Essay on Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property

In marketing AD23 to patients with Alzheimers syndrome, Compcare and its parent company Pharmacare have breached several ethical and legal statutes. These ethical and legal considerations in marketing have been flouted through a combination of corporate and legal maneuvers designed to circumvent regulation and scrutiny. The first part of this essay will discuss the legal and ethical issues that are pertinent in Compcares and by extension Pharmacares marketing of AD23.

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The first ethical norm that Compcare have flouted is continuing to market AD23 despite the attendant risks to the patients cardiac health and the failure to investigate the deaths that have happened among users of the drug. In addition to this, the company has not informed the patients of the risks to using the drug to slow the progress of Alzheimers. In addition to this, the parent company, Pharmacare, has breached ethical norms by distancing themselves from AD23, first by the establishment of a subsidiary compounding pharmacy to market the drugs, and the subsequent sale of the compounding pharmacy to another company once it became apparent that the drug was responsible for cardiac arrests. By doing this, and reaping the consequences, Compcare and Pharmacare have proven that they are responsive of the risks of using the drug but chose to ignore them instead and to receive maximum benefits from the sale and marketing of the drug to Alzheimers patients.

Pharmacare also breached legal and ethical norms by deliberately avoiding regulation by the Food and Drug Administration which is the legally mandated body to provide such statutory regulation ("FDA Basics," 2017). By opening a compounding pharmacy to disguise the sale of the drug, Pharmacare deliberately circumvented statutory regulation to market the drug without legal scrutiny. Further, the subsidiary used unethical tactics to market the drug in bulk which is illegal for compounding pharmacies. This was an extension of the effort to avoid legal scrutiny and regulation in the marketing of the drug. By colluding with doctors to submit fictitious patient lists, Compcare further commits perjury since the records are not true and they are used to circumvent proper legal procedure.

The third ethical breach that has been committed by Pharmacare and Compcare by extension is the lack of proper research into the possible side effects of the drugs they are marketing to the general population. To save costs, Compcare was established using minimum funds, and only a small amount of money was expended to do a quick, low-cost renovation in an attempt to get the drug to the market as soon as possible. The drug did not undergo the mandatory trials that are required by the Food and Drug Authority. These efforts to circumvent regulation and to save costs endangered the lives of potential clients and patients and Compcare was in serious breach of legal and ethical bounds by marketing AD23 as such.

Pharmacare and CompCARE have demonstrated the possibility of culpa for the deaths that have been associated with the use of AD23. They have declined to disclose the potential risks to the clients, ignoring the evidence of such risks and in selling the compounding pharmacy to a drug store chain just before the drug was freely linked to over 200 cardiac deaths. The fact that the company had published an internal memo that describes the potential problems that are associated with the use of AD23 and yet withheld and chose not to act on this information proves PharmaCares criminal culpa for the deaths. Withholding the information about the potential health risks of AD23 amounts to criminal negligence on the part of Pharmacare and a willingness to put the client's life at risk for the sake of profits.

Direct to Consumer marketing of pharmaceutical products is whereby a Pharmaceutical company uses traditional media to directly reach out to clients to inform them about a drug, the indication it should be prescribed for or a combination of the two. Currently, direct to consumer advertising of drugs is legal in the United States but is subject to regulation by the food and drug authority (Donohue JM, 2017). Direct to consumer marketing of drugs is merited because it gives consumers more information and control over the management of their health issues. By receiving information directly from the pharmaceutical companies, consumers are more informed about their choices, and this is especially true for drugs that can be dispensed over the counter. However, direct to consumer marketing by pharmaceutical companies is risky and this manifests mostly when dealing with prescription drugs. Direct to consumer marketing is dangerous because consumers may not have all the requisite knowledge to make an informed medical choice and they should solely rely on the qualified advice of medical experts to responsibly and more efficiently manage their medical conditions. Direct o Consumer marketing, despite the regulation by the Food and Drug Authority, has the potential to mislead and misinform clients and if such patients take it upon themselves to prescribe drugs for themselves, the consequences are potentially catastrophic. Pharmaceutical companies attempting to market directly to consumers primarily have profits in mind, unlike doctors whose primary responsibility as spelled out in the Hippocratic Oath is to save the life of their patients. Due to relaxed legal regulations in the United States especially since 1997, direct to consumer marketing has become harder to enforce (Donohue JM, 2017). The Food and Drug Authority has increasingly issued less warning letters and citations which may be a sign of better compliance by marketers or a sign of weakened oversight by the authority (Donohue JM, 2017). Overall, this paper holds the view that drug marketing should primarily target physicians who are informed enough and have the power to make medical prescriptions.

Since the research that discovered and compounded AD23 as a medicine to prevent Alzheimers was done by a team of researchers at PharmaCARE and not solely by John, John cannot claim to own the intellectual property rights for AD23 wholly. Pharmacare, the company that owns the proprietary rights to the original AD23 also owns the intellectual property rights to the updated and compounded version of the drug by having patented both formulas ass belonging to the company. Because the drug was invented and compounded by a group of researchers under the employ of Pharmacare, PharmaCare can claim to own exclusive intellectual property rights to both the inventions. However, should there need to compensate John for the effort and expertise expended in developing the drugs, there are several ways in which Pharmacare can achieve this. The first method they can use is to publicly include Johns name in the list of credits as one of the scientists who developed the new drug. This would enhance johns standing as an expert by growing his portfolio. The second way in which PharmaCARE can compensate John is by making him a partner in the new subsidiary that has been created specifically to market the compounded version of AD23 for Alzheimers. The third way in which the pharmaceutical company can compensate John for helping invent the new drug is by entering into a licensing agreement with John in which a portion of all the sales of AD23 would be paid to John as a co-creator of the drug.

One of the most potent industries for intellectual property disputes is the technology industry. In the past year, the case of Oracle Vs Google is easily the most high-profile case to have reached the corridors of justice ("USA: Copyright Protection for Java Application Programming Interfaces (API) Oracle America, Inc. v. Google Inc.", 2015). Since the technology industry is mainly built on and propelled by innovative ideas, the ownership of these ideas can be a thorny issue, and the history of the technology industry is littered with a plethora of intellectual property disputes. In the case of Oracle vs. Google, Oracle filed a patent suit in the November of 2014 to challenge Googles use of the user interface applications that Google claimed to have designed for usage in mobile computing devices such as smartphones. The case, which pitted two of the biggest technology giants of our time, is a quick case study of giants who have a culture of meddling with intellectual property rights. Application programmer interfaces act as the bridge between a user and the operating system of the computing device they are employing. In the case, Oracle accused Google of infringing on their intellectual property rights by employing the design which Oracle had patented in the development of their mobile computing operating system and application program interfaces ("USA: Copyright Protection for Java Application Programming Interfaces (API) Oracle America, Inc. v. Google Inc.", 2015). Through the use of fair use, Google was able to defend the development of their application program interfaces in the development of their Android mobile system which Oracle claimed was a rip-off of its implementation program interface protocols which are compatible with Java. The fact that Google had made the Android system compatible with Java was also a factor which Oracle said strengthened their case against Google. ("USA: Copyright Protection for Java Application Programming Interfaces (API) Oracle America, Inc. v. Google Inc.", 2015) The case was eventually won by Google when the court ruled that the use of the Application program Interface was justified under the principle of fair use and that Googles use of the interface in designing the Android operating system did not infringe on Oracles intellectual property rights.

Because Google is a market leader in the technology industry, the intellectual property infringement case filed by Oracle would have damaged Googles reputation and standing in the industry seeing that as it is, intellectual property is the backbone of the technology industry. Googles reputation as an innovative trendsetter in the industry would have been tarnished if Oracle had managed to convince the court that Google had wrongly infringed on their intellectual property rights. Google managed to stem the fallout and the considerable damage to business and reputation they would have suffered by deflecting Oracles suit using the fair use principle. By casting Google as an intellectual property thief, Oracle would have tarnished Googles standing in the technology industry while at the same time promoting their reputation. By successfully deflecting the suit with the fair use argument, Google managed to salvage both the reputation and the finances of the company.

In the Pharmacare scenario, Pharmacare is liable for the deaths caused by AD23 since they have issued the product despite knowledge of the products potential side effects and withholding that knowledge from the public. As such, John and the other bereaved parties can sue PharmaCARE for criminal liability for the deaths of the family members which have been linked to AD23.

The United States Constitution has afforded John protection as a whistleblower. By revealing information about the unethical practices and circumstances that surround the sale of AD23 John qualifies to be offered protection from persecution and retaliation by the exposed party. As John was a member of the organization at the time that the practices were being committed, coming out to expose them and providing evidence of Pharmacares maleficence legally qualifies him as a whistleblower and covers him under the law.

References

Donohue JM, e. (2017). A decade of direct-to-consumer advertising of prescriptio...