The problems cited in the FDA Warning Letter are disturbing. It certainly raises the question of whether Intuitive Surgical was trying to conceal vital information about da Vinci complications from the FDA and the public.
New York, New York (PRWEB) August 02, 2013
As robotic surgery lawsuits (http://www.davincisurgery-lawsuit.com/) involving the da Vinci Surgical System mount in courts around the country, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has released the Warning Letter it issued to Intuitive Surgical, Inc. last month. The letter followed an FDA inspection of Intuitive Surgical’s, Sunnyvale, California headquarters, which according to Bloomberg.com, revealed that the company failed to notify the FDA about field correction letters it sent to doctors and hospitals regarding issues that had the potential to cause da Vinci complications.*
“The problems cited in the FDA Warning Letter are disturbing. It certainly raises the question of whether Intuitive Surgical was trying to conceal vital information about da Vinci complications from the FDA and the public,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free robotic surgery lawsuit evaluations to individuals who allegedly suffered serious injuries in procedures involving the da Vinci Surgical System.
Da Vinci Surgical Lawsuits
According to the FDA Warning Letter, which was posted on the agency’s website on July 23rd, Intuitive failed to notify the agency of correction letters it sent to doctors and hospitals on several occasions. In an October 2011 correction, for example, the company notified its customers about the proper use of a Tip Cover Accessory, and advised that generators should be used with the da Vinci’s monopolar instrument. According to the FDA, Intuitive received 134 complaints of da Vinci complications related to this issue between January 2010 and December 2011. Another correction letter cited by the FDA involved the use of the da Vinci robot in thyroidectomies, a procedure that has not been approved by the agency. Intuitive issued that correction after receiving 13 complaints about problems that occurred in da Vinci thyroidectomies.
On July 22, 2013, an Intuitive Surgical regulatory filing disclosed that the company had been named in 33 individual da Vinci lawsuits filed in various state and federal courts that allege use of the robot caused patients to suffer serious, and in some cases fatal, injuries. According to the company, these lawsuits claim that da Vinci complications resulted from purported defects in the da Vinci Surgical System and/or Intuitive’s failure to provide adequate training resources to the healthcare professionals who performed plaintiffs’ surgeries. Intuitive also disclosed that it had entered into tolling agreements in some of these cases, “in an effort to provide an orderly process for evaluating claims before they result in costly litigation.” **
Patients who experienced alleged Da Vinci complications may be entitled to compensation for medical bills, lost wages, pain and suffering and other damages incurred as a result of their injuries. Read More about filing a robotic surgery lawsuit at 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
** http://www.sec.gov/Archives/edgar/data/1035267/000119312513297410/d551118d10q.htm, Intuitive Surgical, July 22, 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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ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP
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