Legal and Ethical Considerations: PharmCARE Case Study

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Introduction

Issues touching on ethics are distinct subject to the daily morality as well as the social code. A majority of the ethical issues together with those in the business sector always revolve around principles of morality among others. In the enterprise environment, ethical issues derive from personal marketing, promotion, provisions, and contracts cum costing. A good many of the ethical issues related to business activities are drawn from market exploration, market addresses, and costing (Voaklander, Rowe, Dryden, Pahal, Saar, & Kelly, 2008).

The kind of market research that infringes on the confidentiality of consumers or research conducted based on the typecast is unscrupulous. The consumer’s rights ought to be respected as the corporation inquiries for the reasons of advertising or rather getting feedback on their performance. The research techniques engaged for this purpose ought to honor such rights of the clients. It is also unscrupulous for corporations to leave out latent customers from the target market. The hindrance of some customers through conducting discerning or discriminating marketing or rather targeting consumers who are susceptible, such as children or the needy is unethical. In addition to this, price bigotry and rapacious pricing are dishonest in business. From the issues above, PharmCARE desecrated the ethics by, not paying interest to the market addresses. This is because even upon learning that AD23 was linked to about 201 cardiac deaths (Sullivan and She, 2003).

The company went ahead to continue selling the drug AD23 even upon learning that it was linked to the heart attack disease that was infecting those who had taken the AD23 drug. The company overlooked this data and continued to proffer the drug for public consumption despite its injurious effect on human health in terms of heart attacks and cardiac arrests. Marketing ethics demands that consumer satisfaction overrides the profit targets of any business. PharmCARE was more into profit and purposefully ignored the aspect of customer satisfaction. It demonstrated this by continuing to sell the AD23 drug and paying its staff members to lump sums in terms of salaries and benefits despite the public outcry that was pouring in concerning the harmful effects of the drug. In summary, the company violated business ethics as it hardly cared about the consumers who are the building blocks of any business enterprise (Sullivan and She, 2003).

Direct-to-Consumer (DTC) marketing by drug companies

The use of Direct-to-Consumer marketing, particularly when the pharmaceutical companies employ this marketing strategy has evoked a lot of debate all over the globe. The opinions on the weaknesses, as well as the merits of this marketing strategy, have engrossed almost comparable claims. Direct-to-Consumer marketing stratagem allows the pharmaceutical companies to sell their merchandise directly to the clients without any intervention from the intermediaries. Pharmaceutical corporations have the merit of affecting directly the consumers’ decisions as they directly sell their prescriptions to them. Such a decision may be either beneficial or harmful to both the consumers and the patient consumers. In this paper, the writer is in support of the Direct-to-Consumer marketing strategy (Sullivan and She, 2003).

To begin with, this marketing strategy gives room for better engagements with patients hence ensuring that they are well informed of the methods of administering the drugs. Furthermore, the patients tend to help the company to administer the correct drugs. Secondly, this approach tends to offer education to patients hence helping them be in proper control over their medical care (Sullivan and She, 2003). This has the general impact of improving their well-being. As per the research findings by Davison, patients are inspired to consume prescribed medicines as a result of the Direct-to-Consumer selling technique. Concisely, the Direct-to-Consumer marketing strategy by pharmaceutical companies is a better system as it encourages the patients to comply strictly with the drug regimens (Voaklander et al., 2008).

The regulators of compounding pharmacies under the current regulatory scheme and what the Food and Drug Administration (FDA) could or should have done in this scenario

It is uncomplicated to draw a line to make a distinction between large and local pharmaceuticals. This is due to the differences in their production quantities as well as the customer base. Compounding pharmacy is the third classification of compounding medicines. This focuses on the distribution of specific drugs. This product aids in caring for an individual prescription issued by a medic who is licensed (Voaklander et al., 2008). Compounding ought to be assessed and certified to uphold the required standards of medicine manufacturer. This task of ensuring adherence to these rules is accomplished by the State Boards (Sullivan and She, 2003). The Food and Drug Administration (FDA) is the state bureau that responsible for supervising the blending, grinding, casing, as well as tagging of all medicines including the compounded drugs. In this case of PharmCARE, there are patients who suffered the detrimental effects of the drugs despite the market information that brought to the attention of the company the harmful effects of cardiac deaths and heart attacks of the patients who consumed the AD23 drugs (Morgan, Barer, & Agnew, 2003).

The Food and Drug Administration as a state agency mandated to oversee the compounding pharmacy ought to have taken steps to see to it that one, PharmCARE stops the distribution of the drugs upon receiving the market information on the AD23’s health hazards of cardiac arrests and heart failures of the victims who consumed the drug. Secondly, the FDA would have suspended the operations of the PharmCARE upon learning about the harmful effects of AD23 that was being distributed to save the public from further damage. Thirdly, the FDA would have initiated legal action against PharmCARE to demand the compensation of the victims who succumbed to death as well as those who were infected by heart attack by consuming the AD23. Despite the actions that can be taken by the FDA against the PharmCARE, the FDA also has to blame. As a state agency mandated with the responsibility of conducting the quality assurance of the drugs before public consumption, it failed to carry out its responsibility adequately since it approved these drugs prior to marketing (Morgan et al., 2003).

An analysis of the way PharmCARE uses the U.S. law to protect its intellectual property

The corporation makes proper use of the legislation of the United States to safeguard its intellectual property. To realize the US protection, the firm uses the legal guidance to devise a general security tactic (Morgan et al., 2003). PharmCARE too has an entrenched system to supervise and scrutinize all the overseas partners for the reason of sustaining due meticulousness. Furthermore, PharmCARE has registered and secured trademarks, patents, and acquired border protection from the government of the United States (Voaklander et al., 2008). The company has invested in the proper use of well-chosen intellectual property law terminologies while dealing with its subcontractors.

Ways in which the company would compensate John

According to the facts of this case, it is well established that indeed John brought together his team of pharmacists to formulate the AD23 drug to maximize its effect of diminishing the progress of Alzheimer’s disease (Voaklander et al., 2008). As a result of this, John has a claim as to the invention of AD23 drug since he was not only part of the inventing team but also the leader. For this reason and under the intellectual property rights, he, therefore, has a claim to the invention of the drug in question (Morgan et al., 2003). The following are the ways in which the PharmCARE pharmaceutical company can compensate him. To begin with, the first method by which PharmCARE can pay John is through financial compensation. The company can also pay John by getting into an agreement of purchasing the copyrights of from him. The company could also surrender the copyrights to John as a way of compensation (Davidson, 2002).

Comparison of PharmCARE actions with those of the Enron’s Company

Enron is one of the companies in the real world that made use of legal loopholes to engage themselves in unethical business behavior to the detriment of their stakeholders. The company of Enron had promised its stakeholders that it was going to create momentous pecuniary earnings from power and gas. Its share price was the main force behind Enron’s profits (Morgan et al., 2003).

Owing to the monetary losses the company was realizing, it borrowed vast sums of money to sustain its image of profitability, as well as a high share price. On the other hand, it got to a point where it was impossible further to conceal the losses, hence making the complicit financial institutions to withdraw, leaving Enron with a humongous fiscal deficiency of about $700 million. As a consequence of the degeneration of Enron’s monetary structure that had permitted the corporation to keep afloat by mendaciousness to its investors on its share price, the business had no option but to be confirmed insolvent and in turn face lawsuits from the numerous investors who had fallen victims of the fraud scheme. Taking advantage of the legal technicalities as well as ethical limitations that would have discouraged such business malpractices led to the crumple of Enron’s corporation (Davidson, 2002). It suffices to say that it is good for corporate entities to be honest with their stakeholders or shareholders. Furthermore, the business entities ought to be transparent in their dealings.

Potential issues surrounding John’s wife and other possible litigants against PharmCARE as a result of AD23

These items or the issues revolving around the demise of John’s wife can constitute a strong legal case against PharmCARE if it is to be brought by John based on the death of his wife. Subject to the facts of the case, it is well established that John’s wife died due to a heart attack that was caused by consuming the AD23 drug. Her demise took place even after the company had been made aware of the health hazards AD23 had caused the consumers in terms of death by cardiac arrests together with heart attacks (Sullivan and She, 2003). This is an active murder case that John can institute against the company since it is as though the business knew the detrimental effects of AD23 yet it continued to distribute it. The suits that the stakeholders of PharmCARE would bring against it in a court of law of competent jurisdiction would be unsuccessful. This is because PharmCARE would argue that it was not directly involved in the manufacture as well as sales of the AD23 and hence not culpable or liable for any losses (Voaklander et al., 2008).

Other potential litigants who can sue PharmCARE are the families of those persons who died from the heart attack and cardiac arrest after consuming the AD23 drug. They can bring successful suits against the company if they can prove that the ailments suffered were because of drinking AD23. This is apparent from the market study derived from the particulars of the case. The victims of the heart attack caused by the consumption of AD23 can also bring a legal case against PharmCARE seeking the compensation of the medical expenses incurred as a result of a heart attack that was occasioned by consuming AD23.

John as a whistleblower and the protection he is entitled to

Whistle blowing is usually the revelation by a member of staff in a government unit or a private corporation to the public or those in power of the misdeed, bribery, unprofessional conduct and some other malpractices. In the United States, there are diverse federal and State legislations and regulations put in place to guard the whistleblowers against lots of forms of retribution. John could argue for being a whistleblower. To begin with, being a legitimate employee of the PharmCARE Company, he was in a position to disclose to the general public the professional malpractices happening within the company (Sullivan and She, 2003). His information could easily win the public trust since he was one of the top physicists of PharmCARE. This way, he could be volunteering information to the public of the wrong doings in a private corporation. From the facts of the case, AD23 was majorly a drug meant to diminish the progress of Alzheimer’s disease and not for any other purpose as it can be inferred from the facts of this case. John was also one of the victims of the misapplication of the AD23 since he lost his wife through the heart attack caused by the consumption of the AD23 drug (Morgan et al., 2003).

Through revealing the malpractices of the company not only to the government, but also to the general public, John was entitled to various legal protections as a whistleblower. People who play the role of whistleblowers are prone to retaliation by their employers. In most cases, the employer will always discharge the whistleblower. The whistle-blowing legislations guard the whistleblowers against discharge or discrimination of a staff who has initiated an inquiry of the activities of the employer (Noordin, 2012). The False Claims Act protects workers from retaliation and as such, John upon whistle-blowing is entitled to this protection against retaliation by the employer. If John takes lawful steps to investigate the PharmCARE Company, then he will be fully covered by the False Claims Act. In the event, that there can be a work-related retaliation, and then John as a whistleblower is entitled to all the relief required to make him whole (Morgan et al., 2003).

This may involve the reinstatement that is twice the amount of back pay, interest on back pay, reimbursement of the costs of litigation, as well as compensation for special damages. Some State legislation also provides for whistleblower job protection. Though this varies depending on each of the whistleblower’s circumstances (Davidson, 2002).

Conclusion

In summary, this paper is about a case study of a pharmacy compounding company in the name of PharmCARE. The company got flouted the business ethics rules and hence distributed the drug AD23 to the public for consumption. AD23 brought heart attack and cardiac arrest to the patients upon consumption, hence resulting in their subsequent deaths. This essay focuses on the business ethical rules flouted by the PharmCARE Company as it ignored the detrimental effects of AD23 to the consumers even upon getting the information as to the impact of the market research. Furthermore, the paper also touches Enron Company that ran into bankruptcy after conducting legal skirting just as PharmCARE did. Furthermore, the potential litigants who can bring claims against PharmCARE due to its malpractices are also covered in addition to the case of the death of John’s wife. To end with, the paper also recapitulates the legal protection that John is entitled as a whistleblower. This may involve the reinstatement that is twice the amount of back pay, interest on back pay, reimbursement of the costs of litigation, as well as compensation for special damages. Some State legislation also provides for whistleblower job protection

References

Davidson, D. K. (2002). The moral dimension of marketing: Essays on business ethics. Southwestern educational.

Morgan, S. G., Barer, M. L., & Agnew, J. D. (2003). Whither seniors’ pharmacare: lessons from (and for) Canada. Health Affairs, 22 (3), 49-59.

Noordin, M. I. (2012). Ethics in pharmaceutical issues. Contemporary issues in bioethics.

Sullivan, A., & She, S. (2003). Economics: principles in action. New Jersey, NJ: Pearson Prentice Hall.

Voaklander, D. C., Rowe, B. H., Dryden, D. M., Pahal, J., Saar, P., & Kelly, K. D. (2008). Medical illness, medication use and suicide in seniors: a population-based case–control study. Journal of epidemiology and community health, 62 (2), 138-146.

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