Over the last decades, technology surrounding surgeries have focused on improving how operations are conducted, with emphasis on making surgeries as minimally-invasive as possible. These are often referred to as laparoscopic surgeries, and have been topics of heated medical debates and injury lawsuits throughout the country. Our team of da Vinci surgical robot lawyers can answer any questions patients may have about these legal issues.
The New York Times recently published a piece on a series of reports that criticize the da Vinci surgical robots. The piece begins with the story of a woman, Erin Izumi, who underwent a surgery using robotics in 2009. During the 11-hour surgery, which was to treat endometriosis, the robotic arms tore her rectum and colon. She was rushed to the ER more than a week after the initial surgery, and was hospitalized for five weeks.
In a situation like this, both the hospital and the robotic system company are required to report the injury to the FDA. Despite this requirement no report was made about Izumi’s injury in 2009, and a spokesperson for da Vinci told the paper that it became aware of the incident only after Izumi filed a lawsuit.
The da Vinci robots are manufactured by a California-based company called Intuitive Surgical. More than one million surgeries have been conducted using a da Vinci robotic system, with varying consequences. Thousands of incidents have been reported to the FDA, however, as the above situation illustrates, it is certainly possible this is only a minuscule reflection of that actual numbers.
At least one new study attempted to analyze the lapse in reporting, which was recently published in the Journal for Healthcare Quality. Researchers involved in that study are affiliated with Johns Hopkins, and were able to locate examples of horribly-gone-wrong surgeries using da Vinci robots. Based on these findings, they concluded that serious incidents in da Vinci operations were vastly underreported.
This is incredibly important because Intuitive markets this robotic device as an incredibly safe and less intrusive alternative to traditional surgery, although it is increasingly obvious how misleading this is. In reality, very little is known about the disadvantages of the system and the true rates of injury and death.
The Johns Hopkins study followed reports that involved robotic surgeries throughout the country, locating documents specifically mentioning lawsuits filed by injured patients. In many of these legal papers, plaintiffs alleged that Intuitive was aggressively marketing the robots despite lackluster training for physicians. There were also numerous mentions of the immense pressure placed on hospitals and doctors to “keep up,” with new and emerging technologies
Due to this combination of aggressive marketing and pressure to stay ahead of the innovation curve, robotic surgery is growing dramatically in the U.S. Many medical experts argue that this growth is occurring without proper oversight and monitoring. The lead author of the Johns Hopkins study take this one step further, stating that this trend is indicative of a larger problem in American healthcare: lack of adequate evaluation.
The study author, Dr. Martin Makery, said that doctors and hospitals blindly
adopt new expensive technologies without knowing what they’re actually
getting out of it, whether it will be beneficial to patients in the long
run. A large part of the problem is that the federal “requirement”
for hospitals and companies to report adverse events is not at all enforced.
Makery states that the reports have “no oversight, no enforcement,
and no consequences.”
In a statement, the FDA said that it issues warning letters to facilities who do not report adverse events and that it has the authority to take further actions. One study, published in 2010, found that nearly 60% of surgeons had experienced mistakes during da Vinci operations that were irrevocable. Importantly, female patients were more likely to be injured during robotic operations, as these systems are often used during hysterectomies and other gynecological procedures. About one-third of fatalities associated with da Vincis occur during gynecological surgeries.
The da Vinci robot lawyers at Pintas & Mullins Law Firm are currently accepting cases of serious injury and death from these medical systems. If you or someone you love underwent a procedure using a da Vinci robot and suffered serious consequences, contact our firm immediately. We have decades of experience handling these type of medical device claims, and take clients from all 50 states.