B. Braun Medical, a German device maker with U.S. headquarters in Bethlehem, Pa., is set to pay up to $7.8 million to resolve its criminal liability for selling contaminated pre-filled saline flush syringes in 2007, which allegedly led to infections and at least five deaths, the Department of Justice announced Wednesday.
Of the $7.8 million total, $4.8 million is in penalties and forfeiture and the additional $3 million would be for restitution.
"Patients were infected by adulterated syringes distributed by B. Braun," said Acting U.S. Attorney John Stuart Bruce, of the eastern district of North Carolina. "This agreement helps to provide justice for the victims and to deter such future conduct by distributors of medical devices."
B. Braun did not manufacture the syringes in question — AM2PAT in North Carolina did — but the syringes did bear a B. Braun label. In addition to the payments, the company must implement new practices to improve its oversight of product suppliers to prevent future sale of contaminated products, according to the DOJ.
"We are fully committed to ensuring patient safety. In that regard, we have agreed to undertake additional compliance measures related to the qualification and monitoring of third-party manufacturers of finished products distributed by B. Braun with the B. Braun name on the label or logo," Constance Walker, B. Braun's director of marketing and communications, said, according to The Morning Call.
Two AM2PAT employees were sentenced to 54 months in prison in 2009 in connection to the dirty syringes. However, one fled the country and is on the Food and Drug Administration's Office of Criminal Investigations' "Most Wanted" list.