Lilly files suit against more spas, weight-loss centers selling knockoff version of its popular drugs

Just one month after settling with a South Carolina medical spa that was selling knockoff versions of its popular diabetes and weight-loss drugs, Eli Lilly and Co. is going after other sellers.

The Indianapolis-based drugmaker said Thursday it was taking legal action against at least six additional medical spas and weight loss centers that it claimed are selling counterfeit and compounded versions of tirzepatide, the active ingredient in Lilly’s diabetes treatment Mounjaro and weight-loss treatment Zepbound.

The company filed suits in federal district court, saying patients could be harmed by the knockoff products, which in some cases have contained bacteria, high impurity levels, wrong colors or a completely different chemical structure than Lilly’s federally approved medicines.

“They may contain no medicine, the wrong medicine, incorrect dosages, or multiple medicines mixed together, which could result in serious harm,” Lilly said. “They are never safe to use.”

In at least one instance, the product was nothing more than sugar alcohol, Lilly said.

The legal action comes as high consumer demand for Mounjaro and Zepbound has outstripped Lilly’s ability to make and deliver products to pharmacies. In recent months, many patients and doctors have complained they are unable to get the popular drugs.

In response, Lilly is also stepping up its manufacturing activity, investing billions of dollars into plants, including $9 billion into its brand-new plant in Lebanon, which is still in early stages of construction.

In the  lawsuits, Lilly alleges that the defendants misleadingly refer to their knockoff products as Mounjaro or Zepbound (or the “same as”),  misleadingly refer to the results of Lilly’s clinical trials in their advertising, deceive consumers to believe the compounded drugs were part of Lilly’s clinical trials, and misleadingly refer to the Food and Drug Administration approvals for Mounjaro or Zepbound “as if defendants’ compounded drugs were themselves FDA-approved.”

Lilly also published an open letter explaining that counterfeit products and unsafe or untested compounded tirzepatide put people at risk.

Named as defendants were Stuart Lerner MD LLC (also known as Mounjaro Hawaii) of Kailua, Hawaii;  Ed Partners LLC (doing business as Cleveland Health Group) of Independence, Ohio; Wellness  & Health Care Cost Consultants LLC (doing business as Metabolic MD) of Bellbrook, Ohio; AGV Sason Inc., (doing business as Lucy’s Laser & Medspa) of Mentor, Ohio; J. Bergeron MD (doing business as Houston Weight Loss Center) of Houston; and Capitol Contours LLC of Alexandria, Virginia.

The complaints allege false and misleading advertising, trademark infringement and unfair competition.

The lawsuits follow a series of cases Lilly filed in September and October 2023 as part of what it called its commitment to ensure patient safety.