Eli Lilly Sues Clinics Over Alleged Sales of Unapproved Versions of Diabetes Drug

A sign outside an Eli Lilly pharmaceutical manufacturing plant in Branchburg, N.J., on March 5, 2021. Mike Segar/Reuters

Pharmaceutical giant Eli Lilly has filed a lawsuit against multiple medical spas, wellness centers, and compounding pharmacies across the United States in an effort to stop them from allegedly selling products claiming to contain tirzepatide, which is the active ingredient in the company’s diabetes drug Mounjaro.

Announcing the legal challenges in a Sept. 19 press release Eli Lilly said the suits were filed against the various spas and centers to “protect patients.”

The lawsuit accuses the entities of violating both federal and state consumer protection laws and competition laws by selling unregulated versions of Mounjaro.

“Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product,” the company said. “Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro (tirzepatide) by medical spas, wellness centers, and compounding pharmacies.”

Indiana-based Lilly is the only company with U.S. Food and Drug Administration (FDA) approval to sell tirzepatide drugs such as Mounjaro.

Mounjaro, which has been FDA-approved for the treatment of Type 2 diabetes, works by targeting the body’s receptors for the hormone GIP (glucose-dependent insulinotropic polypeptide) and a natural gut hormone called GLP-1 (glucagon-like peptide-1), thus suppressing appetite and reducing food intake.

The drug, which is manufactured by and commercially available only through Eli Lilly, is commercially available only in prefilled single-dose pens.

‘Serious Health Risks’

Eli Lilly filed the lawsuits in the states of Florida and Texas federal courts seeking orders barring Better Life Pharmacy, ReviveRX, Rx Compound Store, and Wells Pharmacy Network from selling tirzepatide.

The drug maker accused the spas, clinics, and compounding pharmacies of marketing and selling their own “compounded” drugs purporting to contain tirzepatide that are not approved by the FDA.

“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 FDA or global regulatory agencies for safety, quality, or efficacy; are not FDA-approved like Mounjaro; and may expose patients to potentially serious health risks,” the company said.

“These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” the company added.

The lawsuits also request unspecified damages.

Previously, the pharmaceutical giant has filed lawsuits seeking similar injunctive orders and damages against six medical spas and wellness centers from federal courts in Arizona, Florida, Georgia, Minnesota, South Carolina, and Utah.

Lawsuit Alleges Severe Injuries

The lawsuit comes as the company is also facing its own legal challenges after a Louisiana woman claimed that both Eli Lilly and Ozempic manufacturer Novo Nordisk failed to adequately warn users that the medications can cause severe gastrointestinal problems including gastroparesis, effectively a paralysis of the stomach.

In a lawsuit filed in August, the woman, identified as 44-year-old Jaclyn Bjorklund, claimed she was left “severely injured” as a result of using the two injectable prescription medications, and suffered ongoing symptoms such as severe vomiting, and gastrointestinal burning that left her teeth falling out.

Ms. Bjorklund, according to the lawsuit, was hospitalized for stomach issues on several occasions, including visits to the emergency room.

At a press conference announcing the lawsuit, attorneys for Ms. Bjorklund said they were currently looking into 400 other inquiries from clients who took Ozempic and Mounjaro across 45 states.

Eli Lilly has not commented on the lawsuit.

Mounjaro is expected to be approved for weight loss later this year.

Demand for the drug, and others like it, has soared in recent months due to its off-label ability to help patients shed unwanted weight.

However, the FDA has warned that shortages of similar drugs such as Ozempic could lead to unauthorized versions being sold across the country which could carry various safety risks because they do not undergo FDA premarket review for safety, effectiveness, or quality.

The Epoch Times has contacted Better Life Pharmacy, ReviveRX, Rx Compound Store, and Wells Pharmacy Network for comment.

Reuters contributed to this report.