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Manhattan U.S. Attorney Settles Civil Fraud Claims Against Medical Device Manufacturer For Selling Products Not Cleared By The FDA

Geoffrey S. Berman, the United States Attorney for the Southern District of New York, and Mark S. McCormack, Special Agent in Charge of the U.S. Food and Drug Administration's Office of Criminal Investigations Metro Washington Field Office ("FDA"), announced today that the United States has simultaneously filed and settled a civil fraud lawsuit under the False Claims Act against AVALIGN TECHNOLOGIES, INC. ("Avalign"), and its subsidiary INSTRUMED INTERNATIONAL, INC. ("Instrumed," and together with Avalign, "Defendants"), for manufacturing and selling medical devices that were not cleared by the FDA. These uncleared devices were used by medical providers in spinal surgeries, circumcisions, and other medical procedures. The providers submitted claims for reimbursement to Medicare and Medicaid for those procedures. As part of the settlement, approved in Manhattan federal court by U.S. District Judge Edgardo Ramos, Defendants agreed to pay the Government $9,500,000 and admitted to conduct alleged in the United States' complaint.


Action Details

  • Date:September 13, 2019
  • Agency:U.S. Attorney
  • Enforcement Types:
    • Criminal and Civil Actions