CHARLESTON – A potential class action lawsuit claims hormone replacement pellets caused a Charleston severe injury that led to multiple surgeries.
Timothy Koontz is the named plaintiff in the complaint filed August 30 in Kanawha Circuit Court against BioTE Corp., BioTE Holdings, BioTE Medical and Dr. Gary S. Donovitz, who is the founder of BioTE.
The potential class, according to the complaint, would be other men and women who have undergone hormone replacement therapy with BioTE.
Headley
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According to the 111-page complaint, Koontz went to a BioTE certified provider on December 13, 2023. He was 60 years old at the time and was a past recipient of FDA-approved forms of testosterone therapy. His most severe symptoms were physical exhaustion, sleep problems, difficulty with memory, headaches and sexual health complaints.
BioTE has 19 certified providers in West Virginia as of August.
Koontz had bloodwork done December 15, showing his testosterone level at 188 ng/dl. During prior testosterone therapy, his highest level was 600 ng/dl. The bloodwork also showed hemoglobin and hematocrit were elevated., measuring 18.1 g/dL and 54.6 percent, respectively.
“Tim’s information and lab results were entered into BioTE’s Proprietary Dosing Algorithm,” the complaint states. “Despite his already existing erythrocytosis, Tim was deemed to be a candidate for the Biote Method of HRT. … BioTE’s Proprietary Dosing Algorithm concluded that the proper dose of testosterone for Tim was 1700 mg via nine implanted testosterone pellets. BioTE’s P.D.A also advised that Time should take five additional BioTE nutraceuticals, including DIM.”
Four days later, Koontz received his first and only pellet implantation, having nine 200 mg testosterone pellets implanted into his right hip.
“Following the implantation of the nine testosterone pellets, Tim experienced almost non-stop headaches,” the complaint states. “On January 15, 2024, Tim returned to LabCorp to have blood drawn. According to his LabCorp results, Tim’s testosterone had risen from 188 to 1201 ng/dL. Tim’s testosterone level had reached a supraphysiologic level.”
His hemoglobin and hematocrit levels also remained elevated, and his red blood cell count, which had been in the normal range before BioTE therapy, was also elevated.
Consistent with BioTE protocols, Koontz was advised to donate blood to continue treatment. He tried to do so on February 20, but the American Red Cross refused to accept his donation because of the elevated hemoglobin level.
BioTE told him to go to Charleston Area Medical Center’s Memorial Hospital to have one unit of blood phlebotomized.
One week later, Koontz presented to the Emergency Room with severe, acute abdominal pain, tachypnea, and tachycardia. He ultimately was diagnosed with acute mesenteric vein thrombosis, small bowel ischemia and sepsis.
“Tim had developed a blood clot in his superior mesenteric vein, a large abdominal vein that serves to drain most of the organs in the abdominal cavity,” the complaint states. “Tim underwent multiple surgeries during his hospitalization, including a small bowel resection.”
He was hospitalized until March 15, and CAMC staff told him to discontinue testosterone.
“As a result of the testosterone pellets that Tim received through the Biote Method, his testosterone level increased to a level more than six times his pre-therapy level and approximately two to three times the normal level for a sixty-year-old man,” the complaint states. “As a direct result of the BioTE Method of HRT, Tim developed multiple health conditions that required hospitalization and underwent extensive medical treatment.
“Tim has experienced severe and permanent injuries including, but not limited to, additional and unnecessary medical treatment, extreme pain and suffering, past and future medical expenses, past and future lost wages, severe emotional distress, embarrassment, humiliation, a loss of life’s pleasures, the inability to function as a whole person, and other incidental damages.”
The complaint says BioTE has defrauded and injured Koontz and others.
“As a fundamental matter, BioTE has developed and marketed a system dubbed the BioTE Method of Hormone Replacement Therapy that is facially dishonest,” the complaint states. “Contrary to its claims, BioTE does not seek to ‘replace’ patients’ hormones. BioTE instead seeks to achieve supraphysiologic levels of testosterone and estrogen in the patients enrolled in the BioTE Method.
“Similarly, BioTE labels entirely normal testosterone and estrogen levels as deficient. BioTE engages in this conduct to expand its Certified Provider network and expand the BioTE patient base.
“BioTE also dishonestly suggests to the public that BioTE itself manufactures the hormone pellets used in the BioTE Method. Through its dishonest and supraphysiologic practices, the self-described ‘world leader in hormone optimization’ has knowingly preyed on a vulnerable group of the population, including those that are struggling with legitimate medical problems entirely unrelated to hormones, those who have genuine hormonal imbalances and deficiencies, and individuals dealing with the natural aging process.”
According to the complaint, from January 2013 through March 2018, there were more than 200 cancer cases (breast, prostate and endometrial), more than 100 cases involving blood flow or clotting issues (heart attacks, strokes and deep vein thrombosis), more than 500 cases of cellulitis and 427 cases of “other” unspecified adverse events reported to BioTE. Of the 3,584 adverse events, the FDA says BioTE only investigated 62 of them.
The complaint says the defendants know and have known supraphysiologic levels of hormones are dangerous and cause serious injuries and unwanted side effects.
It accuses the defendants of fraud, negligence, misrepresentation, violations of the West Virginia Consumer Credit and Protection Act, violation of Federal Trade Commission Act, violation of WV Patient Brokering Act, failure to warn, strict products liability, unjust enrichment, fraudulent concealment, breach of express warranty and breach of implied warranty.
It says the defendants fraudulently represented what the BioTE Method of HRT is designed to do, fraudulently misrepresented that the BioTE Method is individually tailored to each patient, fraudulently represented its role in the manufacturing process of the pellets and fraudulently represented the safety and efficacy of the BioTE Method of HRT.
The class seeks medical monitoring in addition to compensatory damages, punitive damages, court costs, attorney fees, expenses and other relief.
Koontz and the potential class are being represented by Brian J. Headley and Paul A. Kettering of Headley Law Firm in Daniels Island, S.C. The case has been assigned to Circuit Judge Jennifer Bailey.
Headley Law Firm also has three other actions pending against BioTE in Kanawha Circuit Court.
Kanawha Circuit Court case number 24-C-936