B. Braun Medical Group Pays Out $7.8 Million In Legal Settlement
After numerous defective saline syringes sickened hundreds of patients, allegations began piling up against B. Braun Medical Group for distributing the devices. To resolve criminal charges brought against it, the company will pay $7.8 million - $3 million to victims and $4.8 million in penalties and forfeited profit.
[Photo credit: Flick users: Hernan Pinera, Nestor Lacale]
Medical devices used to treat patients should be safe, effective and meet the strictest quality measures. However, sometimes manufacturers – like B. Braun Medical Group – go to market with defective devices that can cause serious harm.
As one of the largest global medical device companies, B. Braun markets and distributes medical devices for patient care matters including:
- Anesthesia/pain management
- Emergency medicine
- Home infusion therapy
- Oncology and hematology
However, the Pennsylvania-based company recently came under fire after failing to pull defective saline syringes that sickened hundreds of people. Numerous allegations soon came against B. Braun for distributing defective devices from a manufacturing facility known to have problems.
B. Braun’s Agreement With Syringe Manufacturer, AM2PAT Inc.
Beginning in 2006, B. Braun agreed to a business relationship with AM2PAT Inc. (also known as Sierra Pre-Filled) to purchase saline syringes manufactured out of their North Carolina facility. After purchasing the pre-filled syringes, B. Braun marketed and distributed them to hospitals across the country.
During the agreement, AM2PAT moved their manufacturing plant and switched to a new syringe sterilization company. Despite the changes, B. Braun continued to distribute the syringes without having visited the new facility or requesting its quality team to review the device sterilization process.
Despite warnings about questionable manufacturing processes, B. Braun continued selling the harmful saline syringes which ultimately found their way into hospitals throughout the country.
B. Braun Linked To Bacteria-contaminated Syringes
Prefilled saline syringes are used by hospitals to flush out a patient’s catheter before and after medication is administered through an IV. Flushing is performed to keep the device clean and sterile, as well as reduce the risk of contamination. If multiple medications are given through the same line, flushing also helps ensure the drugs do not mix and cause a negative reaction. Since it’s possible for some of the solution to enter a patient’s blood, it’s crucial that the saline is completely sterile.
Unfortunately, B. Braun’s negligence to pull the defective syringes led to a recall within just two months of selling them. The first recall was due to a flawed sterilization process that left impurities in the saline solution. Although AM2PAT neglected to review its sterilization operations after moving to the new plant, B. Braun continued to sell the devices.
Only a short period of time later, hundreds of patients across multiple states became sick as a result of the bacteria-contaminated syringes.
Some of the side effects caused by the defective syringes include:
Patients with weakened immune systems – like those going through radiation treatment – are more susceptible to serious health complications and life-threatening injuries. To date, at least five deaths and more than 100 illnesses have been linked to the defective syringes distributed by B. Braun.
By early 2008, B. Braun finally ended its agreement with AM2PAT amid a nationwide recall of the prefilled saline syringes.
B. Braun Medical Group Litigation
Although the defective syringes were manufactured by AM2PAT, they were branded with the B. Braun name. Because of this, B. Braun was held responsible for the harm caused by contaminated devices.
To resolve the criminal charges brought against the company for the sale of dangerous saline syringes, B. Braun will have to pay up to $7.8 million. Of that, they will pay $4.8 million in penalties and forfeited profit and up to $3 million in restitution to victims of the contaminated syringes. The Justice Department is also requiring the company to implement procedures to oversee their suppliers in the future.