Legal, and Ethical Considerations in Marketing, Product Safety, and Intellectual Property
1st Page, Abstract page should include: My name Jo Anne Hall The date of 06/03/2016. The class title is: LEG500. The name of my teacher: Professor Aryka
Moore. Should say and be saved as Week 9 Assignment 4. New Times Roman font and size 12 letters.
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.
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  years) of intellectual property theft, and examine the effect on that company’s
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