Analyze and evaluate laws and regulations relative to product safety and liability.
Legal and Ethical Considerations in Marketing Product Safety and Intellectual Property
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 PharmaCAREs use of AD23 one of the companys top-selling diabetes drugs. Two (2) years ago after PharmaCAREs research indicated that AD23 might also slow the progression of Alzheimers disease John and his team of pharmacists began reformulating the drug to maximize that effect. In order to avoid the Food and Drug Administrations (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 parents headquarters. To conserve money and time CompCARE did a quick low-cost renovation.
CompCARE benefited from PharmaCAREs 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 PharmaCAREs 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 companys 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:
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 inventor 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 [2] years) of intellectual property theft and examine the effect on that companys brand.
Analyze the potential issue surrounding the death of Johns 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 students name the professors 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.
Points: 300
Assignment 4: Legal and Ethical Considerations in Marketing Product Safety and Intellectual Property
Criteria
Unacceptable
Below 70% F
Fair
70-79% C
Proficient
80-89% B
Exemplary
90-100% A
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.
Weight: 15%
Did not submit or incompletely researched 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..
Partially researched 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.
Satisfactorily researched 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.
Thoroughly researched 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.
Weight: 10%
Did not submit or incompletely argued for or against Direct-to-Consumer (DTC) marketing by drug companies.
Partially argued for or against Direct-to-Consumer (DTC) marketing by drug companies.
Satisfactorily argued for or against Direct-to-Consumer (DTC) marketing by drug companies.
Thoroughly argued for or against Direct-to-Consumer (DTC) marketing by drug companies.
3. Determine the parties responsible for regulating compounding pharmacies under the current regulatory scheme the actions that either these parties or the Food and Drug Administration (FDA) could / should have taken in this scenario and whether PharmaCARE could face legal exposure surrounding its practices. Support your response.
Weight: 15%
Did not submit or incompletely determined the parties responsible for regulating compounding pharmacies under the current regulatory scheme the actions that either these parties or the Food and Drug Administration (FDA) could / should have taken in this scenario and whether PharmaCARE could face legal exposure surrounding its practices. Did not submit or incompletely supported your response.
Partially determined the parties responsible for regulating compounding pharmacies under the current regulatory scheme the actions that either these parties or the Food and Drug Administration (FDA) could / should have taken in this scenario and whether PharmaCARE could face legal exposure surrounding its practices. Partially supported your response.
Satisfactorily determined the parties responsible for regulating compounding pharmacies under the current regulatory scheme the actions that either these parties or the Food and Drug Administration (FDA) could / should have taken in this scenario and whether PharmaCARE could face legal exposure surrounding its practices. Satisfactorily supported your response.
Thoroughly determined the parties responsible for regulating compounding pharmacies under the current regulatory scheme the actions that either these parties or the Food and Drug Administration (FDA) could / should have taken in this scenario and whether PharmaCARE could face legal exposure surrounding its practices. Thoroughly supported 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.
Weight: 15%
Did not submit or incompletely analyzed 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. Did not submit or incompletely suggested at least three (3) ways the company could compensate John for the use of his intellectual property.
Partially analyzed 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. Partially suggested at least three (3) ways the company could compensate John for the use of his intellectual property.
Satisfactorily analyzed 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. Satisfactorily suggested at least three (3) ways the company could compensate John for the use of his intellectual property.
Thoroughly analyzed 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. Thoroughly suggested 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 companys brand.
Weight: 10%
Did not submit or incompletely summarized at least one (1) current example (within the past two [2] years) of intellectual property theft and examine the effect on that companys brand.
Partially summarized at least one (1) current example (within the past two [2] years) of intellectual property theft and examine the effect on that companys brand.
Satisfactorily summarized at least one (1) current example (within the past two [2] years) of intellectual property theft and examine the effect on that companys brand.
Thoroughly summarized at least one (1) current example (within the past two [2] years) of intellectual property theft and examine the effect on that companys brand.
6. Analyze the potential issue surrounding the death of Johns wife and other potential litigants against PharmaCARE as a result of AD23.
Weight: 10%
Did not submit or incompletely analyzed the potential issue surrounding the death of Johns wife and other potential litigants against PharmaCARE as a result of AD23.
Partially analyzed the potential issue surrounding the death of Johns wife and other potential litigants against PharmaCARE as a result of AD23.
Satisfactorily analyzed the potential issue surrounding the death of Johns wife and other potential litigants against PharmaCARE as a result of AD23.
Thoroughly analyzed the potential issue surrounding the death of Johns 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.
Weight: 10%
Did not submit or incompletely specified 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. Did not submit or incompletely justified your response.
Partially specified 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. Partially justified your response.
Satisfactorily specified 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. Satisfactorily justified your response.
Thoroughly specified 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. Thoroughly justified your response.
8. 3 references
Weight: 5%
No references provided
Does not meet the required number of references; some or all references poor quality choices.
Meets number of required references; all references high quality choices.
Exceeds number of required references; all references high quality choices.
9. Clarity writing mechanics and formatting requirements
Weight: 10%
More than 6 errors present
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