B. Braun pays nearly $8m to settle contaminated saline case

B. Braun Medical agreed to pay $7.8 million and agreed to the facts in a non-prosecution agreement to avoid criminal charges that it sold contaminated saline syringes.

Bethlehem, Pa.- and Melsungen, Germany-based Braun bought the contaminated syringes from a company called Am2Pat, despite knowing beforehand of manufacturing problems at the North Carolina plant where the syringes were made, federal prosecutors said.

But less than 2 months later Braun was forced to recall the syringes because a new radiation sterilization process caused particulates to develop in the saline, the prosecutors said.

“After the recall, Am2Pat told B. Braun that it gave B. Braun incorrect information about its new radiation sterilization process. It also sent B. Braun information showing that Am2Pat moved manufacturing equipment to its new facility without validating that the equipment worked as expected after the move. As explained in the statement of facts, even with this new information, B. Braun resumed buying B. Braun saline syringes from Am2Pat without going to Am2Pat’s new facility,” according to the NPA signed by Braun.

Less than a month after resuming its purchase of Am2Pat, Braun saline syringes were contaminated with Serratia marcescens bacteria, infecting patients in California, Texas, New York and Nebraska. Those syringes were also recalled, according to the U.S. Justice Dept.

Braun agreed to pay $4.8 million in penalties and forfeiture and up to an additional $3 million in restitution, prosecutors said. The company must also increase its oversight of 3rd-party contractors and hire an independent compliance auditor.

Am2Pat’s quality control director, Ravindra Kumar Sharma, and plant manager Aniruddha Patel pleaded guilty in 2008 to a number of charges, each drawing sentences of 54 months in prison. CEO Dushyant Patel fled the U.S. and is on the “Most Wanted” list of the FDA’s Office of Criminal Investigations, prosecutors said.

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