Bausch + Lomb Settles Federal Suit against ISTA

Bausch + Lomb and ISTA Pharmaceuticals, Inc., has reached agreement with the U.S. government to resolve and conclude civil and criminal allegations against ISTA.  The settlement involves conduct by ISTA that occurred between January 2006 and March 2011, well before Bausch + Lomb’s acquisition. Bausch + Lomb, aware of the government investigation prior to its acquisition, has cooperated with the U.S. federal government. A spokespeson for B+L reported that the government has acknowledged that it has no knowledge that Bausch + Lomb, any current director or officer of Bausch + Lomb, or any current director or officer of ISTA was party to any conduct related to this case. In the settlement, The B+L announcement noted that ISTA has pled guilty to charges of conspiracy to introduce a misbranded drug in interstate commerce with Intent to defraud and mislead and conspiracy to violate the Anti-Kickback Statute.  As part of the settlement, ISTA reportedly has agreed to pay approximately $34M in civil and criminal fines including interest and attorney’s fees, and will be prohibited from participating in federal healthcare programs such as Medicare and Medicaid.  However, Bepreve, Bromday, Istalol, Prolensa and Vitrase have been transferred to Bausch + Lomb Incorporated, and therefore are not subject to any exclusion resulting from this settlement and continue to be eligible for reimbursement under those programs, according to the B+L press release.