Eli Lilly files 10 lawsuits over diabetes drug counterfeits, compounds

Eli Lilly lawsuits overview:

• Who: Eli Lilly and Company has filed several lawsuits alleging spas and retailers are selling unapproved versions of its popular Monjaro diabetes medication.
• Why: The defendants are allegedly capitalizing on Monjaro’s popularity by advertising weight loss treatments even though the drug has not been approved for that purpose.
• Where: The Mounjaro lawsuits have been filed in federal courts throughout the United States.

Eli Lilly and Company has filed 10 lawsuits against retailers and spas that are allegedly selling compounded or counterfeit versions of its new diabetes drug Mounjaro as a weight loss treatment, Law360 reports.

Mounjaro is a billion-dollar drug approved by the U.S. Food and Drug Administration last year. FDA approval gives Eli Lilly the right to use tirzepatide, a compound that is the primary ingredient in Mounjaro. Tirzepatide is covered by various patents that Eli Lilly has secured in recent years.

“Products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the U.S. FDA or global regulatory agencies for safety, quality, or efficacy,” Eli Lilly said.

Mounjaro has been a hugely successful drug for Eli Lilly, bringing in nearly $1 billion in sales during the last financial quarter.

Currently, Eli Lilly is only selling Mounjaro to patients with Type-2 diabetes. The FDA granted the company “fast track designation” allowing it to investigate whether the drug can safely be used by patients who are obese or who have weight-related comorbidities.

Mounjaro lawsuit alleges companies violate trademark and state laws by distributing unapproved drugs

Six of the Eli Lilly lawsuits are aimed at spas and businesses selling “weight loss” treatments. These businesses reportedly utilize the Mounjaro brand name to advertise their treatments, allegedly in violation of trademark laws.

Four Eli Lilly lawsuits were filed against compounding pharmacies in Florida and Texas, claiming they violate their state’s Drug and Cosmetic Acts and unfair competition laws by distributing unapproved new drugs.

“Rather than invest the time and resources necessary to research, develop, and test its products in order to ensure that they are safe and effective and to obtain regulatory approval to market them, [Houston business Revive Rx] is simply creating, marketing, selling, and distributing unapproved new drugs throughout Texas and most of the United States,” one Mounjaro lawsuit alleges.

Eli Lilly was recently sued after a 39-year-old man died suddenly from a massive heart attack after using Axiron, a prescription testosterone replacement product manufactured by the pharmaceutical company.

What do you think about these Eli Lilly lawsuits? Tell us your thoughts in the comments!

Eli Lilly is represented by Charles Spalding Jr., Brian P. Miller, Joseph N. Akrotirianakis, Aaron Craig, Bruce W. Baber and Nicole Bronnimann of King & Spalding LLP; Stewart O. Peay and Ryan S. Alba of Snell & Wilmer LLP; George C. Johnson of Johnson Toal & Battiste PA; and Samuel W. Diehl and Nicholas J. Nelson of Crosscastle PLLC.

The Eli Lilly diabetes lawsuits are Eli Lilly and Company v. Georgia Weight Loss & Aesthetics LLC, Case No. 5:23- tc-05000, in the U.S. District Court for the Southern District of Georgia; Eli Lilly and Company v. Revival Aesthetics and Wellness Inc., Case No. 2:23-cv-00645, in the U.S. District Court for the District of Utah; Eli Lilly and Company v. Renew MedSpa LLC, Case No. 0:23-cv-02880, in the U.S. District Court for the District of Minnesota; Eli Lilly and Company v. Totality Medispa LLC, in the U.S. District Court for the District of South Carolina; Eli Lilly and Company v. Sensational Skin Centers PLLC, Case No. 2:23-cv-01970, in the U.S. District Court for the District of Arizona; Eli Lilly and Company v. Wells Pharmacy Network LLC, Case No. 5:23-cv-00576, in the U.S. District Court for the Middle District of Florida; Eli Lilly and Company v. Archangel Raphael LLC dba Better Life Pharmacy, Case No. 8:23-cv-02111, in the U.S. District Court for the Middle District of Florida; Eli Lilly and Company v. Laura G. Graze et al., Case No. 1:23-cv-23587, in the U.S. District Court for the Southern District of Florida; Eli Lilly and Company v. Rxcompoundstore.com LLC, Case No. 1:23-cv-23586, in the U.S. District Court for the Southern District of Florida; and Eli Lilly and Company v. Revive Rx LLC, Case No. 4:23-cv-03521, in the U.S. District Court for the Southern District of Texas.

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