LEG 500 Assignment 4: Legal and
Ethical Considerations in Marketing, Product Safety, and Intellectual Property
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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.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.
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.
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.
6.Analyze 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.
8.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:
2.Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response.
3.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.
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.
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.
6.Analyze 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.
8.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:
•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.
•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.
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