DaVinci Robot Attorney


  The FDA asked surgeons at to list the complications
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Robotic surgeries have had problems due to the surgeon’s lack of training
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The da Vinci Surgical Robot has been used in surgeries nationwide, including hysterectomies, prostate removal, and other delicate procedures. The robot, which has long arms controlled by a surgeon. The da Vinci robot was supposed to perform faster surgery but that hasn't been truthful with many cases.

Investigators believe there is a design defect in the da Vinci surgical robot. The FDA has received reports that the robotic arms may not be properly insulated. As a result, excess electricity can cause severe injuries, including burns and tearing of the internal organs, vaginal cuff dehiscence, severed ureters, bowel injuries, excessive bleeding, and even death.

Not only is the product considered defective, but there is reason to believe that the device's manufacturer, Intuitive Surgical, Inc, was aware of the issue and its potential risk to patients. Several product liability suits have claimed that Intuitive Surgical failed to disclose the results of pre-marketing testing issues, and also failed to perform "post-marketing surveillance" of the injuries attributed to the device. The manufacturer kept these matters secret from doctors and their patients.


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Litigation News:
March 31, 2013

A da Vinci lawsuit claiming the system led to the death of a patient is set to go to trial April 15, according to Bloomberg News (3/26/13). In the same article, it was reported that defendant Intuitive’s attempt to have the lawsuit thrown out was denied.

Fred Taylor’s family filed a robotic surgery lawsuit against Intuitive Surgical for the death of Fred Taylor. The deceased plaintiff, Fred Taylor, underwent robotic surgery for a prostate procedure in 2008. The family maintains the surgeon who performed the surgery with the da Vinci robotic system was insufficiently trained, and elected to perform the procedure without supervision too soon.


Massachusetts Cautions Hospitals About Robotic Surgery
Hospitals get advisory letter, March 26, 2013

Reports of complications from robot-assisted surgery are rising, according to Massachusetts health officials who sent hospitals an “advisory” letter last week alerting them about their safety concerns.

In some cases, it appears that doctors have used the aggressively marketed robots to perform hysterectomies and colorectal operations that were too complex for the technology, or for the surgeons’ skill level in directing the robots’ actions.

During one hysterectomy, two surgeons failed to coordinate their movement of the remote-controlled robotic arms, damaging the patient’s bowel and causing excessive bleeding, according to the letter from the Quality and Patient Safety Division, part of the agency that licenses Massachusetts doctors.

In another hysterectomy, a woman was anesthetized and placed for nearly four hours in a steep head-down angle — a position often used during robotic operations. She suffered shoulder injuries. The advisory described a number of mishaps but did not identify the doctors or hospitals involved.

Robotic surgery — in which doctors sit at a video console and remotely move robotic arms holding surgical instruments and a tiny camera — has surged in popularity for prostate operations and other procedures. That’s partly because the manufacturer and hospitals heavily advertise the technology as reducing complications and speeding recovery.

Brigham and Women’s Hospital last fall allowed shoppers to “test drive” a robot outside Macy’s at the Natick Mall, by sitting at the console and manipulating the arms. Community hospitals have jumped on the bandwagon, too. St. Luke’s Hospital in New Bedford invited the public to get behind the controls of its new robot in January, while others including Beth Israel Deaconess Hospital Milton have erected highway billboards.

The hospitals now say they are reviewing some of their marketing activities.

The patient safety division urged hospitals to make sure that surgeons are proficient in robotic surgery before allowing them to operate and that doctors carefully screen patients for risk factors. It also advised hospitals to establish multidisciplinary committees to monitor results of the surgeries.

Patient injuries during robotic surgery have grown over the past two years, the division said, but it would not provide the data. The advisory comes amid a growing number of patient lawsuits nationally, some of which allege doctors inexperienced with the robot took so long to complete operations that patients suffered nerve and other injuries from the anesthesia or from the angle of the operating room table.

“The marketing is not based on any data,” said Dr. Peter Dunn, director of perioperative services at Massachusetts General Hospital. “This tool was brought to us [by the manufacturer] solely as a marketing device. The medical community didn’t do what it should have done — say, ‘Wait a minute, hold on.’?”

Surgeons who are enthusiastic about the technology say it allows them to operate with more precision. The robotic arms move in more directions than the human wrist, and the machine’s software smooths out small hand tremors. Images on the video screen are also highly magnified, allowing the surgeon a better view of the patient’s anatomy. They also tend to be less invasive.

Still, proof that these advantages lead to better results has been elusive. In January, a national medical safety organization, the ECRI Institute in Pennsylvania, concluded based on an analysis of relevant studies that robotic surgery is booming despite limited evidence that it works better than standard operations.

Intuitive Surgical Inc. of California, the manufacturer of the da Vinci robot — the only surgical robot on the market — disputes that assertion.

“Numerous peer-reviewed studies including large population studies have demonstrated lower complication rates and mortality rates compared to open surgery,’’ company spokesman Geoff Curtis said in a written statement to the Globe.

Curtis called the state advisory “balanced’’ and said the company “agrees with the report’s conclusions.”

“We think these key points align with our mission to improve surgical outcomes for patients.’’ he said.

The state’s advisory recommended that hospitals pay attention to whether direct-to-patient marketing changes how they select patients, given that such advertising has led patients to seek out the procedure from their doctors. It also cautions hospitals to make sure their websites include the risks as well as the benefits of robotic surgery. Few do, according to a Globe sampling.

The Brigham said it plans to change its website promotion of robotic surgery to reflect the recommendations, while Milton Hospital and Southcoast Health System, which includes St. Luke’s, are considering adding information on risks.

Dunn said that patients undergoing robotic surgery to remove cancerous prostates are surprised when they experience complications because hospitals have been so positive about the technology.

“It’s just that the complications are different’’ from those more common in traditional surgery, he said. “They’re idiosyncratic. For example, your instruments may be out of your field of view so you may injure another organ.’’

Urologists urged Mass. General to buy a robot in 2007, Dunn said, because they were fielding calls from interested patients. The hospital purchased one but has decided not to advertise it, he said.

Dr. Jim Hu, a surgeon at UCLA Medical Center in Los Angeles who has researched robotic surgery, said the da Vinci has been used in prostate cancer surgery since 2000. Complications were high in the early days as surgeons learned how to use the robot, he said, but have since leveled. As surgeons expand their use of the robot to other surgeries, patient injuries may be rising again, he said.

In 2008, more than half of all robot-assisted surgeries were for prostate cancer. Now, hysterectomies are the fastest-growing type of robotic surgery, comprising about 40 percent of operations, according to ECRI.

Still, just because surgeons have more experience with robot-assisted prostatectomies does not mean patients necessarily experience better results than with traditional surgery.

In fact, a study Hu led while he was at the Brigham in 2009 found that cancer patients who underwent minimally invasive prostate removal with the robot were more than twice as likely to experience incontinence or impotence a year and a half after their operations than patients who had traditional surgery using an open incision, though the overall risk was still small in both cases.

Tracy Gay, director of the Division of Quality and Patient Safety, said the agency does not have the authority to require hospitals to change procedures. “We were saying, here are some lessons. We just want them to know this should be on their radar screen,’’ she said.

In a third surgery described in the division’s advisory, a colorectal operation, diseased rectal tissue was left in the patient’s abdomen. It had to be removed during a second operation. The hospital where the error occurred found that the use of the new technology “greatly increased the complexity’’ of the procedure and that the surgeon “was still refining the surgical process.’’ The hospital hired a “robotic resource’’ nurse to improve surgical team communication.

In the two hysterectomy cases, the hospitals also reported improvements, such as reserving the robot for less-complex procedures and repositioning patients during operations to prevent shoulder injuries, the advisory said.

Given the high cost of the robot equipment — $1.5 million to $1.75 million, not including annual service fees and the expense of buying disposable instruments — hospitals must attract manypatients to reap a return on their investment. ECRI said procedures nationwide rose from 25,000 in 2005 to 360,000 in 2011.

“Hospitals have this equipment and they have to use it,’’ said Diane Robertson, ECRI’s director of Health Technology Assessment Information Service. “Hospitals generally speaking in their advertising and marketing have made some claims not necessarily supported by the evidence.’’

Hu said hospitals have engaged in an arms race, while not paying close enough attention to standards for allowing doctors to use robots in surgery. “It’s a great tool,” he said, “but it’s not good if people don’t know how to use it.”


Intuitive Surgical's Robot Surgeons Encounter Human Lawyers

After Michelle Zarick complained of excessive vaginal bleeding in 2008, her doctor found growths in her uterus and suggested she undergo a hysterectomy. Her gynecologist described one option, robotic surgery, as “the latest, greatest” minimally invasive technique available. With robotic instruments doing the delicate work usually performed hands-on by doctors, there’d be less pain and bleeding, Zarick was told. “In my mind,” she recalls, “there was no alternative but to use this fabulous technology.”

Five weeks following her 2009 surgery, in which a robot made by Intuitive Surgical (ISRG) was used to remove her uterus, Zarick felt something pop while she was in the bathroom. She looked down and saw her intestine protruding from her vagina. Four years later, the now 41-year-old sports-medicine student from Lincoln, Calif., says she has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles, and a diminished sex life. The robot “forever changed my life for the worse,” says Zarick, who in December filed a product liability suit against Intuitive. Damages were not specified.

Angela Wonson, an Intuitive spokeswoman, says it’s company policy not to comment on litigation. In a filing in the Zarick case, Intuitive “denies each and every allegation,” arguing the injuries were caused by events that “were extraordinary,” not foreseeable, and outside the company’s control.

Zarick’s suit is one of at least 10 filed in the past 14 months that stem from serious complications involving Intuitive’s robots. According to a federal lawsuit filed in California, the liver and spleen of a Michigan man were allegedly punctured during a heart valve repair, leading to 15 hours of internal bleeding. Another federal suit in Alabama describes a man who suffered damage to his rectum and bowel after prostate surgery.

The U.S. Food and Drug Administration in January sent out surveys to surgeons about the safety of Intuitive’s robo-surgery gear. The FDA hoped to determine whether a rise in reported mishaps is “a true reflection of problems,” says FDA spokeswoman Synim Rivers.

That’s cast a shadow over one of the fastest-growing medical technologies in the U.S.—and Intuitive, which dominates the field. The Sunnyvale (Calif.)-based company received almost all its $2.2 billion in revenue in 2012 from its da Vinci Surgical System and related products. The original prototype was developed under a U.S. Army contract in the 1980s to build a system for remote-controlled battlefield surgery. Intuitive’s robot was cleared for use in 2000, and the company’s products remain the only robotic systems approved in the U.S. for soft-tissue procedures that include general surgery, gynecological surgery, and prostate operations. The machines, which can cost about $1.5 million apiece, were used in 367,000 U.S. procedures in 2012, up from 228,000 two years earlier. That growth helped boost Intuitive’s stock market value 83 percent in the three years ended Feb. 1, to about $23.2 billion.

“Part of what’s driven this market is people seeking out robotic surgery,” says Michael Matson, an analyst with Mizuho Securities USA in New York. “Hospitals market it, and the patients seem to think it’s better.” The real threat to Intuitive is “that the patients would get scared,” he says, and stop seeking robot operations.

In robo-surgery, a doctor peers into a video game-style console several feet from the patient. Foot pedals and hand controls allow the physician, guided by a 3D camera, to maneuver mechanical arms equipped with surgical tools. This differs from other minimally invasive operations in which doctors stand over a patient and manually manipulate instruments and cameras through small incisions. (Many surgeries are still of the traditional variety, with doctors making larger incisions that take longer to recover from.)

The Intuitive machine’s benefits include a high-definition camera system and robot arms and joints designed to precisely mimic natural hand movements, the company says. Critics point to the high price and the lack of large, controlled trials showing clear long-term benefits, compared with standard less invasive operations. A study published in February in the Journal of the American Medical Association found that robotic uterus removal costs 33 percent more than standard minimally invasive hysterectomies, without lowering the complication rate.

A review of adverse event reports—self-reported filings of procedures that don’t go according to plan—sent to the FDA since 2009 shows that reported injuries involving procedures done using Intuitive machines jumped to at least 115 in 2012, from 24 in 2009, and deaths rose to 30 from 11. The robots have been linked to at least 70 deaths since 2009.

The reports—from doctors, patients, and companies—don’t necessarily mean the robots caused any deaths, only that they were involved in procedures in which deaths occurred. Yet adverse event reports have in the past served as an early warning system on medical-device safety. While the number of complications reported may be small given the large volume of operations done, it’s set off warning bells. In January the FDA sent out letters to major hospitals asking surgeons about complications, training, and which procedures Intuitive’s robots may be most and least suited for. Dr. Myriam Curet, Intuitive’s chief medical adviser, says she’s confident the robots are “extremely safe,” noting that the “extraordinarily small” percentage of deaths and injuries hasn’t grown over time.

Martin Makary, a surgeon at Johns Hopkins Hospital, says all complaints may not be reported by hospitals, which often use the machines as a draw to gain patients. “No one knows the [complete] numbers,” says Makary, who’s studied how hospitals market the robots. “But we all have seen or heard of cases of inadvertent injuries.”

The bottom line: Intuitive Surgical, whose sales have more than tripled since 2007, has been sued over complications from robot-assisted surgeries.



Statement on Robotic Surgery by ACOG President James T. Breeden, MD
March 14, 2013

Washington, DC -- Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.

The outcome of any surgery is directly associated with the surgeon’s skill. Highly skilled surgeons attain expertise through years of training and experience. Studies show there is a learning curve with new surgical technologies, during which there is an increased complication rate. Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons. While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.

Vaginal hysterectomy, performed through a small opening at the top of the vagina without any abdominal incisions, is the least invasive and least expensive option. Based on its well-documented advantages and low complication rates, this is the procedure of choice whenever technically feasible. When this approach is not possible, laparoscopic hysterectomy is the second least invasive and costly option for patients.

Robotic hysterectomy generally provides women with a shorter hospitalization, less discomfort, and a faster return to full recovery compared with the traditional total abdominal hysterectomy (TAH) which requires a large incision. However, both vaginal and laparoscopic approaches also require fewer days of hospitalization and a far shorter recovery than TAH. These two established methods also have proven track records for outstanding patient outcomes and cost efficiencies.

At a time when there is a demand for more fiscal responsibility and transparency in health care, the use of expensive medical technology should be questioned when less-costly alternatives provide equal or better patient outcomes. Hysterectomy is one of the most common major surgeries in the US and costs our health care system more than $5 billion a year.

At a price of more than $1.7 million per robot, $125,000 in annual maintenance costs, and up to $2,000 per surgery for the cost of single-use instruments, robotic surgery is the most expensive approach. A recent Journal of the American Medical Association study found that the percentage of hysterectomies performed robotically has jumped from less than 0.5% to nearly 10% over the past three years. A study of over 264,000 hysterectomy patients in 441 hospitals also found that robotics added an average of $2,000 per procedure without any demonstrable benefit.

If most women undergoing hysterectomy for benign conditions each year chose a vaginal or laparoscopic procedure—rather than TAH or robotic hysterectomy—performed by skilled and experienced surgeons, pain and recovery times would be reduced while providing dramatic savings to our health care system. Conversely, an estimated $960 million to $1.9 billion will be added to the health care system if robotic surgery is used for all hysterectomies each year.

Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice. Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.

Intuitive Robot Probe Threatens Trend-Setting Surgeries

By Robert Langreth - Mar 1, 2013
The safety of robots made by Intuitive Surgical Inc. (ISRG) is being probed by U.S. regulators, raising questions about the prospects of one of the hottest technologies in health care.

The Food and Drug Administration asked surgeons at key hospitals to list the complications they may have seen with the machines, which cost about $1.5 million each and were used last year in almost 500,000 procedures. The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training, according to copies of the survey obtained by Bloomberg News.

The answers may sway debate on whether robotic surgeries promoted as being less invasive are worth the extra cost. The findings may also determine the outlook for Intuitive. The da Vinci surgical system and related products generated most of the Sunnyvale, California-based company’s $2.2 billion revenue in 2012, and helped boost market value 70 percent over three years to about $23 billion, according to data compiled by Bloomberg.

The surveys were sent to hospitals that belong to a product safety network overseen by the FDA. What the agency is trying to determine is whether a rise seen in incident reports sent to the agency are “a true reflection of problems” with the robots, or the result of other issues, said Synim Rivers, an agency spokeswoman, in an e-mail. “It is difficult to know why the reports have increased,” she said.

Incident reports are sent to the agency by patients, medical professionals and companies. They “can contain incomplete, inaccurate, duplicative and unverified information,” Rivers said.
‘System Redundancy’

Intuitive fell 11 percent yesterday to close at $509.89. The stock recovered prior to the market opening today, rising 8.8 percent to $554.62 at 9:10 a.m. New York time when at least four analysts reiterated their recommendations of the shares. Jeremy Feffer, a Cantor Fitzgerald LP analyst, raised his rating to buy from hold, saying “We see limited risk of this investigation materializing into significant punitive measures against the company.”

The adverse event reports sent to the FDA outline serious complications, including those involving gynecological surgeries that make up about half of the procedures involving Intuitive’s robotic system. They include damage to ureters and bowels as well as instances when instruments broke off from the robot and fell into patients. Reports also cited burns to various organs or vessels, most repaired during the surgery itself.

Many of the reports were filed by Intuitive Surgical and state that no robot malfunction was found or that the problem came from user error. Several originated from patients, who aren’t identified.

Early Warning
The robots are “extremely safe,” said Myriam Curet, Intuitive’s chief medical adviser, in a telephone interview. “There is a lot of redundancy in the system to make it as safe as possible.” The percentage of deaths and injuries involving the company’s da Vinci robotic system, “is extraordinarily small,” she added, and “hasn’t grown” over time.

While the number of adverse-event reports to the FDA is small compared with the total number of procedures, the agency’s reporting system has in the past served as an early warning system on concerns about medical-device safety.

“One of the risks is that the FDA could recall parts of the product or certain instruments, or somehow put restrictions on certain surgeries,” said Michael Matson, an analyst with Mizuho Securities USA in New York. “But I don’t think that’s very likely,”

A rise in adverse events isn’t necessarily alarming because the number of surgeries done with the robot has been growing rapidly, said Matson, who is based in New York and has a buy recommendation on Intuitive.

Stock Pressure
“The bigger concern would be that the patients would get scared,” he said. “Part of what’s driven this market is people seeking out robotic surgery; hospitals market it and the patients seem to think it’s better.”

Intuitive’s stock is likely to be under pressure until the company can prove the safety worries aren’t a significant issue, Matson said. In the meantime, “there’s going to be an overhang,” he said.

In robotic surgery, the physician sits at a video-game style console several feet from the patient, peering into a high-definition display while using foot pedals and hand controls to maneuver mechanical arms equipped with surgical tools. A camera provides a three dimensional view of the work being done inside the patient.

Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore who has researched the marketing of the systems, said safety should now become part of the debate.

“Patients need to know the truth about robotic surgery,” Makary said in a telephone interview. “The Achilles-heel feature” of the robot is its lack of tactile feedback, which can spur “inadvertent injuries if added caution is not taken.”

Among surgeons, there has been an intensifying debate about whether the benefits of robotic surgery justify the increased costs. A report published in the Journal of the American Medical Association on Feb. 20 found that surgery to remove the uterus with the Intuitive robot costs thousands of dollars more without reducing complications, compared with standard less-invasive surgery.

Examining data from 264,758 women who had a hysterectomy for benign conditions at 441 U.S hospitals, the study found that robotic operations cost hospitals $2,189 more per procedure than performing the same surgery without the robot.

A version of the letter sent to doctors by the FDA in January said the survey was being done because “a recent review of medical device report data is showing an increase in patient adverse reports.” A revision of the document requested by Intuitive and sent again on Jan. 22 deletes that wording, according to the company.

The first version was a draft that was sent out inadvertently, the FDA’s Rivers said. The agency only realized this after the company contacted the regulators, she said.

“We do not ask companies to weigh in” on this type of survey, she said.

The first version of the letter “did not accurately characterize what assumptions can or should be made from the number of reports in the FDA database,” Rivers said.

The critics are right - if they're talking about innovations like the da Vinci robot, which costs more than a million dollars and yet has never been shown by a randomized trial to improve the outcomes of prostate surgery. Indeed, a 2009 study showed that while patients had shorter hospital stays and fewer surgical complications like blood loss when they underwent this kind of robotic surgery, they later "experienced more ... incontinence and erectile dysfunction." Similar problems are occurring with robotic surgery for other cancers.

In other words, this is a pseudo-innovation - a technology that increases costs without improving patients' health.


Comparative Effectiveness of Minimally Invasive vs Open Radical Prostatectomy

Context Minimally invasive radical prostatectomy (MIRP) has diffused rapidly despite limited data on outcomes and greater costs compared with open retropubic radical prostatectomy (RRP).

Objective To determine the comparative effectiveness of MIRP vs RRP.

Design, Setting, and Patients Population-based observational cohort study using US Surveillance, Epidemiology, and End Results Medicare linked data from 2003 through 2007. We identified men with prostate cancer who underwent MIRP (n = 1938) vs RRP (n = 6899).

Main Outcome Measures We compared postoperative 30-day complications, anastomotic stricture 31 to 365 days postoperatively, long-term incontinence and erectile dysfunction more than 18 months postoperatively, and postoperative use of additional cancer therapies, a surrogate for cancer control.

Results Among men undergoing prostatectomy, use of MIRP increased from 9.2% (95% confidence interval [CI], 8.1%-10.5%) in 2003 to 43.2% (95% CI, 39.6%-46.9%) in 2006-2007. Men undergoing MIRP vs RRP were more likely to be recorded as Asian (6.1% vs 3.2%), less likely to be recorded as black (6.2% vs 7.8%) or Hispanic (5.6% vs 7.9%), and more likely to live in areas with at least 90% high school graduation rates (50.2% vs 41.0%) and with median incomes of at least $60 000 (35.8% vs 21.5%) (all P < .001). In propensity score–adjusted analyses, MIRP vs RRP was associated with shorter length of stay (median, 2.0 vs 3.0 days; P<.001) and lower rates of blood transfusions (2.7% vs 20.8%; P < .001), postoperative respiratory complications (4.3% vs 6.6%; P = .004), miscellaneous surgical complications (4.3% vs 5.6%; P = .03), and anastomotic stricture (5.8% vs 14.0%; P < .001). However, MIRP vs RRP was associated with an increased risk of genitourinary complications (4.7% vs 2.1%; P = .001) and diagnoses of incontinence (15.9 vs 12.2 per 100 person-years; P = .02) and erectile dysfunction (26.8 vs 19.2 per 100 person-years; P = .009). Rates of use of additional cancer therapies did not differ by surgical procedure (8.2 vs 6.9 per 100 person-years; P = .35).

Conclusion Men undergoing MIRP vs RRP experienced shorter length of stay, fewer respiratory and miscellaneous surgical complications and strictures, and similar postoperative use of additional cancer therapies but experienced more genitourinary complications, incontinence, and erectile dysfunction.