Week 9 Assignment 4
Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety, and
Intellectual Property
Due Week 9 and worth 300 points
You are a new associate at the law firm of Dewey, Chetum, and Howe. John, a former
researcher at PharmaCARE, comes to your office. He has concerns about PharmaCARE’s use
of AD23, one of the company’s top-selling diabetes drugs. Two (2) years ago, after
PharmaCARE’s research indicated that AD23 might also slow the progression of Alzheimer’s
disease, John and his team of pharmacists began reformulating the drug to maximize that
effect. In order to avoid the Food and Drug Administration’s (FDA) scrutiny, PharmaCARE
established a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy
to sell the new formulation to individuals on a prescription basis. CompCARE established
itself in a suburban office park near its parent’s headquarters. To conserve money and time,
CompCARE did a quick, low-cost renovation.
CompCARE benefited from PharmaCARE’s reputation, databases, networks, and sales and
marketing expertise, and within six (6) months had the medical community buzzing about
AD23. Demand soared, particularly among Medicare, Medicaid, and Veterans Affairs
patients. Seeing the opportunity to realize even more profit, CompCARE began advertising
AD23 directly to consumers and marketing the drug directly to hospitals, clinics, and
physician offices, even though compounding pharmacies are not permitted to sell drugs in
bulk for general use. To circumvent this technicality, CompCARE encouraged doctors to fax
lists of fictitious patient names to CompCARE. PharmaCARE sold CompCARE to WellCo, a
large drugstore chain, just weeks before AD23 was publicly linked to over 200 cardiac
deaths.
As CompCARE and its new parent company enjoyed record profits and PharmaCARE’s stock
price approached $300 per share, reports started surfacing that people who received AD23
seemed to be suffering heart attacks at an alarming rate. The company ignored this data
and continued filling large orders and paying huge bonuses to all the executives and
managers, including John, whose wife recently died from a heart attack after using AD23.
John has come to you with an internal company memo describing the potential problems
with AD23, and information describing the company’s willingness “roll the dice” and
continue to market the drug.
Your senior partner has asked you to write a memo outlining the following issues for review
by the senior partners.
In preparation for this assignment, use the Internet or Strayer Library to research examples
of intellectual property theft that occurred within the past two (2) years.
Write an eight to ten (8-10) page paper in which you:
1. Research three to five (3-5) ethical issues relating to marketing and advertising,
intellectual property, and regulation of product safety and examine whether PharmaCARE
violated any of the issues in question.
2.
Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide
support for your response. 3. 4. 5.
6.
7.
8. Determine the parties responsible for regulating compounding pharmacies under the
current regulatory scheme, the actions that either these parties or the FDA could / should
have taken in this scenario, and whether PharmaCARE could face legal exposure surrounding
its practices. Support your response.
Analyze the manner in which PharmaCARE used U.S. law to protect its own
intellectual property and if John has any claim to being the true “inventor” of AD23. Suggest
at least three (3) ways the company could compensate John for the use of his intellectual
property.
Summarize at least one (1) current example (within the past two [2] years) of
intellectual property theft, and examine the effect on that company’s brand.
Analyze the potential issue surrounding the death of John’s wife and other potential
litigants against PharmaCARE as a result of AD23.
Specify both the major arguments that John can make to claim that he is a
whistleblower and the type of protections that he should be afforded. Justify your response.
Use at least three (3) quality resources in this assignment. Note: Wikipedia is not an
acceptable reference and proprietary Websites do not qualify as academic resources.
Your assignment must follow these formatting requirements:
Be typed, double spaced, using Times New Roman font (size 12), with one-inch
margins on all sides; citations and references must follow APA or school-specific format.
Check with your professor for any additional instructions.
Include a cover page containing the title of the assignment, the student’s name, the
professor’s name, the course title, and the date. The cover page and the reference page are
not included in the required assignment page length.
The specific course learning outcomes associated with this assignment are:
Analyze and assess legal and ethical restraints on marketing and advertising, relative
to both consumers and organizations.
Analyze and evaluate laws and regulations relative to product safety and liability.
Explore copyright laws and intellectual property rights and assess how well they
balance competing interests.
Use technology and information resources to research issues in law, ethics, and
corporate governance.
Write clearly and concisely about law, ethics, and corporate governance using proper
writing mechanics. Grading for this assignment will be based on answer quality, logic / organization of the paper, and
language and writing skills, using the following rubric. Points: 300 Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety,
and Intellectual Property
Unacceptable Fair Proficient Exemplary Below 70% F 70-79% C 80-89% B 90-100% A Did not submit or
incompletely
researched three
to five (3-5) Partially
researched three
to five (3-5) ethical
issues relating to Satisfactorily
researched three to
five (3-5) ethical issues
relating to marketing Thoroughly researched
three to five (3-5)
ethical issues relating
to marketing and Criteria 1. Research three to
five (3-5) ethical
issues relating to
marketing and advertising,
intellectual property,
and regulation of
product safety and
examine whether
PharmaCARE
violated any of the
issues in question. ethical issues
relating to
marketing and
advertising,
intellectual
property, and
regulation of
product safety
and examine
whether
PharmaCARE
violated any of
the issues in
question.. marketing and
advertising,
intellectual
property, and
regulation of
product safety and
examine whether
PharmaCARE
violated any of the
issues in question. and advertising,
intellectual property,
and regulation of
product safety and
examine whether
PharmaCARE violated
any of the issues in
question. advertising, intellectual
property, and
regulation of product
safety and examine
whether PharmaCARE
violated any of the
issues in question. 2. Argue for or
against Direct-toConsumer (DTC)
marketing by drug
companies.
Weight: 10% Did not submit or
incompletely
argued for or
against Direct-toConsumer (DTC)
marketing by
drug companies. Partially argued for
or against Directto-Consumer
(DTC) marketing
by drug
companies. Satisfactorily argued
for or against Direct-toConsumer (DTC)
marketing by drug
companies. Thoroughly argued for
or against Direct-toConsumer (DTC)
marketing by drug
companies. 3. Determine the
parties responsible
for regulating
compounding
pharmacies under
the current regulatory
scheme, the actions
that either these
parties or the Food
and Drug
Administration (FDA)
could / should have
taken in this
scenario, and
whether
PharmaCARE could
face legal exposure
surrounding its
practices. Support
your response. Did not submit or
incompletely
determined the
parties
responsible for
regulating
compounding
pharmacies
under the current
regulatory
scheme, the
actions that either
these parties or
the Food and
Drug
Administration
(FDA) could /
should have
taken in this
scenario, and
whether
PharmaCARE
could face legal
exposure
surrounding its
practices. Did
not submit or
incompletely
supported your
response. Partially
determined the
parties responsible
for regulating
compounding
pharmacies under
the current
regulatory scheme,
the actions that
either these parties
or the Food and
Drug
Administration
(FDA) could /
should have taken
in this scenario,
and whether
PharmaCARE
could face legal
exposure
surrounding its
practices. Partially
supported your
response. Satisfactorily
determined the parties
responsible for
regulating
compounding
pharmacies under the
current regulatory
scheme, the actions
that either these parties
or the Food and Drug
Administration (FDA)
could / should have
taken in this scenario,
and whether
PharmaCARE could
face legal exposure
surrounding its
practices.
Satisfactorily supported
your response. Thoroughly determined
the parties responsible
for regulating
compounding
pharmacies under the
current regulatory
scheme, the actions
that either these parties
or the Food and Drug
Administration (FDA)
could / should have
taken in this scenario,
and whether
PharmaCARE could
face legal exposure
surrounding its
practices. Thoroughly
supported your
response. Did not submit or Partially analyzed Satisfactorily analyzed Thoroughlyanalyzed Weight: 15% Weight: 15% 4. Analyze the manner in which
PharmaCARE used
U.S. law to protect its
own intellectual
property and if John
has any claim to
being the true
“inventor” of AD23.
Suggest at least
three (3) ways the
company could
compensate John for
the use of his
intellectual property.
Weight: 15% 5. Summarize at
least one (1) current
example (within the
past two [2] years) of
intellectual property
theft, and examine
the effect on that
company’s brand.
Weight: 10% 6. Analyze the
potential issue
surrounding the
death of John’s wife
and other potential
litigants against
PharmaCARE as a
result of AD23.
Weight: 10% 7. Specify both the
major arguments that
John can make to
claim that he is a
whistleblower and
the type of
protections that he incompletely
analyzed the
manner in which
PharmaCARE
used U.S. law to
protect its own
intellectual
property and if
John has any
claim to being the
true “inventor” of
AD23. Did not
submit or
incompletely
suggested at
least three (3)
ways the
company could
compensate John
for the use of his
intellectual
property. the manner in
which
PharmaCARE
used U.S. law to
protect its own
intellectual
property and if
John has any claim
to being the true
“inventor” of AD23.
Partially suggested
at least three (3)
ways the company
could compensate
John for the use of
his intellectual
property. the manner in which
PharmaCARE used
U.S. law to protect its
own intellectual
property and if John
has any claim to being
the true “inventor” of
AD23. Satisfactorily
suggested at least
three (3) ways the
company could
compensate John for
the use of his
intellectual property. the manner in which
PharmaCARE used
U.S. law to protect its
own intellectual
property and if John
has any claim to being
the true “inventor” of
AD23. Thoroughly
suggested at least
three (3) ways the
company could
compensate John for
the use of his
intellectual property. Did not submit or
incompletely
summarized at
least one (1)
current example
(within the past
two [2] years) of
intellectual
property theft,
and examine the
effect on that
company’s brand. Partially
summarized at
least one (1)
current example
(within the past two
[2] years) of
intellectual
property theft, and
examine the effect
on that company’s
brand. Satisfactorily
summarized at least
one (1) current
example (within the
past two [2] years) of
intellectual property
theft, and examine the
effect on that
company’s brand. Thoroughlysummarized
at least one (1) current
example (within the
past two [2] years) of
intellectual property
theft, and examine the
effect on that
company’s brand. Did not submit or
incompletely
analyzed the
potential issue
surrounding the
death of John’s
wife and other
potential litigants
against
PharmaCARE as
a result of AD23. Partially analyzed
the potential issue
surrounding the
death of John’s
wife and other
potential litigants
against
PharmaCARE as a
result of AD23. Satisfactorily analyzed
the potential issue
surrounding the death
of John’s wife and
other potential litigants
against PharmaCARE
as a result of AD23. Thoroughlyanalyzed
the potential issue
surrounding the death
of John’s wife and
other potential litigants
against PharmaCARE
as a result of AD23. Did not submit or
incompletely
specified both the
major arguments
that John can
make to claim
that he is a Partially specified
both the major
arguments that
John can make to
claim that he is a
whistleblower and
the type of Satisfactorily specified
both the major
arguments that John
can make to claim that
he is a whistleblower
and the type of
protections that he Thoroughly specified
both the major
arguments that John
can make to claim that
he is a whistleblower
and the type of
protections that he should be afforded.
Justify your
response.
Weight: 10% whistleblower and
the type of
protections that
he should be
afforded. Did not
submit or
incompletely
justified your
response. protections that he
should be afforded.
Partially justified
your response. should be afforded.
Satisfactorily justified
your response. should be afforded.
Thoroughly justified
your response. 8. 3 references No references
provided Does not meet the
required number of
references; some
or all references
poor quality
choices. Meets number of
required references; all
references high quality
choices. Exceeds number of
required references; all
references high quality
choices. More than 6
errors present 5-6 errors present 3-4 errors present 0-2 errors present Weight: 5% 9. Clarity, writing
mechanics, and
formatting
requirements
Weight: 10%
