Eli Lilly Files 6 More Lawsuits Against Medical Spas for Compounded Counterfeit Mounjaro

In the fall of 2023, drug manufacturer Eli Lilly and Company, the only lawful supplier of FDA-approved tirzepatide—the active ingredient in the company’s Mounjaro and Zepbound products—sued Totality Medispa. Eli Lilly alleged that the medical spa was misleading consumers into believing that they were selling FDA-approved compounded Mounjaro or Zepbound, that its compounded medications were clinically tested, and that its compounded medications were safe. In May 2024, Eli Lilly and Totality Medispa entered into a settlement agreement requiring the spa to make a monetary payment, and to take several corrective actions, including not using Eli Lilly branding and not making statements suggesting the products are genuine. The med spa also agreed to only obtain and distribute compounded tirzepatide products that are produced in compliance with US law, report any adverse events due to compounded tirzepatide products to the FDA, and display a warning on its website and ads that compounded tirzepatide is not FDA approved.

In late June 2024, a month after the settlement with Totality Medispa, Eli Lilly filed 6 new lawsuits against medical spas and wellness centers across the country selling products allegedly containing tirzepatide. The lawsuits were filed in courts in Ohio, Texas, Hawaii, and the District of Columbia. Eli Lilly is alleging similar claims to those levied against Totality Medispa—that the spas and wellness centers were misleading consumers into believing that the compounded medications that were being provided were approved by the FDA.

Public demand for the GLP-1 drugs has outpaced the available supply, leading medical spas to offer potentially dangerous, compounded versions of the medications passed off as the genuine product.

Open Letter

In an open letter at the end of June, Eli Lilly and Company set out their concerns regarding this issue, such as the following:

• Mounjaro and Zepbound are not for cosmetic weight loss—Eli Lilly reiterated that their products are for the treatment of diabetes and obesity, not cosmetic weight loss, and must be prescribed by a health care practitioner.
• Mounjaro and Zepbound are not approved for patients under the age of 18. The company expressed concern that social media posts and ads were inappropriately targeting people under 18.
• Mounjaro and Zepbound are the only FDA-approved tirzepatide medicines. Eli Lilly does not supply tirzepatide to compounding pharmacies, medical spas, wellness centers, or online retailers, and does not know where these entities are obtaining tirzepatide. The company reiterated the risk of non-FDA approved medicines and noted that compounded drugs pose a higher risk than FDA-approved medications. Eli Lilly also noted sterility concerns and other safety issues, including bacteria, different chemical structures, high impurity levels, and lack of active ingredients. Eli Lilly also included a visual guide for identifying authentic Mounjaro and Zepbound products.

The Legal Forecast

Expect more of these cases as the demand for GLP-1 drugs remains high. Eli Lilly is particularly concerned that social media is being used to advertise or sell counterfeit drugs, and that illegal online pharmacies will try to cash in on this demand.

References

Lilly update on Mounjaro^® and Zepbound^® (tirzepatide) compounding litigation. News release. Eli Lilly and Company. Published May 14, 2024. Accessed July 19, 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-update-mounjaror-and-zepboundr-tirzepatide-compounding

Lilly warns patients about counterfeit and compounded medicines releases open letter and takes further legal action against counterfeit, fake, unsafe, and untested products. News release. Eli Lilly and Company. Published June 20, 2024. Accessed July 19, 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-warns-patients-about-counterfeit-and-compounded-medicines

An open letter from Eli Lilly and Company regarding certain practices related to Mounjaro^® and Zepbound^®. News release. Eli Lilly and Company. Published June 20, 2024. Accessed July 19, 2024. https://investor.lilly.com/news-releases/news-release-details/open-letter-eli-lilly-and-company-regarding-certain-practices