Analysts Warn That Adverse da Vinci Reports Part of a Larger Problem

da_vinci_reports_warningsCitron Research just published a rather negative report concerning device maker Intuitive Surgical and its da Vinci surgical robot.

Citron discusses a marked increase in reported adverse events, while Intuitive Surgical argues that sudden increases are in filings, not in incidents, adding that a better look at the U.S. Food and Drug Administration’s (FDA) MAUDE adverse events database reveals a drop in injury and death reports, an Intuitive spokesperson told MassDevice.com. “Any assessment of safety trends based on Reporting Dates rather than Event Dates in the MAUDE database will be fundamentally flawed and misleading, and is likely to seriously misrepresent the true performance of a device,” a company statement indicated.

Analysts with Citron faulted Intuitive and other analysts for the way in which they underestimated problems that led to a drop in the device maker’s shares by at least one-third since the same period last year, according to MassDevice.com.

Intuitive is the subject of an FDA investigation into surgical complication rates tied to the da Vinci. Also, the American Congress of Obstetricians & Gynecologists issued a statement questioning any benefits patients may realize with the da Vinci, a high-profile lawsuit has been filed that accuses Intuitive of aggressive marketing tactics, the device maker issued a warning concerning cracks in robot instruments, and a class action lawsuit was brought against da Vinci and its executives, according to MassDevice.com.

Citron analysts warn that recent headlines concerning Intuitive and its da Vinci robot are just a part of a bigger problem and that the device maker is “not investable til it gets its house in order,” according to MassDevice.com. Citron urges Intuitive to accept responsibility and handle the “surprising” rise in adverse event and death reports in 2013.

“In the 1st 8 months of 2013, 2332 Adverse Event records were posted—compare to 4603 records posted in the entire 12-year period since the 1st Adverse Event tracking for da Vinci appeared in MAUDE in 2000,” Citron wrote. “It is the opinion of Citron that the only reason there is not a national outcry is because the da Vinci robot has yet to kill or injure ‘the right person’—like the next of kin of a congress member or a celebrity,” Citron wrote, MassDevice.com reported.

Intuitive Surgical spokeswoman Angela Wonson denies that an actual increase in da Vinci incidents has occurred and says that Citron looked at reporting, not occurrence dates, adding that while reporting has increased, incidents have decreased, according to MassDevice.com.

Intuitive Surgical recently dropped its stock price following slowed sales, a warning issued by a federal regulator, and increasing injury reports and litigation. In the second-quarter of 2013, Intuitive Surgical reported lower-than-expected earnings, noting that revenues only grew by 8 percent, which is significantly lower than 2012 earnings, according to Trefis.

The FDA recently criticized Intuitive saying that the device maker never reported the steps it took to protect patients from accidental electrical burns, according MedScape Medical News, citing a May 30 FDA inspection report that was based on April and May inspections.

Personal injury lawsuits brought over the da Vinci allege severe internal injuries such as burns, tears, and other complications; allegations assert that some procedures caused chronic pain, disability, or death. Lawsuits also accuse Intuitive’s aggressive marketing practices and allege that design flaws inherent in the da Vinci, as well as poor physician training on the device, are to blame. Some 89 deaths have been tied to the da Vinci since 2009.

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