Drugmaker admits kickbacks in record Sunshine Act case; social media addiction suits move forward; first self-balancing exoskeleton cleared — Morning Medical Update

Drugmaker admits kickbacks in record Sunshine Act case

Veloxis will pay more than $46 million over lavish meals, trips and resort stays given to transplant providers.

Veloxis Pharmaceuticals, a drug manufacturer based in Cary, North Carolina, agreed to pay more than $46 million and entered a deferred prosecution agreement to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions of Envarsus XR, its kidney transplant immunosuppressant, the Justice Department announced Monday.

From October 2016 through June 2023, the company took health care providers and at times their spouses to lavish dinners, trips and retreats billed as advisory boards, gave them gifts and expensive alcohol, and made consulting payments for work that was never performed.

The resolution includes a criminal penalty of more than $10 million, $34.45 million to settle False Claims Act allegations with the federal government and state Medicaid programs, and a $1.55 million civil penalty to the Centers for Medicare & Medicaid Services (CMS) for failing to report physician payments. That is the largest recovery under the Open Payments program since the Sunshine Act took effect in 2010.

Prosecutors said Veloxis employees falsified expense reports, padding attendee lists to lower the apparent cost per person and omitting physicians' names to avoid reporting requirements. Veloxis admitted liability, cooperated with investigators and entered a five-year corporate integrity agreement with the HHS Office of Inspector General.

Appeals court lets social media addiction suits proceed

The 9th Circuit rejected a Section 230 appeal from Meta and TikTok and refused to delay a 29-state trial starting Wednesday.

A federal appeals court on Monday allowed more than 3,000 lawsuits against Meta Platforms, Google, TikTok and Snapchat to proceed, rejecting the companies' argument that Section 230 of the Communications Decency Act bars claims that they failed to warn the public about the addictive design of their platforms.

The 9th U.S. Circuit Court of Appeals said the law provides a defense to liability rather than immunity from suit, making the appeal premature. The suits, filed by states, municipalities, school districts and individuals, allege the platforms intentionally addicted young users and contributed to rising depression, anxiety and body-image problems among American youth.

The court also denied Meta's bid to postpone a trial beginning Wednesday in a case brought by 29 state attorneys general over children's data collection, platform design and safety claims. Days earlier, a New Mexico judge found Meta had created a public nuisance in the state and ordered it to pay $567 million into a teen mental health fund, following a March jury verdict ordering $375 million over allegations it misled consumers about platform safety.

First self-balancing exoskeleton cleared for personal use

Wandercraft's Eve lets eligible wheelchair users with spinal cord injury walk hands-free, with a trained companion supervising.

The U.S. Food and Drug Administration (FDA) has cleared Eve, a self-balancing personal exoskeleton made by Wandercraft, for eligible adults with spinal cord injury, the first such device authorized for personal use. Users who can operate the remote control can stand and walk hands-free on level indoor surfaces and adjacent outdoor areas, under the supervision of a specially trained companion.

Clearance was supported by a three-site trial at Kessler Foundation, the James J. Peters Department of Veterans Affairs Medical Center in the Bronx and a Wandercraft walk center in New York.

Participants met functional and usability endpoints including walking performance and activities of daily living, and reported improvements in health status, psychological well-being, endurance, lower-limb spasticity and sitting balance. Those improvements were self-reported, and the announcement did not give enrollment figures or describe a comparison group.

"The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance," said Gail Forrest, Ph.D., director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation. An estimated 308,620 people in the U.S. are living with traumatic spinal cord injury, with about 18,400 new cases a year, according to the National Spinal Cord Injury Statistical Center.

Wandercraft plans a U.S. commercial launch Sept. 17.