Judge splits Lilly's compounded tirzepatide case against Empower, dismissing federal ad claim

A federal court in Texas has dismissed Eli Lilly's federal false-advertising claim against Empower Clinic Services while allowing most of the drugmaker's state-law case over compounded tirzepatide to continue ^[1].

The April 29, 2026 order came from Senior U.S. District Judge Sim Lake in the Southern District of Texas, Civil Action No. H-25-3464 ^[1]. Tirzepatide is the molecule Lilly sells as Mounjaro and Zepbound ^[1].

Lilly's complaint accused Empower — which does business as Empower Pharmacy — of unlawfully producing and selling unapproved forms of the drug and describing them as safe, effective and tailored to individuals, despite what Lilly said was a lack of clinical testing and standardized output at large scale, reported at 70,000 doses a week ^[1]. Empower asked the court to throw out every claim, arguing Lilly had no standing to bring the Lanham Act count, that federal law displaces the state counts, and that Texas common law gives no private right of action tied to drug safety statutes ^[1].

The Lanham Act count failed on causation. Under the Supreme Court's two-step Lexmark framework, Judge Lake found Lilly cleared the first hurdle — lost sales and damage to reputation fall within the interests that law protects — but not the second ^[1]. Lilly's assertion that "some sales" of Empower's product "would have been made by Lilly" did not come close to the almost one-for-one connection the Supreme Court requires, the judge concluded ^[1]. A separate Lilly theory, that patients might blame Lilly for side effects caused by Empower's product, was in the court's view speculative ^[1]. The order pointed to Eli Lilly v. Willow Health Services, a Central District of California case decided February 3, 2026, which reached the same conclusion about a Lilly Lanham Act claim ^[1].

The state counts fared better. Empower invoked the Supreme Court's Buckman doctrine, which blocks state claims that would not exist apart from federal regulatory duties ^[1]. Judge Lake rejected that framing, holding that Lilly's allegations rest on duties created by state law, including state bans on selling unapproved new drugs, and do not amount to enforcing Section 503A of the Federal Food, Drug, and Cosmetic Act ^[1]. He relied on Zyla Life Sciences v. Wells Pharma, a 2025 Fifth Circuit decision ^[1]. Counts brought under the laws of Alaska, Colorado, Connecticut, Hawaii, North Carolina, South Carolina, Tennessee and Washington remain ^[1]. Lilly originally brought state statutory claims under the laws of nine states; the ruling lists eight that survive, and it has not been reported which state's law is no longer in the case or why ^[1].

The Texas common law count was dismissed. The court held that Texas does not recognize a private tort action premised on violations of the Texas Food, Drug, and Cosmetic Act, citing its own earlier ruling in Eli Lilly v. Revive RX ^[1].

One Empower argument was rejected outright: that compounding pharmacy rules give compounders blanket immunity from state consumer protection laws. The court said it would examine the specific nature of the operation — here, mass-scale production — rather than grant categorical protection ^[1].

Why it matters for patients

The order settles which claims can move ahead; it does not decide whether compounded tirzepatide works, whether it is safe, or whether Empower's sales were lawful ^[1]. It came at the motion-to-dismiss stage, early in the litigation, and no injunction or order that would halt sales is described in coverage of the ruling ^[1].

For people who fill tirzepatide prescriptions at a compounding pharmacy, the outcome means the legal picture stays unsettled rather than changing overnight. Because the case continues under state consumer protection laws, the dispute could run for some time, and the court's reasoning suggests state statutes, not the Lanham Act, are where these fights are likely to be decided ^[1].

The decision also adds to a line of rulings in which judges found Lilly's causation arguments too weak, including Willow Health Services and Revive RX ^[1]. Lilly, along with Novo Nordisk, has been suing compounders over tirzepatide and semaglutide products; this order suggests the federal false-advertising route may have trouble getting past the pleading stage ^[1].

What happens next

The surviving state claims continue in the Southern District of Texas ^[1]. No trial date, hearing schedule or further deadlines have been reported ^[1].