Law
Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety THAT PHARMACARE DID and examine whether PharmaCARE violated the law. Be sure to identify the law in all these areas.
The ethical issue in marketing and advertising emanating from PharmaCare’s actions can be attributed to fair treatment in which the company corrupted the medical professionals in terms if illegally acquiring patient information for CompCare. Furthermore, the offensive actions committed by the company also includes concealing the changes in the composition of the drug and marketing it as treatment to slow down the progression of Alzheimer instead diabetes. Such action violates ethical conduct by deceiving consumers, clinics, hospitals, and doctors through false marketing. The deceptive marketing of the drug also violates the company’s social contract in which the consumer’s needs were neglected by focusing on profitability and promotion of unlicensed and dangerous drug. Looking at PharmaCare’s advertising practices, ethical failure can be observed in the manner of promoting dysfunctional drug that does not conform to the guiding standards of DFA. In addition, comply with the product safety regulation because primarily new products particularly drugs require permission from the appropriate government agency before marketing it for public consumption. Hence, the AD23’s lack of approval from FDA demonstrates ethical misconduct towards the consumers and the medical industry because the product did not have evidence of safety and consistency.
Given the ethical misconducts that PhamarCare and CompCare have committed, the company’s actions demonstrate violation of statutory laws. The Federal Trade Commission Act for instance laid out the requirements for truthful marketing and advertising, which suggests that all marketing and advertising efforts should not be deceptive and fair (Mack. 2013). Furthermore, evidence of claims such as the AD23 being a medication to threat Alzheimer’s should support such claim. In addition, the provisions of the FTC suggests that unfair advertising and marketing of products that causes significant injury much worst is to cause the death of the product users will subject the company to class action lawsuit. It was not mentioned whether CompCare is listing the side effects of the using AD23, but the law requires declaration of the side effects when advertising and marketing the product. When it comes to product safety, the Pharmacy Regulation puts emphasis on the sale, dispensing, and establishing evidence of efficacy through clinical trials, which CompCare has failed to comply (Thaul, 2012).
Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response.
The specifics of medical activity enable the pharmaceutical companies to engage in direct to consumer approach in marketing. The arguments surrounding the DTC practice is hanging on a critical balance between its pros and cons where the main concern lies on directly communicating with the consumers, which encompasses inadequate enforcement and unacceptable relaxed rules. The FDA in particular is faced with difficulties in implementing the necessities of DTC practices because of the apparent contradictions of business interests particularly in terms of income distribution. Another important risk attributed to newly approved drugs with no evidence of known effects, which pharmaceutical companies directly communicate to consumers to stimulate purchase even without prescription.
Analyze the U.S. law to protect intellectual property and PHARMACARE's IT rights 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
The existing framework of the intellectual property rights law is intended to provide protection to small-scale inventors and corporation to guarantee the exclusivity of being the first to invent. The primary objective of the law is to encourage an equal footing and incentive for the developers of ideas and products (Saha and Bhattacharya, 2011). In John’s case, the discovery of the AD23 was made during his time with the company as researcher and his scope of work was dedicated to the development of the drug. The rights to invention as stipulated under the Employee Patent Act has certain conditions that has to be considered in determining who owns what to the intellectual property. Assuming that John’s contract with PharmaCare states the fruit of his work belongs to the company, then he is no position to make a claim. However, if John was hired to create the AD23 specifically recognized as diabetes medication, and bringing that idea into practical form was spelled out to John, and then the final product belongs to the company. On the other hand, it was found that after modification of the formulation, the drug could cure another disease, which is considered a result beyond the scope of the company’s business because the company requires only results for diabetes efficacy. Therefore, John owns the right to AD23 in part, which opens the door for the company to exercise “shop right” to the drug (Freilbrun, N.D.). John should be compensated by means of royalty fee, non-transferable license to make use and sell, and revenue share, but only limited to the profits made by AD23 in relation to its use as cure for Alzheimer’s and not diabetes.
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
Intellectual property theft is among the problems that companies are constantly battling in order to keep business exclusivity to products and other practical results of an idea. In 2015 Versata, filed an injunction against Ford motors claiming that company is using a software for its vehicles that has been internally developed, but based on Versata’s code (Bunkley, 2015). The claimant provided the ACM technology to Ford motors since 1998 and the contract ended in 2014, the same year that Ford filed a patent for its internally developed software to replace ACM. This particular case will impact the carmaker in three ways though recalls of deployed vehicle units, paying Versata for the use of its code, or stop Ford motors from using its internally developed software, but regardless, it will still cost the carmaker millions of dollars in settlement. Another case of intellectual property theft is High Point SARL v. Sprint Nextel Corp. et al. (2015) where the assailant asserts that the defendant was able to build its communication network using both the licensed and unlicensed activity since 1997 (Holloran, 2015). High Point owns patents from Avaya, but as soon as the latter was taken over by the former, it ceased its contract with Sprint, but the telecoms company still continues to use the technology from Avaya, which is now owned by High Point. This particular case will affect Sprint as leading brand in telecommunications if the Court decided that it should stop using Avaya’s technology. In addition, the loss of its technology translates to reduced brand market competitiveness.
Analyze the potential issue surrounding the death of John’s wife and other potential litigants against PharmaCARE as a result of AD23
Considering that the use of AD23 and its side effect is attributed to patient deaths, the issue surrounding the death of John’s wife encompasses issues with unethical use of human subjects for medical trials. It is apparent that AD23 has side effects that outweighs its benefits in curing diabetes and Alzheimer’s, this can be perceived as also the cause of death of John’s wife. John should have known about the effects, despite that knowledge he appears to have administered the medication to his wife to demonstrate its effect, but apparently failed. In terms of the legal implications towards PharmaCare, the company will be liable to the deaths that AD23 had caused. Under the tort law (Edersheim and Stern, 2009) it is regarded as professional negligence, which will cause the company to enter into settlement and AD23 to be banned in the market. The settlement is only limited to the company, but the litigation will also likely to involve the doctors who prescribed 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
John could claim that he is a whistleblower if the conditions under the Whistleblower protection Act were satisfied. John could assert that the company is engaged in serious wrong doing exemplified by the fact that several patient deaths are linked to AD23. However, the Act prohibits protection of whistleblowers whose actions perpetuating the alleged wrongdoing of the organization are covered in his job description. On the other hand, John can assert the instrumentalities of his position in the company as a researcher and that the decision to distribute AD23 is a decision beyond his capacity. When placed under the protection of the whistleblower program, the company will not subject John to termination and the investigating agencies will provide mandatory security protocols to ensure John’s survival until the case was decided in the Court or as mandated under the False Claims Act.
References
Bhattacharya, S. & Saha, C. (2011). Intellectual property rights: An overview and implications in pharmaceutical industry. J Adv Pharm Tech Res, 2(2), 88. http://dx.doi.org/10.4103/2231-4040.82952
Bunkley, N. (2015). Ford accused by software maker of intellectual property theft. Automotive News. Retrieved 3 June 2016, from http://www.autonews.com/article/20150604/OEM06/150609919/ford-accused-by-software-maker-of-intellectual-property-theft
Edersheim, J. & Stern, T. (2009). Liability Associated With Prescribing Medications. Prim Care Companion J Clin Psychiatry, 11(3), 115–119. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2708008/
Freibrun, E. Rights to Inventions: Employers v. Employees. Freibrun.com. Retrieved 3 June 2016, from http://www.freibrun.com/articles/articl11.htm
Halloran, J. (2016). High Point SARL v. Sprint Nextel Corp. et al.. Federal Circuit summaries. Retrieved 3 June 2016, from https://lifescienceip.wordpress.com/2016/04/08/high-point-sarl-v-sprint-nextel-corp-et-al/
Mack, S. (2013). Unethical Activities in the Field of Marketing. Smallbusiness.chron.com. Retrieved 3 June 2016, from http://smallbusiness.chron.com/unethical-activities-field-marketing-65705.html
Thaul, S. (2012). How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Washington, D.C.: Congressional Research Service. Retrieved from https://www.fas.org/sgp/crs/misc/R41983.pdf
