Da Vinci Robot Lawsuit
The da Vinci Surgical System, which was originally designed to make life easier for surgeons performing minimally invasive procedures, has instead prompted a growing number of patients to file da Vinci Robot lawsuits. Since being approved by the U.S. Food and Drug Administration (FDA) in 2000, claims filed over this remote-controlled surgery robot say its use in procedures can cause patients to suffer surgical burns, organ damage, torn blood vessels and other life-threatening injuries.
Da Vinci Robot lawsuits, which seek compensation for lost wages, medical expenses, pain and suffering and other damages allegedly caused by the Intuitive Surgical Inc.-manufactured product, are on the rise. According to a recent report from Bloomberg.com, 10 da Vinci Robot lawsuits had been filed over a period of 15 months. These claims were pending in courts throughout the U.S as of March 2013, the article stated.
Intuitive Surgical challenges any suggestion that in attempt to increase the use of its product it engaged in inadequate surgeon training or improper certification resulting in harm to patients.
The following complications associated with the da Vinci Surgery Robot have been named in adverse event reports filed with the FDA:
- Surgical burns and tears to vital organs
- Surgical burns and tears to arteries and other blood vessels
- Excessive bleeding
- Cut ureters
- Bowel injuries
If you suffered one or more of these injuries, contact an attorney at Bernstein Liebhard LLP today. The Firm is currently offering free and confidential case evaluations for potential da Vinci Robot lawsuits.
FDA Investigates Bad Surgery Robot Complications
Originally approved by the FDA in 2000, Bloomberg.com estimates that Intuitive Surgical Inc.’s da Vinci Surgical System was used in 500,000 procedures last year, which include hysterectomies, gall bladder removal, prostate removal, heart surgeries, and thyroid procedures. The da Vinci Surgery Robot is the only robot approved for soft tissue surgery.
However, a wave of studies and a rising number of complaints from patients who underwent a procedure using the device have caused the FDA to start investigating the health care technology. According to a March 1st report from Bloomberg.com, the agency is in the midst of conducting a survey to measure surgeon training and rates of complication associated with the da Vinci Surgical System at major hospitals in the U.S. The article indicated that the FDA has reached out to facilities part of its product safety network, and asked them to respond to questions related to surgeon training, and which surgeries the da Vinci robot is best and least suited for.
With the results of this survey, the FDA is hoping to determine whether the high amount of reports citing complications with the surgery robot is caused by other issues, or is “a true reflection of problems,” a spokeswoman for the agency told Bloomberg.com.
The FDA’s investigation of the da Vinci Surgical System in the U.S. began after the Journal of the American Medical Association (JAMA) published a study in February 2013 revealing that hysterectomies performed with the da Vinci Surgical System did not reduce the amount of complications compared to a traditional laparoscopy, even though they cost thousands of dollars more. It is estimated that a single da Vinci Surgery Robot costs $1.5 million, and Intuitive Surgical Inc. has said several hospitals have more than one.
Before that, the Journal for Healthcare Quality released a study in 2011 that found hospital websites overestimating the benefits of surgery robots, and failing to mention the risks. The research pointed out that there were no controlled studies showing patient benefit in procedures involving surgery robots.
Meanwhile, Citron Research reported in January that approximately 4,600 adverse event reports have been filed over the da Vinci Surgical System since 2000. The FDA’s MAUDE database also indicated that 3,900 of those complaints were filed between 2007 and 2012. 70 deaths have also been associated with the da Vinci Surgery Robot since 2009, Bloomberg.com reported.
The American Congress of Obstetricians and Gynecologists (ACOG) has since advised its members that hysterectomies involving surgery robots do not improve outcomes for patients, and therefore should not be considered the first choice for most patients.
Da Vinci Robot Lawsuits Growing
A March 2013 report from Bloomberg.com stated that 10 claims over the da Vinci Surgery Robot had been filed in the preceding 15 months.
And that’s not all; where the number of da Vinci Robot lawsuits has grown, so has the number of media reports revealing information about the impending litigation.
CNBC.com recently pulled quotes from FDA-filed adverse event reports related to the surgery robot. Found in the FDA’s database, these reports are being used in a court deposition for claims filed against Intuitive Surgical.
One such adverse event report detailed a surgeon’s struggle with the robot. During a hysterectomy he performed on Dec. 28, 2013, the doctor said, “The bipolar instrument fired unintentionally during a procedure. … The instrument tip did touch the patient’s uterus [and] the customer was able to successfully complete the case plus two additional cases using the same generator with no further incidents.”
A Dec. 13 hysterectomy also described in a FDA-filed adverse event report said the da Vinci Surgery Robot hit the patient in the face during a procedure, which prompted the surgeon to revert back to traditional open surgical techniques.
Bloomberg.com reported in March 2013 that 10 da Vinci Robot lawsuits had been filed over 15 months on behalf of patients who allegedly suffered surgical burns, cut ureters, bowel injuries, excessive bleeding and even death.
Considering a da Vinci Robot Lawsuit? Call Us Today.
If you suffered surgical burns, organ damage, cut ureters or another side effect associated with the da Vinci Surgical System, you may be eligible to file a claim against the manufacturer. A growing number of patients have filed da Vinci Robot lawsuits seeking compensation for medical expenses, lost wages, pain and suffering and other damages incurred by their injuries. To learn more about your legal options, the attorneys of Bernstein Liebhard LLP are offering free and confidential case evaluations to anyone who may have been injured by this health care technology. Contact our Firm today to learn more about da Vinci Robot lawsuits by calling.