Affordable Healthcare Pleads Guilty in Adulterated Device Case

Affordable Healthcare Solutions pleaded guilty in a Florida federal court to receiving adulterated medical devices in interstate commerce and delivery for pay with intent to defraud or mislead. The court fined the company and ordered it to forfeit $837,000 worth of medical devices seized during a search warrant executed by the FDA Office of Criminal Investigations, according to a Department of Justice statement.

The statement says that during the FDA search, agents located and seized unapproved foreign-market Supartz Euflexxa, Synvisc, Synvisc-One, and Orthovisc, all prescription hyaluronic acid medical devices intended to treat pain in osteoarthritis of the knee that must be injected by a doctor or other qualified healthcare professional. The devices were legally considered to be adulterated because they lacked FDA approval for distribution and use in the U.S.