Shares for Intuitive Surgical, the makers of the da Vinci Surgical System, have dropped significantly over the the past 24 hours, following disappointing sales numbers for the surgery robot reported by the company.
Amid recent concerns over the safety and effectiveness of da Vinci robot surgery, including a recent warning issued by the company about problems with a component in the machine that may cause internal electrical burns for patients, second quarter sales came in well under prior estimates.
On Monday, Intuitive Surgical reported that second quarter sales of the da Vinci robot only generated about $215 million, compared with $229 million in the same quarter last year. As a result, the company expects to bring in a net income of $160 million, and total revenue of $575. That compares to analyst predictions of about $178 million in net income and a total revenue of $630 million.
Following the report, Intuitive’s stock value dropped 18 percent, hitting a low of $407 as of mid-afternoon.
While the manufacturer indicates that the lower sales are due to attempts by hospitals to cut costs and reduced interest in using the da Vinci for gynecological surgery, it appears that problems with the da Vinci surgery robot may be catching up with the company.
Concerns Over Da Vinci Complications
Over the past year, as the popularity of robotic surgery involving the da Vinci Surgical System has increased at hospitals throughout the United States, concerns have also emerged about risks associated with the procedures and whether Intuitive Surgical may have withheld information about the potential risk of injury caused by da Vinci surgery robot problems and inadequate training provided for surgeons.
The da Vinci robot contains four metal arms that are remotely controlled by the surgeon during robotic procedures, using hand and foot controls while looking at a virtual reality representation of the patient’s internal organs.
While da Vinci surgery has been promoted as a superior and less invasive procedure, questions have been raised about the risk of da Vinci robotic surgery complications that have surfaced when individuals suffered burns, tears and other injuries from electrical arcing. These problems often are not recognized during the procedure, and may result in re-hospitalization for complications that surface days later.
In May, Intuitive Surgical issued a warning to health care providers about problems with the da Vinci robot cauterizing scissors, which are known as Hot Shears and could have micro-cracks that allow the electrosurgical energy to “leak” to nearby tissue and cause thermal injury or burns to internal organs. Last month, replacement parts for the da Vinci robot began shipping, which reportedly are not prone to develop these micro-cracks.
In January, the FDA began probing the safety of the da Vinci robot, sending a survey out to doctors asking them to detail any da Vinci robot issues that they have encountered, including information on patients who suffered internal injuries or death, as well as details about their training in the use of the device.
The Massachusetts state medical board has also cautioned doctors this year to review potential robotic surgery problems, risks and benefits carefully when selective patients for the procedures.
The Massachusetts advisory came shortly after the American Congress of Obstetricians and Gynecologists (ACOG) issued a report recommending against robotic hysterectomy surgery, indicating that there is a lack of evidence showing any benefit to patients compared to other means of doing a hysterectomy, yet there are increased costs and a serious risk of complications.
Analysts Predicted Intuitive Surgical Problems
As more information on the da Vinci robot and potential problems have come to light, a number of Wall Street analysts have tried to sound a warning bell to investors that Intuitive Surgical may be in trouble in the long term.
In March, Northland Capital Markets warned that the popularity of the da Vinci Surgical System may be more due to aggressive marketing by Intuitive Surgical than any actual medical benefits provided over alternative surgical methods.
It was at least the second research firm to highlight concerns about the company’s stock price as more information comes to light about problems with their main product and an increasing number of da Vinci robotic surgery lawsuits are filed by individuals who experienced complications following surgery that were allegedly caused by training problems or design defects with the machine.
Late last year, the investment research firm Citron Research released a report that predicted the stock price for Intuitive Surgical will drop to $350 before eventually falling to $250 by mid-2014.
That group indicated in January 2013 that the number of robotic surgery procedures involving the da Vinci robot will dramatically drop over the coming year and new sales will “flatline” amid increased awareness about the risk of complications following da Vinci robot surgery and evidence emerges about the lack of established long-term benefits.
Da Vinci Robot Lawsuits
A growing number of da Vinci surgical robot lawsuits filed by patients in federal and state courts nationwide claim that they suffered burns, tears and other complications caused by the defective design of the robot and a failure to adequately warn them of the risks. Many also claim that Intuitive Surgical offers inadequate training to surgeons on proper use of the device.
The company also faces a number of da Vinci robot class action lawsuits brought by investors who say that the company misrepresented information about the safety of the robot, which is the company’s only product.
To date, just one da Vinci case has reached a jury, with a Washington state court returning a defense verdict in a wrongful death lawsuit in May.