Hailed as the latest breakthrough in virtually scarless, minimally invasive surgery, da Vinci robotic surgery devices were adapted from systems used in war torn areas and manufactured by Wall Street darling Intuitive Surgical, Inc. They has been made available to the general public over the last decade, but the very high risk of deaths and adverse events, almost 5,000 to date according to the MAUDE database (Manufacturer and User Facility Device Experience) kept by the FDA, are largely unknown by the general public, who continue to undergo these very costly procedures without full knowledge of the risks involved.
Many doctors who are peddling these procedures hand their patients glossy marketing materials produced by Intuitive Surgical which highlight the most positive aspects of the surgery, but hardly anything about the real dangers and risks involved. Consultation times are kept to a minimum and some surgeons direct patients to their websites where glorious videos are posted. If patients ask too many questions they get brusque answers, as doctors head for the door and say quick goodbyes because they are very busy, important people you know.
But despite the Da Vinci's popularity, its surgical talents may not surpass those of flesh-and-blood physicians.http://articles.latimes.com/...
"There's never been a study showing clinical superiority," says Dr. Marty Makary, a surgeon at the Johns Hopkins University School of Medicine in Baltimore. "For the patient, there's clearly no difference."
Citron Research has been compiling huge amounts of data on several lawsuits pending and detailing all cases of adverse outcomes in the FDA records to make investors aware of potential trouble ahead for Intuitive Surgical.
In a damning two-part report, the research firm describes how the company targets doctors who perform high volume procedures like hysterectomies and prostatectomies in order to maximize profits. For many patients, the outcome is loss of life or severe injury. Approximately two to five deaths involving da Vinci robotic devices are reported each month. The most horrific cases include a patient who's intestines were hanging out of her vagina; another was uncontrollably passing urine out of her vagina, and a prostatectomy patient who urinated out of his rectum and defecated out of his penis. The surgeon, Christopher Kopp, MD, said in his operative report that the robot malfunctioned several times. When he and the technicians couldn't get it working properly, he decided to convert to an open procedure.
Medicine for profit over utility is not an uncommon theme, but now the lawyers have taken notice – and investors should take note as well.Anyone considering and of these procedures should check out the report by Citron Research and visit the FDA website where these adverse events are described in great detail. http://www.accessdata.fda.gov/...
It is Citron's opinion that Intuitive Surgical has reached exactly this tipping point.
Not a tipping point which will put the company out of business, but rather a tipping
point that could break the halo and have Wall Street assign a comparable multiple to
other mainstream medical device companies… that could take this stock down 50%.
Here are the new data points of the last four weeks:
Three new highly credible lawsuits over hysterectomies with bad outcomes have
been filed – in addition to six really ominous ones from earlier in the year
Large insider sales. Within the last month, Chairman Lonnie Smith sold shares from
options exercise (not 10(5)b) netting over $50 million, a rather large percentage
of his recently apportioned stake
- Peer criticism – a number of recent articles summarizing from highly credible,
recent studies that highlight the gap between the company marketing materials'
claims and full scientific disclosure of the true risks and differentials in medical
outcomes. This gap creates the basis for legal challenges to the company due to
inadequate disclosure of the risks of bad outcomes.
- Further skepticism about the true cost/benefit of robotic surgeries
- Indications of loss of morale and sharp erosion of confidence in management and
oversaturation coming through the sales force.
But the most serious issue facing Intuitive is that while its deployment is well past the 10 year point into mainstream healthcare in the US, there is still a severe vacuum of real scientific evidence that the da Vinci is of any clinical benefit when the
full arc of costs and outcomes are weighed, in the most commonly performed
surgeries in which it is utilized. While this is not a new thought, the current legal cases will bring this issue to the forefront.
Robot lawsuits involving da Vinci Surgical Robot procedures allege that patients have suffered serious, and even deadly, injuries including:
- Surgical Burns to Arteries or Organs
- Peritonitis (painful and tender inflammation of the lining of the abdomen)
- Excessive bleeding
- Burning of nearby organs including the intestines
- Punctured blood vessels, organs or arteries
- Burns and/or tears of the intestines
- Severe bowel injuries
- Punctured or cut ureters
-Vaginal cuff dehiscence (reopening of the incision made to remove the uterus
and cervix during a hysterectomy)
- Additional Surgical Procedures Following Robot Surgery
- Wrongful Death
At least one plaintiff in a da Vinci Surgical Robot lawsuit alleges that the device is defectively designed. Other lawsuits have alleged that doctors lack the training needed to properly use the robot. Critics of the da Vinci Surgical Robot have also questioned the way it was marketed, charging that Intuitive Surgical touts the robot as a way for hospitals to increase revenues and market share.http://fightforvictims.com/...
March 2012: A New York father filed a federal lawsuit in the Southern District of the State of New York alleging complications related to the use of the da Vinci Surgical Robot caused the death of his 24-year-old daughter. The young woman underwent a hysterectomy in a Bronx hospital in August 2010, and the robot caused burns to an artery and her intestines, which led to her death two weeks later. The lawsuit alleges the woman’s injuries were the result of design flaws, including un-insulated surgical arms and use of electrical current which can jump to healthy internal organs and tissue. The lawsuit is believed to be the first to be filed alleging da Vinci Surgical Robot design defects.
February 2012: The family of a Chicago man who died following a da Vinci Surgical Robot procedure was awarded $7.5 million in a medical malpractice lawsuit against his doctors. The man had died in 2007, after doctor using the robot to remove his spleen accidently punctured the lower intestine. The injury wasn’t discovered for two weeks, and by then, there was no way to save the man’s life. The man’s surgeon testified it was the first time he had used the robot on a living person, according to court documents.
May 2010: Sherry Long, a 47-year-old woman, sued New Hampshire’s Wentworth-Douglass Hospital alleging that both of her ureters were severed during a robotic hysterectomy performed on March 2, 2009. The injury resulted from the surgeons’ lack of training on the da Vinci, the suit alleged.
December 2003: The widow of a Florida teacher filed a lawsuit after a doctor at St. Joseph’s hospital in Tampa accidently cut his aorta and the vena cava while using the da Vinci Surgical Robot to remove a cancerous kidney. The lawsuit alleged that the hospital allowed doctors inexperienced with the robot to perform the surgery. The claim further charged that the hospital was more interested in using its new device than in ensuring her husband’s safety.
The media is oversaturated with coverage of Beyonce's Superbowl Halftime show and the latest edition of 'Right Wing Racist Clap Trap" while these real stories are largely untold, but now you have been warned.