Saturday, April 20, 2013

Intuitive Surgical, Inc. Da Vinci Surgical Robot Lawsuits Regarding Wrongful Injuries and Wrongful Death (2013)





Intuitive Surgical da Vinci robotic surgical system components showing typical operating room setup and positioning of surgeon, assitants, anesthesioligist and nurses
Here is an example of the typical set-up for a Da Vinci Robot System

     Intuitive Surgical, Inc. is the global technology leader in minimally invasive robot assisted surgery headquartered in Sunnyvale, California and employs about 2,362 employees worldwide. Intuitive Surgical’s only product is the Da Vinci Surgical System, which offers many benefits for the surgeon or hospital that purchases this product. Intuitive Surgical is completely reliant on their Da Vinci system, as it defines the company.
     The original prototype Da Vinci Surgical System was developed in the late 1980’s at the former Stanford Research Institute under contract to the United States Army. This technology was originally developed for remote on the battle field war procedures, but the possibility to sell the product to commercial medical facilities was far more beneficial and that this technology would accelerate the application of minimally invasive surgical to a broad range of surgeries. In 1995 Intuitive Surgical was founded specifically to test out this technology. It took till 1999 for the official launch of the Da Vinci Surgical System, where in 2000 this system because the first robotic surgical system cleared by the FDA for general laparoscopic surgery, in the following years the FDA also cleared this system to perform chest surgery, cardiac, urologic, gynecologic, pediatric, and trans-oral otolaryngology procedures. The Da Vinci system provides surgeons with a plethora of benefits, benefits such as superior 3D HD visualization, enhanced dexterity, greater precision, greater control, and ergonomic comfort to provide the optimal performance for the minimally invasive surgery. The Da Vinci system is so precise Intuitive Surgical says they can perform extremely complex procedures such as heart valve surgery and cancer removal surgery through one to two centimeter incisions.


Intuitive Surgical da Vinci robotic surgical system


The Da Vinci surgical system is under fire by people who suffered serious injuries during the procedures where the Da Vinci system was used. The lawyers backing these lawsuits are making many claims that the Da Vinci system has the potential to cause: surgical burns to arteries or organs, peritonitis which is painful and tender inflammation of the lining of the abdomen, sepsis, excessive bleeding, burning of nearby organs including the intestines, punctured blood vessels, punctured organs, punctured arteries, burns and/or tears of the intestines, severe bowel injuries, punctures or cut ureters, vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy), wrongful death, addition surgical procedures caused by the initial operation of the Da Vinci system. (fightforvictims.com)

Some examples of cases that have already happened and may still be in court are the following. The oldest lawsuit against the Da Vinci Surgical robot is from December 2003, where 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 claimed that the doctors were far too inexperienced to perform the surgery claiming the hospital was more interested in using their new device than the safety of the patient. In May 2010 another in experience lawsuit was claimed where Sherry Long, 47 years old, sued New Hampshire’s Wentworth Douglass Hospital alleging that both of her ureters were severed during a robotic hysterectomy performed in 2009. In February 2012, the family of a Chicago man who died following a Da Vinci procedure was awarded 7.5 million due to medical malpractice, again the lawsuit was based on an inexperienced doctor operating the Da Vinci robot. The details of the incident were the patient had died in 2007 after the doctor performed a procedure to remove his spleen accidently punctured his lower intestine. The injury was not discovered for two weeks, and at that point it was too late to save the man. During the lawsuit testimonies, the surgeon said “it was the first time he had used the robot on a living person.” (fightforvictims.com) The last major case was on March 2012 where a New York father filed a federal lawsuit in the Southern District of the State of New York alleging that complications from the Da Vinci Robot surgery caused the death of his 24 year old daughter. The daughter underwent a hysterectomy in a Bronx hospital on August 2010 and the Da Vinci Robot caused burns to an artery and her intestines which led to the daughter’s death two weeks later. The lawsuit states that the daughter’s injuries were the result of design flaws where un-insulated surgical arms and the use of electrical current had the potential to jump to health internal organs and tissue.




Intuitive Surgical da Vinci robotic surgical system'a surgical arms and spincers emulate the natural movement of your hand 



The stakeholders in this case are: Intuitive Surgical Inc., the customers who purchase the Da Vinci Robot, the patients who are operated on. Intuitive Surgical has to deal with all the negative publicity from these lawsuits, Intuitive Surgical was founded specifically for the Da Vinci Surgical Robot. So any bad publicity the Da Vinci Robot receives directly impacts the company. The hospitals and private doctors who purchase the product are responsible for the training of their staff; to perform these operations hundreds of procedures are necessary to become adept at the procedure. Otherwise the doctors who work and use these devices are being negligent, and have the potential to harm innocent patients. The patients who go under are the biggest stakeholder; these patients go into the procedure thinking that the newest technology will help them. When in reality these inexperienced doctors operating on patients are putting them at risk for injury and possibly death!

Intuitive Surgical da Vinci robotic surgery system


Now I will go through ethical theories and how they relate to this case, the theories are: individualism (economic theory), utilitarianism, kantianism, and virtue theory.

Individualism (Economic Theory)
            On the topic of individualism there are a few theories all with the same main idea. Normative theories on individualism, also called the economic theory, states that individualism equals egotism (selfishness) plus rights based constraints.  Where everyone has the right to pursue his own interests and should do so but no one has the right to make other people’s choices about their pursuits for them. We need to respect’s people’s right to pursue their choices so we can all live in the ways we want. The company Intuitive Surgical, are following this theory, as they are not forcing anybody to buy their Da Vinci Surgical Robot product. The people in violation of this theory are the hospitals being negligent in the training of their robot operators. The hospitals are going to want to push to use their new toy, which costs one million to three million. Thus putting pressure on the patients to want to use this robot, since it makes the surgery much easier on the doctor physically and is much more efficient allowing the hospital to place more surgeries in planning.
Friedman’s theory on individualism states that the only goal of business is to profit, so the only obligation that the business person has is to maximize profit for the owners or the stakeholders. For everyone involved there is booming profits to be found, this machine allows private doctors and public hospitals to move people in and out of surgery much faster. Patients are found to have smaller wounds thus allowing those patients to take up less time in bed. Meaning the hospital can push patients in and out fast to collect more money from the insurance of all the patients involved. From the Intuitive Surgical website they state this key figure “Intuitive Surgical ended 2012 with cash, cash equivalents, and investments of $2.9 billion, up 34% over 2011. Fiscal year 2012 revenue was $2.18 billion up 24% compared to 2011.” (intuitivesurgical.com)
The before stated also follow Machan’s Individualism, where it’s all about profit maximization but the biggest difference is where there may be indirect goals not aimed at profit but ultimately will gain profit on the large scale. For intuitive Surgical this would involve providing a two day training class that Intuitive surgical pays for. This makes potential buyers less wary about how complicated this technology is and makes the customers more likely to buy the Da Vinci Robot.

Utilitarianism
            According to Utilitarianism happiness or pleasure are the only things of intrinsic value. That we ought to bring about happiness and pleasure in all being capable of feeling it and do so impartially; the reasoning behind it being happiness is valuable with there being no difference morally speaking between my happiness and yours. For the Da Vinci Surgical Robot it does make everyone happy, it improves the bottom line for the hospital profit wise, the doctor involved is able to perform the surgery quicker with less strain to his muscles, and the patient is less scarred with a much faster recovery time. Essentially doctors are healing the sick, so this would bring happiness in the form of relief for the patient following the ideas of utilitarianism.
Kantianism
            According to Kantianism the main principles are act rationally, to not act inconsistently in your actions or consider yourself exempt from rules: The second rule is to allow and help people to make rational decisions and the third is to respect people, respect their autonomy and their individual needs and differences. The final principle is to be motivated by good will seeking to do what is right because it is right. In this case I would say no Intuitive Surgical on the bigger scale wants to improve the lives of people by providing a quicker way to get through surgery that is minimally invasive. Because of Intuitive Surgical providing the patients a quicker way to get through surgery, this costs the patient less money because they do not need to spend all the extra recovery time in the bed. This also allows the private doctor or hospital to move through many more patients essentially making more money in the long run. The only people who do not follow this theory are the doctors thinking they can tamper with human lives by not being fully trained and comfortable with the Da Vinci Robot. These doctors are essentially taking the lives of their patients into their incapable untrained hands. They are motivated by laziness since it takes hundreds of Da Vinci procedures to be considered skilled in operating the Da Vinci Robot.


Virtue Theory
            Virtue theory in business is the core set of values that the business and the employees take to and exhibit in their workplace. The definition of virtue is behavior showing high moral standards, these are qualities employers want to see in their employees. If their employees exhibit this behavior then it will reflect well on the business and help the bottom line for the business involved. There are four virtues in business to be followed: the want to be honest in agreements, hiring and treatment of employees, customers and other companies; courage and willingness to stand for the right ideas and actions; and temperance in setting reasonable expectations and standards, unreasonable expectations can put pressure on everyone in the company and, as seen in the past, expectations may drive people to be unethical in getting the numbers proposed. Intuitive Surgical’s main goal is a virtuous one; the core of this product is to help the patients and the doctors whom have to perform many surgeries every day. Again as stated earlier the people not showing virtuous traits are the doctors and hospitals that purchase this product and perform the surgery inexperienced. The inexperienced operators of the Da Vinci Robot are against all the four virtues: courage, honesty, temperance, and justice.


Intuitive Surgical da Vinci robotic surgical system'a robotic surgical arms being readied for surgery




Next is my action plan for what I believe to be the fix for this situations. The two major issues in this case are: issues with doctor malpractice being untrained to operate such a technical device, and one lawsuit with defective equipment. The issue with doctor mal practice needs to be dealt with carefully, because we are dealing with experienced professionals who can perform this procedure by hand. By calling these doctors inexperienced Intuitive Surgical may insult these potential buyers and push them away from buying a one million dollar plus product. That means any sale Intuitive Surgical makes is a large one, especially since Intuitive Surgical is based solely on this one product. So any bad publicity hit this company harder than other companies with multiple products. I would first hold events that educate potential buyers about the event, in an event setting where potential buyers come and learn about the product. This way we can weed out who really is interested in the product for purchase, and the onlookers. Since Intuitive Surgical already pays for a two day two doctor learning class I would expand on that idea for a bit. I would have a training dummy made out of ballistics gel, the show Mythbuster’s has made this material popular. The training dummy would be anatomically correct from the neck to the waist, and this would allow doctors to practice with the Da Vinci Surgical Robot on a training dummy to get the doctor more experienced with the technology. Intuitive Surgical would sell this training dummy in sets of ten, because it takes many procedures to become adept at the new technology. This would help the doctors who purchase this product the option to train more, and if they don’t take the option for extra training the negligence would fall onto the doctor instead of Intuitive Surgical. Unfortunately, the lawsuit dealing with defective equipment is a much larger issue. To keep the electric technology from cutting through tissue or jumping to healthy organs, the robot would require a different electrical current, one that is more controlled to minimize the risks. The other solution could be to outfit the robot with materials that are not conducive with electricity. However, this lawsuit has not been settled through court so the Da Vinci Robot may not be the problem here.




By: Joshua Concepcion








Krangle, Alonso. "Da Vinvi Surgical Robot Lawsuit." Alonso Krangle LLP Fight For Victims. Fight for Victims Alonso Krangle LLP, n.d. Web. 20 Apr 2013. <http://fightforvictims.com/medical-devices/da-vinci-surgical-robot-injury-lawsuit>. 

Salazar, Heather. Business Ethics Lectures. WNEU. Spring 2013. 

Surgical, Intuitive. "Company Profile." . Intuitive Surgical, n.d. Web. 20 Apr 2013. <http://www.intuitivesurgical.com/company/profile.html>.










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