Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property.

Assignment 4: 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 researcherat PharmaCARE, comes to your office. He has concerns about PharmaCAREs use of AD23, oneof the companys top-selling diabetes drugs. Two (2) years ago, after PharmaCAREs researchindicated that AD23 might also slow the progression of Alzheimers disease, John and his teamof pharmacists began reformulating the drug to maximize that effect. In order to avoid the Foodand Drug Administrations (FDA) scrutiny, PharmaCARE established a wholly-ownedsubsidiary, CompCARE, to operate as a compounding pharmacy to sell the new formulation toindividuals on a prescription basis. CompCARE established itself in a suburban office park nearits parents headquarters. To conserve money and time, CompCARE did a quick, low-costrenovation.CompCARE benefited from PharmaCAREs reputation, databases, networks, and sales andmarketing expertise, and within six (6) months had the medical community buzzing about AD23.Demand soared, particularly among Medicare, Medicaid, and Veterans Affairs patients. Seeingthe opportunity to realize even more profit, CompCARE began advertising AD23 directly toconsumers and marketing the drug directly to hospitals, clinics, and physician offices, eventhough compounding pharmacies are not permitted to sell drugs in bulk for general use. Tocircumvent this technicality, CompCARE encouraged doctors to fax lists of fictitious patientnames to CompCARE. PharmaCARE sold CompCARE to WellCo, a large drugstore chain, justweeks before AD23 was publicly linked to over 200 cardiac deaths.As CompCARE and its new parent company enjoyed record profits and PharmaCAREs stockprice approached $300 per share, reports started surfacing that people who received AD23seemed to be suffering heart attacks at an alarming rate. The company ignored this data andcontinued 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 withAD23, and information describing the companys willingness roll the dice and continue tomarket the drug.Your senior partner has asked you to write a memo outlining the following issues for review bythe senior partners.In preparation for this assignment, use the Internet to research examples of intellectual propertytheft that occurred within the past two (2) years.Write a ten (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 PharmaCAREviolated any of the issues in question.2.Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Providesupport for your response. 3. Determine the parties responsible for regulating compounding pharmacies under thecurrent regulatory scheme, the actions that either these parties or the FDA could / should havetaken in this scenario, and whether PharmaCARE could face legal exposure surrounding itspractices. Support your response.Analyze the manner in which PharmaCARE used U.S. law to protect its own intellectualproperty 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 intellectualproperty theft, and examine the effect on that companys brand.Analyze the potential issue surrounding the death of Johns wife and other potentiallitigants against PharmaCARE as a result of AD23.Specify both the major arguments that John can make to claim that he is a whistleblowerand the type of protections that he should be afforded. Justify your response.Use at least (5) quality resources in this assignment. Note: Wikipedia is not an acceptablereference 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 marginson all sides; citations and references must follow APA or school-specific format. Check withyour professor for any additional instructions.Include a cover page containing the title of the assignment, the students name, theprofessors name, the course title, and the date. The cover page and the reference page are notincluded in the required assignment page length. .


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