We’ve always been interested in litigation over efforts to access “drugs” that are not legally available due to lack of any FDA approval – whether that involves attempts to force drug companies to provide discontinued investigational drugs, “Right to Try” legislation, or as in today’s decision, attempts to broaden the “practice of medicine” to include not just off-label use, but no-label-at-all use.  The defendant physicians’ efforts failed in United States v. California Stem Cell Treatment Center, Inc., ___ F. Supp.3d ___, 2026 WL 2575467 (C.D. Cal. Aug. 28, 2026), and they were enjoined from engaging in “adipose tissue-derived stem cell therapies.”

The defendants – a couple of doctors with no relevant background (one was a urologist and the other a cosmetic surgeon, id. at *5) and their business entities – set up a system of “more than 100 clinics, located throughout the United States and other countries” that marketed what sound like biologics that had no FDA approval, clearance, or other form of marketing permission:  several  product[s] containing “stromal vascular fraction” (“SVF”), which is “manufactured from a patient’s adipose tissue, and then combined with other components.”  Id. at *4.  The defendants licensed their “intellectual property and equipment to manufacturer and administer” these products.”  Id. at *5.  They claimed that the products could treat “neurological, autoimmune, orthopedic, and degenerative medical conditions and/or diseases, including, but not limited to, cancer, arthritis, stroke, amyotrophic lateral sclerosis, multiple sclerosis, macular degeneration, Parkinson’s disease, and chronic obstructive pulmonary disease.”  Id. at *6 (abbreviations omitted).  These products were manufactured using a patient’s own “adipose tissue,” which was removed, manipulated in various ways, and returned to the patient’s bodies.  Id. at *8-9, 11-12.

Reading the opinion’s findings of facts sure makes it sound like the defendant’s operation was an elaborate scam, but that’s not what makes the decision blogworthy.  Most of the Blog’s readers hardly need to be told that, in the USA, completely unapproved drugs (or other FDA-regulated products) are, by definition, adulterated and misbranded.  The legally interesting (and thus blogworthy) parts of the lengthy California Stem Cell opinion are the decision’s analysis, and rejection, of the defendant’s various defenses.  We count nine of those. These defendants tried everything but ultimately got nowhere.

First, the defendants were not merely engaging in surgery and otherwise practicing medicine on their patients.  Instead, they were administering products that were both “drugs” and “biologics.”  2026 WL 2575467, at *18.  “Because Defendants’ ‘intended use’ of the . . . products is to treat or mitigate a variety of diseases and medical conditions” those “products are ‘drugs’ under the FDCA.”  Id. at *32.  They were also “‘biological products’ . . . because each is a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.”  Id. (citations and quotation marks omitted).

Second, the products had not undergone any “adequate and well-controlled studies,” so they were “new drugs.”  Id. at *19.  The defendants’ failure to comply with virtually any of the FDA’s current good manufacturing practices or to have any FDA-approved labeling meant that the products were both adulterated and misbranded.  Id. at *34-35.  “Failure to comply with even one CGMP regulation renders the drugs legally adulterated.”  Id. at *34.  It was “impossible to draft adequate directions for use because there is no scientifically valid evidence to show that the . . . products are safe or effective for any indication.  Id.

Third, that the defendants’ products were “autologous” did not somehow exempt them from FDA regulation:

Autologous biological products may be created for individual patients using the patients’ own cells.  Because these autologous biological products are subject to FDA regulation, CBER routinely reviews applications concerning such products.  Autologous biological products . . . can and should be produced “with consistent strength, quality, and purity. . . .  [T]he . . . products are intended for autologous use, which refers to the “implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered.

2026 WL 2575467, at *20-21 (citations omitted).  The “products are intended for autologous use, which refers to the ‘implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered.’”  Id. at *33 (quoting 21 C.F.R. §1271.3(a)).

Fourth, defendants could not get away with their claim that their completely unapproved products were being “studied” as medical procedures governed by state law.  Defendants concededly had never sought to conduct any FDA-regulated investigational drug or biologic clinical trial.  2026 WL 2575467, at *28 & n.21.  Far from regulating the defendants’ activities, the “California state health authorities worked together [with the FDA] to embargo and seize the [product] that Defendants were using to make the treatment” because it was “human experimentation.”  Id. at *30 (citations omitted).  Defendants could not simply “take something that is unapproved . . ., combine it with something that is approved, and use that to treat diseases and conditions” . . . because they are doctors and/or conducting clinical research.”  Id. at  *31 (citation omitted).

Defendants’ unauthorized experiment treating cancer patients with an unproven product containing live [smallpox] virus not only put the patients at risk, but also represented a risk to the public health because people in close contact with those patients could have been infected with live virus.

Id. at *35 (citation omitted).  Plaintiffs often purport to equate off-label use with medical “experimentation.”  California Stem Cell illustrates what true “experimentation” looks like.

Fifth, defendants could not avoid regulation by characterizing their activities as “patient-funded research.”  Id. at *36.  “A ‘sale in the strict sense’ does not have to occur to bring a physician within the reach of” the FDCA’s “held for sale” requirement.  Id. at *35 (citation omitted).  “[A] physician’s use of a device on a patient is covered by the statutory phrase ‘held for sale.’”  Id. (citation and footnote omitted).  That phrase “does not focus narrowly on whether a physician charges for the device (or drug) consumed in the course of treating the patient, but focuses more generally on the commercial nature of the transaction, actors, and products at issue.  Id. (citation and quotation marks omitted).

Defendants’ . . . products are “held for sale” within the meaning of [21 U.S.C. §]331(k).  Defendants are practicing physicians engaged in the business of providing [those] products to patients to treat a variety of diseases and conditions . . . .  Many patients pay thousands of dollars to receive a single . . . product, and some patients pay much more to receive multiple treatments . . . .  Defendants are commercial actors who market and offer their . . . products to patients for commercial purposes other than Defendants’ own personal consumption, thereby rendering the CSCTC products “held for sale” within the meaning of [the statute].

2026 WL 2575467, at *36.

Sixth, defendants’ claim that they were not in “interstate commerce” also failed.  “The final drug product . . . need not have been shipped in interstate commerce in completed form.”  Id. at *37.  It was sufficient that “only an ingredient is transported interstate.”  Id. at  (citation and quotation marks omitted).  Defendants could not escape by performing “procedures” only in one state.  “[E]ven purely local activities that are part of an economic class of activities that have a substantial effect on interstate commerce,” are legitimately subjected to the FDCA.  Id. (citation and quotation marks omitted).

[E]ven where the purported medical procedure occurred entirely within the state, the . . . product nonetheless had sufficient connection to interstate commerce to permit federal regulation under the Commerce Clause.  Both the constitutional and statutory requirements for interstate commerce are satisfied here.

Id. (citation and quotation marks omitted).

Seventh, the FDA’s “same surgical procedure exception” (21 C.F.R. §1271.15(b)) does not apply.  The “adipose tissue that Defendants remove from patients is not just modified, but actually dismantled and destroyed, via . . . various . . . processing steps.”  2026 WL 2575467, at *11.  The regulation’s “narrow exceptions” do not apply to the defendant’s wholesale processing of removed patient tissue.  Id. at *38.  Rather, tissue that is reimplanted “must be . . . in the form removed from the patient for the SSP exception to apply.”  Id. at *39.  Defendants did much more than the “minimal manipulation” allowed by the regulation.  Id. at *44-45.

Defendants’ establishments do not qualify for the SSP exception because Defendants remove from patients . . . adipose tissue − and following processing implant a [something] different . . . − a cellular product [that was] combined with other drug components. . . .  Defendants’ manufacturing process fundamentally alters the adipose tissue that they removed from the patient, and further alters the physical and biological characteristics of the cells originally contained in the tissue.

Id. at *39 (footnotes omitted).  Defendants’ interpretation of the regulation was rejected because it:

would allow an establishment to remove any tissue from any part of a patient, perform any number and type of manufacturing steps on that tissue in relation to any purported surgical procedure . . ., inject the end product into any part of the patient, and then invoke the SSP exception as long as the end product contained one or more cells that were present in the original tissue − no matter how wildly different the end product might be.

Id. at *40.  Nor was the FDA’s construction of §1271, a “surprise” or any change from the Agency’s longstanding view of how its regulation operated.  Id. at *43-44.  “Under its enforcement power, FDA has absolute discretion as to whether to bring an enforcement action” and “ha[d no obligation to refrain from enforcing against Defendants’ violations of the FDCA.”  Id. at *44 (citation omitted).

Eighth, defendants were “manufacturers” under the FDCA, despite their arguments that “they are simply physicians who are practicing medicine and performing surgery.”  Id. at *47.  This was not a case of mere off-label use.  The FDCA’s practice of medicine exemption, 21 U.S.C. §360(g), “does not authorize doctors to use unapproved drugs, even in their ‘practice of medicine.’”  California Stem Cell, 2026 WL 2575467, at *47 (citations omitted) (emphasis original).

[E]ven doctors must comply with FDCA requirements. . . .  Congress did not create a broad “practice of medicine” exception that allows physicians to do whatever they please.  While the FDCA was not intended to regulate the practice of medicine, it was obviously intended to control the availability of drugs for prescribing by physicians.

Id. (citations and quotation marks omitted).

The Blog has been supportive of physician off-label use since its inception.  What went on in California Stem Cell was not off-label use, but rather involved manufacturing practices that simply ignored any and all FDA good manufacturing practices:

Although Defendants claim they merely engage in “off-label uses” of drugs and other medical products, that argument fails because − as Defendants admit − the . . . products have not been approved by FDA for any use. . . .  Although off-label use allows physicians to prescribe lawful drugs for unapproved uses, off-label use of adulterated products is beyond the scope of the privilege  Thus, it is well-settled that while a physician may exercise professional judgment in the off-label use of unadulterated products, nothing in the FDCA or caselaw suggests that the use of adulterated products is ever permissible.

2026 WL 2575467, at *47 (citation and quotation marks omitted) (emphasis original).  Whatever the defendants’ may have subjectively believed they were doing, what they actually did was manufacture and sell unapproved drugs and biologics, making them subject to FDA regulation and prosecution.  Id. at *48-49.

Ninth, and finally, defendants could not invoke their “patients’ rights to control their own cells.”  Id. at *48.  No such “constitutional right” exists.  “[T]here is no constitutional right to receive unapproved drugs, regardless of their composition,” even for “terminally ill patients.”  Id. (citations omitted).  Nor did defendants’ activities fit within any “right to try” statutory provision. 

The[se] products do not meet the statutory definition of an “eligible investigational drug” that patients have a “right to try” because, inter alia, [they] have been placed on clinical hold, are not subject to an effective [investigational application], and have not been studied in a completed, FDA-approved Phase 1 clinical trial.  Thus, the FDCA’s “right to try” provisions decidedly do not permit Defendants to use their unapproved drugs to treat patients.

Id. (citations omitted).

California Stem Cell thus contains by far the most thorough treatment of issues related to the manufacture and use of entirely unapproved drugs that we have ever seen – far exceeding the prior record holder, Harborth v. State, ex rel. Dep’t of Workforce Services, 424 P.3d 1261 (Wyo. 2018), which we discussed here.  Other cases on the topic, such as United States v. Livdahl, 459 F. Supp.2d 1255, 1266-67 (S.D. Fla. 2005); Gaston v. Hunter, 588 P.2d 326, 351 (Ariz. App. 1978); and Retkwa v. Orenteich, 584 N.Y.S.2d 710, 713 (N.Y. Sup. 1992), are much older and contain even less analysis.

There’s even more.  Beyond the decision’s rejection of no fewer than nine (as we see it) various defenses to trafficking in unapproved drugs/biologics, California Stem Cell also contains a useful (and rather humorous) takedown of one of defendant’s “expert” witnesses as “unreliable and [who] should be disregarded.”  That witness – it is difficult to continue with the adjective expert, even in quotes – “admitted . . . that substantial portions of her expert report were not her own.”  2026 WL 2575467, at *16. 

When . . . questioned about the content of her expert report and opinions, she not only conceded that she had not authored substantial portions of her report, but also stated that she had no idea how those portions had come to be included in her report.  When confronted with a side-by-side comparison of her expert report in this case and [a different expert’s report in related litigation] − and questioned about their extensive similarities, which had been highlighted in yellow . . . – [she] testified that those portions had been merged with her report, that she had not written the additional portions, and that much of the text in the two reports was identical.

When asked whether she had, in fact, reviewed the scientific literature cited throughout the footnotes to her expert report upon which her opinions purportedly were based, [she] testified, “I had nothing to do with the writing of any of the things that you just highlighted or any of the references that you’re pointing to.  I had nothing to do with that.  I was surprised when I saw that merged together with what I had written. What I wrote was completely separate.”

Id. at *17 (citations omitted).  Wow!  That’s bad enough to qualify for one of our “stupid expert tricks” posts.