The EvexiPEL lawsuit history involves two distinct legal battles: a four-year trade dispute in which competitor BioTE Medical sued Evexias and its affiliated compounding pharmacy Farmakeio over their hormone pellet program, and a 2024 case Evexias itself brought against the U.S. Food and Drug Administration challenging a ban on peptide compounding. The BioTE case settled in May 2022 with a public apology from BioTE’s founder. The FDA case settled in 2024 and was administratively closed in August 2025, but it can still be reopened depending on how the FDA’s rulemaking on four disputed peptides plays out.
The BioTE Medical Lawsuits (2018–2022)
Evexias Health Solutions launched its EvexiPEL bio-identical hormone pellet training program in the spring of 2018. Within months, BioTE Medical, a competing hormone pellet company founded by Dr. Gary Donovitz, began suing. Over the course of the dispute BioTE filed seven separate lawsuits against Evexias and related parties.1Yahoo Finance. Dr. Gary Donovitz, Founder of BioTE, Provides Public Apology
The lead case, BioTE Medical, LLC v. Jacobsen et al. (No. 4:18-cv-00866), was filed on December 13, 2018, in the U.S. District Court for the Eastern District of Texas before Judge Amos L. Mazzant III. BioTE alleged that the Evexias and Farmakeio defendants were manufacturing and selling unapproved new drugs under the guise of legitimate compounding, running false and misleading advertising in violation of the Lanham Act, and operating an enterprise that violated the Racketeer Influenced and Corrupt Organizations Act (RICO).2Justia. BioTE Medical, LLC v. Jacobsen et al, No. 4:2018cv00866
Neither side could win the case on paper. In November 2020, the court denied BioTE’s motion for summary judgment on both its Lanham Act and RICO claims, and it also denied the Evexias defendants’ own summary judgment motion.3Justia. BioTE Medical, LLC v. Jacobsen et al, Memorandum Opinion and Order The case was heading toward trial when the parties settled.
Settlement and BioTE Founder’s Public Apology
All seven BioTE lawsuits settled on May 24, 2022. As part of the settlement, Dr. Donovitz issued a public apology that ran in the Dallas Morning News in late April 2022. His statement read in part: “Certain litigation positions were taken, which the DeNeuis object as being factually inaccurate, that caused anguish and suffering for Dr. Terri DeNeui and Dan DeNeui. Dr. Donovitz apologizes for any pain or mental anguish that his litigation positions may have caused.”1Yahoo Finance. Dr. Gary Donovitz, Founder of BioTE, Provides Public Apology Financial terms of the settlement were not publicly disclosed.
Evexias v. FDA: The Peptide Compounding Case
In September 2023, the FDA placed more than a dozen peptides into Category 2 of the Section 503A interim bulk drug substances list, effectively banning their use in pharmacy compounding by classifying them as posing “significant safety risks.”4Alliance for Pharmacy Compounding. Settlement Reached in Evexias Suit Against FDA
On March 29, 2024, Evexias Medical Centers, Evexias Health Solutions, and Farmakeio sued the FDA in the U.S. District Court for the Northern District of Texas. Evexias Medical Centers, PLLC et al. v. United States Food and Drug Administration et al. (No. 4:24-cv-00293) was assigned to Chief Judge Reed C. O’Connor.5PacerMonitor. Evexias Medical Centers, PLLC et al v. United States Food and Drug Administration et al
The complaint alleged that the FDA violated the Administrative Procedure Act by prohibiting 17 peptides without engaging in reasoned decision-making, giving notice, or accepting input from pharmacies, practitioners, or patients. It specifically faulted the agency for failing to convene the Pharmacy Compounding Advisory Committee (PCAC) before reclassifying the peptides, as the FDA’s own procedures require. Lead counsel Andrew M. Grossman of Baker & Hostetler LLP said the FDA “fell far short of its obligation to engage in reasoned decision-making” and that the agency’s justification amounted to “a couple sentences of boilerplate language.”6Peptide Legal Fund. FDA Peptide Lawsuit
Settlement Terms
The parties settled later in 2024. Under the settlement, the FDA agreed to publish Federal Register notices for PCAC meetings to review four of the disputed peptides for potential inclusion on the 503A bulks list: AOD-9604, CJC-1295, Ipamorelin acetate, and Thymosin Alpha-1. The settlement reinforced that the FDA must follow formal notice-and-comment rulemaking, including PCAC review, before categorizing any active pharmaceutical ingredient.4Alliance for Pharmacy Compounding. Settlement Reached in Evexias Suit Against FDA
The PCAC Vote Went Against Evexias
The PCAC met on October 29 and December 4, 2024, to review the four peptides. The votes were unfavorable to the plaintiffs. The committee unanimously rejected CJC-1295 (13–0) and AOD-9604 (12–0), citing a lack of evidence of effectiveness. It also rejected Thymosin Alpha-1 by a vote of 17–4, with the majority finding no compelling evidence of clinical effectiveness and safety.7U.S. Food and Drug Administration. PCAC Meeting Summary Minutes, December 4, 2024 PCAC recommendations are advisory, but the FDA typically follows them in final rulemaking.
Case Administratively Closed, Not Dismissed
On August 18, 2025, Judge O’Connor administratively closed the case without prejudice under a joint agreement by the parties. Either side may move to reopen the case at any time. The order requires both parties to file a joint status report within 14 days after the FDA publishes its final rule on the four peptides, or by March 14, 2027, whichever comes first.5PacerMonitor. Evexias Medical Centers, PLLC et al v. United States Food and Drug Administration et al The case is paused rather than over, and Evexias has preserved its ability to resume litigation if the final rules go against it.
A Separate FDA Matter: The 2021 Farmakeio Warning Letter
One item that sometimes gets folded into discussions of EvexiPEL litigation is not a lawsuit at all. On July 29, 2021, the FDA issued a warning letter to Farmakeio Outsourcing based on an October 2019 inspection. The letter cited failure to comply with adverse event reporting requirements under Section 503B, marketing drug products without approved applications, and producing misbranded drugs whose labeling lacked adequate directions for use. The agency also flagged that Farmakeio’s compounded testosterone pellets were “essentially a copy” of the approved drug Testopel, which can violate a condition of 503B outsourcing facility status.8U.S. Food and Drug Administration. Farmakeio Outsourcing LLC Warning Letter A warning letter is a regulatory notice, not a lawsuit, and it is separate from both the BioTE and FDA peptide cases.