The Justice Department and CDRH director Jeffrey Shuren say Carefusion Corp., San Diego, CA, will pay $3.3 million to the federal government to resolve charges that it bought and sold medical devices that were not cleared or approved by FDA. A Justice Department statement says the unapproved devices were used by healthcare providers in medical procedures and the providers then submitted claims for reimbursement to federal healthcare programs for the procedures. The charges were brought under the False Claims Act.
Of the $3.3 million Carefusion agreed to pay as part of a settlement approved 5/7 by a New York federal judge, $2.8 million will go to the U.S. and $478 460.08 will go to states adversely affected by Carefusion’s conduct through separate settlements with those states.
In connection with the settlement, the federal government joined a private whistleblower lawsuit that had previously been filed under seal under the False Claims Act. The statement says that suit remains under seal as the government continues its investigation.