The family of a 27-year-old man who died from ketamine toxicity has filed a wrongful-death lawsuit against Orlando, Florida-based telehealth company Mindbloom, Inc., alleging the at-home ketamine program prioritized profits over patient safety.
The lawsuit, filed Tuesday in Pitt County Superior Court, North Carolina, claims that Mindbloom’s model of providing at-home ketamine—a Class III controlled substance—failed to adequately screen and monitor Phillip Ward of Greenville, who died on October 29, 2023.
Mindbloom, which markets itself as a provider of medically supervised at-home ketamine therapy for mental health disorders, claims on its website that none of its nearly 60,000 customers has ever overdosed.
The lawsuit, filed by Ward’s parents, John and Linda Ward, as administrators of his estate, targets Mindbloom and its partner, California-based compounding pharmacy Enovex Pharmacy LLC. It accuses the companies of negligence, product liability, and unfair and deceptive trade practices.
Allegations of Insufficient Oversight
According to the complaint, Ward’s death was caused by “ketamine toxicity in the presence of hypertension.” The lawsuit asserts that several red flags should have triggered a clinical review and discontinuation of treatment, including Ward’s missing “mandatory” clinician appointments and subscription payments.
Despite these missed checkpoints, the compounding pharmacy, Enovex, allegedly continued to supply Ward with the square ketamine tablets, called troches, that dissolve under the tongue.
The family’s attorney, James A. Morris Jr. of the Morris Law Firm, stated that Ward’s medical history—which included depression, hypertension, tachycardia, and substance abuse—should have immediately disqualified him from unsupervised, at-home anesthetic use, especially since he disclosed he was a current ketamine patient who had recently been undergoing in-person, medically supervised Spravato treatments.
“Mindbloom’s negligence, and its entire business model, failed this young man whose medical history, according to Mindbloom’s own marketing, should have disqualified him from among the people they profitably supply with this Class III controlled substance,” Morris said.
The lawsuit further alleges that following an initial video consultation on April 4, 2023, a Mindbloom clinician “recognized the danger and noted that Phillip ‘will need a therapist before approval’ and must obtain a letter from his prior Spravato provider confirming his treatment had ended.” However, the complaint states, the defendants allegedly “never confirmed that these safety conditions were met before proceeding with treatment.”
FDA Warning on Compounded Ketamine
The lawsuit highlights the regulatory gap used by telehealth providers like Mindbloom. While ketamine itself is an FDA-approved injectable anesthetic, the compounded oral formulations, or troches, are not. The companies bypass the usual drug approval process because licensed compounding pharmacies are permitted to fill individual prescriptions.
The complaint notes that just days before Ward’s death, the U.S. Food and Drug Administration (FDA) issued a public warning about the risks associated with compounded ketamine products, including oral formulations, when used for psychiatric disorders.
“Ketamine is not FDA approved for the treatment of any psychiatric disorder,” the FDA warning stated, emphasizing that compounded drugs are not evaluated for safety, effectiveness, or quality. Furthermore, the FDA cautioned that using compounded ketamine products without monitoring by a healthcare provider for sedation, dissociation, and changes in vital signs “may put patients at risk for serious adverse events.”
Morris argued that by “cloaking an unapproved drug in a deceptive appearance of medical legitimacy,” Mindbloom exploits vulnerable individuals, “offering an illusion of safety where none exists.”
Mindbloom is one of a growing number of telehealth companies that have expanded the use of compounded ketamine for conditions such as depression and anxiety.
In a statement to the Tampa Free Press on Thursday, Mindbloom’s CEO and Medical Director, Dylan Beynon, said, “The Mindbloom team and I were saddened to learn of Phillip’s death. I lost my mother and sister during their battles with mental health challenges, and my heart goes out to his family.”
“The facts will bear out that Mindbloom provides the highest quality of clinical care backed by the largest peer-reviewed clinical studies in ketamine therapy history and proven out across hundreds of thousands of treatments, and the care provided to Phillip by Mindbloom was no different,” said Beynon.
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