sagan’s Last Interview. Fast forward, and today we’re discussing a case where the court quotes Carl Sagan and notes that, in the context of vaccines, science is “the best we have.”  Am. Acad. of Pediatrics v. Kennedy, __ F. Supp. 3d __, 2026 WL 733828 (D. Mass. Mar. 16, 2026).  Through a combination of good science and government oversight, the United States’ vaccination program has been a beacon for public health: 

Congress and the Executive have built—over decades—an apparatus that marries the rigors of science with the execution and force of the United States government. One extraordinary product of that apparatus has been the eradication and reduction of certain communicable diseases through the development and use of vaccines.  In the words of the Centers for Disease Control and Prevention (CDC), vaccines are one of the greatest achievements of biomedical science and public health.

Id. at *1 (cleaned up).  That success in the eradication of certain diseases is based on a rigorous method by which decisions about vaccine policy are made—“a method scientific in nature and codified into law through procedural requirements.” Id.  In this case, that rigorous and well-established method (both scientific and legal) was ignored.Continue Reading Injunction Granted against Revised Childhood Vaccination Schedule and Wholesale Reconstitution of Vaccine Advisory Committee

Photo of Lisa Baird

We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption. 

Yes, we need a life, but let’s put that aside for the moment.

In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval…

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Have you ever heard of the “Presentment Clause” to the United States Constitution?  U.S. Const. Art. I §, cl. 2.  While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation.  That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.Continue Reading Presenting the Presentment Clause

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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…

Photo of Stephen McConnell

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…

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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”

Photo of Steven Boranian

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

Photo of Stephen McConnell

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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Bexis’ Book

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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