B. Braun, a medical device maker, is being sued in a class action lawsuit due to issues with its artificial knee replacements. The devices, which are coated with ceramic, were promoted to surgeons in spite of the company having knowledge that some of the Aesculap knee replacement devices could potentially fail, according to the lawsuit, which was filed in a California court.
What Went Wrong with the Devices?
The company, which is based in Bethlehem, has a subsidiary in Aesculap Implant Systems that marketed the “advanced surface” ceramic artificial knee replacement devices as being superior to the standard metal type and claimed that they would last longer, according to the lawsuit. However, the ceramic joints proved to be defective because they failed to properly adhere to the cement that was used to bond the devices to patients’ bones, according to the suit.
As a result of the malfunction, 25 patients who received knee replacement surgeries with the devices are suing both B. Braun and Aesculap in a class action lawsuit in a California court. The patients were or will be required to endure additional surgeries to rectify the problem with the joints or have a completely different knee replacement device put in place, according to the lawsuit.
The lawsuit was filed by a group of attorneys in the Los Angeles Superior Court in October 2017. The attorneys represent patients from Florida, Louisiana and 10 additional states.
How did the Devices Get on the Market?
The Aesculap knee replacement class action suit alleges that the company look for and got permission from the US Food and Drug Administration to sell the advanced surface knee replacement devices. To get that approval, Aesculap misrepresented that the devices were equally as safe and effective as those that had already been approved and on the market. The class action lawsuit alleges that this particular process is far less involved than the FDA’s standard medical device approval process.
The lawsuit further alleges that the surface of the ceramic coating on the knee replacement devices is prone to collecting moisture at the exact point where the bone cement is used to bond the devices to the tibias or femurs of patients. As a result of that moisture, the knee implants became loose and prematurely failed.
According to the lawsuit, it is fairly common for a doctor to saw to cut through bone cement when removing a replacement knee implant. However, in the cases in which the ceramic joints made by Aesculap were used, surgeons discovered that the components of the implants were very easily removed by hand and even when just using “two fingers or after a single mallet strike,” according to the class action suit.
The Companies Were Aware of the Problem
Doctors told B. Braun and Aesculap multiple times that the replacement knee devices had come loose in patients and that no bone cement was present, according to the lawsuit. The two companies replied by placing the blame on defects in the brand of bone cement, the use of cement that included antibiotics or surgeons adding antibiotics in their personal cementing techniques, according to the suit. However, the suit alleges that the companies failed to include detailed instructions with the knee replacement implants as to the type of bone cement that should be used or the technique to apply it.
Furthermore, the lawsuit claims that B. Braun and Aesculap deliberately hid the extent of the issue from doctors, people involved in sales and the FDA. The suit further alleges that the two companies failed to adequately test the devices prior to putting them out on the market. In addition, according to the lawsuit, a clinical trial was prematurely ended after a doctor noticed that the bond between the device and bone cement had malfunctioned.
The lawsuit alleges that the defendants deliberately, and in bad faith, terminated the study on the devices to conceal the dangers and risks associated with the devices’ ceramic coating. It also states that the companies did not report the problems to the FDA.
Learn more about Medical Device Lawsuits.
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