New York, New York (PRWEB) December 30, 2013
As da Vinci robot lawsuits (http://www.davincirobotlawsuithelp.com/ ) alleging serious injuries due to the da Vinci Surgical System continue to mount in courts around the country, Bernstein Liebhard LLP notes that a new investigation is raising questions about the manner in which robotic surgery complications are reported to the U.S. Food & Drug Administration (FDA). The review, which was conducted by Bloomberg.com, found that dozens of injuries associated with the da Vinci robot were only reported years after they occurred. Other robotic surgery complications, including those alleged in da Vinci lawsuits, were never reported at all. *
For its part, Intuitive Surgical, Inc., the manufacturer of the da Vinci Surgical System, maintains that the issues uncovered by Bloomberg.com occurred because the company often doesn’t find out about an injury until years after it happened. The Bloomberg article also noted that an adverse event report doesn’t necessarily mean that the da Vinci robot caused an injury, only that the device was being used in an operation where the complication occurred.
“These revelations are disturbing, because without accurate reporting of robotic surgery complications, it is difficult to get a clear picture of the risks potentially associated with the da Vinci robot. Many of the unreported injuries noted by Bloomberg echo what we have heard from our own clients,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free da Vinci lawsuit evaluations to individuals who allegedly suffered serious injuries in procedures involving the da Vinci Surgical System.
Robotic Surgery Complications
The Bloomberg.com report is not the first to raise questions about the way in which adverse events associated with the da Vinci are reported to the FDA. In August, a study published in the Journal of Healthcare Quality reached a similar conclusion. Among other things, the report revealed that even though over one million robotic surgeries have been performed since 2000, just 245 complications were reported during that time period to the FDA. The authors of the study asserted that the number is “very low for a complex technology” that has been used so frequently, and expressed concerns that underreporting would make it difficult for doctors and patients to accurately evaluate the safety of robot-assisted surgery.**
In recent months, adverse event reports related to robot-assisted procedures have been increasing. For example, in November, the FDA confirmed to Bloomberg that reports of robotic surgery complications related to the da Vinci Surgical System had more than doubled over the past year. The same report also noted that Intuitive Surgical, Inc., the manufacturer of the robot, is facing at least 50 da Vinci robot lawsuits, all filed on behalf of individuals who allegedly suffered serious injuries due to the device.***
Alleged victims of robotic surgery complications associated with the da Vinci robot may be entitled to compensation for medical bills, lost wages, pain and suffering, and other injury-related damages. To learn more about filing a da Vinci robot lawsuit, please visit Bernstein Liebhard LLP's website, or the Firm's Facebook page: https://www.facebook.com/davincirobotlawsuit. To obtain a free review of your da Vinci lawsuit, please call 800-511-5092.
*bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html, Bloomberg.com, December 30, 2013
**onlinelibrary.wiley.com/doi/10.1111/jhq.12036/abstract, Journal of Healthcare Quality, August 27, 2013
***bloomberg.com/news/2013-11-08/intuitive-surgical-robot-incident-reports-double-in-year.html, Bloomberg.com, November 9, 2013
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 11 consecutive years.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP
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