{"id":5487,"date":"2025-04-26T11:42:33","date_gmt":"2025-04-26T11:42:33","guid":{"rendered":"https:\/\/usatrustedlawyers.com\/blog\/eli-lilly-files-slew-of-lawsuits-over-zepbound-and-mounjaro\/"},"modified":"2025-04-26T11:42:33","modified_gmt":"2025-04-26T11:42:33","slug":"eli-lilly-files-slew-of-lawsuits-over-zepbound-and-mounjaro","status":"publish","type":"post","link":"https:\/\/usatrustedlawyers.com\/blog\/eli-lilly-files-slew-of-lawsuits-over-zepbound-and-mounjaro\/","title":{"rendered":"Eli Lilly Files Slew of Lawsuits Over Zepbound and Mounjaro"},"content":{"rendered":"\n
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Pharmaceutical giant Eli Lilly and Co. sued Willow Health Services <\/a>and three other companies in federal court in New Jersey and California, accusing them of selling unapproved compounded tirzepatide products for weight loss without FDA approval or proper testing.<\/p>\n<\/div>\n

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But some say the move is Big Pharma’s attempt to control the market and limit patient choice.<\/p>\n<\/div>\n

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Eli Lilly sued Willow Health Services Inc., based in Austin, over allegations of unfair competition, false advertising and deceptive business practices.<\/p>\n<\/div>\n

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The lawsuit accuses Willow of marketing and selling untested and unapproved compounded tirzepatide products, including “Tirzepatide Drops” and “Tirzepatide Plus,” for cosmetic weight loss, which is not an FDA-approved use for tirzepatide.<\/p>\n<\/div>\n

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The attorneys representing Eli Lilly are from Kirkland & Ellis. \u200b<\/p>\n<\/div>\n

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Counsel has not yet presented for Willow Health Services, and a request for comment was not immediately answered.<\/p>\n<\/div>\n

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In addition to Willow, Lilly sued three other compound drug distributors, Henry Meds, Mochi Health, and Fella Health, in the U.S. District Court for the Northern District of California in San Francisco on April 23. The companies did not immediately respond to a request for comment.<\/p>\n<\/div>\n

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\u201cEmpower claims to be our country\u2019s ‘most advanced 503A compounding pharmacy and 503B outsourcing facility,'” according to the lawsuit. \u201cIn reality, Empower has a long history of cutting corners and leaving serious safety risks in its wake.\u201d<\/p>\n<\/div>\n

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Plaintiff attorneys are Liza M. Walsh, Selina M. Ellis and Lauren R. Malakoff from Walsh Pizzi O\u2019Reilly Falanga in Newark, New Jersey. Also on the team: James F. Hurst, Diana M. Watral, Robin McCue, Ryan Moorman, James Hileman, Joshua L. Simmons and David I. Horowitz from Kirkland & Ellis, with offices in Chicago, New York and Los Angeles.<\/p>\n<\/div>\n

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But the defense pushed back.<\/p>\n<\/div>\n

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\u201cAt its core, this lawsuit is about more than us. It\u2019s about Big Pharma testing its power, challenging health care companies like Empower who prioritize personalized, affordable care over profit. It\u2019s Big Pharma\u2019s attempt to limit patient and provider choice and restrict access to individualized treatment,\u201d Empower wrote in a statement. \u201cThis lawsuit brings to light a critical divide in healthcare: Traditional health care\u00a0is reactive, one-size-fits-all, and driven by shareholder profits. Personalized health care\u00a0is proactive, tailored to each individual, and focused on long-term health.\u201d<\/p>\n<\/div>\n

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The telehealth clinics send the compounded weight loss drugs directly to consumers after an online consultation and approval with a health care provider.<\/p>\n<\/div>\n

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Eli Lilly alleges Willow falsely claims its products are safe, effective and superior to its FDA-approved tirzepatide medicines, sold under Lilly’s brand names: Mounjaro, which treats diabetes, and Zepbound, which treats obesity.<\/p>\n<\/div>\n

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Compound medicine providers were allowed to make and distribute copycat versions of tirzepatide injection products until December 2024, when the FDA issued a new decision determining the tirzepatide injection shortage had been resolved following two years of shortages.<\/p>\n<\/div>\n

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However, Eli Lilly claims those products were not comparable to its patented medicine. To clarify, “compounded” medicines are custom-made by pharmacists to meet the unique needs of individual patients, while “patented” medicines are mass-produced and regulated by the FDA.<\/p>\n<\/div>\n

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According to Eli Lilly’s lawsuit, compound tirzepatide products lack FDA approval and have not undergone the rigorous testing required to ensure safety, effectiveness, or quality. The FDA has explicitly warned that these compounded medications do not carry the same assurances as approved drugs.<\/p>\n<\/div>\n

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Health officials report that compounded tirzepatide formulations have not been clinically tested, and there is no evidence supporting claims of safety or effectiveness for any use, including cosmetic weight loss, according to the suit. The FDA has received reports of adverse events linked to these products, with some cases requiring hospitalization. Additional concerns include potential dosing errors and contamination risks that could harm patients.<\/p>\n<\/div>\n

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According to the lawsuit, Willow markets its products as “personalized” and sourced from pharmacies that “pass rigorous evaluations,” which Eli Lilly asserts is untrue.<\/p>\n<\/div>\n

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Willow’s compounded tirzepatide products are marketed for cosmetic weight loss, a use not supported by clinical trials, which, according to Lilly, potentially endangers patients. Willow’s practices allegedly harm Lilly’s reputation and customer goodwill by misleading consumers about the safety and effectiveness of tripeptide products. Willow asserts that its partner compounding pharmacies “pass rigorous evaluations” and produce “high-quality medication” despite documented regulatory violations and safety concerns at these pharmacies.<\/p>\n<\/div>\n

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Eli Lilly seeks injunctive relief to stop Willow’s alleged deceptive practices. It also wants corrective advertising, monetary damages, restitution and attorneys’ fees. The lawsuit is based on alleged violations of the California Unfair Competition Law and the Lanham Act.<\/p>\n<\/div>\n

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Eli Lilly is seeking to prevent Willow from marketing, distributing, selling, or promoting Tirzepatide Drops and Tirzepatide Plus for cosmetic weight loss or any other unapproved uses, and to stop alleged false claims about the personalization of its drugs and the quality of its partner pharmacies.<\/p>\n<\/div>\n

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Eli Lilly is also seeking an accounting and payment of Willow’s profits, including any profits gained from its alleged unfair competition and false advertising.<\/p>\n<\/div>\n

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The plaintiff also requests compensatory damages for harm caused by Willow’s alleged false advertising, and restitution for damages caused by Willow’s alleged unfair competition and false advertising.<\/p>\n<\/div>\n

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Eli Lilly further seeks reimbursement for its costs and attorney fees incurred, and requests any other relief the court deems appropriate.<\/p>\n<\/div>\n

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