Da Vinci Surgery Deaths, Injury Reports Highlighted
UPDATE 5/14/2015: Saiontz & Kirk is no longer accepting new clients for da Vinci Surgical Robot Lawsuits
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A new report compiled by an investment analysis firm highlights the number of adverse event reports submitted to the FDA involving individuals who have died or suffered a severe injury following da Vinci robotic surgery, and echos many claims made in product liability lawsuits filed against the manufacturer of the device, alleging that Intuitive Surgical has attempted to minimize the da Vinci surgery injury risks and aggressively marketed the complex machine without conducting adequate research to establish it is safe and effective.
▸ More Information: Da Vinci Surgery Lawsuit
A two-part report on Intuitive Surgical (PDF) has been compiled by Citron Research, designed to warn potential investors about the increasing problems associated with the da Vinci Surgical System.
The da Vinci is a complex surgery robot that has been aggressively promoted by the manufacturer and increasingly adopted by hospitals throughout the country in recent years. However, it has also been increasingly linked to severe and debilitating injuries and deaths that result from internal burns, tears and perforations that may occur during da Vinci surgery.
The report highlights how Intuitive Surgical promoted the da Vinci Surgical System without conducting the type of testing and evaluation that most people expect of such a device. The findings are similar to allegations raised in a number of lawsuits filed in courts throughout the United States.
The research firm states:
If the da Vinci were a drug, the US public would not be so exposed to this uncertain situation. Drugs require double-blind testing for safety and efficacy before receiving licensing to enter the market place. It is due to the unique regulatory environment for “medical devices” that da Vinci can be deployed so widely in the market for routine use without a full suite of safety and efficacy testing.
It is astonishing that after being in the marketplace for 10 years, Intuitive finds itself with its only product having no scientific justification for widespread use in the 70%+ of its most common applications: Prostatectomies, and gynecological procedures such as hysterectomy and fibroid surgery. Citron can think of no other correlate in the medical field in the last generation.
As part of the analysis, Citron Research has compiled a database of 4,600 adverse event reports that were submitted to the FDA. Amid reports involving an alarming number of surgical tears, perforations and electrical burns were more than 80 reported deaths following da Vinci surgery.
After evaluating the reports, the financial research firm indicates that it is “disturbed” by Intuitive Surgical’s apparent abuses of the FDA reporting system. Over 90% of the reported incidents were submitted by Intuitive Surgical, and the manufacturer often inserted “unfathomable” assertions that the complications had nothing to do with the da Vinci robot.
Many of the issues highlighted in the report have remained largely unknown to potential investors and hospitals purchasing the device, leading Citron Research to predict that the medical device manufacturer’s stock price is likely to plummet as more information comes to light over the coming year.
If Intuitive were clearly disclosing the risks and the overall data to prospective patients, they would be covered by the principals of “informed consent”. But from a marketing standpoint, the company has incited tremendous demand from the public with its “glowing testimonial” advertising. Meanwhile, it has incited an “arms race” between hospitals, driven more by the threat of losing “customers” at any cost, than by dedication to delivering the best outcomes for patients, regardless of tools and methods.
Therefore the ultimate judgment on da Vinci’s safety and efficacy is shifted from the clinical trial to the courts. That is the essence of the situation the company finds itself in today. Instead of a medical subcommittee of experts determining if the benefits outweigh the risks in a safety and efficacy consideration, it will be juries. And in that context, the company will face steep legal liabilities as consequence of its marketing excesses.
Lawsuits for da Vinci Surgery Injuries and Deaths
The robotic surgery lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing financial compensation against Intuitive Surgical for their decision to place profits before patient safety.
In many cases, problems with the training of physicians, design of the machine and warnings provided could be responsible for serious injury or death from:
- Organ Perforation
- Organ Tearing
- Electrical Burns
- Infections
UPDATE 5/14/2015: Saiontz & Kirk is no longer accepting new clients for da Vinci Surgical Robot Lawsuits
The contents of this page are provided for informational purposes only
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