Da Vinci Lawsuit News: Bernstein Liebhard LLP Notes Recent FDA Letter Stating Intuitive Surgical Could Have Violated Federal Regulations Regarding its da Vinci Robot


New York, NY (PRWEB) June 27, 2013

In a current notice from the U.S. Meals and Drug Administration (FDA) that might impact da Vinci lawsuit claims, the agency states that Intuitive Surgical possibly violated federal law by failing to initial alert regulators when it warned consumers about difficulties with the da Vinci Surgical Program, Bernstein Liebhard LLP reports.

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According to the letter issued May 30th by the FDA, Intuitive Surgical received 134 complaints and filed 83 medical device reports stemming from use of the device between January 2010 and December 2011.* Following these reports, Intuitive sent a letter to buyers in October 2011 providing ideas and recommendations for appropriate use of the da Vinci Surgical Technique. According to a CNBC.com report published on June 25th, the FDA said Intuitive Surgical wrote to its customers in response to complaints concerning arcing by way of broken tip covers that caused patient injury.**

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Intuitive Surgicals failure to very first notify the FDA begs the question of whether or not they were attempting to hide one thing from the regulator. We will be watching this improvement carefully. Our Firm continues to hear from individuals who allegedly skilled surgical burns, excessive bleeding and other critical undesirable robot surgery complications stemming from use of the da Vinci Surgical Technique, says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and healthcare devices. The Firm is presently supplying totally free and confidential case evaluations to individuals who may have experienced robotic surgery complications after undergoing a procedure aided by the da Vinci Surgical System. Da Vinci Lawsuit Claims

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According to a statement issued April 19th by Intuitive Surgical, 26 da Vinci lawsuits alleging complications due to the surgery robot had been filed in the U.S. Court records indicate that the nations very first trial for a claim alleging robotic surgery complications concluded with a ruling in favor of Intuitive last month, but a May possibly 23rd report from Bloomberg.com stated that the lawyer for the plaintiff in the case was optimistic that future lawsuits more than the da Vinci Surgery Robot would result in favorable outcomes for allegedly injured sufferers.***(Estate of Fred E. Taylor v. Intuitive Surgical, 09-two-03136-5, Superior Court, State of Washington, Kitsap County)

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In a regulatory filing with the U.S. Securities and Exchange Commission issued by Intuitive on April 19th, the manufacturer reported that it had entered tolling agreements in specific bad robot surgery lawsuits more than its da Vinci Surgical System to allow additional time to evaluate the claims, to discover regardless of whether the claims have merit and whether they can be resolved without having litigation.**** As of March 14th, 2013, a notice entered in the U.S. District Court, Eastern District of Louisiana on March 14th indicated that Intuitive had settled a lawsuit alleging injuries sustained by a woman whose thyroid process was aided by the da Vinci robot. (Silvestrini v. Intuitive Surgical Systems Inc., No. 11-2704 (E.D. La.))

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The da Vinci Surgical Method was authorized in 2000 to aid surgeons performing minimally-invasive laparoscopic, urologic and gynecologic procedures. The device is now also utilized in thousands of hysterectomies, gall bladder and prostate removal surgeries, thyroid cancer procedures and heart surgeries, according to a Bloomberg.com report from February 28th.*****

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Individuals who knowledgeable robotic surgery complications may possibly be entitled to compensation for healthcare bills, lost wages, discomfort and suffering and other damages incurred by their injuries. Understand a lot more about bad robot surgery complications by visiting Bernstein Liebhard LLPs website. To speak with one of the Firms attorneys, please call 800-511-5092.

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*fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM358468.pdf&#13

**cnbc.com/id/100843549&#13

***bloomberg.com/news/2013-05-23/intuitive-wins-trial-defeats-negligent-coaching-claims.html&#13

****sec.gov/Archives/edgar/data/1035267/000119312513162385/d508282d10q.htm &#13

*****bloomberg.com/news/2013-05-23/intuitive-wins-trial-defeats-negligent-education-claims.html

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About Bernstein Liebhard LLP

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Bernstein Liebhard LLP is a New York-primarily based law firm exclusively representing injured persons in complex person and class action lawsuits nationwide since 1993, which includes those who have been harmed by dangerous drugs, defective health-related devices and consumer goods. The firm has been named by The National Law Journal to the Plaintiffs Hot List, recognizing the leading plaintiffs firms in the nation, for the past 10 consecutive years.

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800-511-5092

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da Vinci Surgical Robot News: Rottenstein Law Group LLP Comments on FDA Allegation That Intuitive Surgical Failed to Report Warning to Regulators


(PRWEB) June 28, 2013

The U.S. Food and Drug Administration has alleged that da Vinci surgical robot maker Intuitive Surgical warned customers before the FDA about a potentially hazardous problem with the da Vinci in 2011, breaking an established regulatory protocol. The Rottenstein Law Group LLP, a da Vinci law firm that explains da Vinci lawsuits and side effects at http://www.davincilawsuit.us, notes that this is however another FDA announcement involving the business following a preceding a single in April 2013.

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According to CNBC*, Intuitive notified surgeons about appropriate protocols for tip covers and for the correct generators to be utilized with those instruments. The FDA stated the correction was in response to complaints about problems with electrical currents jumping from the equipment to sufferers throughout surgery, major to injury. Nonetheless, the article said, the firm did not initial warn the FDA.

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The sort of letter the FDA sent Intuitive is not a final determination, but it does imply that the FDA considered Intuitive in violation of regulations, stated Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. The situation addressedthe arcing of electricity from the surgical tools to the patientcould cause the patient internal burns, an alleged side impact that we usually hear about when fielding telephone calls from possible plaintiffs.

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Intuitive Surgical asserts that it is fully committed to superior instruction opportunities for surgeons and surgical teams in the use of its items, but notes that it does not participate in determining when a surgeon is adequately prepared to operate employing the da Vinci Surgical Method. According to a USA Nowadays post, the da Vinci surgical robot was employed in about 400,000 surgeries in 2012.** Recently CNBC aired a documentary about the da Vinci, focusing on the prospective dangers. In May 2013 Intuitive defeated a negligent instruction claim in court (Estate of Fred E. Taylor v. Intuitive Surgical Inc. 09-2-03136-5, Superior Court, Port Orchard, Wash.).

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The Rottenstein Law Group LLP encourages men and women to pay a visit to its site to download a free brochure to aid them determine if they are eligible to file a da Vinci lawsuit.

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For the most current news on defective medicines and healthcare devices and associated lawsuits, visit the Rottenstein Law Group LLPs Injury Lawyer Newswire at injurylawyernewswire.com. Readers can subscribe to the news websites stories and videos to remain on prime of individual injury news.

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*cnbc.com/id/100843549 (June 25, 2013)&#13

**usatoday.com/story/news/nation/2013/04/09/robot-surgery-fda/2067629/ (April 9, 2013)

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About THE ROTTENSTEIN LAW GROUP LLP&#13

The Rottenstein Law Group LLP is a New York-primarily based firm that represents clientele nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has much more than two decades of encounter as a lawyer, to represent consumers hurt by defective healthcare devices and medicines. (Attorney advertising. Prior final results do not guarantee a similar outcome.)

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Get in touch with:&#13

The Rottenstein Law Group LLP&#13

Rochelle Rottenstein, Esq.&#13

321 W. 44th Street&#13

# 804&#13

New York NY 10036&#13

(212) 933-9500 (office phone)&#13

(212) 933-9980 (facsimile)&#13

rochelle (at) rotlaw (dot) com

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