A Company That Has Had a Lawsuit in the Last 10 Years - Research Paper Example

? A Company That Has Had a Lawsuit in the Last 10 Years A Company That Has Had a Lawsuit in the Last 10 Years Describe the company and the product safety issue that led to the lawsuit. Abstract This paper discusses a lawsuit that was filed against accompany that manufactured defective drugs that caused the death of the patient. The paper chronologically accounts for the case how it started, got to be developed and concluded in a court of law. In the determination of the ruling, this paper has considered that basics that were used by the court of law to determine this case. In relation to this, the paper also gives accounts of the changes that has characterized the company following the law suit, the agencies charged with giving certificate of operation for drug companies as well as the recommendation to the companies in similar products based on the suit. Mylan Company is one of the world’s biggest and leading generics and pharmaceutical companies. The company’s products are available in almost over 150 countries worldwide; Germany, New Zealand, Austria, Belgium, Zech Republic, Denmark, Finland, and France are among the countries where the company operates. In its production, the company relies on contemporary production mechanisms where drugs safety and hygienic processes are observed. Through this, the company is producing reliable pharmaceutical products for consumers (Ceder, 2011). The company employs about 18,000 employees in all the branches all over the world. Given the company’s growth and service to the consumers, it has realized tremendous success in the industry. In this regard, it supplies most of the pharmaceutical drugs including the antiretroviral for treatment of HIV/AIDS patients (Ceder, 2011). The company was started in 1961 and became a publicly traded company in 1973 (Ceder, 2011). In 2002, the company was involved in a legal issue with the one of its client who sustained a back pain while changing the tires of the vehicle and was administered a painkiller fentanyl. Fentanyl is an addictive narcotic that affects the nervous system. After two days, the patient died and the postmortem results indicated that a lethal dose of the drug, Fentanyl was found in his blood stream, this was in 2002. The family filed a lawsuit against Mylan of manufacturing lethal products since the physiological effects of the drugs contradicted the recommendation given in the package. The plaintiff lawyer argued that a defect in the drug and the only thing that has not been ascertained is the type of defect that was in the drug. During the period of the suit, Mylan maintained that the products were not defective and that they complied with the food and drugs administration that inspects quality of the drugs (Sobel, 2012). Discuss the legal theories used by the plaintiff to recover in this lawsuit. How the lawsuit was resolved, and why you agree with the decision in the case. The plaintiff asserted during their argument that there was defect in the drug and that is the company’s responsibility to identify such mistakes and to address any defect before releasing the drugs into the market. Specifically, they asserted that the defect was occasioned by negligence of the company workers during manufacturing. That the company has the duty of care to its customers and should ensure that their products in the market are suitable for use by the customers (Mickey, 2004). The plaintiff accused the company of not observing professional due diligence in drug manufacturing and that this was not followed, defective drugs found their way into the market and resulted in to the death of their own. The defective in the drug was in its physiological departure where it affected the functionality of the nervous system. In the decision that was reached by the court over the case is that the company was liable for the death and they had to compensate the family appropriately for contributing into the death of the family’s bread winner. The court found that the company was liable for the death as the pharmaceutical companies have the duty if care to ensure that their products are safe and harmless to the consumers (Mickey, 2004). Describe the changes that have taken place in the company to ensure greater safety of this product or its products Following the court’s ruling, the company has embarked on a more stringent screening process during the manufacture of the drugs to ensure that no defective drugs are released in the market due to either negligence or any other factor that might contributes to the same. The department has also ensured those professionals who are required to attend a workshop quarterly to maintain the ethical and the professional requirements in daily operation of the company’s employees who heads the quality assurance department. The company has also contacted the Food and Drugs Administration department to counter check the efficacy of their products before they are released into the market (FDA, 2007). This they do to ensure further safety guarantee. Apart from employing and training professionals, the company has also invested in the technology and acquired the new machines that can detect any inconsistency during the manufacturing process so that they can be addressed on time. This, the company insists will enable them to identify any departure during the manufacturing stages and rectify the situation before it gets out of control. The company has tried to reduce release of the defective drugs as this do contributes to loss of customers. The prospective customers can opt for the alternative drugs if there are several cases of injuries or deaths associated with a company’s product. Discuss which regulatory agency oversees the particular industry the company is in In the field of drugs, it is the Food and Drugs regulatory that is in charge. The regulatory body ensures that the products produced meet the standards set by the agency and that they are suit for human consumption. The agency other duty is to ensure that the provisions given by the company about the products to the final consumers are true and that the consumers are not defrauded by the manufacturers (Cohen, & Stigler, 2005). It acts as the consumer protection, if a company does not comply with the set standards, then the company will not be allowed to operate or the operational license is withdrawn and the public are informed about the products of the company as unfit for utility. The regulation agency away from ensuring that the products are safe and are of prescribed efficacy, they also ensure that the consumers get value for their money (Cohen, & Stigler, 2005). The agency’s mandate is to ensure that foods and drugs manufactured by companies and fit for use by the public without causing any harm to them. They can issue warrant of closure to a company that does not comply with the regulations stipulated. The functions of the agency is not only limited to Foods and drugs as such but also extends to vaccines, tobacco products, medical services, veterinary products among others. The Drugs and Food Commissioner who is the president appointee head the agency (Augusta, 2009). The agency with the powers given to them does formulate policies related to food and drugs and execute them Make recommendations to the company about avoiding future lawsuits Following the lawsuit, the company should have some plans to avert any product defectiveness that will contribute to it facing a similar or related suit. This, the company can ensure happens by taking the necessary steps in doing reinforcement in areas where loopholes must have existed. First, the company should ensure that all the stages of drug manufacturing pass through test requirement; ingredients, safety, and microbial contamination. This test will ensure that there is no external contamination of the drugs during the manufacturing process that can lead to contamination of the drug. The company should also outsource for the expertise in the required fields in the line of production to ascertain that the production stages are not defective and that the final product will be safe for use by the consumers. As a long-term plan, the company should also have a research-based department in which there is continual product research where their employees will be doing regular research on how to improve the reliability of their product and to ensure that any defect is notice timely for early action to be taken. Such program endow the employees with the relevant experience required in the field of production and can help make the production more stringent in screening any production departure. Faulty products or those that bears wrong labels are against the law and such companies not only risk closure but also lawsuit because of endangering the lives of the people. Reference Cohen, M. F., & Stigler, G. J. (2005). Can regulatory agencies protect consumers?. Washington: American Enterprise Institute for Public Policy Research. Consumer rights if you are sold defective goods or services (Rev. Mar. 2009. ed.). (2009). Augusta, Me.: Maine Dept. of Attorney General. Filthy food, dubious drugs, and defective devices: the legacy of FDA's antiquated statute : a staff report. (2007). Washington: U.S. G.P.O. :. Mickey, L. (2004). Defective Goods: a Kyle Shannon mystery. Lincoln, NE: IUniverse, Inc.. Sobel, L. A. (2012). Consumer protection. New York: Facts on File. Top 50 pharmaceutical companies: a competitive analysis. (1993 ed.). (2011). Cedar Grove, NJ: POV. Read More