NEW YORK--(BUSINESS WIRE)--Apr 23, 2013--The law firm of Wohl & Fruchter LLP has commenced an investigation into possible violations of federal securities laws by officers and directors of Intuitive Surgical, Inc. (Intuitive) (Nasdaq: ISRG).
Intuitive manufactures and markets the da Vinci robotic surgical system, which consists of robotic arms tipped with tiny surgical tools that allow surgeons to perform minimally invasive surgeries on patients remotely from a computer terminal with joy-stick-like controls.
On February 28, 2013, the U.S. Food and Drug Administration (FDA) sent a letter to surgeons participating in MedSun, an FDA-sponsored medical product safety network, asking them to provide information about medical complications associated with use of the da Vinci system. The FDA indicated that the survey was prompted by an “increase in [the] number of reports” of “adverse events” involving the da Vinci system.
On March 14, 2013, the president of the American Congress of Obstetricians and Gynecologists (ACOG), Dr. James Breeden, issued a statement contending, among other things, that “[r]obotic surgery is not the only or the best minimally invasive approach for hysterectomy,” and “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.” On March 20, 2013, Massachusetts’ Quality and Patient Safety Division of the Executive Office of Health and Human Services issued an advisory, which stated in part: “Over the last two years, the Quality and Patient Safety Division has received an increasing number of Safety and Quality Review reports of patient complications associated with robot-assisted surgery.” On April 18, 2013, CNBC’s Investigations, Inc. broadcast an expose of the da Vinci system consisting of interviews with, among others, doctors, lawyers, and patients who have filed lawsuits against Intuitive claiming they suffered injury while being operated on by surgeons using the da Vinci system.
During the broadcast, CNBC referenced the FDA’s MAUDE database, which contains voluntary reports by manufacturers concerning adverse events involving medical devices, including reports of injuries and deaths associated with use of the da Vinci system.
A former ISRG employee, interviewed by CNBC during the show on condition of anonymity, stated that she recalls instances of da Vinci-related complications that were not reported in MAUDE, and contended that the MAUDE database is "significantly understated in terms of [da Vinci-related] complications." Concurring was Dr. Martin Makary, a prominent surgeon with the Johns Hopkins School of Medicine, and an international expert on patient safety, who shared with CNBC details of a study he co-authored entitled "Underreporting of Robotic Surgery Complications." The study contends there is "massive underreporting" of robotic surgery complications. In particular, the report states that "[i]n the case of Intuitive Surgical . . . some incidents [involving the da Vinci system] that have resulted in serious injury and death were never reported or were reported late." Since February 27, 2013, the day before the FDA announced its MedSun survey, ISRG stock has fallen over 17% on account of the above news from $573.52/share to a close of $474.87 on April 22, 2013, resulting in a loss of nearly $4 billion in shareholder value.
Wohl & Fruchter’s investigation concerns whether officers and directors of Intuitive violated federal securities laws by, among other things, concealing the number and severity of surgical complications associated with the da Vinci system; misrepresenting the degree of training required for surgeons to become proficient in the use of the da Vinci system; and misrepresenting the alleged medical advantages of the da Vinci system as compared to alternative surgical treatments for various conditions.
Persons with relevant information, and ISRG shareholders with questions about this investigation, are invited to contact our Firm by calling 866.582.8140.
Additional information, including links to documents and reports discussed above, is available on our website at: http://www.wohlfruchter.com/cases/isrg.
About Wohl & Fruchter
Wohl & Fruchter LLP represents plaintiffs in litigation arising from fraud and other fiduciary breaches by corporate managers, as well as other complex litigation matters. Please visit our website, www.wohlfruchter.com, to learn more about our Firm, or contact one of our partners.