Medical boon or bust?

When the Silicon Valley startup Intuitive Surgical went public 13 years ago, the company was posting $10 million in annual sales, and its little-known surgical robot had been used on just 600 patients worldwide.

Intuitive has since experienced the kind of meteoric growth cherished in the nation's high-tech hotbed, blossoming into a corporation with $610 million in sales of a product, the da Vinci Surgical System, which is considered one of the most coveted status symbols of 21st-century medicine. But along the way, scores of critics say, the company exhibited a baffling disregard for patient safety as it aggressively marketed machines that can cost up to $2.3 million each.

Intuitive is now facing at least 25 product liability lawsuits, and one attorney in the field confirmed that he personally has more than 1,000 potential clients who are claiming injuries from the device. While a Washington state jury cleared the company of liability last week in an initial case involving allegations that the company failed to properly train surgeons, scores of other cases are waiting in state and federal courts that contain wider allegations about defects in the surgical robots themselves.

“This company grew at a tremendous rate, and they were able to successfully create this aura of the robot that everyone fell in line with,” said malpractice attorney and obstetrician Dr. Francois Blaudeau. “We can't let a company from Sunnyvale, Calif., just walk in and change medicine that easily. There will be a lot of litigation, and some of it is going to carry over to the hospitals and the doctors. … They are not going to escape the blowback as more and more information comes out.”

Regulators have already taken note of the complaints. The Food and Drug Administration opened an inquiry this year into the safety of the da Vinci system following numerous adverse event reports. Massachusetts and New Hampshire are also investigating safety concerns stemming from an increasing number of patient complications.

This month the company published an urgent medical device warning of a potential flaw in one of the components of the system that can cause tissue burns inside patients. Hospital officials across the country are now reconsidering their rules for which patients are right for robotic surgery.

The da Vinci system is branded as a minimally invasive alternative to many forms of laparoscopic and traditional abdominal and pelvic surgery. To use it, a surgeon watches a computer monitor displaying images from inside the body and manipulates the robot's arms through a console of hand controls and foot pedals.

Although lawyers and physicians fault the company for exploiting hospital executives' insecurities about falling behind their competitors in the technology arms race, none say that robotic surgery is inherently problematic or that it won't be used in the future. In fact, some of the strongest critics, including Blaudeau, credit Intuitive executives with finally listening to patient concerns in recent months.

That won't necessarily absolve the company from liability if the product itself is found at fault for injuries and deaths.

The jury concluded last week that the company's brief training regimen for two urologic surgeons in Silverlake, Wash., did not make Intuitive liable for any damages when Fred E. Taylor died in 2012 after robotic surgery. Though Taylor died four years after the procedure, his widow Josette Taylor claimed the death was directly caused by complications from a botched operation to remove his prostate.

“We are pleased with the jury's verdict,” company spokesman Geoff Curtis said in an e-mail. “Intuitive Surgical's technologies have extended the benefits of minimally invasive surgery to over 1.5 million patients around the world. We will continue our commitment to patients, surgeons and hospitals to uphold the highest standards of safety.”

Taylor also sued Harrison Medical Center, Bremerton, and the two independent surgeons who performed the procedure. Records on file with the Kitsap County Superior Court say the hospital and surgeons settled those claims without going to trial.

“If I was an attorney working in a hospital risk-analysis department, I would be concerned. I would definitely be interested in reviewing the training protocol that da Vinci is providing my physicians. I would be interested in looking at the product recall closer. I would be interested in talking to the manufacturer further,” said William Dubanevich, a New York attorney with Parker Waichman, which is investigating potential claims involving robotic surgeries. “They may be a potential target.”

Numerous hospitals with da Vinci machines declined or did not return calls for comment, including Harrison Medical Center.

Next year, Intuitive is scheduled to defend a $200 million lawsuit filed by Gwendolyn and Amos Jones of Ethelsville, Ala.—a case seen as a potential “bellwether” trial because it presents allegations that are wider than the Taylor case, and that are alleged by many of the other people claiming to have been harmed.

Gwendolyn Jones, 44, sued the robot manufacturer in federal court April 10 after she said a flawed hysterectomy left her with severe pelvic pain, a damaged bladder and ongoing vaginal leakage of urine, along with emotional distress and loss of normal bodily functions.

The lawsuit says the device is “defective” because it relies on a technology known as monopolar energy, which uses a single electrode to deliver electric current to cauterize wounds, instead of safer methods such as bipolar or ultrasonic energy. The device lacks insulation to prevent electric currents from affecting nearby tissues, according to the lawsuit, and the company doesn't provide the surgical training or support that it promises or notify healthcare providers of known defects.

Jones' suit also takes aim at the company's marketing practices, which it called “a calculated program of intimidation … forcing hospitals and physicians to purchase it in order to appear competitive. (Intuitive) creat(ed) a fear in their minds that if they did not have this technology they would lose business to competitors,” the suit said.

Company lawyers denied the Joneses' allegations, asserting that the da Vinci system was not responsible for the injuries. “The risks, if any, associated with the use of the da Vinci Surgical System are outweighed by the device's utility” and any injuries may have been caused by “misuse or unintended use” of the system, the company response said.

The controversies put hospitals in a tough position. After spending about $2 million to acquire the technology, and then from $100,000 to $170,000 on a service contract each year, hospitals now have to contend with concerns that the device isn't living up to its financial promise or the clinical claims.

Few providers turn a profit on robotic procedures, which are, on average, 15 to 30 minutes longer and cost about $3,000 more than laparoscopic surgeries, many physicians said. Payers generally reimburse robotic and laparoscopic procedures at the same rate.

On the other hand, they have what Dr. Martin Makary, a surgeon at Johns Hopkins Medicine in Baltimore, calls an “intangible marketing benefit.” A study published in 2011 found that more than a third of 400 randomly selected U.S. hospitals promoted robotic surgery on their website homepages. None of the 400 hospitals provided any risk information on the websites. Many hospitals with installed systems have purchased billboard ads touting their robots, launched “name the robot” games within their communities, or displayed the robotic systems at local high school football games.

Patients are now choosing hospitals because they offer robotic surgery, which makes them come across as more technologically advanced even though some critics say there's no evidence to suggest the robots or the hospitals have better outcomes than their competitors. “The broad application of robotic surgery in the U.S. without the proper evaluation … is the story of what's wrong with healthcare today,” Makary said.

Some hospitals are refusing to advertise robotic surgery for this reason. Executives at Beth Israel Deaconess Medical Center in Boston and the University of Illinois Hospital and Health Sciences System, Chicago, for instance, said the recent controversies surrounding robotic surgery will likely lead to further assessments of how the providers talk to patients about surgical options, as well as what kind of training and operational standards are in place.“The reality is that it's a case-by-case unique decision” for each patient, said Dr. Jaewon Ryu, associate vice president for professional practice and chief medical officer at the University of Illinois hospital. “We just don't want to create those preconceived notions.”

Intuitive Surgical recently incurred a setback when the American Congress of Obstetricians and Gynecologists repeated its concern that “aggressive direct-to-consumer marketing” of new medical technologies was misleading the public. The trade group cited a study published in the Journal of the American Medical Association that found that clinical outcomes were no better for patients who underwent robotic hysterectomies for benign gynecologic disorders than those who had laparoscopic procedures. In addition, the costs of the robotic procedures were substantially higher.

Dr. James Breeden, the obstetrician group's president, said there may be clinical benefits to robotic surgery, but the lack of good data and “unprecedented advertising to consumers and hospitals” has raised concerns.

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