NEW ORLEANS (CN) - Fifteen patients demand $1.2 billion from a robotic surgery equipment maker, claiming it uses "fear" and "intimidation" to push the defective Da Vinci Robotic Device on doctors and hospitals.
Lead plaintiff Twila Beasley et al. sued Intuitive Surgical in Federal Court.
They claim Intuitive suppressed evidence that its defective Da Vinci Robotic Device can injure and kill patients.
"Defendant sold its device through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear to be competitive, and creating a fear in their minds that if they did not have this technology they would lose business to competitors," the plaintiffs say in the complaint.
"On its website, defendant asserts that it is the global technology leader in surgical robotic products," the complaint states.
"Said robotic device is used in hospitals for a variety of surgeries.
"Defendant has promoted its device as (a) safe, and (b) safer than other comparative methods of surgery including, laparoscopy, vaginal surgery, prostatectomy surgery and open surgery.
"Defendant utilizes prominent websites aimed at consumers, seeking to create demand for the use of its robotic device by patients who consult surgeons.
"Defendant sold its device through a calculated program of intimidation and market management, forcing hospitals and physicians to purchase it in order to appear to be competitive, and creating a fear in their minds that if they did not have this technology they would lose business to competitors.
"Defendant reinforced its calculated program, as stated in the preceding paragraph, by placing, on its website for potential patients, names of certain physicians who had performed 20 surgeries with the device.
"The use of defendant's robotic device in surgery presents substantial risks of complications and injuries, including de-vasculization of the vaginal cuff impeding healing, partial thermal injury burns to bowel, post-surgical abscesses, tears, dehiscences, bleeding, hematomas, sepsis and fistulas.
"More specifically, defendant's robotic device can cause damage to the bowel, blood vessels, arteries, ureters, bladder, vaginal cuff and other nerve injuries.
"In addition, due to lengthened time of surgery, patients are unnecessarily exposed to anesthesia for a dangerous period of time.
"On occasion these complications and injuries cause and/ or contribute to infectious processes from thermal injury causing abscess formation and can lead to the untimely and premature death of the patient.
"Defendant is aware of the aforesaid risks and complications associated with the use of said robotic device.
"Defendant does not provide adequate warnings to physicians and patients about the risks and complications associated with the use of its robotic device.
"Defendant has not done, nor sponsored, adequate testing on its device before and after marketing it to determine whether in random tests its device is either safer or more effective or otherwise superior to other surgical and laparoscopic methods to which it compares itself."
The plaintiffs add: "Defendant has suppressed reports and complaints of complications and performance errors due to the use of its device. ...
"The device has inadequate insulation for its arms, allowing electrical current to pass into tissue outside of the operative field. ...
"Due to design defects, defendant's devices have malfunctioned during the course of operative use causing injury, including the necessity of converting the procedure into open surgery, or often requiring subsequent surgeries to deal with complications of robotic use. ...
"Defendant has obtained and continues to maintain approval of the uses of its device from the Food and Drug Administration by failing to fully inform them of its knowledge of the risks and complications associated with the use of its device. ...
"Defendant was aware that there were safer energy modalities including ultrasonic energy and bipolar energy, yet maintained teaching the use of monopolar current in the Da Vinci Robotic Surgery. Defendant did so based on not wanting to pay for the cost of having to license these safer energy technologies.
"Defendant was also aware, or should have been aware, of the Active Electrode Monitoring System, or AEM Technology, which shields and monitors instruments continuously directing stray energy, the cause of stray electrosurgical burns, away from the patient. With the AEM system, the patient is never at risk for stray electrosurgical burns due to insulation failure and capacitive coupling. ...
"Defendant over-promoted its device and minimized its risks, for the purpose of making sales of its device, its maintenance, and the use of replaceable parts, and skewed the cost-benefit ratio inaccuracy in its favor.
"The said conduct was so willful, wanton, malicious and reckless that it merits the imposition of punitive damages. ...
"Da Vinci Robotic Surgery does not conform to defendant's express representations, because it is not safe, efficacious, has numerous serious unwarned-of side effects, causes severe and permanent injuries including death, and was not adequately tested.
Plaintiffs seek $1.2 billion for product liability and personal injuries, negligence, fraud, breach of warranty and unjust enrichment.
They are represented by Daniel Becnel Jr. of Reserve, La.
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