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Today’s opinion, In re SoClean, Inc., Mktg., Sales Pracs., & Prods. Liab. Litig., No. 22-MC-00152-JFC, 2025 WL 974258 (Sp. Mstr. W.D. Pa. Mar. 20, 2025), involves a lot of case-specific discussion with little applicability to the broader readership of the Blog. But it also contains some general observations regarding invading the province of the FDA that are “so fresh and so clean” (if this litigation name takes you back, as it does us, to circa 2000 Outkast).Continue Reading Same Rule, Different Setting: Litigants Cannot Usurp the FDA’s Authority

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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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Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene.  That post also commented:

By the way, guess who says they found the benzene in the products?  It was that good, old “independent” lab, Valisure −  which proceeded to file a citizen’s petition with the FDA seeking action against [these] products.  Sound familiar?

Last month, the FDA responded to the petition.  The agency was not impressed.  Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about.  It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.”  FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id.  Only six of 95 products were recalled, and even then, only specified lot numbers.  FDA Statement ¶7.Continue Reading It’s About Time – FDA Calls Foul on Valisure

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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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Like the radio stations of yore did with songs, we offer up two related posts back-to-back instead of the usual one.  We cannot offer a “favorite artist” as the source of consecutive songs, we offer two posts that relate to the legal implications of some of the typical things that FDA does and has been…

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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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The Drug and Device Law Blog is deliberately apolitical.  Our purpose is to support the defense of prescription medical product liability litigation, and we recognize that the political views of our intended audience undoubtedly vary widely.

But one of the foundational grounds of our defense efforts is that the FDA, in its approval and subsequent regulation of prescription medical products, does so through skilled experts impartially evaluating well-conducted research and sufficiently supported facts.  The agency’s adherence to the scientific method and scientific principles is essential to our clients as they develop, and seek regulatory approval for, new prescription medical products, as well as changes to existing labeling, designs, and manufacturing processes.  In litigation, the FDA’s adherence to the scientific method and scientific principles is the underpinning of our clients’ two most powerful defenses – preemption and Rule 702/expert admissibility.  If the FDA (and other federal agencies such as the CDC, NIH, and ACIP) ever abandoned, or were perceived to have abandoned, the scientific method in its decision-making, both regulatory and litigation chaos quite likely would result.

That’s why we are disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. might be given authority over the FDA – and allowed to “go wild” over “health care” and “medicines.”  Here is a video link to a recent Trump speech, and here is our transcript limited to the relevant statements:Continue Reading This Is Disturbing

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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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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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