B. Braun Melsungen AG is a German medical and pharmaceutical device company, which operates out of 50 countries. The company was founded in 1839. As with the “brand” concept these days, the company does not directly manufacture all of the products that carry its logo.
The pay-outs the company has made relate to the distribution of contaminated in the U.S. The syringes infected patients in multiple U.S. states were made by a third party supplier called AM2PAT.
The syringes were pre-filled saline flush syringes and they were sold in 2007. The syringes contained potentially dangerous particles. According to the U.S. Food and Drug Administration (FDA): “The introduction of particulate matter into the blood stream may result in phlebitis and / or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is a potential for the development of pulmonary embolism.”
The FDA noted initially that this was a potential risk, and that B. Braun had received no reports of any patient injury associated with this issue. However, it was later found that 100 patients became sick due to the syringes, as a result of the contamination.
The key point in the legal case was the brand name of syringes. Speaking with QMed, Benjamin C. Mizer, head of the Justice Department’s Civil Division explains: “The Federal Food, Drug and Cosmetic Act prohibits companies from selling contaminated products, even when the company did not make the product itself.”
The lawyer adds: “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 end result is that B. Braun has agreed to pay $4.8 million in penalties and $3 million in restitution to settle with the U.S. Justice Department in response to the criminal complaints.
