Every year, thousands people get heart valve replacements for various health reasons. There are multiple options for replacement valves that can generally be put into two categories, mechanical and biological. One of the mechanical options from the 1970s and 1980s was the Bjork-Shiley valve, which became infamous because of the controversy surrounding its stress fracture failures. These failures resulted the death of about 400 people, causing the value to be taken off the market. Using various ethical standpoints, the decisions made surrounding this issue must be examine so that an incident like this will not occur in the future. Ultimately, the FDA should require either third party or FDA in-house testing in order to ensure the safety of a …show more content…
Shiley Laboratories did not seem to use any type of cost/benefit analysis to determine the best way forward. Instead, the company’s best interests were put first, leading to incorrect information reported to the FDA so that the valve could stay in production. It also intentionally or unintentionally put the lives saved by the heart values above those that it potentially would kill. Although the reports vary with the exact number of people, of the approximately 85,000 people that received the Bjork-Shiley heart valve, somewhere between 400 and 700 valves fractures, two-thirds of those resulting in death. This means that the valve has a failure rate of less than 1%. Since utilitarianism is solely focused on the greatest good for the greatest number people, it would initially suggest that Shiley Laboratories did the right thing by allowing the production and implantation of this valve to continue. However, upon further inspection, it becomes clear that the ultimate result did not serve the greatest good for the greatest number people. While the valve saved or prolonged the lives of many, the long term results of Shiley Laboratories and …show more content…
The universality imperative states that any action can only be ethical if it remains ethical if it was expanded to a universal law that would apply in any situation. In the case of the Bjork-Shiley heart valve, both the actions of Shiley Laboratories and the FDA must be considered. Using the actions of Shiley Laboratories and Pfizer, the corresponding universal law would be that it is acceptable to sell medical devices, even though it has a known issue. Applying this to any number of situations would result in the loss of credibility and sales for medical device companies if it was acceptable for companies to sell potentially faulty devices. The FDA’s actions can be expanded to the universal law that it is always acceptable to trust companies to properly report all issues with medical devices. However, this too results in a loss of credibility on the part of the FDA since, while it is acceptable to have faith in a company, there is no guarantee that all the information will be properly reported. If any issues go unreported, as they did in the case of the heart valve, the public’s trust in the FDA decreases drastically since it shows that they cannot properly regulate within
Medtronic (Minneapolis) and Edwards Lifesciences (Irvine, California) are not strangers to patent lawsuits. Edwards is specializing in the production of artificial heart valves and new hemodynamic monitoring technology, whereas Medtronic is specializing in the production of medical devices. In the past, the two companies have had problems in patent infringement lawsuits over annuloplasty procedures and endovascular grafts (1,2). However, the latest patent infringement lawsuit has been filed and reported between Medtronic and Edwards Lifesciences. Edwards claimed that it has prior intellectual property rights in the new transcatheter aortic valve technology.
American Medical Int’l, Inc. According to this theory, individuals’ decisions are guided by what they are supposed to do, not by consequences or effects. That is to say, a person’s action is ethically right if it coincides with a prevailing moral duty (“Deontological Ethics,” 2007). In the dilemma involving the patient Riser, Dr. Lang violated the theory of deontological ethics by not performing his duty of acquiring informed consent from the patient. By standard of conduct, Dr. Lang was supposed to present a consent form to Riser prior to the operation that would explain the procedure of a femoral arteriogram (although it was supposed to be bilateral arteriograms instead) and thoroughly explain the possible benefits and risks of the procedure. As a result, the patient should have the right to decide whether the femoral arteriogram should be performed or not. However, Riser was not aware of the femoral arteriogram at all. Therefore, deontological ethics should have been followed, which would advise Dr. Lang to follow the ethical duties of a healthcare professional, and those include obtaining informed consent from the
“One of those obligations is that it must exercise a proper degree of care for its patients, and, to the extent that it fails in that care, it should be liable in damages as any other commercial firm would be
Healthcare creates unique dilemmas that must consider the common good of every patient. Medical professionals, on a frequent basis, face situations that require complicated, and at times, difficult decision-making. The medical matters they decide on are often sensitive and critical in regards to patient needs and care. In the Case of Marguerite M and the Angiogram, the medical team in both cases were faced with the critical question of which patient gets the necessary medical care when resources are limited. In like manner, when one patient receives the appropriate care at the expense of another, medical professionals face the possibility of liability and litigation. These medical circumstances place a burden on the healthcare professionals to think and act in the best interest of the patient while still considering the ethical and legal issues they may confront as a result of their choices and actions. Medical ethics and law are always evolving as rapid advances in all areas of healthcare take place.
A powerful speech given by Don Berwick on December 2004 explains ways in which healthcare industries needs to implement in order to save lives and to reduce the mortality death rates that occur in the healthcare (i.e. no needless death). In his speech entitled “Some Is Not A Number…. Soon Is Not A Time” invites all healthcare care organization U.S. and the world to come together to save 100,000 lives by June 14th 2006 at 9am exactly 18 months from the day of the speech. In order to achieve this goal Dr. Berwick suggests there should be a high standards protocol that will help improve care and reduce patients harm.
A). Abiomed got an approval for their fully implantable artificial heart through and HDE approval. The purpose of the HDE is that it helps small numbers of patients who have no alternatives. However, the company is unable to sell more than 4,000 devices per year and must be able to monitor every patient who receives their device. First, Abiomed was able to convince the Office of Orphan Products Development (OOPD) that their device can be designated as a HUD. Next, they were able to submit their application (for a fee of $0). This application is very similar to that of PMA, but doesn’t require to contain results that the device is effective for its intended purpose (fda.gov). However, the application does need to show that the device does not pose a risk and that the health benefits outweigh the risk or injury after use. Additionally, no other devices are available for treatment and that they could not otherwise bring it to market. Approximately after 75 days of review time, CDRH approved AbioCor. Next, Abiomed had to obtain an IRB approval before they would be able to use Abiocor at any facility.
Heart disease is one of the most common causes of the mortality and morbidity in most well developed countries. They come in different forms such as stroke and other cardiovascular diseases and it’s the number one cause of death in the state of America. In the year 2011 alone nearly 787,000 people were killed as a result of this epidemic. And this included Hispanic, Africans, whites and Americans. As for the Asian Americans or pacific Islanders, American Indians and the natives of Alaska, the concept to them was a second only to cancer. However, statistics has proved that a person gets heart attack every 34 seconds and in every 60 seconds, someone dies out of it which include other related event. Additionally, majority of the women are the
The Burden of the disease is high with a prevalence of 3.4% 2. With the progressive nature of the disease and the increased severity of the symptoms made the surgery the gold standard for symptomatic AS patients ,however up to 30% of cases are considered too high risk for classical valve replacement surgery and remain untreated and experiencing poor prognosis . Fortunately , with the introduction of TAVR its offer a valuable option for the inoperable or at high risk of surgery patients3..the annual eligible candidate for this procedure expected to be 27,000 in 19 European countries and North America according to recent meta-analysis an...
Stakeholders in health care include health care organizations, physicians, insurers, employers, consumers, and policymakers. The complexity of health care itself makes balancing the needs of all stakeholders and compliance with health care law a challenge for American Well. Ethical issues in telehealth include concerns of health care quality and buy-in from physicians and policymakers. American Well must use the ethical decision making process to ensure compliance with health care law while also developing products that physicians are willing to utilize and policy-makers are willing to support. Ethical reasoning, ethical principles and decision making are valuable tools that will assist American Well in aligning decisions with changes in health care
Providers must act in the best interest of the patient and their basic obligation is to do no harm and work for the public’s wellbeing. A physician shall always keep in mind the obligation of preserving human life. Providers must communicate full, accurate and unbiased information so patients can make informed decisions about their health care. As a result of their recommendations, providers are responsible for generating costs in health care but do not generate the need for those expenses. Every hospital has both an ethical as well as a legal responsibility to provide care, even if the care may be uncompensated.
Ethical dilemmas have long been issues that have plagued all of mankind for generations. Since the beginning, the majority of humanity has struggled to do what is right when the answer wasn’t clear. Sometimes, however, the answer is not as difficult to realize, but is much more difficult to accept. In the case of the Gee-Whiz Mark 2 (GWM2), the dilemma that faces its respective company is whether or not the units that are defective should be exported to countries that have no enforceable rules to punish the marketing of said defective units. If the company does not do so and instead decides to scrap the units, there will be a loss of profit. For the company though, the answer is clear; though it may be challenging for its leaders to accept,
The purpose of this paper is to identify a quality safety issue. I will summarize the impact that this issue has on health care delivery. In addition, I will identify quality improvement strategies. Finally, I will share a plan to effectively implement this quality improvement strategy.
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
There are weaknesses in professional guidelines and rules because they are unable to provide the directives for moral reasoning and action is health care situations. Many people state that biomedical ethics provides a framework and emphasis on the person rather than the professional code and legal policy (Beauchamp and Childress, 2001). On the other hand they serve a purpose to provide some direction for professionals however codes of practise do not dismiss.
Statement of Purpose: Children with congenital heart disease (CHD) are at increased risk for psychosocial issues (PSI) associated with lower quality of life (QOL) and decreased resilience. Psychosocial issues, such as depression and/or anxiety, may increase medical noncompliance and mortality in this population. The purpose of this project was to implement a psychosocial screening protocol with appropriate referral for children with CHD who are followed in a heart transplant/heart failure clinic with the hopes of identifying at-risk children.