Assignment 4: Legal and Ethical Considerations in Marketing, Product Safety, and lntellectual Property
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Due Week I and worth 300 points
You are a new associate at the law firm of Dewey, Chetum, and l-lowe" John, a former researcher at PharmaCARE, cornes to your offlce. He has concerns about PharmaCARE's use of AD23, one of the cornpany's top-selling diabetes drugs. Two (2) years ago, after PharmaCARE's research indicated that AD23 nnight also slow the progression of Alzheimer's disease, John and his team of pharmacists began refonnulating the drug to maximize that effect. ln order to avoid the Food and Drug Adminislration's (fDA) scrutiny, PharmaCARE established a wholly-owned subsidiary, CompCARE, to operate as a cornpounding 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 cornrnunity 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 direclly 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 fitling 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.
ln preparation for this assignment, use the lnternet 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 lo marketing and advertising, intellectual propedy, and r"egulation of produci safety and examine whether PharnraCARE violated any of the issues in question.
2. Argue for or against Direct-to-Consumer (DTC) rnarketing by drug ccmpanies. Provide support for your response.
3. Determine the parties responsible for reEulating compounding pharmacies under the cunent regulatory scheme, the actions that either these parties or the FDA could I 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 FharmaCARE used U.S. law to protect its own intellectuel property and if John has any claim to being the true "rnventod'of AD23. Suggest at least three (3)ways the company could compbnsate 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 exarnine the effect on that company's brand.
6. Analyze the potential issue suriounding 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 ycur professor for any additional instructions. lnclude a cover page containing the title of the assignment, the student's name, the professor's narne, 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: a a 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 technoloEy and information resources to research issues in law, ethics, and corporate govemance" Write clearly and concisely about law, ethics, and corporate governance using proper writing mechanics. 5. 6" 7. 8. Click here to view the grading rubric
11 years ago
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