Telehealth Psych

Benefytt Technologies, FTC v.

The FTC took action against Benefytt Technologies, its two subsidiaries, former CEO Gavin Southwell, and former VP of sales Amy Brady for deceiving consumers about sham health insurance plans, using deceptive lead generation websites, and illegally charging junk fees for unwanted add-on products without consumer consent. The proposed court orders require Benefytt to pay $100 million in consumer refunds and prohibit the company from making false claims about its products or imposing illegal junk fees. Southwell and Brady face permanent bans from selling or marketing any healthcare-related product, and Brady is additionally banned from telemarketing.

Vision Path, Inc., d/b/a Hubble Contacts, U.S. v.

Vision Path, Inc. (d/b/a Hubble Contacts), an online direct-to-consumer contact lens seller, settled FTC charges in January 2022 for violating the Contact Lens Rule by failing to obtain and properly verify prescriptions and substituting Hubble lenses for those actually prescribed. The FTC also alleged the company violated the FTC Act by failing to disclose that many consumer reviews were written by compensated reviewers, including at least one company executive. The settlement required Vision Path to pay $3.5 million in penalties and consumer redress.

AH Media Group, LLC

AH Media Group, LLC was the subject of an FTC enforcement action targeting a deceptive negative option scheme. The operators misled consumers about 'free trial' offers, enrolled them in unwanted continuity plans, billed them without authorization, and made cancellation nearly impossible. A court-ordered preliminary injunction was issued in September 2019 barring this conduct. In June 2022, the FTC announced it was returning $5.4 million to defrauded consumers.

Jon B. Cole, MD

FDA issued a warning letter to Dr. Jon B. Cole, MD, of Hennepin County Medical Center, regarding two clinical investigations of ketamine, haloperidol, and midazolam for severe agitation in the pre-hospital setting conducted without required Investigational New Drug Applications (INDs). The investigations (Protocols HSR 14-3841 and HSR 17-4306) were found to be clinical investigations rather than standard medical practice because they pre-specified drug interventions, limited EMT-P clinical judgment, and removed alternative treatments from ambulances. FDA further found the studies did not qualify for IND exemption because they failed to adequately exclude pregnant women, pediatric patients, and intoxicated subjects, and lacked specific safety measures for the pre-hospital setting. Dr. Cole was required to respond within 15 business days with corrective actions to prevent future violations.