Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual

| September 29, 2018

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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:
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.Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response.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.Click .strayer.edu/bbcswebdav/institution/LEG/500/1146/Week%209/Week%209%20Assignment%204%20Rubric.html”>here to view the grading rubric.
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: 300Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual PropertyCriteriaUnacceptableBelow 70% FFair70-79% CProficient80-89% BExemplary90-100% A1.
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.Weight: 15%Did
not submit or incompletely researched 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..Partially
researched 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.Satisfactorily
researched 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.Thoroughly
researched 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.Weight: 10%Did not submit or incompletely argued for or against Direct-to-Consumer (DTC) marketing by drug companies.Partially argued for or against Direct-to-Consumer (DTC) marketing by drug companies.Satisfactorily argued for or against Direct-to-Consumer (DTC) marketing by drug companies.Thoroughly argued for or against Direct-to-Consumer (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.Weight: 15%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.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%Did
not submit or 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.Partially
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. Partially suggested at least three (3) ways the
company could compensate John for the use of his intellectual property.Satisfactorily
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. Satisfactorily suggested at least three (3) ways
the company could compensate John for the use of his intellectual
property.Thoroughlyanalyzed
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.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%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.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%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 AD23.7.
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.Weight: 10%Did
not submit or incompletely 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. Did not submit or incompletely
justified your response.Partially 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.
Partially justified your response.Satisfactorily
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. Satisfactorily justified your response.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. Thoroughly justified your response.8. 3 referencesWeight: 5%No references providedDoes 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.9. Clarity, writing mechanics, and formatting requirementsWeight: 10%More than 6 errors present5-6 errors present3-4 errors present0-2 errors present

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