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 PharmaCAREâ€™s use of AD23, one of the companyâ€™s top-selling diabetes drugs. Two (2) years ago, after PharmaCAREâ€™s research indicated that AD23 might also slow the progression of Alzheimerâ€™s disease, John and his team of pharmacists began reformulating the drug to maximize that effect. In order to avoid the Food and Drug Administrationâ€™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 parentâ€™s headquarters. To conserve money and time, CompCARE did a quick, low-cost renovation.
CompCARE benefited from PharmaCAREâ€™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 PharmaCAREâ€™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 companyâ€™s willingness â€œroll the diceâ€ 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 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 â€œinventorâ€ 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  years) of intellectual property theft, and examine the effect on that companyâ€™s brand.
- Analyze the potential issue surrounding the death of Johnâ€™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 studentâ€™s name, the professorâ€™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