Since their debut in the 1980s, robotically-assisted surgeries have grown increasingly common. In a robotically-assisted procedure, a surgeon uses a robot to manipulate instruments, allowing for more precise control on actions such as incision and removal. Robots reduce the stress and fatigue experienced by surgeons, especially during longer operations. In addition, the robotic arms are remarkably steady.
Introduced in 2000, the da Vinci surgical system manufactured by Intuitive Surgical is a popular robotic device. Da Vinci systems are currently installed in over 1,400 hospitals nationwide and have been used in more than 1.5 million procedures globally. These robotic systems are often used in cancer operations, gallbladder removals, and hysterectomies (removal of the uterus).
Unfortunately, there have been numerous reports that the da Vinci robots have injured patients. These patients, in turn, are filing a growing number of lawsuits against Intuitive. Some of these lawsuits have alleged that the da Vinci robot failed to let go of a patient's tissue.
Others claim that faulty surgical tips caused injuries to patients. Tip covers are made of silicon and are intended to prevent injury to the surrounding tissue by insulating the instrument. When the tips fail, patients could potentially suffer burns and other injuries to their organs and tissue.
Although Intuitive has admitted to no wrongdoing, the company has recalled its old tips and issued new tip covers with the instructions for immediate use. A number of failed hysterectomies due to improper suture of the vaginal cuff have also been reported. In extreme cases, some da Vinci robots have committed fatal mistakes that led to the deaths of some patients.
The Food & Drug Administration (FDA) sent a warning letter to Intuitive criticizing their safety notification procedures in the summer of 2013. According to the FDA, Intuitive had failed to adequately report da Vinci surgical system malfunctions. In addition, the FDA criticized the company for failing to include instructions on cleaning the da Vinci's robotic instruments. Without proper cleaning, some robots became damaged, thus exposing patients to stronger germs and causing them more harm than good.
Recently, the FDA has reported a greater number of related errors committed by da Vinci systems. For example, a robotic hand may fail to release tissue grasped during a procedure or perforate nearby organs. In some cases, these errors have allegedly led to patients' deaths. However, this increase in raw numbers may be attributable to the growing popularity of da Vinci robots.
Currently, there are a number of lawsuits pending against Intuitive to recover compensation for injuries suffered because of da Vinci robots. Many of these lawsuits are based a theory of product liability. Under product liability law, manufacturers and sellers have a duty to ensure that any products they place on the market are free from unreasonable defects and dangers.
In a product liability claim, there are three ways in which a product may be defective: design defect, manufacturing defect, and defect in warnings. In order for liability to attach, the alleged defect must have caused the patients' injuries. The most common defect is a design defect, which occurs when there is an inherent flaw in a product's design. For example, a patient may allege that the da Vinci robot had a design defect because the way in which the surgical tips were designed allegedly led to an increased risk of burns.
A manufacturing defect, on the other hand, occurs during the production process. Finally, a defect in warning is a problem not with the product itself but with the adequacy of warnings accompanying the product. For example, patients have alleged that Intuitive gave doctors and patients inadequate warnings about the possibility that the robots may malfunction or injure a patient.
Patients injured by the da Vinci robots may also have legal claims against hospitals and health care professionals for medical malpractice. Under medical malpractice law, doctors and hospitals can expose themselves to liability by acting negligently, meaning their conduct fell below the standard of care generally practiced within the profession. For example, hospitals may be deemed negligent for failling to provide their surgeons with proper training in handling da Vinci robots.
People who have lost a close relative to a da Vinci surgical system malfunction may file a wrongful death lawsuit against Intuitive. Under wrongful death laws, surviving spouses, parents, and siblings may sue the party responsible for their loved one's death. In a successful suit, relatives may recover compensations for any medical or funeral expenses, the loss of the deceased's financial assistance, and the loss of comfort and companionship.
Filing a da Vinci injury lawsuit is a complicated undertaking, often requiring medical evidence, expert witnesses, and a detailed knowledge of product liability law. As a result, it's in your best interests to consult with a product liability attorney experienced with medical device cases before deciding on a course of action.Â
