Medical Device Company Pleads Guilty to Dealing in Adulterated Devices, Forfeits Over $800,000 in Non-FDA Approved Devices
Miami, Florida – Affordable Healthcare Solutions, LLC, d/b/a Affordable Healthcare Solutions 1, LLC has pled guilty and was sentenced in South Florida federal court to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to Defraud or Mislead, in violation of 21 USC 331(c) and 333(a)(2).
According to the facts admitted at the change of plea, on May 11, 2016, Special Agents with the United States Food and Drug Administration, Office of Criminal Investigations, executed a search warrant at Affordable Healthcare Solutions 1, LLC (Affordable Healthcare), a business managed by R.A. During the search, agents located and seized unapproved, foreign-market Supartz Euflexxa, Synvisc, Synvisc-One, and Orthovisc, which are prescription hyaluronic acid (HA) medical devices intended for the treatment of pain in osteoarthritis of the knee that must be injected by a doctor or other qualified health care professional. Because these prescription medical devices lacked FDA approval for distribution and use in the United States, they were adulterated.
Under 21 U.S.C. § 331(c), it is unlawful to receive in interstate commerce an adulterated device and to deliver or proffer delivery of such device to others for pay or otherwise. Reviews of the labeling conducted by FDA’s Center for Devices and Radiological Health on the injectable HA devices seized from Affordable Care confirmed various differences between the outer box and carton labels, patient information brochures, and instructions for use between the FDA-approved labeling for Supartz, Orthovisc, Synvisc, Synvisc-One and Euflexxa versus the labeling included with the unapproved versions being distributed by Affordable Healthcare. The value of the devices seized were in excess of $800,000.
As a result of the plea agreement, Affordable Healthcare Solutions, LLC pled guilty to a felony, was fined and ordered to forfeit the $837,000 worth of medical devices seized during the search warrant executed by Special Agents with the FDA.
Juan Antonio Gonzalez, Acting United States Attorney for the Southern District of Florida, and Special Agent in Charge, Justin C. Fielder, FDA Office of Criminal Investigations, Miami Field Office, announced the felony guilty plea and sentence.
“Medical device suppliers whose greed leads them to disregard FDA protocols and approval processes put the public in danger” said Juan Antonio Gonzalez, Acting United States Attorney for the Southern District of Florida. “These are serious crimes and, in our district, companies that put profit over patient safety will be held accountable.”
“FDA regulates the manufacturing and distribution of medical devices to help ensure the safety of American patients,” said Special Agent in Charge Fielder. “Today’s announcement should serve as a reminder of the FDA’s continued focus on companies that put profits ahead of the U.S. public health.”
FDA-OCI Miami investigated the case. Assistant U.S. Attorney Laurence Bardfeld is prosecuting it. Assistant U.S. Attorney Richard Brown is handling asset forfeiture.