Manufacturers that sell dangerous medications can face government fines, as well as lawsuits from injured consumers. Experienced attorneys recognize that the only message these companies understand are ones that affect their pocketbook. The manufacturers of popular drugs all have had to pay the price for their dangerous actions at one time or another.]” Abilify is classified as a second- generation antipsychotic prescribed to treat bipolar disorder and schizophrenia. Unlike other drugs in its class, Abilify regulates both dopamine and serotonin levels. Doctors regularly pair it with other antidepressants. However, studies linked it to compulsive behaviors, like binge eating and compulsive gambling. Its manufacturer, Bristol-Myers Squibb, settled federal charges of illegal marketing for $515 million after it tried to market the drug for unapproved off label uses in children and elderly patients. Accutane, which is made from vitamin A, was approved for the treatment of severe acne in 1982. The Roche Holding product suppresses the amount of oil released by the skin. Accutane has triggered many lawsuits and multi-million dollar settlements because it has been associated with Irritable Bowel Syndrome (IBS), Crohn’s disease, gastrointestinal disorders, liver damage and severe birth defects. The company voluntarily pulled Accutane from the market …show more content…
in 2009, citing business concerns. One of the top monetary judgments to date was for more than $25 million. Actos is a Type 2 diabetes drug that is credited with decreasing insulin resistance and the amount of glucose made in the liver in order to allow the body to dispose of excess blood sugar with greater ease. However, studies linked it to several severe side effects like increased risk of bladder cancer, congestive heart failure, chronic kidney disease and lactic acidosis. The drug’s manufacturer Takeda Pharmaceuticals settled lawsuits claiming the drug caused bladder cancer for $2.37 billion. Avandia, a diabetes drug manufactured by GlaxoSmithKline, has been linked to as many as 100,000 heart attacks since it received FDA approval in 1999. Despite clinical trials that showed increased heart risks related to the drug, however the FDA did not add a black-box warning to Avandia until 2007. Sales of the drug have since been severely restricted. GlaxoSmithKline paid out at least $750 million to settle more than 50,000 Avandia lawsuits and has set aside more than $6 billion for all litigation and settlements related to the drug. In July 2012, GlaxoSmithKline agreed to pay $3 billion to settle charges brought by the U.S. Department of Justice. The government charged the drug manufacturer with failing to report clinical data on Avandia, to which GlaxoSmithKline pleaded guilty. In addition, the company was charged with improper marketing of Paxil and Wellbutrin. Azmacort, Nasacort and Nasacort AQ are all steroid-based anti-inflammatory nasal sprays used to treat nasal congestion during the onset of a sinus infection, the common cold or hay fever. Their manufacturer, Aventis Pharmaceutical, which is a subsidiary of Sanofi-Aventis, agreed to $95.5 million in fines after the company was found to have misreported the drugs’ best prices, thereby avoiding paying millions of dollars in rebates to Medicaid between 1995 and 2000. Benicar is used to treat high blood pressure by helping keep blood vessels dilated (open). However, the FDA eventually issued black box warnings warning of severe gastrointestinal side effects and fetal toxicity when taken by women who are pregnant. The drug’s manufacturer Daiichi Sankyo settled a case against the U.S. Department of Justice claiming it violated the False Claims Act for $39 million. Bextra is a selective COX-2 inhibitor, which is a type of non-steroidal anti-inflammatory drug (NSAID) used to treat chronic pain, such as arthritis or a back injury. Bextra is manufactured by Pharmacia & Upjohn Co., a subsidiary of Pfizer Inc. Pfizer faced a $2.3 billion fine in 2009 for promoting off-label use of Bextra and three other drugs — Geodon, Zyvox and Lyrica — through marketing materials, talking points for drug representatives and ghostwritten articles. Pfizer also was accused of providing kickbacks to physicians who prescribed the four medicines. At the time of manufacturer Allergan’s $600 million fines and penalties in 2010, Botox was only approved for temporary removal of facial wrinkles. Botox is a toxin produced by the bacterium Clostridium botulinum and is delivered to the body via injection. Allergan was found guilty of promoting off-label use of Botox for headaches, pain management and cerebral palsy. Since then, Botox has been approved for treating migraines, stress urinary incontinence (SUI) in people with neurologic conditions, muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid and misaligned eyes. Celexa, Lexapro and Levothroid, all manufactured by Forest Laboratories, treat different conditions but were linked together in a $313 million penalty the manufacturer was forced to pay the U.S. government in 2010. Celexa is an antidepressant approved only for use in adults, but Forest promoted it as a safe drug for children and adolescents suffering from depression. The company distributed Levothroid when it was not yet approved by the U.S. Food and Drug Administration (FDA), and all three drugs were linked to false claims submitted to federal health care programs. Depakote is an anti-seizure drug that the FDA also approved to treat bipolar disorder and to prevent migraines. It works by increasing the amount of a special neurotransmitter in the brain, but studies linked its use to suicide, liver toxicity, pancreatitis and birth defects. Its manufacturer Abbott settled a case for $3 million in Arkansas for illegally promoting it to treat schizophrenia and autism, and it settled a $1.5 billion case for illegally promoting it to elderly dementia patients. Fosamax is used to prevent osteoporosis and bone fractures mostly in postmenopausal women by slowing bone loss while increasing bone mass. Lawsuits have arisen because the Merck & Co. drug has been linked to serious side effects, including esophageal cancer, disfigurement of the jaw and femur fractures. In 2012, Merck was fighting about 1,000 federal lawsuits over osteonecrosis of the jaw (ONJ) that had been consolidated into a multidistrict litigation (MDL) and about 200 additional cases in state courts. Early reports in 2013 indicated the company would settle 1,140 lawsuits for $27.7 million, but the company never officially released the amount of the settlement when it became official in 2014. In July 2012, GlaxoSmithKline paid the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company at $3 billion. The drug manufacturer pleaded guilty to federal charges of misbranding two antidepressants, Paxil and Wellbutrin, and failing to report safety information about Avandia, which is used to treat type 2 diabetes, to the FDA. GlaxoSmithKline previously was in hot water over promoting off-label uses of its nine best-selling drugs in Colorado and had to pay the state $400 million in 2009. Pradaxa is a blood-thinner that helps prevent strokes and blood clots. However, it does not have an antidote and thousands of people claimed it caused uncontrollable bleeding and hemorrhaging sometimes resulting in death. Its manufacturer Boehringer Ingelheim settled thousands of cases for $650 million. Risperdal is an antipsychotic used to treat schizophrenia and bipolar disorder in adults and adolescents and autism spectrum disorders in children and adolescents. However, its manufacturer was accused of hiding some of its dangerous side effects like diabetes, substantial weight gain, stroke and gynecomastia – or breast development in boys. Its manufacturer Johnson & Johnson settled claims in Kentucky, Texas and Montana for a total of more than $340 million and settled multiple cases in Pennsylvania for undisclosed amounts. Seroquel is a second-generation anti-psychotic drug used to treat schizophrenia and bipolar disorder. Manufacturer AstraZeneca was accused of promoting the drug for unapproved uses, such as the treatment of insomnia and Alzheimer’s disease. In 2010, the company paid a $520 million fine for marketing Seroquel off label. By 2011, AstraZeneca paid $647 million to resolve global lawsuits claiming Seroquel causes diabetes. Topamax has been approved by the FDA to treat epilepsy in adults and children and migraines in adults. The manufacturer, two subsidiaries of health care giant Johnson & Johnson, were found guilty of marketing the drug for unapproved treatments, such as weight loss and bipolar disorder. The Department of Justice fined Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals more than $81 million in 2010 for this dangerous practice. TriCor is Abbott Laboratories’ high-selling cholesterol drug that the company was accused of protecting against generic versions by continually revising its formula, and thus creating an illegal monopoly. Abbott and its partner, Fournier Industrie et Sante, were ordered to pay $22.5 million to 23 states in 2010 to settle claims from pharmacies, wholesalers and generics makers. Trileptal is an anti-convulsant and mood-stabilizer that is used to treat epilepsy and bipolar disorders. The drug was designed to subdue partial seizures, or ones that begin in a limited part of the brain. However, manufacturer Novartis marketed Trileptal and five other drugs — Diovan, Exforge, Sandostatin, Tekturna and Zelnorm — for treatments not approved by the FDA, including relieving psychiatric symptoms and pain. The false promotions led to false claims in federal health care plans. Novartis also was accused of paying kickbacks to physicians who prescribed the six drugs. Novartis plead guilty to a misdemeanor and paid $185 million in 2010. Vioxx was a popular selective COX-2 inhibitor with anti-inflammatory properties used to treat chronic pain. Vioxx, however, was found to increase the risk of heart attack and stroke in certain patients who took the drug for more than 18 months, so manufacturer Merck & Co. voluntarily recalled it in 2004. Within a year, claims were filed, and eventually 50,000 cases joined an MDL based in New Orleans. The company agreed to settle the cases without admitting fault, setting aside $4.85 billion. Vytorin, which combines brand-name pills Zocor and Zetia, is a popular cholesterol drug from manufacturers Merck and Schering-Plough. In 2009, the ENHANCE study found that Vytorin was no more effective than the older, less expensive cholesterol drugs. Merck and Schering-Plough were accused of delaying the publication of study results for their financial gain and ended up paying $5.4 million in state fines without admitting they were at fault. Bayer Pharmaceuticals is facing more than 12,000 lawsuits over two birth control pills, Yaz and Yasmin. Thousands of women have been injured and dozens have died from blood clots, strokes or other serious side effects associated with these contraceptives. The FDA added a black-box warning to the product labels in 2008, just two years after the pills hit the market. Federal cases against Bayer have been transferred to the U.S. District Court for the Southern District of Illinois. Bayer has paid more than $1.6 billion to settle more than 7,600 Yaz and Yasmin claims so far. Zofran is an anti-emetic which treats nausea and vomiting. It was not approved for women who are pregnant, but women who took it for morning sickness claim it led to birth defects. Its manufacturer GlaxoSmithKline settled a case against the U.S. Department of Justice which claimed the company promoted it to pregnant women for $3 billion. Zonegran is an epilepsy drug also used to treat partial seizures in people older than 16. It is designed to be used in combination with other epilepsy medicines. In 2010, manufacturer Elan Corporation received a $203.5 million fine from the federal government for its marketing of Zonegran for a variety of unapproved uses, such as psychiatric disorders, movement disorders, obesity or weight loss, pain management and headaches. These off-label uses then triggered false health care claims. Zyprexa, which was approved by the FDA in 1996, is an anti-psychotic drug used to treat schizophrenia and bipolar disorder and is manufactured by Eli Lilly & Co. It has been the subject of multiple lawsuits and large settlements because of the ways in which it was marketed. Eli Lilly was accused of downplaying the side effects of its top-selling drug while promoting it for unapproved uses, such as the treatment of dementia. As such, the company agreed to plead guilty to the misdemeanor of violating the Food, Drug and Cosmetic Act in 2009 and paid $615 million in criminal fines. Eli Lilly also paid $800 million to settle related civil lawsuits on both the state and federal levels. Pharmaceutical companies have also settled cases accusing them of illegally inflating drug prices in order to increase their profits.
In the most recent case, McKesson Corp., without admitting fault, chose to settle claims that it inflated drug prices by as much as 25 percent, which triggered overpayments by Medicaid. The $151 million settlement, announced July 27, 2012, is divided among 29 states. Federal and state investigations uncovered the price increase in more than 1,400 brand-name medications, including Adderall, Allegra, Ambien, Celexa, Lipitor, Neurontin, Prevacid, Prozac and Ritalin, according to the Chicago
Tribune. In 2010, Abbott Laboratories, B. Braun Medical and Roxane Laboratories agreed to pay $421 million to resolve claims they had reported false and inflated prices for their drugs, again without admitting fault. The grossly inflated average wholesale price (AWP) affected federal health care reimbursements—causing Medicare and Medicaid programs to spend more per patient than was necessary, thereby reducing the amount of funding available for all patients in need. In 2007, Bristol-Myers Squibb and a subsidiary paid $515 million to settle allegations of illegal pricing and marketing of Serzone and other various oncology and generic drugs from 1994 through 2005. As an incentive to correct health care fraud, company whistleblowers are rewarded with a portion of the settlement. The strategy seems to be effective—according to The New York Times, such internal reports account for two-thirds of the payouts in the last 10 years.
In Melody Peterson’s “Our Daily Meds” , the history of marketing and advertising in the pharmaceutical industry is explored. The first chapter of the book, entitled “Creating disease”, focuses on how major pharmaceutical companies successfully create new ailments that members of the public believe exist. According to Peterson, the success that these drug manufacturers have experienced can be attributed to the malleability of disease, the use of influencial people to promote new drugs, the marketing behind pills, and the use of media outlets.
Med-Pharmex Incorporated is known nationally and abroad as a pharmaceutical manufacturer of animal-related products. Before gaining fame worldwide, the business began its journey to success as a small lab in 1983, which slowly grew over time. Since then, the company maintains its main goal, and that is to produce drugs that promote the health of companion animals, such as dogs, cats, and horses, as well as food-producing animals, such as pork and chickens. To ensure legal responsibility, the company’s manufacturing process is examined by the United States Food and Drug Administration (FDA). Med-Pharmex works closely with veterinary clinics who purchase their life-saving drugs and represent them in the market. Despite manufacturing drugs, the
In some instances, the pharmaceutical industry in the United States misleads both the public and medical professionals by participating in acts of both deceptive marketing practices and bribery, and therefore does not act within the best interests of the consumers. In America today, many people are in need of medical help. In fact,the Federal Trade Commission estimates that 75% of the population complain of physical problems (Federal Trade Commission 9). They complain, for example, of fatigue, colds, headaches, and countless other "ailments." When these symptoms strike, 65% purchase over-the-counter, or OTC, drugs.
Tired and overworked students will try anything to get that extra edge to stay up all night and study. Students, specifically college students, find solace in a little pill called Adderall. Adderall is a drug used for treatment and control of neurological disorders that affect adults and kids, specifically those with attention deficit hyperactive disorder (ADHD) and narcolepsy. Formerly known as Obetrol, it was first approved on February 21st, 1996 by the FDA and was in the warehouses by March 11th, 1996. However, Adderall was used as a substitute to caffeine, speed, or to even reach a natural high by students at high pressure college and prep schools before it was a drug known to aid people with ADHD (Kent 2013).
Yu, Winnie and Joel Hay. 1999. “Drug Patents and Prices: Can we Achieve Better Outcomes?” Measuring the Prices of Medical Treatments. Pages 27-28.
Why are the prices so high? Some critics of the drug companies argue that the larger firms are ripping off the American public, are dishonest and, in some cases, unsafe. On the other hand, there are health care workers such as doctors and their supporters who claim that research and testing for drugs costs money. This supposedly justifies their prices for their products. Also, as an argument to their side, they say that their practice is a benefit to the improvement to mankind. It is a life saving business, but are these prices justified? As one can see, this is a very important issue in medicine today. It affects everyone involved with medicine, which is much of the American public. It also affects the physicians and drug makers.
What would you give to rid yourself of acne? What would you do? The bane of every adolescent’s existence, these red spots develop to some degree in 85% of the population between ages 12 and 25 (Lamberg). Teenagers wake up every morning, look at the mirror, and sigh at the acne on their faces and often other places on their bodies. They dread these awful things that are absolutely ugly. They get desperate and eventually, if the acne grows worse than ever before, they resort to Accutane. Accutane, also known as isotretinoin, is a medication for acne. However, despite isotretinoin’s helpfulness in controlling acne that is unresponsive to other treatments, this medication should not be used because of its harmful physical side effects, its association with psychiatric adverse effects, and its effects on reproduction.
The lack of accountability for those responsible for the opioid crisis continues to be a point of contention and frustration for many affected by this devastating epidemic. The Sackler family's involvement in the opioid crisis warrants severe punishment akin to drug dealers. For instance, court documents reveal that Purdue Pharma, owned by the Sacklers, aggressively marketed OxyContin while downplaying its addictive nature (FILLER 1). Furthermore, Purdue's sales representatives targeted vulnerable populations, contributing to the widespread addiction epidemic (Ryan et al). The Sacklers knowingly profited from the suffering of countless individuals and communities devastated by opioid addiction, similar to the actions of drug cartels.
Martinez, Barbara “Firms Paid to Trim Drug Costs Also Toil for Drug Makers” The Wall Street
Accutane is a prescription medication used for treating severe acne. Being a teenager is hard enough without having to deal with the embarrassing issues that come with acne. Many people can suffer from acne. It affects teenagers and sometimes adults as well. Some cases are very severe and can even result in scarring. The scarring is usually a permanent disfigurement that can follow a teenager into adulthood. In most cases peoples’ acne is not very bad. People with mild acne cases usually seek treatment from over the counter topical crèmes or gels. Some people resort to using a low grade prescription antibiotic to keep their acne under control. For most, this is a simple resolution. However, for people with more severe outbreaks, there is a solution. This solution that is available has many advantages and disadvantages.
In recent years’ health reform has been a driving force in the United States political system. If you watch the news, you will understand how citizens, the government, or the economy are or might be affected by some sort of change in medical regulation. One of these hot topic issues is the cost of prescription drugs. Every major drug market besides the United States regulates the price of drugs in some way (Abbott and Vernon). By the United States not doing so, many believe it opens consumers up to being exploited by large pharmaceutical companies.
When Accutane became available to consumers in 1982 as a treatment for recalcitrant nodular acne, it was regarded as a wonder drug. Researchers began investigating the risks of the medication only after news of adverse effects were reported to the Food and Drug Administration (FDA). Although Accutane has the ability to resolve persistent acne, the known side effects are of great importance to the consumer. Several studies have been conducted to elucidate the adverse effects of Accutane, as well as studies to show the medication’s efficacy and success rates. Accutane has high success rates in the cure of acne, with low recurrence rates. However, there are several adverse effects that every patient must be made aware of before they
With the increased cost of manufacturing, pharmaceutical companies have been divesting in their smaller or less profit making operations and focus on large segments. Many Pharmaceutical companies sold their manufacturing sites to contract manufacturing organizations. The dynamics of interfacing with contract manufacturing organization added intricacy in pharmaceutical supply chain network of pharmaceutical companies.
Pfizer Case Study Pfizer Inc. is a large pharmaceutical company that engages in the discovery of new technologies, the manufacture of prescription and "over the counter" (OTC) medicines, as well as the marketing of such products. It operates in three distinct segments that include Human Health, Consumer Healthcare, and Animal Health. For fiscal year 2004, the company generated approximately $53 billion in revenue that contributed to over $11 billion in net income. Pfizer, 2004. "The 'Pfizer'" The Cow and Calf division of the Animal Health segment markets its products direct to cattle ranchers.
The case under analysis, Eli Lilly & Company, will be covering the positives and negatives with regards to the business situation and strategy of Eli Lilly. One of the major pharmaceutical and health care companies in its industry, Lilly focused its efforts on the areas of "drug research, development, and marketed to the following areas: neuroscience, endocrinology, oncology, cardiovascular disease, and women's health." Having made a strong comeback in the 1990's due to its remarkably successful antidepressant Prozac, was now facing a potential loss in profits with its patent soon to expire. The problem was not only the soon to expire patent on Prozac, but the fact that Prozac accounted for as much as 30% of total revenue was the reality Eli Lilly now faced. (Pearce & Robinson, 34-1)