Lilly sues med-spas over compounded tirzepatide marketing

Eli Lilly filed several new lawsuits on June 20, 2024 against med-spas, wellness centers and other sellers of compounded products that the sellers claim contain tirzepatide, the molecule in Lilly's Mounjaro and Zepbound ^[1]. The company filed the suits alongside an open letter warning patients about counterfeit and compounded versions of its medicines ^[1].

Lilly says the defendants misled consumers in three specific ways: by referring to their compounded products as Mounjaro or Zepbound or as the same as those drugs; by using results from Lilly's clinical trials in their advertising, which the company says led consumers to believe the compounded drugs were part of those trials; and by referring to the FDA approvals for Mounjaro and Zepbound as if the compounded products themselves were FDA-approved ^[1]. Lilly says the actions also identify "significant dangers to patient safety" tied to the defendants' products and their marketing ^[1].

Lilly's release describes what the company says it has found in compounded drugs advertised as tirzepatide: products with safety, sterility and efficacy problems, including some that contained bacteria, high impurity levels, or a different color than Lilly's medicine (pink instead of colorless), and some with a completely different chemical structure ^[1]. In at least one instance, Lilly says the product was nothing more than sugar alcohol ^[1].

The open letter also says some online pharmacies are advertising compounded pill or other oral versions of "tirzepatide." The FDA has approved tirzepatide only as an injection under the skin, and no regulator has evaluated the safety or effectiveness of pill or oral versions, according to the release ^[1]. Lilly adds that Mounjaro and Zepbound are approved only for adults treating serious diseases, not for cosmetic weight loss or for people under 18 ^[1].

On counterfeit products, Lilly says they are often sold online, through social media or at certain med-spas and "may contain no medicine, the wrong medicine, incorrect dosages, or multiple medicines mixed together," which could cause serious harm ^[1]. The release quotes the National Association of Boards of Pharmacy saying that "illegal actors are taking advantage of high demand and short supply" of incretin medications to sell substandard and falsified versions, and that those actions "put patients at risk" ^[1].

Lilly acknowledges that compounded products may be legal in limited circumstances to address specific patient needs, but says they are not FDA-approved and lack the same safety, quality and efficacy protections as FDA-approved medicines ^[1]. The release cites FDA language that "compounded drugs pose a higher risk to patients than FDA-approved drugs" and that unnecessary use of them exposes patients to potentially serious health risks ^[1].

Lilly also disclosed that in May 2024 it reached a settlement with Totality Medispa requiring a monetary payment and barring certain conduct that Lilly said misled consumers into believing the business sold Lilly's Mounjaro or Zepbound or an FDA-approved alternative ^[1]. The payment amount was not disclosed. Lilly says it has reached similar settlements with other med-spas and wellness centers that it said had infringed its trademarks and falsely advertised their products ^[1]. The new suits follow a series of cases Lilly filed in September and October 2023 ^[1].

Why it matters for patients

The legal filings and the open letter focus on how compounded tirzepatide is described and sold. According to Lilly, compounded products are not FDA-approved and do not carry the same safety, quality and efficacy protections as the approved drugs ^[1]. If a product is marketed under the Mounjaro or Zepbound name, or in a way that suggests FDA approval, that is the kind of claim Lilly is now suing over ^[1].

The release does not address compounded semaglutide, the molecule in Ozempic, Wegovy and Rybelsus, by name. The National Association of Boards of Pharmacy quote refers to incretin medications more broadly ^[1]. How many people have been harmed by the products described in the suits has not been reported.

What happens next

Lilly did not disclose the courts, case numbers or hearing dates for the new lawsuits, or the size of the Totality Medispa payment ^[1]. The company says it filed the new cases as part of its commitment to patient safety, and the release describes the earlier 2023 cases as part of the same effort ^[1]. No outcome or timeline for the new suits has been announced.