How B. Braun Got in Big Trouble Over Tainted Syringes

The medical device manufacturer didn't even make the syringes, but its brand name was on them. Now the company is paying $7.8 million to settle a U.S. criminal case that provides a reminder of the need to properly monitor suppliers.

Chris Newmarker

B. Braun has agreed to pay $4.8 million in penalties and $3 million in restitution to settle with the U.S. Justice Department over criminal complaints related to contaminated pre-filled saline flush syringes sold in 2007.

The syringes, which infected patients in multiple U.S. states, were actually made by a supplier, AM2PAT, but B. Braun's brand name was on them.

"The Federal Food, Drug and Cosmetic Act prohibits companies from selling contaminated products, even when the company did not make the product itself," Benjamin C. Mizer, head of the Justice Department's Civil Division, said in a news release.

"Companies must take reasonable steps to ensure that their suppliers are making quality products that help rather than harm patients. Today's settlement shows that the government will continue to hold companies accountable for failing to fulfill this critically important responsibility," Mizer said.

Under the U.S. government's non-prosecution agreement with B. Braun, the company acknowledges that it distributed syringes under its label that were adulterated under the FDCA.

B. Braun in a statement shared by a spokeswoman noted that the relationship with AM2PAT ended eight years ago. The German medical device and drug manufacturer, with U.S. headquarters in Bethlehem, PA, said: "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."

According to the statement of facts in the federal case settlement, B. Braun was aware that AM2PAT had manufacturing problems, even before it started buying pre-filled saline flush syringes from AM2PAT in March 2006.  Both FDA and B. Braun audits had found that AM2PAT had problems complying with good manufacturing processes.

Worse, AM2PAT informed B. Braun in 2007 that it was moving to a new manufacturing facility and changing the company sterilizing the B. Braun saline flush syringes through a new radiation sterilization process, according to the statement of facts. Before B. Braun's quality department approved the changes, B. Braun was already selling saline flush syringes made at the new facility, and under the new sterilization provider. The changes were eventually approved, even though B. Braun officials had not seen operations at the new facility or confirmed AM2PAT's representations that it had properly validated its cleanroom and equipment. B. Braun was already receiving complaints about the syringes changing colors. AM2PAT was also having to make changes to its radiation process to avoid "overcooking" the saline syringes. 

Two months after B. Braun started selling pre-filled saline flush syringes made at AM2PAT's new facility, it recalled them because the sterilization process was causing white particles to develop in the saline inside the syringes.

After the recall, AM2PAT acknowledged to B. Braun that it had provided incorrect information about its new radiation sterilization process, and provided information showing that manufacturing equipment in fact had not been validated after the move to the new facility. Despite these potentially disturbing revelations, B. Braun resumed buying saline syringes from AM2PAT anyway, according to the statement of facts.

Within a month of the decision to resume buying from AM2PAT, saline flush syringes from the supplier became contaminated with blood infection-causing Serratia marcescens bacteria. The syringes were recalled after patients were infected in California, Texas, New York, and Nebraska. 

Besides admitting that it distributed an adulterated product, B. Braun has agreed to increase oversight of its product suppliers, including with on-site audits. On top of that, an independent auditor will assess whether B. Braun is making good on its promises.

"Today's announcement should serve as a reminder of the FDA's continued focus on companies that put profits ahead of the public health." George M. Karavetsos, director of FDA's Office of Criminal Investigations, said in a news release.

Two previous AM2PAT officials, former quality control director Ravindra Kumar Sharma and former plant manager Aniruddha Pate, were each sentenced in 2009 to nearly five years in prison after pleading guilty in federal court in North Carolina to violating the FDCA. AM2PAT's president Dushyant Patel was indicted on similar charges in 2009, but fled the country. He is presently the only medical device executive on the "Most Wanted" list at the FDA's Office of Criminal Investigations. 

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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