Pennsylvania- and Germany-based company B. Braun Medical has agreed to pay nearly $8 million after being accused of selling saline syringes fraught with contamination. Braun purchased the syringes from Am2Pat, a manufacturing company, even though it had acquired information prior to the purchase indicating that the syringes suffered from manufacturing issues at the plant in North Carolina where they were produced. Two months after Braun purchased the syringes, it initiated a recall based on information indicating that the radiation sterilization process used caused the saline to develop particulates.
Following the recall, Am2Pat stated that it had not provided correct information to Braun before the sale of the syringes. According to this information, the manufacturing company had installed new equipment at its plant without first ensuring that the equipment was in good working order following the move. Despite this provision of information, Braun started purchasing saline syringes from Am2Pat again and did not conduct its own independent inspection of the manufacturing facility prior to doing so.
Roughly one month later, the syringes were found to contain a dangerous bacteria called Serratia marcescens. Patients in New York, Texas, California, and Nebraska reported experiencing illness and contamination as a result of using the syringes. A second recall of this batch of syringes was also initiated.
Medical device manufacturers have a duty to use due care when designing and producing medical devices. This includes ensuring that they are manufactured properly and are free of any harmful contaminants. Also, a product must contain a sufficient warning to the consumer about any known dangers, such as the potential presence of contaminants. If the plaintiff can show that the manufacturer failed to use reasonable care, the plaintiff may recover compensation for any injuries or damages resulting from the defective device. After a retailer has actual notice of deficiencies or problems with the device, the retailer can be held liable for placing these products in the stream of commerce.
A plaintiff may also assert a product liability claim against the manufacturer, which involves showing that the product was designed in an unreasonably dangerous manner or suffered from a defect while it was being manufactured. A manufacturer can also be liable according to a product liability theory for failing to include proper warnings and instructions about the safe use and handling of the product. There are a handful of other causes of action that may apply, including breach of warranty and fraudulent misrepresentation.
At Moll Law Group, our dedicated team of defective medical device lawyers has substantial experience investigating and litigating these complex and technical claims. The last thing you should have to worry about at this time is figuring out how to navigate the legal system while coping with painful injuries. We offer a free consultation to help you determine the best causes of action available to you, and we represent clients throughout the U.S., including in Texas, California, New York, and Illinois. Call us now at 312-462-1700 or contact us online to schedule your appointment.