Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property
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
topselling 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 whollyowned 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, lowcost 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 (8) page paper in which you:
1. Research three to five (35) 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 DirecttoConsumer (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
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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 oneinch margins on all sides; citations
and references must follow APA or schoolspecific forma
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