Drug and medical device company B. Braun Medical Inc. has agreed to pay $4.8 million in penalties and forfeiture and up to an additional $3 million in restitution to resolve its criminal liability for selling contaminated B. Braun pre-filled saline flush syringes in 2007, the Department of Justice has announced.
The B. Braun saline syringes had a B. Braun label but were manufactured by another company. This resolution includes a non-prosecution agreement that requires B. Braun to implement additional practices designed to increase its oversight of its product suppliers to prevent future sales of contaminated products. B. Braun, a medical device manufacturer, has global headquarters in Melsungen, Germany, and corporate headquarters in Bethlehem, Pa., with primary manufacturing facilities in Allentown, Pa., and Irvine, Calif.
“The Federal Food, Drug and Cosmetic Act (FDCA) prohibits companies from selling contaminated products, even when the company did not make the product itself,” says Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “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.”
“Patients were infected by adulterated syringes distributed by B. Braun,” says Acting U.S. Attorney John Stuart Bruce for 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.”
According to the agreed upon statement of facts that accompany the non-prosecution agreement, in March 2006, B. Braun started buying B. Braun saline syringes from AM2PAT, Inc. (AM2PAT), which manufactured the syringes at a small facility in North Carolina. The saline solution in pre-filled saline flush syringes must be sterile because it can enter a patient’s bloodstream when the syringes are used to flush out or clean medical devices that provide access to a patient’s veins, such as central lines, ports, and short peripheral catheters.
As noted in the statement of facts, B. Braun was aware of manufacturing problems at AM2PAT, even before it began purchasing syringes from AM2PAT. In separate audits, both the U.S. Food and Drug Administration (FDA) and B. Braun had found that AM2PAT was having problems complying with current good manufacturing practices. Although AM2PAT addressed some of these initial problems, additional problems persisted. In the spring of 2007, AM2PAT notified B. Braun that AM2PAT intended to move to a new manufacturing facility and change the company that would sterilize the B. Braun saline syringes through a new radiation sterilization process. Sterilization, a vital step in the manufacture of these syringes, can be complex. Before B. Braun’s quality department approved either of these changes, B. Braun began selling B. Braun saline syringes made at AM2PAT’s new facility and sterilized by the new sterilization company. B. Braun later approved both of these changes even though B. Braun had already received complaints about the syringes changing colors and information from AM2PAT that it was making changes to its radiation process to avoid “overcooking” the syringes. B. Braun approved AM2PAT’s facility move without ever seeing AM2PAT’s operations at its new facility or confirming AM2PAT’s representations that it had properly validated its clean room and equipment after the move.
Less than two months after B. Braun started selling syringes that AM2PAT made at its new facility with the new sterilization company, B. Braun recalled all of them because the radiation sterilization process caused dangerous white particles to develop in the saline inside the syringes.
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.
Less than a month after B. Braun resumed buying syringes from AM2PAT, AM2PAT manufactured B. Braun saline syringes contaminated with Serratia marcescens bacteria. S. marcescens can cause blood infections. These contaminated syringes infected patients in California, Texas, New York, and Nebraska. The syringes were recalled.
In the government’s non-prosecution agreement with B. Braun, B. Braun admits that it distributed B. Braun-labeled syringes that were adulterated under the FDCA. Under the terms of the agreement, B. Braun will increase oversight of its product suppliers by conducting on-site audits of companies that design and make finished products that bear the B. Braun name on the label or logo and testing such products for sterility, identity and purity, as appropriate, on a periodic basis. B. Braun will also be monitored by an independent compliance auditor during the term of the agreement. The auditor will assess B. Braun’s implementation and maintenance of the enhanced compliance measures through on-site audits of B. Braun. B. Braun’s chief executive officer and board of directors will also review and certify B. Braun’s compliance efforts on an annual basis.
“Americans expect and deserve medical devices that are safe, effective, and that meet appropriate standards for quality,” says Director George M. Karavetsos of FDA’s Office of Criminal Investigations. “Today’s announcement should serve as a reminder of the FDA’s continued focus on companies that put profits ahead of the public health.”
This settlement with B. Braun follows the earlier, related prosecution in the Eastern District of North Carolina of AM2PAT and three individuals who worked at AM2PAT. In 2008, Ravindra Kumar Sharma, AM2PAT’s quality control director and Aniruddha Patel, AM2PAT’s plant manager, both pleaded guilty to criminal informations charging conspiracy to commit a number of federal offenses including felony violations of the FDCA. Both were sentenced in 2009 to 54 months in prison. AM2PAT and its former president, Dushyant Patel, were indicted on similar charges in 2009. Patel fled the country and is currently on FDA’s Office of Criminal Investigations’ “Most Wanted” list.
Principal Deputy Assistant Attorney General Mizer and Acting U.S. Attorney Bruce commended the efforts of the FDA’s Office of Criminal Investigations and its Special Agent Paul Pierce for their work on this matter. The matter was also handled by Assistant U.S. Attorney Evan Rikhye of the U.S. Attorney’s Office for the Eastern District of North Carolina and Senior Litigation Counsel Allan Gordus and Trial Attorney Shannon Pedersen of the Department’s Consumer Protection Branch.
Source: U.S. Department of Justice