The Kline v. Pfizer case took place on July 10, 2008 in the United States District Court Eastern District of Pennsylvania. The case involves two parties: Pfizer, Inc., Defendant and Brian Kline, Plaintiff. The Defendant in this case is the prescription drug manufacturing company called Pfizer. One of Pfizer’s product is know as Chantix, which is a prescription drug used to aid individuals who are in the process of quitting their smoking habits. The plaintiff in this cases is Brian Kline, and he was one of the individuals who had been prescribed the Chantix drug in order to quit smoking. As soon as Kline began taking Chantix, he started to get extreme side effects. Kline claimed that he began experiencing and expressing violent, aggressive, and moody behaviors. He was eventually diagnosed with a psychotic disorder and hospitalized for it the same year in August of 2007. On July 10, 2008 Kline filed a lawsuit against Pfizer. Kline’s main complaint targeted Pfizer’s failure to provide adequate warning and precautions of the potential risks that may be caused by the use of Chantix. Kline complained that the company should have announced the risks that may come with taking Chantix to him as an individual, his physician, and the public. Kline’s complaint contained several claims against Pfizer, including: negligence (Count I); strict liability (Count II); breach of express warranty (Count III); breach of implied warranty (Count IV); fraudulent misrepresentation (Count V); fraudulent concealment (Count VI); reckless and/or negligent misrepresentation & concealment (Count VII); gross negligence (Count VIII); and unjust enrichment (Count IX) (Civil Action No. 08-3238. UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVA... ... middle of paper ... ...de affects of taking the drug Chantix. This essentially caused Kline to have erratic behaviors. Although Pfizer was not required to warn the public and Kline, they were responsible for warning physicians. Pfizer dismissed Kline’s Complaints pursuant to Federal Rule of Civil Procedure 12(b)(6), which successfully dismissed Counts I and VII. Motion to Dismiss under Federal Rule of Civil Procedure 12(b)(6) “for failure to state a claim for which relief can be granted.” As the Plaintiff, Kline should have provided several sets of proof in order to support his claim and be granted the relief. Kline failed to provide the Fact Sheet and Authorization forms under the Joint Coordinate Plan. Health information professionals need to have knowledge of legal and ethical situations in order to prevent themselves or their department from ever being tried in the court of law.
Explain the issue or dilemma using information from the readings in the book and other sources.
Mrs. Ard brought a wrongful death law suit against the hospital (Pozgar, 2014). The original verdict found in favor of Mrs. Ard, but the hospital appealed the court’s ruling (Pozgar, 2014). During the course of the appeal, an investigation of the records showed no documentation, by a nurse; of a visit to Mr. Ard during the time that Mrs. Ard stated she attempted to contact a nurse (Pozgar, 2014). The nurse on duty stated that she did check on Mr. Ard during that time; however, there were no notes in the patient’s chart to backup the claim that Mr. Ard had been checked on (Pozgar, 2014). One expert in nursing, Ms. Krebs, agreed that there was a failure in the treatment of Mr. Ard by the nurse on duty (Pozgar, 2014). ...
In the case of Burger v. Blair Medical Associates, Inc. (BMA), we can see the need for extensive legal knowledge on the part of a health information management (HIM) director. BMA tried several times to have the courts revisit their case based on the statute of limitations. Here the Superior Court declared, “the torts of invasion of privacy and breach of physician-patient confidentiality are distinct, such that the former is expressly governed by the one-year statute of limitations and the latter falls within the catch-all two-year limitations period” (Burger v. Appeal, 2009). Because of this breach, BMA had to pay out over $60,000 to Burger. In this case the Superior Court identified the breach of physician-patient confidentiality and the
In 2008, CVS/Caremark found itself with more legal problems when it was accused of deceptive business practices. A lawsuit was filed implicating CVS/Caremark stores in 28 different states of deceptive practices, when they directly recommended to Doctors that they write their patients prescriptions for name brand drugs instead of generics. CVS/Caremark led the doctors to believe that their patients would save money by using the brand name drug, when in fact, the opposite was true and it was costing their patients more money.
Green committed negligence when she administered the incorrect dosage to her patient. Dr. Green could have avoided this mistake from occurring if she had followed administering medication strategies. For example, healthcare providers should follow the basic check list and double check their check list for right medication, person, dose, route, time, and documentation (Washington Advocates for Patient Safety, 2016). Being that Dr. green did not verify her work, she caused Mr. Parker to take ten pills per day for three weeks. Also, Dr. Green did not instruct Mr. Parker if he was feeling any of the side effects or continuation of the signs and symptoms to feel free to go to the nearest emergency room, stop taking the medications, and/or to come back to the office to be seen
Per mental health records (2016), the claimant had a significant history of mental illness, including depression and anxiety. Additionally, he had a history of drug, alcohol, and tobacco abuse. He received inpatient psychiatric treatment multiple times, mostly because of suicidal ideation with plan and intent. He also received ongoing outpatient treatment.
Black Box Warning regarding serious neuropsychiatric events including depression, suicidal thoughts, and suicide.1,2 In addition, Chantix have no known drug interactions with her medications with metformin, olmesartan, and fluoxetine. However, Chantix may enhance the toxic effect of alcohol and stimulated neuropsychiatric effects.3,4 Although, a primary literature reported Chantix to significantly decrease alcohol consumption for smokers and has also reported low results of depression.5 Another recent literature showed the incidence of psychiatric disorder did not change for patients that took Chantix or
In this case, PharaCARE is liable or responsible for the death of John 's wife and another 200 patients death because it has not followed law or regulation as produce or marketing AD23 (diabetes drugs) insignia officially authorized FDA approval (Johnson, 2003). Use of AD23 (diabetes drugs) impacted on the health of patients that is the main reason of the death of John’s wife and another 200 patients, so the company’s is liable for this issue. John has right to sue a lawsuit against PharmaCARE 's similarly as Joe Strom sued a lawsuit against J&J Company in the above-described
Furthermore, Nurses should be able to identify and recognize what confidential data is and take practical measures to protect this information. They should take advantage of the policies and procedures to protection and dissemination of personal information. They should recognize that no one has automatic access to medical information with the patient consent.
The ethics surrounding the Pharmaceutical Industry in the United States and around the world have long been debated by not only healthcare professional, but the general public as well. Due to their high revenues rates and constant legal battles with the government and consumers, new regulations are constantly being developed. For example, in 2009, new voluntary regulations were put out by The Pharmaceutical Research and Manufacturers of America in order to establish guidelines regarding the relationship between physicians and drug representatives in an attempt to improve patient care as a whole. As stated in the new code, “Interactions should be focused
My experience working within the legal system, from a medical prospective, has been limited to the rules, regulations, and policies of the Department of Defense (DoD). Traditional DoD medics work under the license of a medical officer, operate under established protocols, an receive leniency or restriction of medical practices in accordance with medical control (the medical officer responsible for unit medics). DoD medics maybe granted authorities to work on the civilian populous or limited to DoD members/service members. Students of medicine must be aware of the governing laws and policies within their respective scope of practice. Intimate knowledge of the applicable laws and policies governing the learning medical practitioner protects both the student (both in training and in the professional workforce) as well as future patients. Laws and policies are created out of necessity, regrettably often after unfortunate events occurred. Students of medicine must respect this notion, and apply the gravity of their
A blockbuster drug, Rofecoxib, with sales of 2.5 billion dollars of annual sales was pulled off the market (Topol, 2004). The drug was pulled off after epidemiological studies had noted 1.4 million people have had a serious side effect (Medscape Medical News, 2004; Topol, 2004). Rofecoxib side effects were all associated with myocardial infarction, cardiovascular risks, and even death (Smith, 2007; Topol, 2004). Merck a drug manufacturing company and the Food and Drug Administration (FDA) commissioners apparently did not or concealed relevant data from the public that would otherwise be known to protect population health.
...doctors and pharmaceutical companies. Though there should be some boundaries or acceptable guidelines to avoid unethical medical practice such as the PhRMA code and the U.S. law. Unfortunately, these guidelines and regulations have a common drawback which is they can be written for subject to interpretation. To blame it on the lack of guidelines or regulations would be inappropriate because there is an assumption that medical doctors and pharmaceutical companies are incapable of thinking if their actions have any ethical implications or they were not able to differentiate from right and wrong. It takes two to tango, both teams are at fault. They have forgotten how their decisions would take in effect on patients. Pharmaceutical companies and medical doctors need to remember that their actions are to better help humanity and never forget the that power entails of.
Merck, one of the largest pharmaceutical companies in the world and that was established in 1891, is currently facing disputes of ethical dilemmas and federal charges of fraud from the whistleblowers. In the pharmaceutical industry, Merck has had a government-granted monopoly by which it was given exclusive license to be the sole manufacturer and seller of a mumps vaccine in the U.S. Thus, its’ potential competitors are excluded from the market by law. The first FDA approved vaccine was developed from the mumps virus that infected a five year-old girl, Jeryl Lynn, in 1967. Nevertheless, as of today, Merck continues to use Jeryl Lynn strain of the virus for its vaccine, which is no longer providing patients with an adequate level of protection.
Federal and state legislation characteristicallycommand how long a commercial activity must retain personnel records and other worker data, what can be kept. For instance, the Health Insurance Portability and Accountability Act, Americans with Incapacities Act and the Genetic Information Non-discrimination Act all place compulsions on owners to safeguard the confidentiality of worker medical information and to enable company managers activate within the confines of law. Moreover, HR professionals have to stay abreast of legislation and train managers towards their