Federal Preemption of Class III Medical Devices Receiving Premarket App

Federal Preemption of Class III Medical Devices receiving premarket approval Case in Review Court rulings have held that the preemption clause included in the Medical devices act of 1976 protects class III medical devices which have been approved through the Food and Drug Administration’s (FDA) premarket approval process (PMA) from litigation. Injured parties have no means to seek relief from device manufacturers for injuries sustained due to the use of a class III medical device receiving PMA. Overview of the FDA and Medical devices act of 1976: Congress created the Food and Drug Administration in 1938 under a statute known as the Federal Food, Drug and Cosmetic Act. Under the 1938 act, the FDA could not prevent medical devices from entering the market but they could remove unsafe devices from the marketplace. The FDA believed that those same powers given to regulation of drugs should be extended to medical devices to ensure public safety. The Medical devices act of 1976 granted oversight and approval of medical devices to the FDA as a logical extension of duties already provided under previous legislation. The act provided for three classes of medical devices, levels I, II and III. Devices classified under level III were given the most rigorous level of testing and review due to the fact that these devices could produce the greatest level of harm. Level III devices are the only class of devices that are subject to premarket approval which requires manufacturers to submit information related to the safety and effectiveness of their devices for FDA review and approval. The Medical devices act of 1976 included a preemption clause over state law to ensure the federal statutes held supremacy over any state statut... ...mble_fda_final_rule.php>. "Medical Devices." U S Food and Drug Administration Home Page. N.p., n.d. Web. 22 Apr. 2012. . Miller, Roger Leroy, and William Eric Hollowell. Business Law. Mason, OH: South Western Cengage Learning, 2011. Print. "The Development of the Medical Device Amendments | MDDI Medical Device and Diagnostic Industry News Products and Suppliers." MDDI Medical Device and Diagnostic Industry News Products and Suppliers. N.p., n.d. Web. 5 May 2012. . measure, the most plausible, [PDUFA] did not, and in. "Project FDA Report 1 | In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation." Manhattan Institute. N.p., n.d. Web. 21 Apr. 2012. .

Ceaseless controversy †Christianity Essay

The 18th century England was embroiled in ceaseless controversy. The first half of the century was marked by political movements, the rise of skeptics and deists (enlightenment period) whereas in the second half, revival within the church became the issue at stake. Harris states that the century witnessed deterioration in religious tradition, which resulted from a new spirit of individualism, accompanied by the development of new literary forms.1 Ancient records served as the basis for the claims of Christian theology,2 and the deists questioned their authenticity. The deists also ignored revealed religion, laying emphasis on the religion of nature, which is based on reason. As Cragg infers, gradually reason took the place of theology, and served as a principal factor preoccupying the century’s thought. Moreover, its supremacy as a foundation of faith was universally accepted.3 As a result, the deists expressed their objections to Christianity, considering it as a religion contrary to reason. The enlightenment period of the 18th century also came up with biblical criticism. New methods of empirical science were applied to the study of all disciplines, including the Bible.4 Consequently, a number of distinguished writers subjected the Bible to criticism. One of these personalities was Thomas Paine. In his second part of The Age of Reason, he attacked the Bible based on his own investigation. In 1796 Richard Watson, bishop of Liandaff (1737-1816),5 wrote a refutation against Paine’s book, entitled: â€Å"An Apology for the Bible.† Thus, Paine’s The Age of Reason (II) and Watson’s refutation represent enlightenment insights and religious authority respectively, which stood at conflict in the 18th century. By comparing their different perspectives, this paper will demonstrate that Paine’s argument is based on reason whereas Watson’s is based on Biblical authority and tradition. Paine is a believer in natural religion, and so his writings are opposed to the assumptions of revealed religion. For him, God fully reveals himself not in written scripture but through the universe, which can be communicated to anyone without being falsified as the Bible is. Therefore, in his attack against the revealed religion, he primarily searched for defects in the Bible. Raising a moral issue, he quoted a verse from the Bible wherein God ordered the Israelites to attack the Canaanites. From this he concluded that the Bible cannot be the word of God, as it includes a morally defective account which the creator of man by no means commissions to be done.6 According to Paine, it is repugnant to God’s moral justice that he should doom to destruction the crying or smiling infants of the Canaanites. In his reply, Watson demonstrated his defense of the revealed religion. He contends that if we are to despise the revealed religion in this way, the same will be true for natural religion, because it is obvious that earthquakes too swallow up men, women, the little ones, and infants. Then, â€Å"why do you not maintain it to be repugnant to God’s moral justice,† Watson asks Paine, † that he should suffer crying or smiling infants to be swallowed up by an earthquake, drowned by an inundation, consumed by fire, starved by famine or destroyed by pestilence?†7 This indicates that according to Watson, there is also a defect in the deist’s bible, i.e. nature. If the Bible is to be regarded defective in moral accounts because of the destruction of the infants of the Canaanites, Paine’s bible (nature) too is equally defective. In another words, Watson infers that what is revealed in nature is found in the Bible, so they are not contradictory to each other. Therefore Watson argues that it is unfair for Paine to criticize the Bible without equally comparing it with his bible (nature). He strongly expresses his objections as: â€Å"you have no right, in fairness of reasoning to urge any apparent deviation from moral justice as an argument against revealed religion because you do not urge an equally apparent deviation from it, as an argument against natural religion: you reject the former and admit the latter† (Apology, 91). In this way, Watson views Paine’s argument of morality as biased and unjust. For Watson, the Bible which he regards as â€Å"a divine instruction given to some, and traditionally communicated to all† is infallible, for it is the inspiration of God (Apology, 85). In my opinion, all Watson’s arguments lie on this key assumption. He does not critically question the authenticity of the books in the Bible as Paine does. For example, one of the books in the Pentateuch tells us that Moses spoke face to face to God, and wrote down what God had instructed him. This is undoubtedly acceptable for Watson. He does not accept any philosophical thought that may rob him of his Bible. But Paine, following his motto: â€Å"my own mind is my own church†8 accepts only what seems agreeable to his mind. Watson considers the Bible as an infallible guide, but Paine considers his â€Å"reason† as infallible and self-sufficient. While Paine tries his best to prove that the Bible contains morally offensive accounts, Watson learns morality from the Bible. He addressed Paine: â€Å"the Bible, which you despise, has taught me not to judge anyone; it has said to me, ‘who are you to judge another man’s servant? To his own master he stands or falls† (Apology, 7.) Watson came to know everything acceptable to his mind from the Bible, as his confesses: â€Å"God’s word has assured me of all that I am concerned to know† (Apology, 17.)

Parle G

Parle G The following case study is from the Richard Ivey School of Business. It is about the development of a leading Indian biscuit manufacturer, called Parle Products Pvt. Ltd. Company overview The company was found in 1929 as a candy manufacturer and started producing biscuits in 1939. At this time only few processed and ready-to-eat food items were available. Parle G are glucose biscuits and the company’s flag brand. It became the largest selling biscuit brand by volume in 2002.The company was using a mass market strategy which is why the price of the Parle G biscuits has maintained 1$ per Kilo since 1990. In 2009 the company had 74% of the market shares of the Indian glucose biscuit category. The biscuits were sold in 2. 5 million outlets. Other brands of Parle Products Pvt. Ltd. are Marie in the tea time category and Hide n Seek and five other brands in the premium category. In 2008/2009 the company recorded sales revenues of INR35 billion. 68 percent came from Parle G. The company is known all over India for offering high value for a low price (value for money).The products are available in India, Bangladesh and South Africa because the company had adopted a â€Å"follow the costumer† strategy in order to maintain low marketing costs. The two main target groups are 5-14 year old children and their mothers next to institutions. Until 1992 there was only little competition in the sector when Surya Food & Agro Limited entered the market. From 1999 on several companies such as Britannia Industries Ltd. and Hindustan Unilever Ltd. also entered the market because of the high potential in the premium category due to the change of income in Indian households.Problem statement Since 2004 the company had to deal with rising costs of the two main raw materials – sugar and wheat. In 2004 the company tried to raise the prices of its most popular product the 100g packet by 12. 5%. Within 6 month the sales dropped by more than 40%. In 2008 the raw material prices raised again. The management decided to do a hidden raise in price by reducing the weight of the 100g package slowly to 82. 5g without losing high sales. In 2009 the margin from Parle G had fallen from 15 to 10% of the revenue within the last 18 years, which is why Parle G needs a new strategy.The consumers’ perception was rooted so strongly in the low price that it was undermining other product attributes such as quality and taste. This made it impossible to raise the price. The company tried to deal with this problem by changing to a cheaper packaging material and dealing directly with the raw material deliverers. Alternatives There are several approaches to restore the margins to minimum 15% of the revenues again. To evaluate the different strategies two criteria have been selected – costs and time.One approach would be repositioning the brand as a qualitatively high and tasty product for which the costumers do not mind spending more money on. This strategy would be cost intensive and would take at least 12 – 18 month to see the first results. The brand also exists since 1939 which is why it would be very difficult to change people’s prescription of the brand. Therefore it is not the best strategy at this moment. The second strategy could be introducing product variations like for example with different flavours which can be sold for 20 – 25% more expensive than the normal Parle G.The costs for this would be high because of the different researches that have to be conducted, the increasing production costs and the upcoming marketing costs. It would take 6 – 12 month to introduce a new product. This is why this strategy is also not ideal. The third strategy is offering one more brand in the premium category because of the increasing demand in this sector. The fact that Parle Products Pvt. Ltd. already offers 6 brands in the premium category, as well as the high costs of research, production and marke ting are the reason to dismiss this idea.It would also again take 6 – 12 month to introduce the new product which is why a better strategy needs to be found. Plan of Action Another approach would be offering only 4 or 5 instead of 12 different price categories to safe packaging costs. The costs for this action would be very low compared to the other strategies. The time this strategy needs would also be short which is why this a very good short term approach. In order to also find a long term strategy the idea of exporting into more than 2 countries should be reconsidered. A brand can only grow to a certain point f it does not become an international brand. Parle G is at the point where it is no longer enough to only sell within India, Bangladesh and South Africa. The company has to expand in countries with a high amount of Indian citizens, low competition and an increasing demand in biscuits. Therefore several researches have to be conducted because this measure is very cost ly and also very time intensive. But it is necessary for Parle Products Pvt. Ltd. to become a global player in order to restore the margins to minimum 15% of the revenues again and to secure company growth within the next 15 – 20 years.Therefore both criteria time and money can be neglected. The best course of action is changing the offers from 12 to 4 price categories starting within the next 10 – 14 days as a short term plan. The long term plan is exporting Parle G into at least 3 different countries within the next 15 month and 10 countries within the next 3 years. The company should try to conquer the institutional sectors first by offering at least 5-7% discount on bulk purchases at the beginning and create a demand within the rest of the population (pull-concept).

Eugenics the Unethical Pseudoscience Essay

Our topic was on selective human breeding, or in other words eugenics. If you don’t know what eugenics is don’t worry I’ll tell you, according to Oxford dictionaries eugenics is the science of improving a population by controlled breeding to increase the occurrence of desirable heritable characteristics. Desirable heritable characteristics for example can be things like a particular eye color, hair color, height, etc. My question to you all is if you think eugenics is ethical or not? I want to hear your answer after I give you my reasons of why I don’t believe eugenics is ethical. Now this might not sound like such a controversial topic but the history of eugenics is not exactly a bright one. Now everyone knows how WWII began, and the people responsible for it. Hitler and his henchmen victimized an entire continent, murdered millions, during his search for what he called the â€Å"Master Race. † His vision of the ideal race was white, blonde-haired, and blue-eyed, but contrary to popular belief, this idea of the â€Å"Master Race† did not originate with Hitler. The idea came from the United States and its eugenics program. The E. R.  O also known as the Eugenics Record Office was founded on 1910 in New York. A thing that not many people know is that the United States actually had one of the largest eugenic movements in the world. Eugenics was used by scientists as a way to control people, by that I mean they would use various research methods, hereditary questionnaires, and interviewing groups with special interests. The E. R. O. was able to convince the U. S. government to administer eugenic laws nationwide. This included immigration and marriage restrictions, race segregation, and forced sterilization of criminals and who was seen as undesirable. Well what is forced sterilization you ask? To simplify it for males it’s a vasectomy and for woman it’s a tubal ligation, getting your tubes tied. The U. S. was forcing people to be sterilized just because they were seen as unfit to breed, because they didn’t fall under what was seen as desirable. Now this thing eugenics they called it science, I personally see it as pseudoscience used to discriminate people, was used for decades. Oh and did you know that California had the largest eugenics movement in the country. From 1907 to the 1970’s over 60,000 people were forced sterilized in the U. S. alone, and 20,000 of those people were in California. Now who decides if a person should be forced sterilized or not, well a list was made and if a person has or falls under any of the items on that list, they are to be sterilized right away. The few things on that list are paralysis, congenital blindness, acquired deafness, sexual promiscuity, and not being physically attractive. Now I have a video I’d like to show you about eugenics and its forced sterilization.

Auditing Essay Example | Topics and Well Written Essays - 1750 words - 2

Auditing - Essay Example As the report declares the evolution of auditing ethical standards has abdicated the powers governing ethical issues of objectivity from the institutes and placed it in the hands of the ASB, this doesn’t seem to enough to properly control the behaviour of auditors in terms of objectivity and independence. In some cases, the Auditor becomes too financially dependent on the client that it cannot afford to give negative reports regarding the company for fear of losing his/her job. After all, good paying clients are becoming quite scarce nowadays. Other auditors are also providing very profitable advisory services to the client and even go to the extent of deciding for the company instead of merely advising the same. This discussion stresses that standards be set and properly instituted through statutes to provide effective deterrent to potential violators. The low cost auditing services proves to be a major reason why most auditors are resorting to unethical practices of the profession to augment their income. Standards have to be upgraded in terms of professional fees for auditors to prevent them from becoming too financially dependent to the clients. The decision rendered by the Court on the Caparo Industries plc v Dickman case, it if now very difficult to prosecute the auditor. Two provisions of Civil Law can be used to sue auditors for breach of contract, where the client sues the auditor for giving clean report which the client subsequently feels unjustified, and for tort which can be brought to court by anybody other than the client being audited for breaching their duty.

Physiology Assignment about developing human Example | Topics and Well Written Essays - 2000 words

Physiology about developing human - Assignment Example blood, will enter into the foetus' and destroy foetal blood cells. The resulting anemia, which results out of destruction of foetal blood cells, that is, haemolytic anemia may be severe enough to cause foetal death. If the foetus survives to be born, this will invariably lead to severe jaundice in the newborn shortly after birth. Several measures may be adopted to prevent this catastrophe. A regular antenatal care and medical supervision in early pregnancy are needed to detect the risk of the blood type incompatibility. If there is a risk, anti-Rh gamma globulins may be injected to the mother at 28 weeks of gestation and within 72 hours after delivery or miscarriage, abortion, or ectopic pregnancy with a mismatched blood type. The foetal health status can be determined in suspected mismatch and isoimmunization by amniocentesis and cordocentesis. Q2. Answer: This is a mathematical model of a bicycle ride on a mountain terrain. This represents a journey. The vertical axes represent the change in the heart rate in beats per minute of the biker as well as the altitude he covers in metres (represented by the blue line). The horizontal axis represents the timeline in minutes. All these parameters were measured from the start of the journey. At the first stage of the journey at time 0, the altitude is just 20+ metres. The heart rate at that point was approximately 100, and that can be taken as the baseline heart rate. As cycling continues, and the biker reaches the base of the mountain, his heart rate gradually increases until he reaches the middle of the altitude to achieve a maximal heart rate of 180. Before that, the biker reaches another lower peak heart rate of 170. The range of maximal heart rates is, hence, 170 to 180.... [ Despite trying hard I could not accommodate in 7 pages, please have a look, if you desire some parts to be compressed, please let me know, I will make the necessary changes. Since it is question and answer, I did not use in-text citations and bibliography]

Social policy Case Study Assignment Example | Topics and Well Written Essays - 1500 words

Social policy Case Study - Assignment Example They can seek help from programmes or organisations such as Childline, Sane, Supporting people, Refugee council, The Children's society, Housemate, NCH, De Paul Trust, Crisis, Scottish Churches Housing Action etc.that are specifically dealing with problems like those of Jake's. These social work organisations do help people as much as possible but after a point, they find difficult to move further as different policies prove to be a setback to their efforts of improvement. The current white paper that propagates the idea of 'valuing people' is the first of its kind since the last 30 years. So it is quiet evident that not much has been done for the improvement of this sector in the past. According to Department of Health the programs for improving services are based on the key principals; civil rights, independence, choice and inclusion. It stated, "Valuing people takes a life-long approach beginning with an integrated approach to services for disabled children and their families and then providing new opportunities for a full and purposeful adult life." (para.3) From this it appears that all are welcome for support and assistance but if we study the white paper in detail some other facts come into light. The National Austic Society has rightly pointed after observing the definition of 'Valuing people' that "the definition goes on to say that IQ below 70 is not in itself a sufficient reason for deciding whether an individual requires support. An assess ment of social functioning and communication skills should also be taken into account when determining need." (para.7) So the discussed white paper brings both; a ray of hope and a situation of dilemma to people like Jake. All this affects the social work professionals' attitudes too. The Independent Living Bill of disabled persons states that the disabled people are equal in freedom, choice, dignity and control to others and have the right to assistance and support. This automatically implies that Jake and his family can expect an independent and decent life for him. The current white paper also has set an objective to provide choices of housing to people like Jake so that they can live independently. According to Twigg, NHS and the Community Care Act 1990, "established the current arrangements for community care, introducing care management and according primary responsibility for community care-lead agency status-to social services." (1999, p.370). Sadly the housing policy is not aimed at those who need it badly. The housing policy that greatly follows the key legislation like the 1972 Housing Finance Act, 1977 Homeless Act, and 1996 Housing Act etc. is not completely a social policy. Of late it has taken a social character, which does not enable the social workers to fully utilize it for the betterment of the needy. Still the social policy is an indicator for the social workers to decide upon their plan of action. (Pahl, 1999, p.173) stated: 'social policy is now beginning to recognize the contribution which carers make to individualsThe National Health Service and