The TigerPaw System has been recalled after reports of heart tissue tears and severe bleeding. More than 4,000 devices, commonly used during open heart surgery, were recalled after dozens of injuries and one death. Medical device lawyers at Pintas & Mullins Law Firm detail this recall below.
The device is manufactured by Maquet Medical Systems and is most commonly used to obstruct the left atrial appendage during surgery. Recently, Maquet has received reports that the device has been tearing the appendage, causing serious bleeding. This recall is considered a Class I, the most serious of its kind.
The FDA has documented many violations at Maquet in the past few years, resulting in five Class I recalls and 40 other recalls between 2009 and 2014. These violations also led to a $6 million settlement in February 2015, which stemmed from a federal lawsuit accusing Maquet of maintaining poor quality standards.
At least one of Maquet’s products involved with that settlement was associated with a suspicious patient death. The FDA requested the company stop production on several devices after its inspections, including hernia meshes and vascular grafts and patches.
The medical device industry reaps sales of more than $85 billion per year, and companies have the legal and ethical responsibility to ensure their devices are safe and effective. When the device is designed or manufactured improperly, or if the approval process was flawed, patients can be subject to serious injury or even death from complications.
If an injured patient decides to sue the medical device manufacturer for negligence, it is considered a product liability lawsuit. Any and all companies that manufacture products are responsible for making a safe product; therefore, the company could be liable for any injuries caused by defects or a dangerous design.
Companies are also required to warn the public about the risks associated with their products. Unfortunately, device manufacturers try to get new innovations onto market as soon as possible, often failing to adequately test for long-term complications and other serious side effects. Product liability lawsuits fall under three general categories:
1. Manufacturing defects – this applies if the design and promotions of the device were proper, but there were flaws in the manufacturing process causing the product to be defective.
2. Design defects – if the original design of the product can cause serious injury or death.
3. Marketing defects – if the company improperly markets the products, either failing to warn the public about the risks or by giving inadequate instructions to physicians.
A great example of the third type of claim is the recent deadly outbreak from a particular kind of medical device called a duodenoscope. Hundreds of patients have been infected by this medical scope and dozens have died. The duodenoscopes can infect patients with a “super bug”, or drug-resistant bacteria that can be fatal in vulnerable patients.
The devices were contaminated with this super bug because they were not
properly cleaned by hospital staff. Duodenoscopes are supposed to be cleaned
and disinfected with a special machine, though the instructions provided
by the device manufacturer are inadequate. This makes it difficult to
fully disinfect the device, causing dangerous bacteria to be transferred
The FDA released an alert in early 2015 stating the duodenoscope’s complex design makes cleaning challenging. Hospitals state they have been sterilizing the scopes according to the manufacturer’s standards, which opens the company up to possible liability. At least one infected patient has filed an injury lawsuit against the company, Olympus American, for failing to instruct hospitals on proper disinfection techniques. More on this issue can be found here.
Our team of product liability lawyers is currently accepting cases of serious injury and death from dangerous, defective, and recalled products. We provide free, no-obligation case reviews to injured victims and families nationwide.