The issues detailed in the FDA’s warning letter are disturbing, and we will be monitoring these developments very carefully.
New York, New York (PRWEB) July 19, 2013
As robotic surgery lawsuit claims involving the da Vinci Surgical System continue to move forward in courts throughout the U.S., Bernstein Liebhard LLP comments on Intuitive Surgical Inc.’s recent disclosure that it has received a warning letter from the U.S. Food & Drug Administration (FDA) . According to a report from Bloomberg.com, the letter, dated July 17, 2013, was sent after FDA inspectors uncovered a number of issues at Intuitive Surgical’s Sunnyvale, California, headquarters this Spring.*
“Our Firm continues to receive da Vinci surgery lawsuit inquiries from patients who allegedly experienced surgical burns, excessive bleeding and other serious robotic surgery complications stemming from use of the da Vinci Surgical System. The issues detailed in the FDA’s warning letter are disturbing, and we will be monitoring these developments very carefully,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free legal evaluations to individuals who allegedly suffered serious robotic surgery complications in procedures involving the da Vinci Surgical System.
Da Vinci Surgery Lawsuits
Launched in 2000, the da Vinci Surgical System is now used by some 1,300 U.S. hospitals for minimally invasive surgeries, according to Bloomberg.com. The FDA warning letter was issued to Intuitive Surgical following the release of a May 30th inspection report that cited the company for failing to inform the FDA about device corrections and patients who had experienced robotic surgery complications. In the letter, the FDA asks Intuitive Surgical to take additional steps to resolve some issues cited in the inspection report.*
The FDA warning letter comes just as sales of the da Vinci robot have slowed, according to Bloomberg.com. The agency is also surveying doctors about problems they may have observed with the device, following an increase in robotic surgery complication reports, including 70 deaths since 2009.*
Intuitive Surgical has been named in at least 26 robotic surgery lawsuits filed on behalf of patients who allegedly suffered serious injuries in da Vinci procedures. In a regulatory filing submitted to the U.S. Securities and Exchange Commission (SEC) on April 19th, Intuitive said the da Vinci surgery lawsuits allege robotic surgery complications due to defects in the device and/or inadequate surgeon training on the part of the company.**
Patients who experienced robotic surgery complications may be entitled to compensation for medical bills, lost wages, pain and suffering and other damages incurred as a result of their injuries. Learn more about filing a robotic surgery lawsuit by visiting Bernstein Liebhard LLP’s website. To speak with one of the Firm’s attorneys, please call 800-511-5092.
*bloomberg.com/news/2013-07-18/intuitive-surgical-declines-on-warning-letter-from-fda.html, Bloomberg, July 18, 2013
** sec.gov/Archives/edgar/data/1035267/000119312513162385/d508282d10q.htm, Intuitive Surgical, April 19, 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 10 consecutive years.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP
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