Tuesday, April 4, 2017

IVC Filters: Helpful or Heart Attacks? (2015)

An Inferior Vena Cava (IVC) filter is “a small cone-shaped device that is implanted in the inferior vena cava just below the kidneys” (Michigan Medicine). The use of the IVC filter is to “capture an embolism, a blood clot that has broken loose from one of the deep veins in the legs on its way to the heart and lungs” (Michigan Medicine). IVC filters have been used in medicine for over 30 years. IVC filters are more of a temporary solution in which they should be used in smaller increments of time rather than long periods of time. In the short run, IVC filters do almost no damage to the human body. However, when they are left in a patient too long they can do more harm to the person than they do good.
The IVC Filter
IVC filters are used to limit blood clots in the body, but lately they have been doing more harm than good. Florida woman, Carolina, had suffered a double pulmonary embolism and a heart attack since she’s had her IVC filter that was implanted in 2000. Carolina was not the only person that has had problems with her IVC filter. In 2010, the FDA had received over 900 additional reports involving a person’s IVC filter going bad. Carolina explains that she had a lack of information on them, like how long to keep it in for. She said that she didn’t blame the doctors but the manufacturer of the IVC filter (Mundy). In 2015, JAMA published a study about the negative effects of keeping an IVC filter in too long. One effect is that someone is twice as likely to suffer a pulmonary embolism when they have an IVC filter implanted. Carolina explained that she has gone through a lot of trauma from the effects of the filter and she feels that what happened to her was not fair. Carolina received a large blood clot and the doctors could not tell where it came from. The blood clot was in her lungs and the only way to save her was to put her on blood thinners. Carolina will be on blood thinners for the rest of her life to make sure that this does not occur again. The manufacturers of the IVC filters have not taken responsibility for what has happened to the people that have been affected by them.

A stakeholder is anyone that has an interest or concern in something, typically a business. In this case, the stakeholders of the IVC filter are the manufacturers, doctors (hospitals) and patients that use them. The manufacturers of the filters are stakeholders because whatever happens to the people that use the filters can be because of how they manufactured their product. The patients that are being given the IVC filters would like to know where they come from and how they work. If the manufacturers cannot answer the questions of these people they could potentially find themselves losing business or potentially getting a lawsuit from a patient. The doctors that use the IVC filters are stakeholders because they are responsible for the affects that the filters give to their patients. Patients trust these doctors to help them with their medical issues. If a doctor implements an IVC filter into a patient and the filters backfire, the hospital and that doctor could potentially be liable for what happens to that patient. In Carolina’s case, she did not blame the doctors for what had happened to her but others may not feel the same way as she did. The patients of the IVC filters may be the most affected of all the stakeholders because it dangers their personal health. These filters have had a history of harming patients that use them so new patients have to realize the potential negative effects it may cause to them, which is something they really want to know.

How the IVC Filter Works
Milton Friedman’s individualism states; “the only goal of a business is to profit, so the only obligation that the business person has is to maximize profit for the owner or the stakeholders.” Friedman stresses that the only goal of a business is to make profit and they should do whatever it takes, within the constraints of the law, to do so. The IVC filter is a medical instrument that has been used for many years. It has only been in the recent years where people have started to realize the problems that come with the use of the filters. In Friedman’s view of individualism, the manufacturers of the IVC filter have been acting ethically with their decision to keep selling their IVC filters. Friedman’s view of individualism is based around maximizing profits; in that sense the manufacturers of the IVC filter are not thinking ethically. For these companies to maximize their profit they should recall their product to see what specifically is so harmful in their product. If they eliminate the harmful effects that the filters may give, they will sell more of their product which will make them more profit in the long run. IVC filters are not very well known by people who do not or have never had them. However, those who are offered IVC filters are going to be reluctant to have them implemented after these cases have emerged. Even doctors now are weary to use them on their patients because they do not want to put their patient's in harm's way, which the IVC filter is proving to be more harmful than helpful. They are making profits because they are still being used, but they are not making the most potential money they could be making.

Utilitarianism explains that the only things that have intrinsic value are happiness and pleasure. A utilitarian would push for a business to make sure that they bring happiness and pleasure to everyone that they can. Utilitarianism would measure happiness of their stakeholders and look to see what they can change for the better of others. The manufacturers of the IVC filters have not pushed to make their business a happy and pleasurable business. If they were to find what is wrong with their product and fix it, they will make many people happy. If they were to compensate these people for their wrongdoings, they would bring even more happiness and pleasure. However, they have not done these things mostly because it would be very costly for them. If they compensate their patients or recall the product, they will have to spend a lot of their own money. Plus, there is no guarantee that this will reignite their business. Rather, they have not taken the blame for what has happened to these people. Carolina explains how she was not upset with the doctors, but the manufacturers because the doctors had little knowledge of what they were capable of, as well. According to Utilitarianism, the manufacturers were acting unethical because they simply did not bring any happiness or pleasure to the people that they had served their products to. 

Surgeons at Work
            Kantianism is broken down into four main principles; the first is to act rationally, nobody should think themselves as above the rules. It also stresses to help and allow others to act rationally. Kantianism stresses how people should be motivated by Good Will, doing what is right because it is the right thing to do. Finally, Kantianism is about respecting people, their autonomy and individual needs and differences. The IVC filters have clearly had their problems, but there has been no clear efforts to fix them. When there were over 900 accounts reported by the FDA, there were still no clear efforts that came from the manufacturers to fix the problems they were having. In the Kantian view, not halting the distribution of the IVC filters was unethical because they were not following the four main principles. If the manufacturers of the IVC filters were acting in a Kantian way they would have been looking out for the people that were given them. A rational way to go about this case would have been to recall the product and do some studies as to why these people were getting sick and injured from it. This would be costly but it would find the underlying reason as to why people were getting sick. A Kantian person would try and fix the problem with the product because it is the right thing to do. It is irrational for the manufacturers to keep selling a product that is harming people because people are going to keep getting hurt if something does not change. The manufacturers of the IVC filter did not think this way which opposes the Kantian view. 

Virtue Theory
The Virtue Theory consists of characteristics that “emphasize an individual’s character as the key element of ethical thinking, rather than rules about the acts themselves or their consequences” (Mastin). The four virtues that is stressed by the Virtue Theory are courage, honesty, temperance, and justice. Courage consists of risk-taking and the willingness to take a stand for the right ideas and actions. Honesty should always be used in business because many acts of business are based around honesty. Temperance is having “reasonable expectations and desires” (Soloman 34). Justice is all the hard work, good ideas, and fair practices that come together. Manufacturers of the IVC filter have had gotten a lot of fingers pointed at them for what has happened to the patients who were using them. If they followed the four virtues that are in the Virtue Theory they would make a lot of people less angry at them. They have not taken action for what they have done to their patients, which shows how they went against honesty and courage. It takes a lot of courage for someone to step up and admit that they were wrong. None of the manufacturers have been courageous enough to be honest about their product. Also, there is no justice that is being served. The manufacturers are not recalling their product to fix what they have wronged, which is no justice to neither the manufacturers nor the patients that were affected. Looking at this case from a virtue point of view, this case would be considered unethical.

Justified Ethical Decision
The Use of the IVC Filter
The manufacturers of the IVC filters have acted unethical in this case because they have gone wrong on all of the theories. Carolina was one of the first people to step up and talk about how the IVC filters have affected her life. There are hundreds, potentially thousands more of people that have been hurt like she was. The manufacturers of the IVC filters are more than likely responsible for what happened and they have not accepted that responsibility. Carolina will be on blood thinners for the rest of her life because of what their product had done to her. The ethical decision in this case is to help those who are in need, not leave them stranded.

Mundy, Jane. “LawyersandSettlements.com.” Lawyers and Settlements. N.P., 25 Feb. 2017. Web. 01 Apr. 2017. https://www.lawyersandsettlements.com/articles/ivc-filters-adverse-events-filter-side-effects/interview-ivc-filter-inferior-vena-cava-5-22097.html
"Inferior Vena Cava (IVC) Filters." Inferior Vena Cava (IVC) Filters - University of Michigan Vascular Surgery. University of Michigan Medical School, n.d. Web. 03 Apr. 2017. http://surgery.med.umich.edu/vascular/patient/treatments/ivc_filters.shtml
"IVC Filter Lawsuits - Complications & Litigation Status." DrugWatch. N.p., 10 Apr. 2015. Web. 03 Apr. 2017. https://www.drugwatch.com/ivc-filters/lawsuits/
"IVC Filter Injury Lawsuits Continue to Grow." Baron Budd. N.p., n.d. Web. 03 Apr. 2017. https://baronandbudd.com/protecting-whats-right/pharmaceuticals/ivc/ivc-filter-injury-lawsuits/
"Greenfield™." Boston Scientific | Advancing Science For Life. N.p., n.d. Web. 03 Apr. 2017. http://www.bostonscientific.com/en-US/products/embolic-protection/greenfield-vena-cava-filter.html

Mastin, Luke. "Virtue Ethics - By Branch / Doctrine - The Basics of Philosophy." Virtue Ethics - By Branch / Doctrine - The Basics of Philosophy. N.p., 2008. Web. 03 Apr. 2017. http://www.philosophybasics.com/branch_virtue_ethics.html

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