MedTech Losers of 2013: Intuitive Surgical

Posted in Medical Device Business by Shana Leonard on December 17, 2013

                  Intuitive Surgical da Vinci

Intuitive Surgical
The PR and media relations people at Intuitive Surgical probably worked a lot of overtime in 2013. And, boy, did they have their work cut out for them. The robotic surgery pioneer seemed to be fending off bad press, criticism, lawsuits, and allegations left and right this year. In March, FDA launched a probe into Intuitive Surgical by surveying certain surgeons about the company's da Vinci surgical system in an effort to investigate whether an uptick in adverse event reports represented an accurate reflection of problems. And while the company did win its first patient injury lawsuit in May, it had 25 additional cases pending at the time. Soon after, the company was slapped with a lawsuit courtesy of its shareholders that claimed the company's stock price was "fraud inflated."

In July, the company received a series of subsequent harsh blows. First, Intuitive Surgical's stock plunged 18% following the release of poor Q2 results. Then, FDA issued a warning letter to Intuitive Surgical that addressed several violations, including failure to notify the agency of corrections, despite having notified customers. In response, the company's stock once again plummeted. Intuitive Surgical continued its downward spiral in September with the release of a study in the Journal for Healthcare Quality that claimed robotic surgery complications were underreported. However, the company fought back, noting that an increase in adverse event reportingdoes not necessarily equate to an increase in adverse events. To top off the headaches around quality issues, FDA admonishment, and lawsuits, Intuitive Surgical also faced mounting scrutiny over whether or not robotic surgery really is worth it. All eyes will be on Intuitive Surgical in 2014 to see whether it can rebound from such a detrimental year.



[Image: © 2013 Intuitive Surgical, Inc.]

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