Assignment 4: 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 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.

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:

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 [2] years) of intellectual property theft, and examine the effect on that company’s brand.
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 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 student’s name, the professor’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.

Please read the transcript and answer three questions. Need this back today in a few hours.

I am a licensed clinical social worker, and I am on the faculty of Excelsior College, School of Health Sciences.
I have worked closely with people suffering from post traumatic stress syndrome for over 15 years in both individual therapeutic settings as well as critical incident debriefings.  I am quite grateful today to have the opportunity to talk with a special guest.
Our special guest is an individual, who has experienced PTSD herself, and she will remain anonymous in terms of identifying information but she has graciously agreed to talk with us about her experiences.
So, let’s get started:
Thank you so much for talking with us today.

J: You’re welcome.

CO: I am sure students would be interested in hearing a little about why, what’s your interest in PTSD and why you agreed to volunteer and take some time to talk with us.

J: Well, when I went through it I did not even know that such a thing existed.  It is only in hindsight that I know it was PTSD.  I think if we bring awareness to things it is helpful to anybody who can listen to us.

CO: I would agree with you, and I think that really sums up very nicely a lot of the reasons that we developed this course.
I’m curious: You said that you really weren’t aware of it at the time.  Did you have any general awareness about post traumatic stress?

J: No, I did not.  I just thought I was losing my mind.  Being able to just get up and put one foot in front of the other was a very difficult thing.

CO: Which is very classic, it sounds like very classic symptoms of someone who’s really been hit with that debilitating, or this, debilitating disease and issues.
I guess rather than me continue to ask a lot of pointed questions at this point, if you wouldn’t mind, could you share with us a little bit of your story and a little bit about what happened leading up to the PTSD and when you finally did recognize something was wrong?

J: In 2002 [sic], my husband of 28 years tried to commit suicide for the first time, and he continued to try different methods until 2002 when he completed suicide [Editor’s Note: Suicide attempts began in 2000.].  And it is a very traumatic thing, not only for me, my family, my children; it is just a very stressful time.  I didn’t really know how to deal with it. And I was seeing a psychologist.  I was taking medication, something to help me sleep, something to help me get up in the morning and be alert.  But I found myself after a while, after several weeks, and I was driving up a one-way street the wrong way and I just started crying because I wasn’t really sure what I was going through … I knew what I going through, but I wasn’t sure how I was handling it.  And then I got more counseling.  I probably was in counseling for six months if not longer, and off medication, before I actually moved back to this area.  I was living in another state at the time; I moved back to this area, and I found the American Foundation for Suicide Prevention, and I got involved with that.  I did walks with them, my children got involved, and now I am an outreach volunteer.  I think the only reason I do it is it helps me heal, and it helps the people that I meet.

CO: I can only imagine, that is wonderful that you found a way to re-channel some of that grief and loss and all of the horror that you went through into helping other folks.  It has to have some really important healing qualities to it, I have to imagine.

J: Yes, it does.  When you meet other people that have been through the same thing, like I was saying earlier, it’s like a club that you don’t want to belong to, but you have a bond with all the people you meet, and that’s very helpful.

CO: Yes, it has to be. It is wonderful that you found that and you are contributing to it in the way that you are now.  So when you think back to the early stages, you experienced and lived through just a horror of a trauma that most people can’t even imagine, really; it sounded like there was maybe some, in terms of the impact on your emotional well-being, that the time leading up to your husband eventually completing a suicide was a factor.  It sounds like it was more than, the suicide sort of finished you off, in terms of a process.  Is that right?

J: Yes, that is correct.

CO: In that process, earlier before your husband’s suicide, did you realize you were beginning to deteriorate emotionally?

J: Yes, I did.

CO: You did, yeah.

J: Not only did I live with him, I worked for him.  So, I was with him all the time.  And there were days when I would go grocery shopping and come home and wonder if he was still going to be alive in the house.  It went on like that for almost two years.  And that was very difficult.

CO: Wow.  It is.  And like I said, for anyone who hasn’t lived anything like that, you can’t even really completely imagine it.  You talked a little about it, at one point realizing you were driving down a one-way street the wrong way.  Can you talk a little bit more about some of the other symptoms in the time period leading up to his eventual suicide?  Were you sleep disrupted; were you anxious all the time?

J:  I was sleep disrupted.  I wasn’t anxious all the time; I was anxious a lot of the time.  I didn’t sleep well at night because it was like waiting for the other shoe to drop.

CO: So, not real restful sleep as a general rule.

J: Yes, correct.

CO: Yeah, OK.  Can you pinpoint, do you think, where you realized or you began to have this awareness that, ‘Gosh, I think am suffering with symptoms of PTSD.’?

J: I was actually, prior to him committing suicide, I was in counseling between the first time he tried it and then after he succeeded, I was in counseling for a very long time, and I think that was helpful.  But I knew, I used to walk around with an 800 number in case I needed to get out of the house because many times it becomes, a suicide is a homicide.  There is a homicide attached to it.  And that was very stressful, walking around with this number just in case I needed to get out of the house in a hurry.

CO: Yeah, I can only imagine that has to be difficult and wear on you.
Was it hard to find help? It sounds like you got counseling early and then you continued to get some more help later. Was it difficult to find resources?

J: Actually it wasn’t.  He was a doctor.  So, through people I knew and people that knew of the situation, they reached out to me, they decided, or suggested, I get counseling.  So I had counseling for a long time.
And I think if you didn’t, if I didn’t, I don’t know where I would be now emotionally.

CO: That is a really important point that you just raised, which is a lot of what I see in the folks that I work with and the families I work with.  I work in rural social work.  The folks that I work with are all in small towns and a lot of them are very isolated and folks usually don’t have much a sense, first of all, that they are at a point that they need help, and second of all, where to even go or how to get it even if they needed it. So, it sounds like you had a little bit of help there in the sense of being married to a professional — a doctor — and having folks who recognized that you needed to get some help.

J: Prior to this, we had a patient, a husband and wife where the husband tried to commit suicide, and I got involved in that, and I actually found help for the wife.  So it was, I don’t know if it was meant to be or I don’t know, but that helped a lot.

CO: OK, that makes sense.  So when the, sort of the other side of the, if we go from the build up to realizing you had such emotional and psychological damage from all this, which only makes sense, anyone who went through something like that would, so now you are in this process, it is a journey, I’m sure, it’s not one stop, where you’re volunteering, you’re helping, you’re doing .something.  How are your symptoms? Would you say your symptoms peaked at some point and you’re now, I don’t know, 50 percent better than you were at your worst point?

J: Yes, my symptoms did peak. I think I peaked when he committed suicide.

CO: OK, I was wondering about that.  Thank you for saying that.  That was sort of like the climactic moment for you in this big build up?

J: Yes, it was. It was.

CO: So, what’s helped you, what’s helped you heal and take this journey of recovery instead of just kind of collapsing and giving up?

J: Well, like I said, I was on medication, and I was going to counseling.  It was counseling one-on-one.  And then joining and becoming a member, not a member, but joining the, I was actually on the board for the Suicide Foundation for a while but then it was too much, too many meetings, too much, and now I just volunteer, and that’s good because when I talk to people it’s helping me heal.  And I don’t think I’m completely healed, it is a very long journey; I don’t think I have completely healed, but I can deal with it, and I am in a better place in my life than I was before.

CO: OK, well, that is wonderful to hear.  Thank you.
Is there anything that you think that’s important for us to know, for students to know, for any of us to know about anyone in similar circumstances whether it may not be a suicide, but it may be some other tragedy or traumatic event that just leaves somebody really in rough…

J: I think you need to reach out.  

CO: OK.

J: I don’t know if it’s just for professionals, from professionals, or people who are going through what you are going through, if you reach out to each other, it’s very comforting, and I think that helps a lot.  Because when you are going through this you think you’re the only one going through it, and you don’t realize how many people out there are going through the same thing or a very similar thing.

CO: That is so, I am so glad you said that because that is so common for this type of distressing emotional impacts on an individual, on a person or a family, and it is for all — almost all — really all the different types of emotional health and mental health wellness kinds of issues.

J: Yes, it is

CO: Did you in your own journey and in now the work that you are doing with others, are you finding any amount of stigma? Do you find that some people …

J: There is a lot of stigma attached to it, and I don’t think that is a good thing.  I know when I was growing up if anybody that we knew committed suicide it was a big secret.  Even years ago, cancer was a big secret.  We didn’t talk about it.  And the more we talk about it, the more we can help.

CO: Right.  I thank you for stressing that.  I think that’s a wonderful thing for all of us who participate in this video or listen to this and watch this video to take away and just really hang on to, and you brought it up in a number of different ways to, to reach out and to connect are so important.
Is there anything else that you would like to share?  Is there anything that I haven’t asked about that you think is really an important part of this?

J: I really can’t think of anything.  Can you?

CO: No.  It has been really very helpful for me to hear because we in, throughout this course students are looking at post traumatic stress from a variety of different standpoints: They’re looking at what creates it, what is it, what are the symptoms, and then what can you do about it, and you touched on all of those, and I really appreciate that.  Thank you.

J: You’re welcome.  I just think that you are not alone and the sooner you realize that the sooner you can get help.

CO: My last question was, ‘What would you like to leave us with?’  That’s it; that’s beautiful. So thank you very much.  I appreciate it.  I really appreciate you taking the time.  It has been really nice to talk.

J: You’re welcome very much.

• What symptoms of PTSD did “Jenny” experience?
• What actions did “Jenny” and others take that reflected resilience? Was there more that could have been done? Please provide specific examples.
• What factors (e.g. internal, familial, environmental, cultural) promote – or hinder – healing for people who have endured either ongoing trauma or one-time traumatizing events? 

Assignment 1: Implications of Health Economic Concepts for Health Care

Due Week 4 and worth 200 points

Select at least five (5) economic concepts covered in the first four (4) weeks’ readings, and discuss the primary manner in which these concepts impact the world of health care economics. Some examples of selected concepts are health demand and supply, elasticity, resources, health measures, and costs.

Write a four to six (4-6) page paper in which you:

1. Assess the value of health care professionals and decision makers understanding the discipline of health economics.
2. Defend or critique the importance of considering the complex nature of health and health care when examining the economic principles related to health care delivery.
3. Analyze the primary potential benefits of learning about health economics related to government involvement in health care economics, financing, and delivery.
4. Analyze the main potential benefits of learning about health economics related to private sector government involvement in health care economics, financing, and delivery.
5. Use at least five (5) current references. Three (3) of these references must be from current peer-reviewed sources to support and substantiate your comments and perspectives.

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 student’s name, the professor’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:

• Explain how selected economic principles apply to the health care market and the provisions of health care services.
• Analyze the factors that are influencing the demand and supply of health care services in the U.S.
• Assess current economic trends that influence the cost, quality, and access to care.
• Use technology and information resources to research issues in health economics.
• Write clearly and concisely about health economics using proper writing mechanics.

 

Lab 3 – Biodiversity

 

Experiment 1: Effects of Water Pollution on Plant Diversity

 

Water pollution can have severely negative effects on biodiversity and ecosystems, particularly on plant populations. In many cases, these pollutants are introduced to the environment through everyday human activity. In this experiment, you will contaminate several water samples, as well as purify a water sample. You will then evaluate the effects of water pollution and purification on the biodiversity of wildflowers.

 

 

 

POST-LAB QUESTIONS

 

 

 

Table 1: Water Observations (smell, color, etc.)
Beaker	Observations
1
2
3
4
5
6
7
8

 

 

 

 

 

 

 

 

 

1. What effects did each of the contaminants have on the water in the experiment? Use Table 1 for reference.

 

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2. What kinds of human activities could cause oil, acids, and detergents to contaminate the water supply?

 

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3. What are the differences in color, smell, visibility, etc. between the “contaminated” water and the “treated” water?

 

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4. From the introduction to Lab 2, you know that there are typically five steps involved in the water treatment process. Identify the processes (e.g., coagulation) that were used in this lab and describe how they were performed.

 

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5. Develop a hypothesis regarding how using contaminated or purified water might affect plant biodiversity. Which pot do you believe will contain the greatest biodiversity (greatest number of species)? Why?

 

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6.      Based on the results of your experiment, would you reject or accept the hypothesis that you produced in question 5?  Explain how you determined this.

 

 

 

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7.      Alum contains aluminum. Research the effects of aluminum on plants by finding a scholarly source online. Does your research provide any insight into your results? Discuss your findings as they relate to the results of your experiment.

 

 

 

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8.      Imagine that each pot was a sample you found in a group of wildflowers. Based on the diversity of flowers in each pot, would you consider the ecosystem to be healthy? Why or why not?

 

 

 

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9.      How does biodiversity contribute to the overall health of an ecosystem?  Provide specific examples and utilize at least one scholarly resource to back your answer.

 

 

 

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10.  Rank the following three scenarios in terms of having the most to least biodiversity and provide your rationale for these rankings.

 

·         A vacant lot behind a car repair facility.

 

·         A designated national wilderness area.

 

·         A grassy strip along the highway.

 

 

 

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References

 

Any sources utilized should be listed here.