B. Braun Medical, a drug and device maker, has admitted wrongdoing and will pay up to $7.8 million to avoid criminal charges related to the distribution of contaminated saline syringes. The U.S. Department of Justice (DOJ) announced the settlement, which included a non-prosecution agreement last month. The payout includes $3.8 million in forfeitures, a $1 million civil penalty and up to $3 million in restitution for patients who were “directly and proximately harmed” by bacteria-laced saline produced by North Carolina-based AM2PAT Inc. and sold by Germany-based B. Braun.
Although B. Braun did not manufacture the syringe products, it sold them under its name and was responsible for taking certain steps to ensure the products were safe. The company failed to adequately oversee quality control and therefore could have faced criminal liability under the Federal Food, Drug and Cosmetic Act for distributing tainted products, the DOJ said. Benjamin C. Mizer, head of the DOJ’s civil division, said:
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.
The improper manufacturing and sales stretch back almost a decade. Two employees of AM2PAT ultimately received 54-month prison sentences for fraud. Reportedly, the company’s former president, Dushyant Patel, a wanted fugitive, is still on the run. He is believed to have fled the United States. B. Braun’s nonprosecution agreement says that AM2PAT used “dirty and filthy equipment” to manufacture sterile syringes that are used to flush out medical devices, such as catheters. On several occasions, the agreement said that AM2PAT falsified data and hid its wrongdoing from B. Braun. The agreement also contains elaborate detail on B. Braun’s admitted conduct.
On repeated occasions, company employees are described as raising concerns about AM2PAT and being alerted to suspicious products but failing to follow through, sometimes amid the backdrop of overdue syringe orders from customers. The agreement revealed the following:
For example, B. Braun in 2006 conducted an on-site audit of AM2PAT to confirm remedial actions in the wake of a warning letter issued by the U.S. Food and Drug Administration (FDA). However, B. Braun’s auditor signed off on the remedies without even viewing AM2PAT’s manufacturing operations. In 2007, B. Braun began selling syringes without visiting or auditing AM2PAT’s new manufacturing plant. B. Braun ultimately received numerous complaints about saline tainted with orange or black particles and brownish saline that “looked like it contained water from the Hudson River.”
B. Braun is agreeing to an array of compliance actions. The agreement includes the following:
improved vetting and monitoring of suppliers, stronger tracking of customer complaints, enhanced training of auditors and annual certifications of the stepped-up compliance by B. Braun’s CEO. The compliance obligations will last for 30 months, although an extension or early termination are possible depending on B. Braun’s adherence.
In a statement, a B. Braun spokesperson said that the events occurred almost a decade ago and that the company is “fully committed to ensuring patient safety.” The government is represented by Benjamin C. Mizer, John Stuart Bruce, Michael S. Blume, Felice M. Corpening, Allan Gordus, Shannon L. Pedersen and Evan Rikhye of the U.S. Department of Justice.
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