The pharmaceutical company Eli Lilly is suing a telemedicine company that allegedly markets untested weight-loss drug compounds, resulting in risks to patient safety, deception and the “improper corporate practice of medicine.”
Eli Lilly, whose products include the weight-loss drugs Mounjaro and Zepbound, filed the federal lawsuit April 23 in the Northern District of California against Mochi Health Corp., Mochi Medical CA P.C. and Aequita Pharmacy LLC, among other related entities. The defendants sell compounded drugs containing tirzepatide, the active ingredient in the Eli Lilly weight-loss drugs, even though the Mochi Health compounds have not been approved by the federal Food and Drug Administration, according to the lawsuit.
Mounjaro and Zepbound are also approved for other uses, including the treatment of type-2 diabetes and sleep apnea.
“Compounded drugs are not approved by regulators, have not been clinically studied and are riskier than FDA-approved medicines,” the complaint states. “Mochi Health’s sale of untested, unproven tirzepatide is divorced from good medicine and patient health.”
An Eli Lilly spokesperson indicated both the FDA and a federal court have said the companies producing tirzepatide “knockoffs” must cease production of the drugs. If they continue to sell such compounds, they are breaking the law and engaging in deceptive practices, the spokesperson said.
“Lilly filed lawsuits alleging entities are deceptively marketing knockoff tirzepatide as safe and effective for ‘cosmetic weight loss,’ improperly practicing medicine or influencing medical decisions, and falsely claiming to sell ‘personalized’ compounded tirzepatide,” the Eli Lilly spokesperson told the Southern California Record in an email.
The company will continue to take actions to protect patients’ safety, according to the spokesperson, who urged regulators and law enforcement to take similar steps.
The lawsuit accuses the founder of Mochi Health, Myra Ahmad, of not being a physician who is licensed to practice in any of the 50 states. In addition, the defendants have violated California state law and the federal Lanham Act, which regulates trademarks, the complaint states.
The complaint also argues Mochi Health altered the dosages and prescriptions of its patients several times over an eight-month period. Such non-standard doses have not been scientifically examined for safety, the lawsuit says.
Eli Lilly, which operates the San Diego Biotechnology Center and other facilities in California, also accuses Mochi Health of falsely stating on its website that it sells the Eli Lilly-branded Mounjaro and Zepbound.
“In reality, upon information and belief, the vast majority of patients on the Mochi Health platform do not actually receive Lilly’s genuine medicines – and instead are prescribed mass compounded tirzepatide,” the lawsuit says.
Eli Lilly has also sued another medical firm, Empower Clinic Services LLC, for allegedly making false statements about selling “personalized” compounded tirzepatide, including claims that it follows state and federal regulations to assure patient safety.
In April, the FDA sent a warning letter to Empower pointing out that the firm has violated several safety regulations, including product preparation that took place in unsanitary conditions and put patients at risk.
In the lawsuit against Mochi Health, Eli Lilly is seeking a court order declaring that the firm was involved in unfair and unlawful trade practices, an injunction to stop the distribution of the firm’s compounded tirzepatide and an order to correct previous advertising claims.