Johnson & Johnson Settles States Cases over Risperdal - Research Paper Example

 Johnson & Johnson Settles States Cases over Risperdal Introduction This case analysis involves Janssen Pharmaceutical incorporation, which is a subsidiary company of Johnson & Johnson. The case involves a number of state officials, investigative bodies, affected patients and regional states found in America (Thomas, 2012). The case is about an introduction of the antipsychotic drug Risperdal for an unapproved use into interstate commerce. The use of the drug Risperdal for described prescription given by Janssen pharmaceutical instead of the intended use of the drug by the manufacturer rendered the product misbranded in the market. The delusion of the public by Johnson & Johnson Company, lead to customer exploitation at the expense of making huge profit by Johnson & Johnson Company. Therefore, this paper gives an in-depth analysis of Johnson & Johnson Company court cases. It unravel how and why the case came about, what laws or statutes rules that the company violated as well as the final decision of the judges. The Name of the Case Thomas (2012) proposes that Janssen pharmaceutical company now for quite a long time has been promoting the use of Risperdal, which treats symptoms of bipolar mania and schizophrenia. However, the State and federal authorities found out that Janssen pharmaceutical promoted the use of the drug that it did not seek approval for as contained in the US Department of Justice (2013). Instead, the authorities found out the drug caused dementia problems in adult patients, anxiety, bipolar disorder in juvenile and adolescents and depression just to mention but a few. These allegations by the state on Janssen become a global history on health care fraud where Johnson & Johnson Company had to win public trust back through fine and charges. How and Why the Case Came About Johnson & Johnson is a worldwide health care company that has other subsidiary incorporations such as Janssen pharmaceuticals. The court ordered the Johnson & Johnson Company to pay more than $ 2.2 billion to resolve cases of civil liability that arose from allegations relating to prescription that jeopardize health care and safety of the public (Thomas, 2012). The Johnson & Johnson Company promoted the use of antipsychotic drug Risperdal to the public when the drug use should be for a different purpose as per the manufacturer. The company violated the regulations of the U.S’ Food and Drug Administration Act, which approves all the substances produced by industries before their use allowed in public. Because of this breach, Johnson & Johnson Company had cases to settle of health care fraud, criminal fines, forfeiture and civil liabilities. The origin of Johnson & Johnson case over Risperdal demonstrates the commitment of Justice Department’s farm to thwart fraudulent activities in health care. This is because the fraud case jeopardise the healthcare and safety of the patients. The antipsychotic drug Risperdal promotion did damage the public trust image. Because of this, the action taken by Justice Department proves their commitment to hold accountable any operation that breaks the law at the expense of offering drugs to the American people (Thomas, 2012). In a statement made by the associate Attorney General Tony West, he claimed that the state demand accountability of companies operations to identify those companies that put profit over patients’ health (Drugwatch, 2015). In addition, there is need to put sanctions and other non-monetary measures to facilitate change of the corporate behaviour and ensure a level platform for all market participants. Pertinent Details and Those Involved Johnson & Johnson case over Risperdal involved so many entities. The Corporate Integrity Agreement (CIA) requires an imposition of sanction to a corporate, which its activities are not in accordance with the law. Therefore, it was a requirement of CIA to impose sanction on Johnson & Johnson Company until all the issues pending on allegations resolved. The violation of the customers’ right on the content of the drug not concealed to them was a matter under the Department of Health and Human Services (HHS) to deal with. There is coordination of the State’s institutions to help increase accountability and transparency of corporate activities in order to prevent patient abuse and possible future fraud. The prosecutors also accused Johnson & Johnson Company of concealing the risks associated with the use of Risperdal to the patients. Janssen did not admit any of the allegations or any violation of the law but claimed that it settled on the lack of the drug identity to the patient in order to avoid unnecessary expense or prolonged legal process. The court got the claim though its president Michael Yang. Janssen president Michael Yang said their company is committed to resolve all the state claims and to ensure their company continues to provide medicines to many needy people who suffer from mental illness (Thomas, 2012). Johnson and Johnson subsidiary company, Janssen was a very important entity in the entire misbranding of antipsychotic drug case. According to media information released by the Department of Justice (U.S), the government through its institutions had many allegations including Janssen sales representative promoted to physicians and other drug prescribers to use Risperdal in treatment of deleterious symptoms including agitation, hostility, depression and confusion when the drug approval is for treating schizophrenia. Another allegation is that the company minimised the written instruction to reach the patients concerning Food and Drug Administration (FDA) approval (Thomas, 2012). Another allegation was on the provision of the off-label promotion of Risperdal to suit all the uses describe by the company and not just for the FDA use approval. The Laws, Statutes and Acts Pertained In This Case The Federal Food, Drug and Cosmetic Act (FDCA) should protect the public on health and safety matters as contained in the press released by the US Department of Justice. They should also ensure that the drug intended for use by human are safe and their efficacy should not be in question during their administration. Another mandate is that the labelling of drug should bear truly the content of that drug in true and complete quantity for a dose and contain the right information (Drugwatch, 2015). Janssen pharmaceutical violated all of these regulations since these regulations form part of the allegation. Janssen also violated the statute monitory institution called the Food and Drug Administration (FDA). The Janssen pharmaceutical changed the intended use of the drug after its approval into commerce. Janssen introduced a drug into interstate commerce for new and unapproved use (Drugwatch, 2015). This rendered the drug misbranded as explained in the US Department of Justice. The result of this compromised the duties of FDA. When corporates interfere with the mission of FDA by compromising the safety, efficacy and the dosage quantity of drugs, they pose challenge on the doctor-patient relationship and consequently put the health and safety of patients at stake. Several cases in the in history pertain to Johnson and Johnson its subsidiary Janssen incorporation. Most importantly, the company’s resolution to settle the cases with the states relates to other large state settlements and court verdict involving Risperdal (Thomas, 2012). A judge in Arkansas ordered Janssen to pay fines on the same issue of Risperdal. Another judge in South Carolina charged a civil penalty on Janssen. This left Jansen to appeal the fines in both the states after dismissal of similar cases against Janssen in Pennsylvania and West Virginia (Feeley and Voreacos, 2014). Most court hearings on Jansen cases over Risperdal considered it as a landmark settlement. The judges believe that such fines and civil penalties will hold corporate accountable for practices they carry out that put most patients in danger (Kmietowicz, 2013). They also serve as a warning to pharmaceutical giants to operate by one set of the rules that the States provides in the statutes and Acts. Other states involved in the settlement on the same case include Texas, Florida, Colorado, Pennsylvania and Arizona. The Court Case Decision and the Findings Johnson and Johnson settled civil allegations after unearthing of corporate move to target vulnerable patients using drug Risperdal for off label uses. Thomas (2012) adds that in the case filed in the Eastern Pennsylvania, the United States alleges that the corporate marketed Risperdal to control the conduct and behaviour of the nation’s vulnerable patients. The government also alleges that Janssen used an off-label promotion to make false and misleading statement about the efficacy and safety of the Risperdal (Tanne, 2012). Janssen also had an allegation of paying kickbacks to doctor so that they can prescribe Risperdal to their patients. Other findings were also the promotion of Risperdal for unapproved use. This threatened the most vulnerable population in the society especially children and the elderly. In an article of Risperdal and verdicts & Settlements, the complaint further alleges that Janssen breached the rule of law after FDA severally advised and warned on the marketing of Risperdal. Other furtherance allegation of the complainants that Janssen was aware of the serious risks that Risperdal poses on the health of adult and juvenile including an increased exposure to stroke (Thomas, 2012). Other finding was that Jansen knew that the patient taking Risperdal had increased risks of developing diabetes but instead promoted the Risperdal. In addition, of promoting Risperdal for the elderly, Jansen also allegedly promoted the antipsychotic drug for use in children and individual with problems of mental disabilities. A global resolution reached at ordered Janssen incorporation to pay $ 1.3091 billion to resolve the false claims allegedly emanating from their off-label marketing and the money paid as kickbacks for Risperdal prescription (Tanne, 2012). Janson conduct caused losses to both federal and the state governments. For this reason, the state and federal governments will share any additional payments by Janssen where the federal government will receive $749 million and the states receiving $524 million. In addition to the fines and public penalty, there was introduction of non-monetary sanctions provisions as agreed by the global resolution team and Corporate Integrity Agreement (CIA). As asserted by Kmietowicz (2013), through the involvement of Department of Health and Human Services, Johnson and Johnson had a provision to implement major transformations concerning how its pharmaceutical subsidiaries operate in business. The CIA also wanted the corporate to maintain transparency regarding their research practices, payments to doctors and publication policies. Another resolution was on patients’ eligibility for compensation. A patient, the plaintiff who developed gynecomastia after use of Risperdal was eligible for compensation due to both physical and emotional injuries. Settlements for this case were to source money for surgery, ongoing medical attention and counselling (Tanne, 2012). The award for a settlement involves prior activities of visiting an attorney to help explain the legal process of a case as well as highlighting strengths and weakness of the trial verdict to help a plaintiff in Risperdal cases know whether he or she is likely to get compensation. Johnson and Johnson need to settle claims for the actual filing of the claim on Risperdal to avoid trial verdicts. This is because the jury orders the corporate to pay more to the plaintiff with a Risperdal legal claim (Drugwatch, 2015). In addition, the legal process also exposes more information about its marketing scandal. For example, a 21-year-old Aron Banks claimed that the drug caused him to grow breast because he used prescribe Risperdal at age of nine. As a result, Johnson and Johnson in a Philadelphia court agree to settle the case. After the agreement, Banks’ attorney told the media about the evident effects of Risperdal. Therefore, out of court settlement is paramount in protecting the image of the court. References Drugwatch. (2015). Risperdal and verdicts & Settlements. Web. April 17, 2015. Retrieved from http://www.drugwatch.com/risperdal/settlements-verdicts/ Kmietowicz, Z. (2013). Johnson & Johnson to pay $2.2 bn to settle charges of false marketing on three drugs. British Medical Journal, 347. Tanne, J. H. (2012). US judge fines Johnson & Johnson $1.1 billion for misleading marketing of Risperdal. British Medical Journal, 344. Feeley, Jef and Voreacos, David. April 12, 2012. J &J Ordered to Pay $1.1 Billion Penalty Over Risperdal. Bloomberg Business. Web. April 17, 2015. Retrieved from http://www.bloomberg.com/news/articles/2012-04-11/jnj-told-to-pay-1-1-billion-penalty-in-arkansas-risperdal-trial Thomas, K. (Aug. 30, 2012). Johnson & Johnson Unit Settles State Cases Over Risperdal. Arthur Ochs Sculzberger Jr. New York. US Department of Justice. (Monday, November 4, 2013). Press Release: Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations. Web. April 17, 2015. Retrieved from http://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations Read More