Robotic surgery systems are supposed to make surgical procedures less invasive and more precise, and to leave patients with quicker recovery times. Unfortunately, some systems, including the da Vinci Robotic Surgery system has left too many patients burned, injured, and even dead. Maker Intuitive Surgical is facing a number of lawsuits started by patients harmed by surgical complications or the loved ones of those who died after surgery. da Vinci Robotic Surgery lawsuits are only expected to increase and if you have been hurt by this surgical technology, you might want to consider adding your name to the list.
The Robotic Surgery System
Intuitive Surgical, headquartered in Sunnyvale, California, created the da Vinci system to improve surgical outcomes. The system is supposed to make more precise movements than a human surgeon can do with his or her hands. It is supposed to be less invasive than traditional surgery, reduce the number and severity of complications, and lessen the recovery time patients experience after surgery. It is also supposed to make surgeries less expensive because it reduces the number of personnel needed in the operating room.
The system works by using robotic arms and tools, operated remotely by the surgeon, to make incisions and perform surgical procedures. There are two main components to the system: the cart with four robotic arms sits right next to the patient on the operating table. The console is typically in the operating room as well, with a surgeon using it to direct the robotic arms. Through the console the surgeon gets a high-definition, three-dimensional view of the surgical area and through the arms of the robot can make very precise movements.
The U.S. Food and Drug Administration (FDA) have approved the da Vinci system for use in a number of different types of surgical procedures. These include tumor and gallbladder removals, heart surgeries, prostatectomies, and hip replacements. The system is also often used for gynecological surgeries like tubal ligations and hysterectomies.
Complications and Injuries
Although the robotic system is supposed to make surgery safer for patients, there have been a lot of complications that would not have happened in traditional surgeries. These complications have had serious consequences for some patients, and have even caused fatalities. It is because of these incidents that there are several da Vinci Robotic Surgery lawsuits going through the court system.
One major concern with the robotic system is that it requires longer surgical times. This means that patients must stay under anesthesia longer and that carries risks. One of the general risks of any surgery is a bad reaction to anesthesia. The longer a patients stays under, the greater the risk for complications and reactions, such as breathing difficulties.
Many patients have reported being burned by the da Vinci robot. The machine has been found to malfunction and cause sparks, which have burned patients on the operating table. It has also been blamed for heating up organs and causing damage to them. In some cases these heat and burn injuries were not discovered right away. If they had, the patient could have been spared more damage and harm.
Some of the most disturbing reports, which have spurred some of the lawsuits, include cases of excessive bleeding during and after surgery. There have been cases in which the robot accidentally cut a main artery and caused massive bleeding. In other cases, patients experienced serious internal bleeding and scarring after surgery. There have also been reports of serious infections and damaged organs because of the robotic system.
Cost vs Risks
There have been many criticisms of the da Vinci system from experts and surgeons. In addition to the dangers that have been reported, there is the high cost. One system costs around $2 million, which seriously limits access to it. Many are questioning whether this high cost is worth the risks of complications that come with the surgical robot.
Evidence from research seems to prove that there is good reason to doubt the value of such an expensive machine. One study found that the complications after hysterectomy surgery were no less common or severe with the da Vinci system when compared to traditional surgeries. There is also evidence that surgeons using the system have not been adequately trained and that this may lead to more complications.
Unethical Marketing
In spite of the risks and the possible complications, Intuitive has engaged in aggressive marketing to sell its pricey robotic surgical system. These marketing strategies have been called into question. One issue is that the company has been accused of pushing the system on doctors who are not trained well enough to use it. One study found that a doctor needed to conduct about 200 surgeries before being qualified to operate the da Vinci system without supervision.
Emails between sales representatives and other people inside Intuitive have shown that they pushed the machine on untrained doctors. In one case a sales representative told hospital administrators and doctors that requiring a surgeon to have five practice surgeries before being allowed to use the machine unsupervised was too high. This is in sharp contrast to the study that found doctors need hundreds of supervised surgeries to be adequately trained. This negligence in sales and marketing could help plaintiffs in lawsuits against the company make their cases.
FDA Warnings
Intuitive has been issued warnings by the FDA regarding the da Vinci system, and these warnings may lend credibility to the lawsuits pending. The problems with the system that the FDA listed in its warnings included instructions that were incorrect regarding system accessories and inspections and tip covers that injured patients. The agency also warned the company against marketing the machine for certain procedures that the FDA did not consider it safe for, including certain pediatric procedures and thyroid surgeries.
da Vinci Lawsuits
Several patients who suffered complications from da Vinci surgery have filed lawsuits against Intuitive. There have even been suits filed by the loved ones of patients who died during or after a surgery. In one case a young woman died from internal bleeding and her father filed a lawsuit claiming it was the robotic surgery system that caused the bleeding and her death. The surgery should have been a routine hysterectomy.
In another suit a woman claims that she also suffered serious injury after what should have been a routine gynecological surgery. She was having tissue removed because of endometriosis and claims that the da Vinci system tore her colon and rectum. This required multiple corrective surgeries, but she also now lives with permanent damage that could not be corrected.
Settlements
Many people are awaiting settlements and decisions from their da Vinci lawsuits, but one woman at least has received a monetary settlement for her pain and suffering. Michelle Zarick received more than $10 million in early 2016 for injuries caused by a da Vinci-operated hysterectomy, although the specific terms of the settlement have not been made public. Her case was only the second to go against da Vinci, but several more are still pending.
If you have been injured during a da Vinci robotic surgical procedure, you can join the list of pending lawsuits and seek the financial compensation you need to overcome your health problems and emotional suffering. Consult with a lawyer to find out what step to take next.
Sources
- http://well.blogs.nytimes.com/2013/09/09/new-concerns-on-robotic-surgeries/?_r=1
- http://www.nytimes.com/2013/03/26/health/salesmen-in-the-surgical-suite.html?pagewanted=all&mtrref=undefined&gwh=6E4F1AC7E5A50E4C8229D6BD7CAD5CB4&gwt=pay
- http://www.aboutlawsuits.com/wp-content/uploads/2014-03-12-Starr-Complaint.pdf
- http://www.nbcnews.com/health/health-care/electrical-burns-may-burst-surgical-robots-bubble-f6C10321766
- http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm363260.htm
- http://well.blogs.nytimes.com/2013/02/25/questions-about-a-robotic-surgery/?_r=0
- http://www.mercurynews.com/bay-area-news/ci_29791334/intuitive-surgical-settles-robot-arm-litigation