If a manufacturer fails to alert the public to the potential risks of any types of drug or other product, the individual who is harmed by the drug can pursue a claim of damages.
This document discusses the current and potential future regulation of video games by the U.S. Food and Drug Administration (FDA). The FDA regulates medical devices and could consider some video games to be medical devices, subjecting them to FDA oversight, if the games are intended to diagnose, cure, mitigate or treat disease. Currently, no video games have received FDA clearance or approval. The level of FDA regulation will depend on how video games are classified based on their intended use and risk level. The FDA's evolving approach to mobile medical applications may provide a framework for regulating some health-focused video games in the future.
The document provides information about unlicensed activity (ULA) in Florida, including guidelines for reporting ULA and examples of ULA investigations and actions taken. It discusses the Florida Department of Health's efforts to protect residents from unlicensed medical practitioners through enforcement of licensure regulations and investigating ULA complaints.
Changing times ask for solid relationships.
Times are changing. A renewed interest from big pharma in the rare disease landscape
has awakened due to large-scale patent expirations, competition from generics &
biosimilars, anemic pipelines, escalating clinical trial costs and a global health-care
reform. This means that the traditional blockbuster model has become less viable while
the revenue-generating potential of orphan drugs has shown to be huge with a greater
return on investment than non-orphan drugs. According to EvaluatePharma, the orphan
drugs sales will grow at an annual rate of 11% and constitute 19% of the total share of
prescription drugs by 2020, totalling 176 billion dollars.
The rare disease landscape is very complex due to the large amount of stakeholders
involved. Despite their different interests they have one goal in common: getting an
orphan drug approval that will help save or improve lives. But there are many challenges
on the road to orphan drug designation:
• Complex and changing national and regional regulations
• Clinical trial design and finding & keeping patients
• The lack of a central database designed specifically to list patient registries, which
asks for close stakeholder engagement
• Partnering and establishing financing for future development
• Establishing a foundation for price that is balanced and sustainable
• Achieving an efficient and timely access to market with equal access for patients
around the world
• Achieving timely and correct diagnosis to enable higher quality of life and more time
and information for developers
More information: http://www.orphandrugssummit.com/
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
What to Consider When Filling a Prescription Sherif El Refai
Sherif Mohamed El-Refai is a pharmacist in Jersey City, New Jersey who earned his doctorate of pharmacy from UNC Eshelman School of Pharmacy. When getting a prescription filled, it is important to check with your insurance company to determine if your medication is covered and to obtain an updated list of approved prescriptions. Pharmacists need a customer's insurance information and accept prescriptions in various forms, so having your insurance card ready is necessary for fulfilling a prescription.
Short Version of Wet Area Mapping CANNORGustavo Moran
This document discusses four planning tools for wet area mapping and geoscience innovation: Flood, Locate, Trail, and Spill. Flood delineates likely flood extent. Locate ranks hydrological infrastructure by flow accommodation capacity. Trail optimizes trail and linear project routing. Spill tracks the likely path of waterborne contaminants. The tools are supported by a knowledge base and aim to further economic activities while managing uncertainty and supporting flood management strategies like reducing flow rates and restricting developments.
The document contains several maps showing watershed boundaries, elevation data, stream networks, depth to water, and mining claims overlaid on top of each other. The maps were generated from digital elevation data and hydrologically corrected using vector data. Watershed borders and networks of streams were delineated from digital elevation models at varying resolutions and flow accumulation thresholds. Depth to water maps also show estimates generated from digital elevation data. Mining claims polygons are overlaid on top of the hydrological features and watershed boundaries.
This document discusses the current and potential future regulation of video games by the U.S. Food and Drug Administration (FDA). The FDA regulates medical devices and could consider some video games to be medical devices, subjecting them to FDA oversight, if the games are intended to diagnose, cure, mitigate or treat disease. Currently, no video games have received FDA clearance or approval. The level of FDA regulation will depend on how video games are classified based on their intended use and risk level. The FDA's evolving approach to mobile medical applications may provide a framework for regulating some health-focused video games in the future.
The document provides information about unlicensed activity (ULA) in Florida, including guidelines for reporting ULA and examples of ULA investigations and actions taken. It discusses the Florida Department of Health's efforts to protect residents from unlicensed medical practitioners through enforcement of licensure regulations and investigating ULA complaints.
Changing times ask for solid relationships.
Times are changing. A renewed interest from big pharma in the rare disease landscape
has awakened due to large-scale patent expirations, competition from generics &
biosimilars, anemic pipelines, escalating clinical trial costs and a global health-care
reform. This means that the traditional blockbuster model has become less viable while
the revenue-generating potential of orphan drugs has shown to be huge with a greater
return on investment than non-orphan drugs. According to EvaluatePharma, the orphan
drugs sales will grow at an annual rate of 11% and constitute 19% of the total share of
prescription drugs by 2020, totalling 176 billion dollars.
The rare disease landscape is very complex due to the large amount of stakeholders
involved. Despite their different interests they have one goal in common: getting an
orphan drug approval that will help save or improve lives. But there are many challenges
on the road to orphan drug designation:
• Complex and changing national and regional regulations
• Clinical trial design and finding & keeping patients
• The lack of a central database designed specifically to list patient registries, which
asks for close stakeholder engagement
• Partnering and establishing financing for future development
• Establishing a foundation for price that is balanced and sustainable
• Achieving an efficient and timely access to market with equal access for patients
around the world
• Achieving timely and correct diagnosis to enable higher quality of life and more time
and information for developers
More information: http://www.orphandrugssummit.com/
The document discusses the dangers American patients face from counterfeit medications obtained outside of the regulated US drug supply chain, such as through fake online Canadian pharmacies. It details how breaks in the secure supply chain, such as patients buying drugs online or some doctors and pharmacists obtaining drugs from unlicensed distributors, can endanger patients by exposing them to counterfeit and unsafe medications. The document aims to dispel myths about obtaining cheaper drugs from outside the US and provides tips for patients to stay safe.
What to Consider When Filling a Prescription Sherif El Refai
Sherif Mohamed El-Refai is a pharmacist in Jersey City, New Jersey who earned his doctorate of pharmacy from UNC Eshelman School of Pharmacy. When getting a prescription filled, it is important to check with your insurance company to determine if your medication is covered and to obtain an updated list of approved prescriptions. Pharmacists need a customer's insurance information and accept prescriptions in various forms, so having your insurance card ready is necessary for fulfilling a prescription.
Short Version of Wet Area Mapping CANNORGustavo Moran
This document discusses four planning tools for wet area mapping and geoscience innovation: Flood, Locate, Trail, and Spill. Flood delineates likely flood extent. Locate ranks hydrological infrastructure by flow accommodation capacity. Trail optimizes trail and linear project routing. Spill tracks the likely path of waterborne contaminants. The tools are supported by a knowledge base and aim to further economic activities while managing uncertainty and supporting flood management strategies like reducing flow rates and restricting developments.
The document contains several maps showing watershed boundaries, elevation data, stream networks, depth to water, and mining claims overlaid on top of each other. The maps were generated from digital elevation data and hydrologically corrected using vector data. Watershed borders and networks of streams were delineated from digital elevation models at varying resolutions and flow accumulation thresholds. Depth to water maps also show estimates generated from digital elevation data. Mining claims polygons are overlaid on top of the hydrological features and watershed boundaries.
This document discusses memory techniques and memorization. It begins with an overview of the presenter's background and credentials. The agenda then outlines discussing a memory experiment, the case for memorization, key memory concepts, and foundational memory techniques. Memory is described as an explicit, emotional, creative act requiring discipline and structure rather than just happening through repetition alone. Different memory tools and techniques are presented for memorizing different types of information effectively.
Presentación en la 12as Jornadas Internacionales gvSIG: Conoce el territorio...Gustavo Moran
Towards improved planning procedures through digital datalayer processing: a case study for the Choapa River Watershed in Chile
Gustavo Moran1, Pedro Paolini Cuadra2, Valenty Gonzalez3, John-Paul Arp4, Paul A. Arp5
1gmoran@surnorte.ca; 2pedro.paolini@lp-consultores.cl; 3valenty@creativa-consultores.com, 4arp.johnpaul@gmail.com, 5arp2@unb.ca
ABSTRACT
Urban and non-urban settlements in many regions are usually located in the lands bordering shores, rivers, canals or streams. Housing complexes, landfills, and project areas for agriculture and mining are generally assigned to locations without sufficiently detailed hydrographic information about subsequent potential if not actual flow and flooding impacts. Yet, for sustainable project and community planning with an emphasis on harmonizing social, economic, environmental and institutional aspects, such information is essential. This article demonstrates how this need can - at least in part - be addressed by way of a digital elevation and wet-area modelling and mapping, using the upper component of the Choapa watershed in Chile as a case study for the Chilean mining sector.
Biotic components are living things like plants, animals, and humans that shape ecosystems. They need energy and food - plants produce food through photosynthesis, animals and humans consume other organisms or their byproducts, and decomposers like bacteria and fungi break down dead matter. Abiotic components are non-living environmental factors such as sunlight, soil, water, and air that affect ecosystems. Both biotic and abiotic factors work interdependently to provide a functioning environment for organisms in an ecosystem.
This document discusses factors to consider when selecting serials for a library collection. Serial publications like journals, magazines, and newspapers require long-term commitments as they are intended to continue indefinitely. This means that serial costs become a fixed part of the budget each year and occupy more storage space over time. When deciding whether to subscribe to a serial, librarians must weigh the ongoing costs of subscriptions, processing, packaging, and potential photocopying against how patrons will access the information and whether to purchase back issues.
Biotic components are living things like plants, animals, and humans that shape ecosystems. They need energy and food - plants produce food through photosynthesis, animals and humans consume other organisms or their byproducts, and decomposers like bacteria and fungi break down dead matter. Abiotic components are non-living environmental factors such as sunlight, soil, water, and air that affect ecosystems. Both biotic and abiotic factors work interdependently to provide a functioning environment for organisms in an ecosystem.
This document discusses microbial spoilage of various foods including meats, cereals and bakery products, and dairy products. It provides details on the specific microorganisms that cause spoilage in each food type and how they affect quality through changes in color, texture, odor and flavor. For meats, both aerobic and anaerobic bacteria can cause spoilage through slime formation, fat decomposition and off-odors. In cereals and bakery products, molds are a major cause of spoilage and can grow on bread, cakes and other products. For dairy products, bacteria like streptococci and pseudomonads can result in souring, ropiness, proteolysis and off-flavors during spo
Este documento describe los tipos de drogas más comunes, sus efectos y formas de consumo. Explica que la drogadicción es una enfermedad que afecta el sistema nervioso central y las funciones cerebrales, produciendo alteraciones en el comportamiento. Luego detalla drogas como el alcohol, la marihuana, LSD, cocaína, heroína, metanfetaminas, anfetaminas, hongos, esteroides y crack, describiendo sus métodos de consumo y efectos.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
The document discusses the role of the FDA in regulating drugs and pharmacies in the United States. The FDA sets strict guidelines that pharmacies like McCrory's Pharmacy must follow to prevent issues like contaminated drugs. The FDA's Center for Drug Evaluation and Research ensures that prescription drugs and over-the-counter drugs are safe and effective for Americans. Pharmacies are responsible for providing customers with safe products and information on recalls to avoid liability if a customer gets sick from a drug.
Pharmacovigilance role and challenges phased by doctorsSneha Pandey
This document discusses adverse drug reactions (ADRs) in India's healthcare industry. It notes that ADRs are a major concern due to lack of regulation. It describes the different types of ADRs and their potential impacts on patients, doctors, and pharmaceutical companies. The document also outlines challenges faced by these groups and discusses legal remedies for patients harmed by ADRs. Finally, it stresses that preventing ADRs requires collaborative efforts through education, improved oversight, and enhanced reporting systems.
This document summarizes a seminar presentation on orphan drug designations and approvals. It begins with introducing rare diseases and defining orphan drugs. It then discusses the key aspects of the Orphan Drug Act of 1983 in the US that provides incentives for orphan drug development, including 7 years of market exclusivity. The document outlines the orphan drug designation process through the FDA, including the application process. It also summarizes the incentives provided through the Act, such as tax credits, grants, and fee waivers, to encourage pharmaceutical companies to develop treatments for rare diseases.
Xarelto is a blood thinner used to treat deep vein thrombosis and atrial fibrillation. A patient named Virginia Stunteneck sued the manufacturers of Xarelto after experiencing severe internal bleeding from taking the drug. She claimed they failed to properly warn the public of the health risks. Manufacturers can be held liable for products that negatively impact consumer health. Hiring a lawyer is recommended if someone is considering filing a lawsuit against the manufacturers of Xarelto due to injuries or wrongful death resulting from its use, as lawyers understand the legal policies and options in such cases. Statutes of limitations vary by state, so it is important to file any claim before the time limit expires.
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
This document summarizes a webinar about product liability risks for pharmaceutical companies in California following a recent court case, Conte v. Wyeth. The webinar discusses how the case established that innovator drug companies can be held liable for injuries caused by generic drug competitors, even if the plaintiff did not use the innovator's product. It also discusses federal preemption which can protect both innovator and generic drug companies from certain liability claims. The webinar aims to help pharmaceutical companies understand and utilize preemption as a defense in product liability lawsuits in California.
Claims involving defective medical deviceskrish stha
This document discusses defective medical devices and filing claims against their manufacturers. It defines medical devices and outlines three types of defects - design, manufacturing, and marketing defects. It explains that to prove a defective product claim in Oklahoma, one must show the device caused injury, was defective when it left the manufacturer's control, and the defect caused unreasonable danger. Potential defendants include manufacturers, testing labs, medical representatives, doctors, and retailers. Recoverable damages for defective medical device claims include punitive damages to punish wrongdoing and deter others, and compensatory damages to restore the injured party.
The document discusses the growing heroin addiction epidemic in the United States. It notes that prescription opioid misuse has led many Americans to turn to heroin and that overdose deaths have more than tripled since 2010. It provides information on prevention and treatment efforts, including expanding access to the overdose reversal drug naloxone and increasing medically-assisted treatment programs. The document also discusses Walgreens' efforts to install safe drug disposal kiosks and make naloxone available without a prescription to help address the crisis.
This document discusses several key issues in medical ethics including conflicts that can arise between patient/family values and treatment guidelines, the complex nature of healthcare ethics, and important principles like autonomy, beneficence, non-maleficence, justice, dignity, and truthfulness. It also summarizes two cases involving pharmaceutical companies illegally promoting drugs and a kidney transplant racket in India. Finally, it discusses the importance of patient safety, avoiding medical errors, and the ethical duty of physicians to disclose errors to protect patients.
This paper discusses the growing problem of prescription drug abuse in the United States. It examines the roles of physicians overprescribing drugs, pharmaceutical companies aggressively marketing drugs, and individuals needing to take responsibility for their health. The paper argues that while prescription drugs can help some patients, too many are prescribed unnecessarily or dangerously. Physicians should recommend lifestyle changes before drugs, and individuals should research alternatives to newly prescribed drugs which are often pushed by pharmaceutical advertising. Overall responsibility lies with physicians to consider patient well-being over profits, pharmaceutical companies to curb misleading marketing, and individuals to make informed health decisions.
This lecture discusses health policy related to curbing abuse of controlled substances - like narcotics. This article discusses several steps Utah has made to decrease the number of opiate-related deaths.
This document discusses memory techniques and memorization. It begins with an overview of the presenter's background and credentials. The agenda then outlines discussing a memory experiment, the case for memorization, key memory concepts, and foundational memory techniques. Memory is described as an explicit, emotional, creative act requiring discipline and structure rather than just happening through repetition alone. Different memory tools and techniques are presented for memorizing different types of information effectively.
Presentación en la 12as Jornadas Internacionales gvSIG: Conoce el territorio...Gustavo Moran
Towards improved planning procedures through digital datalayer processing: a case study for the Choapa River Watershed in Chile
Gustavo Moran1, Pedro Paolini Cuadra2, Valenty Gonzalez3, John-Paul Arp4, Paul A. Arp5
1gmoran@surnorte.ca; 2pedro.paolini@lp-consultores.cl; 3valenty@creativa-consultores.com, 4arp.johnpaul@gmail.com, 5arp2@unb.ca
ABSTRACT
Urban and non-urban settlements in many regions are usually located in the lands bordering shores, rivers, canals or streams. Housing complexes, landfills, and project areas for agriculture and mining are generally assigned to locations without sufficiently detailed hydrographic information about subsequent potential if not actual flow and flooding impacts. Yet, for sustainable project and community planning with an emphasis on harmonizing social, economic, environmental and institutional aspects, such information is essential. This article demonstrates how this need can - at least in part - be addressed by way of a digital elevation and wet-area modelling and mapping, using the upper component of the Choapa watershed in Chile as a case study for the Chilean mining sector.
Biotic components are living things like plants, animals, and humans that shape ecosystems. They need energy and food - plants produce food through photosynthesis, animals and humans consume other organisms or their byproducts, and decomposers like bacteria and fungi break down dead matter. Abiotic components are non-living environmental factors such as sunlight, soil, water, and air that affect ecosystems. Both biotic and abiotic factors work interdependently to provide a functioning environment for organisms in an ecosystem.
This document discusses factors to consider when selecting serials for a library collection. Serial publications like journals, magazines, and newspapers require long-term commitments as they are intended to continue indefinitely. This means that serial costs become a fixed part of the budget each year and occupy more storage space over time. When deciding whether to subscribe to a serial, librarians must weigh the ongoing costs of subscriptions, processing, packaging, and potential photocopying against how patrons will access the information and whether to purchase back issues.
Biotic components are living things like plants, animals, and humans that shape ecosystems. They need energy and food - plants produce food through photosynthesis, animals and humans consume other organisms or their byproducts, and decomposers like bacteria and fungi break down dead matter. Abiotic components are non-living environmental factors such as sunlight, soil, water, and air that affect ecosystems. Both biotic and abiotic factors work interdependently to provide a functioning environment for organisms in an ecosystem.
This document discusses microbial spoilage of various foods including meats, cereals and bakery products, and dairy products. It provides details on the specific microorganisms that cause spoilage in each food type and how they affect quality through changes in color, texture, odor and flavor. For meats, both aerobic and anaerobic bacteria can cause spoilage through slime formation, fat decomposition and off-odors. In cereals and bakery products, molds are a major cause of spoilage and can grow on bread, cakes and other products. For dairy products, bacteria like streptococci and pseudomonads can result in souring, ropiness, proteolysis and off-flavors during spo
Este documento describe los tipos de drogas más comunes, sus efectos y formas de consumo. Explica que la drogadicción es una enfermedad que afecta el sistema nervioso central y las funciones cerebrales, produciendo alteraciones en el comportamiento. Luego detalla drogas como el alcohol, la marihuana, LSD, cocaína, heroína, metanfetaminas, anfetaminas, hongos, esteroides y crack, describiendo sus métodos de consumo y efectos.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
The document discusses the role of the FDA in regulating drugs and pharmacies in the United States. The FDA sets strict guidelines that pharmacies like McCrory's Pharmacy must follow to prevent issues like contaminated drugs. The FDA's Center for Drug Evaluation and Research ensures that prescription drugs and over-the-counter drugs are safe and effective for Americans. Pharmacies are responsible for providing customers with safe products and information on recalls to avoid liability if a customer gets sick from a drug.
Pharmacovigilance role and challenges phased by doctorsSneha Pandey
This document discusses adverse drug reactions (ADRs) in India's healthcare industry. It notes that ADRs are a major concern due to lack of regulation. It describes the different types of ADRs and their potential impacts on patients, doctors, and pharmaceutical companies. The document also outlines challenges faced by these groups and discusses legal remedies for patients harmed by ADRs. Finally, it stresses that preventing ADRs requires collaborative efforts through education, improved oversight, and enhanced reporting systems.
This document summarizes a seminar presentation on orphan drug designations and approvals. It begins with introducing rare diseases and defining orphan drugs. It then discusses the key aspects of the Orphan Drug Act of 1983 in the US that provides incentives for orphan drug development, including 7 years of market exclusivity. The document outlines the orphan drug designation process through the FDA, including the application process. It also summarizes the incentives provided through the Act, such as tax credits, grants, and fee waivers, to encourage pharmaceutical companies to develop treatments for rare diseases.
Xarelto is a blood thinner used to treat deep vein thrombosis and atrial fibrillation. A patient named Virginia Stunteneck sued the manufacturers of Xarelto after experiencing severe internal bleeding from taking the drug. She claimed they failed to properly warn the public of the health risks. Manufacturers can be held liable for products that negatively impact consumer health. Hiring a lawyer is recommended if someone is considering filing a lawsuit against the manufacturers of Xarelto due to injuries or wrongful death resulting from its use, as lawyers understand the legal policies and options in such cases. Statutes of limitations vary by state, so it is important to file any claim before the time limit expires.
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
This document summarizes a webinar about product liability risks for pharmaceutical companies in California following a recent court case, Conte v. Wyeth. The webinar discusses how the case established that innovator drug companies can be held liable for injuries caused by generic drug competitors, even if the plaintiff did not use the innovator's product. It also discusses federal preemption which can protect both innovator and generic drug companies from certain liability claims. The webinar aims to help pharmaceutical companies understand and utilize preemption as a defense in product liability lawsuits in California.
Claims involving defective medical deviceskrish stha
This document discusses defective medical devices and filing claims against their manufacturers. It defines medical devices and outlines three types of defects - design, manufacturing, and marketing defects. It explains that to prove a defective product claim in Oklahoma, one must show the device caused injury, was defective when it left the manufacturer's control, and the defect caused unreasonable danger. Potential defendants include manufacturers, testing labs, medical representatives, doctors, and retailers. Recoverable damages for defective medical device claims include punitive damages to punish wrongdoing and deter others, and compensatory damages to restore the injured party.
The document discusses the growing heroin addiction epidemic in the United States. It notes that prescription opioid misuse has led many Americans to turn to heroin and that overdose deaths have more than tripled since 2010. It provides information on prevention and treatment efforts, including expanding access to the overdose reversal drug naloxone and increasing medically-assisted treatment programs. The document also discusses Walgreens' efforts to install safe drug disposal kiosks and make naloxone available without a prescription to help address the crisis.
This document discusses several key issues in medical ethics including conflicts that can arise between patient/family values and treatment guidelines, the complex nature of healthcare ethics, and important principles like autonomy, beneficence, non-maleficence, justice, dignity, and truthfulness. It also summarizes two cases involving pharmaceutical companies illegally promoting drugs and a kidney transplant racket in India. Finally, it discusses the importance of patient safety, avoiding medical errors, and the ethical duty of physicians to disclose errors to protect patients.
This paper discusses the growing problem of prescription drug abuse in the United States. It examines the roles of physicians overprescribing drugs, pharmaceutical companies aggressively marketing drugs, and individuals needing to take responsibility for their health. The paper argues that while prescription drugs can help some patients, too many are prescribed unnecessarily or dangerously. Physicians should recommend lifestyle changes before drugs, and individuals should research alternatives to newly prescribed drugs which are often pushed by pharmaceutical advertising. Overall responsibility lies with physicians to consider patient well-being over profits, pharmaceutical companies to curb misleading marketing, and individuals to make informed health decisions.
This lecture discusses health policy related to curbing abuse of controlled substances - like narcotics. This article discusses several steps Utah has made to decrease the number of opiate-related deaths.
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
Understanding Georgian Pharmaceutical LawMelinda_White
According to the document, pharmaceutical law in Georgia covers issues with medications including inadequate testing, insufficient warnings, and poor prescriptions from doctors. The document discusses how deaths from prescription drug overdoses have increased dramatically in Georgia in recent years. It provides an overview of pharmaceutical law and what legal recourse victims may have, including compensatory damages, if they have been harmed by dangerous drugs prescribed negligently in Georgia.
American Green Rush: Business Opportunity & RisksAncella Simoes
This is a report I wrote recently on the impact of the growing legalized Marijuana industry, on the Insurance industry. The legal marijuana market is slated to grow about 700 percent in the next few years; for insurers, this means a specialized market with growing needs and immense business opportunity to determine the basic coverages which can be provided along with other specialized ones.
Pharmacovigilance is the science of monitoring the safety of medicines. It involves detecting, assessing, understanding, and preventing adverse effects of drugs. Pharmacovigilance activities begin during clinical trials and continue throughout a product's lifecycle. The goal of pharmacovigilance is to improve patient safety, public health, and understanding of medication risks and benefits. Careers in pharmacovigilance include roles monitoring adverse events, assessing drug safety, and reviewing medical information to evaluate safety profiles.
Running Head MEDICAL MALPRACTICE LAWSUIT1 MEDICAL MALPRACTICE .docxglendar3
Running Head: MEDICAL MALPRACTICE LAWSUIT 1
MEDICAL MALPRACTICE LAWSUIT 5
Term Paper “The Lawsuit of Medical Malpractice”
Marilyn Diaz
Professor George Ackerman
PLA4522 Health Care Law
July 17th, 2019
Abstract
This paper explores “Medical Malpractice” in the field of law in detailed explanation. The paper begins with an introduction to medical malpractice giving statistics and data. Data from the European Union is used to give a detailed illustration. The introduction is followed by elements of medical malpractice lawsuit, defenses to a medical malpractice lawsuit, ways of avoiding a medical malpractice lawsuit and the policy of medical insurance. The method used to gather information was reading of various articles on the subject. The results of the study revealed an increase in the number of medical malpractice cases. Results also revealed that some medical practitioners are using the defenses available in medical malpractice lawsuit to evade penalties. The study emphasizes on ways in which physicians can avoid malpractice by way of precautionary measures.
The Lawsuit of Medical Malpractice
Introduction
Medical malpractice is a precise kind of negligence defined as an act of omission by a physician during treatment of a patient that departs from accepted standards of practice in the health sector and causes an injury to the patient (Bal, 2009). In the last decade, medical malpractice has increased in Europe to double-digit percentage i.e. >50% in Eastern States, Great Britain and the Baltic, a maximum three-digit percentage i.e. 200-500% in Mediterranean area, Germany, the Iberian countries and Italy. France and Scandinavian counties have seen reduction in malpractice because of simplification of procedures and exemplary innovations.
The Special Eurobarometer on Medical Error in 2006 revealed that 80% of EU citizens view medical error as a key issue and close to 50% believed they would be tangled in a case of medical malpractice. This revealed that the public has become aware that claims of medical malpractice against health practitioners can be successful. In Sweden and Denmark between 2005-2010, the ratio of approval for compensatory claims rose to 40%, the average settlement of around €30,000 per case in EU countries. The European Hospital and Healthcare Federation Standing Committee estimates cost of coverage to be in excess of 200%. Costs fluctuated between 9 and 15 euros per capita with Britain exhibiting the highest figures (Ferrara, 2013).
Elements of a Medical Malpractice Lawsuit
The burden of proof in a Medical Malpractice Lawsuit lays on the plaintiff. The plaintiff needs to prove all the elements of medical malpractice in order to stand chance of success in a courtroom.
Existence of physician-patient relationship. Breach of duty of cared owed to patient by physician. Duty upheld at a professional standard of care. Duty of the physician to the patient established by the relationship. Patient sust.
Running Head MEDICAL MALPRACTICE LAWSUIT1 MEDICAL MALPRACTICE .docxtodd581
Running Head: MEDICAL MALPRACTICE LAWSUIT 1
MEDICAL MALPRACTICE LAWSUIT 5
Term Paper “The Lawsuit of Medical Malpractice”
Marilyn Diaz
Professor George Ackerman
PLA4522 Health Care Law
July 17th, 2019
Abstract
This paper explores “Medical Malpractice” in the field of law in detailed explanation. The paper begins with an introduction to medical malpractice giving statistics and data. Data from the European Union is used to give a detailed illustration. The introduction is followed by elements of medical malpractice lawsuit, defenses to a medical malpractice lawsuit, ways of avoiding a medical malpractice lawsuit and the policy of medical insurance. The method used to gather information was reading of various articles on the subject. The results of the study revealed an increase in the number of medical malpractice cases. Results also revealed that some medical practitioners are using the defenses available in medical malpractice lawsuit to evade penalties. The study emphasizes on ways in which physicians can avoid malpractice by way of precautionary measures.
The Lawsuit of Medical Malpractice
Introduction
Medical malpractice is a precise kind of negligence defined as an act of omission by a physician during treatment of a patient that departs from accepted standards of practice in the health sector and causes an injury to the patient (Bal, 2009). In the last decade, medical malpractice has increased in Europe to double-digit percentage i.e. >50% in Eastern States, Great Britain and the Baltic, a maximum three-digit percentage i.e. 200-500% in Mediterranean area, Germany, the Iberian countries and Italy. France and Scandinavian counties have seen reduction in malpractice because of simplification of procedures and exemplary innovations.
The Special Eurobarometer on Medical Error in 2006 revealed that 80% of EU citizens view medical error as a key issue and close to 50% believed they would be tangled in a case of medical malpractice. This revealed that the public has become aware that claims of medical malpractice against health practitioners can be successful. In Sweden and Denmark between 2005-2010, the ratio of approval for compensatory claims rose to 40%, the average settlement of around €30,000 per case in EU countries. The European Hospital and Healthcare Federation Standing Committee estimates cost of coverage to be in excess of 200%. Costs fluctuated between 9 and 15 euros per capita with Britain exhibiting the highest figures (Ferrara, 2013).
Elements of a Medical Malpractice Lawsuit
The burden of proof in a Medical Malpractice Lawsuit lays on the plaintiff. The plaintiff needs to prove all the elements of medical malpractice in order to stand chance of success in a courtroom.
Existence of physician-patient relationship. Breach of duty of cared owed to patient by physician. Duty upheld at a professional standard of care. Duty of the physician to the patient established by the relationship. Patient sust.
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St. Louis Pharmaceutical Liability: Even Over-The Counter Medications Present Risks
1. ST. LOUIS PHARMACEUTICAL LIABILITY: EVEN OVER-THE- COUNTER MEDICATIONS PRESENT RISKS
If a Manufacturer Fails to Alert the Public
to the Potential Risks of Any Type of Drug
or Other Product, the Individual Who Is Harmed
by the Drug Can Pursue a Claim for Damages
CAREY, DANIS & LOWE
PERSONAL INJURY ATTORNEYS
2. Even Over-the-Counter Medications Present Risks Carey, Danis and Lowe, Attorneys at Law 2
Despite regulations intended to protect patients from dangerous medications, drugs with unexpected and serious side effects frequently come onto the marketplace. From SSRIs, a type of anti-depressant that can cause birth defects, to diabetes drugs like Actos that have been linked to bladder cancer, there are thousands of patients harmed every single year by medications that they expect to help them. Unfortunately, the list of dangerous drugs is not limited to prescription medications only. Even over-the-counter medications can present significant risks to patients if manufacturers fail to provide adequate warnings about the risks of the medicine. When a patient is injured by a prescription or over-the- counter defective medication, the patient has legal rights. An experienced defective drug lawyer can assist in pursuing a claim for compensation and recovering monetary damages for losses that the drug has caused.
3. Even Over-the-Counter Medications Present Risks Carey, Danis and Lowe, Attorneys at Law 3
OVER-THE-COUNTER MEDICATIONS AND TREATMENTS CAN BE DANGEROUS
Many different types of over-the-counter medications have led to defective drug litigation. For example, patients have filed lawsuits based on problems with Tylenol causing liver damage, Advil and Aleve causing birth defects, and denture creams like Poligrip and Fixodent causing zinc poisoning or neuropathy.
Just recently, the Food and Drug Administration issued a new warning about over-the-counter products that are used to treat acne. As Time reports, the FDA acted to alert the public of potential dangers in response to receiving reports of 131 different adverse reactions regarding acne treatments. The affected medications that the FDA has alerted the public about include acne medications with the ingredients benzoyl peroxide or salicylic acid. Products include: Neutrogena Ambi MaxClarity Oxy Clean and Clear Aveeno
4. Even Over-the-Counter Medications Present Risks Carey, Danis and Lowe, Attorneys at Law 4
These acne medications include lotions, face scrubs, face washes and cleansing gels. Unfortunately, when individuals use these products, there is a risk of serious or even potentially fatal side effects.
Adverse events that have been reported to the Food and Drug Administration include symptoms that are similar to a severe allergy attack. Approximately 40 percent of adverse event reports included patients experiencing breathing problems, tightness in the throat, and blood pressure that was lower than a healthy level. Among this group, some patients also experienced swelling of the face or broke out in hives, while others collapsed or fainted.
Symptoms associated with a severe reaction to the acne medications generally begin shortly after the product is used. In approximately 42 percent of problem incidents, the affected individual had a bad reaction within 24 hours of applying the acne medication. There have been no deaths reported yet that have been linked to the use of the acne products, but the risks are very serious. In approximately 44 percent of cases, the individual who experienced the severe reaction required hospitalization to be treated for the medical issues.
5. Even Over-the-Counter Medications Present Risks Carey, Danis and Lowe, Attorneys at Law 5
The FDA issued a warning about these adverse event reports and about the possibility of problems for acne medication users because the labels for the products do not currently warn users of the potential risks that they take when they apply the products. An FDA spokesperson indicated that the label did not make patients aware of the dangers and that the warning was intended to ensure that users of the products would be able to respond appropriately and in a timely manner if they began to experience an adverse reaction. Unfortunately, many people assume that over-the-counter products are safe, especially products that are applied topically. The reality is that a serious adverse reaction can occur with any treatment that is taken orally or that is applied to the skin. MANUFACTURER OBLIGATIONS IN DEFECTIVE PRODUCT CASES
Manufacturers of prescription and over-the-counter medications, as well as other types of products, must ensure that the items they are releasing to the public are reasonably safe. Some products and some drugs inherently have risks or have the potential to cause side effects or harm. When this occurs, it is the obligation of the manufacturer to provide adequate warning so consumers can make an informed choice and determine if they wish to proceed with using the product.
6. Even Over-the-Counter Medications Present Risks Carey, Danis and Lowe, Attorneys at Law 6
If a manufacturer fails to alert the public to the potential risks of any type of drug or other product, the individual who is harmed by the drug can pursue a claim for damages. The victim could claim that the manufacturer is liable for failure to warn. Victims in defective products may also make a claim based on strict liability, which means that here is no requirement to prove the manufacturer failed to fulfill any duty or did anything wrong. If the product was used as intended and it is defective and unreasonably dangerous resulting in harm to its user, the victim may pursue a strict liability claim and should be able to obtain monetary damages. An experienced defective drug lawyer can assist clients in pursuing a claim after being harmed by a prescription or over-the-counter medication.
7. Even Over-the-Counter Medications Present Risks Carey, Danis and Lowe, Attorneys at Law 7
About Carey, Danis & Lowe, Attorneys at Law Carey, Danis & Lowe exclusively represents plaintiffs in litigation. The firm practices a wide area of personal injury law including trucking accidents, medical malpractice, auto accidents, motorcycle accidents, product liability, burn injuries, defective prescription drugs, and defective medical devices. Currently approximately 50% of the practice is devoted to prescription drug litigation, including drugs such as Yaz, Pradaxa, Zoloft, Prozac, Lexapro, Paxil, Celexa, Effexor, Wellbutrin, and defective medical devices including Mirena, Transvaginal Mesh, Depuy ASR Hips, and Nextgen Knees. The remainder of the practice is devoted to trucking accidents, auto accidents, motorcycle accidents, medical malpractice, and other serious personal injuries. The firm is headquartered in St. Louis, Missouri, but practices throughout the nation. We have successfully handled cases from coast to coast. The law firm prides itself on personally handling all cases it takes in, and has the expertise to, if necessary, try the case to a jury no matter how complex or lengthy. The firm has a successful track record in obtaining large jury verdicts for their injured clients as well as substantial settlements.
The firm has obtained multi-million dollar verdicts and settlements in personal injury cases, including a $105 million jury verdict involving the explosive separation of a multi-piece wheel against Firestone which was the largest verdict in Missouri that year, a $13 million verdict against a hotel where a boxing match was held for not having an ambulance on site, a $4.5 million jury verdict against Medical Engineering Corporation for a defective breast implant, a $2 million jury verdict in a medical malpractice case, a $2.1 million settlement involving a trucking accident, a $1.1 million verdict in a motorcycle accident case, a $1,050,000 verdict in a trucking accident case, a $1 million judgment in underinsured motorist case, and many others. The firm has also represented thousands of clients in pharmaceutical and medical device cases and recovered over a billion dollars. Some of the settlements and judgments involve Fen Phen, Baycol, Vioxx, Bextra, Avandia, Paxil, Smith & Nephew Macrotextured Knees, and Depuy ASR metal on metal hips. The firm is dedicated to providing excellent legal representation for people injured by defective products or in a variety of accidents. Carey, Danis & Lowe, Attorneys at Law 8235 Forsyth Blvd, Suite 1100 St. Louis, Missouri 63105
http://www.cdlinjurylaw.com
Practice Areas Trucking Accidents / 18-Wheeler Crashes Pharmaceutical Liability Motor Vehicle Accidents Personal Injury Medical Malpractice Defective Medical Devices