Ethical Case Study Report: Analysis of the Artificial Heart Valve Case

This report presents an ethical case study centered on the Bjork-Shiley convexo-concave artificial heart valve. It examines the engineering and biomedical aspects of the device, including its development, implementation, and subsequent malfunctions. The case study details the financial aspects, the number of implants, and the resulting deaths due to the failure of the valve's metal components. The report highlights the ethical issues involved, such as informed consent, conflict of interest, and professional self-regulation. It applies the teleological ethical theory, specifically 'Eudaimonism', to justify the case study's relevance to medical procedures and patient well-being. The analysis includes references to relevant literature and provides a comprehensive overview of the ethical and practical considerations associated with this medical device.

ARTIFICIAL VALVE FOR HEART
What is Biomedical engineering
?Biomedical focusses on improvement in human
health and healthcare associated to humans
(Fournier 2017). Principles of engineering when
applied to medicine and biology, gives rise to
biomedical engineering.
Case study identification
(Convexo Concave valve)
Decision timelines
Cost of implementing the device was
stated t be around two hundred million
dollars.
This was left for the court to approve on 5th
June.
99% of the implemented heart valves were
found to be successful in their functioning.
An amount with a fourth quarter of
$900,000 gave rise to a profit of $195
million per year.
The revenue raised to a much higher value
due to the rise in mortality due to the
malfunctioning of the device.
Key aspects
 A total of 55,000 people were implemented
with the artificial health valve named as Bjork-
Shiley Convexo-Concave valve.
 A subsidiary of Pfizer sold the device in year
1979 to 1986.
 Deaths resulted due to malfunctioning of the
artificial heart valve, implanted in patients.
 This condition occurred due to the fact that,
the metal wires and discs connected together
to form a strut.
 Fracture occurred in the metallic portions
resulting in the malfunctioning stated above
and resulting in deaths (Bishop, Uong and Lashinski et
al. 2016).
 The main key aspect
was the replacement
of the two metal
struts with one thick
metal strut.
 100,000 single strut
implants resulted in a
successful restoration
of valve functions.
 The primary failure
that occurred due to
the failure of the
artificial valves was
the uncontrollable
flow of blood
throughout the body.
 This condition
resulted in death of
an individual within
few hours.
Ethical issues and
theoryInformed consent,
conflict of interest and
professional self
regulation are the three
main ethical issues
associated to this case
study. Since the patients
were assured of the fact
that they would get
Fig 1: Artificial
heart valve
Teleological ethical theory
supports this case study
since it deals with
“Eudaimonism”
(Westermarck 2017). This
theory leads to the well
being of human beings and
is directly associated to
References
Bishop, G.B., Uong, D. and
Lashinski, R.T., Direct Flow Medical
Inc, 2016. Translumenally
implantable heart valve with
formed in place support. U.S.
Patent 9,308,360.
Fournier, R.L., 2017. Basic
transport phenomena in
biomedical engineering. CRC
press.