Archive for November 2011

Yasmin Birth Control Lawsuit – A First in Canada

November 29, 2011

(November 29, 2011) 26-year-old Vicky Caprice Mersereau died in 2009 of a large pulmonary embolism following ingestion of Yasmin, a “low-dose” hormonal contraceptive which is manufactured by Bayer, Inc.


The relatives of Ms. Mersereau have launched the very first individual civil lawsuit against the drug manufacturer in Toronto, Canada.  The FDA’s reproductive health and drug safety committee will be looking at the safety of Yasmin and its unique progestin, drospirenone.


Last month the FDA warned that the oral contraceptives, which contain the hormone drospirenone and sold in Canada under the name Yasmin (or its sister pill, Yaz), increase the risk of blood clots by 74%, as compared with other pills on the market.


The following side effects have been linked to the use of Yasmin and Yaz:


–                Stroke

–                Deep vein thrombosis

–                Pulmonary embolism

–                Heart attack

–                Gall bladder disease


More than 10,400 individual lawsuits regarding Yasmin and Yaz have been filed in the U.S. to date.


According to the lawsuit, the claim alleges that Bayer failed to adequately warn patients and physicians of the increased risk of heart disease associated with the use of Yasmin and Yaz, compared to safer oral contraceptives.


Time and time again, it’s the same song and dance with these pharmaceutical companies. They try to take advantage of the “little guys” (us, the consumers) while their bank accounts pile up with money from sales. They must conduct the research to prove their products are safe before they can release these products to the public. My guess is that they know these drugs cause some type of harm, and they believe the benefits (which they claim are the positive effects of the drug, when in reality, it is just their wallets getting fatter) outweigh the “small” risks they might cause. Do you think this is justice?


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CDC Reports Four Drugs To Blame for Majority of E.R. Visits

November 27, 2011

(November 27, 2011) A study this week by researchers from the US Centers for Disease Control and Prevention revealed that there are four drugs (and drug classes) mainly responsible for emergency room visits in the U.S.  These include warfarin, oral antiplatelet medications, insulins, and oral hypoglycemic agents. The study also suggested that with better management of anti-thrombotic and anti-diabetic medications, thousands of emergency room admissions can be avoided.


The study published this Thursday, in the New England Journal of Medicine, alerts doctors and patients of a few warnings:  the first is adverse reactions to medication, and the second is unintentional overdoses.


Researchers say nearly 100,000 hospitalizations annually are linked to adverse drug incidents such as allergic reactions, as well as unintentional overdoses.  Nearly 48% of those hospitalized were adults 80 years old or more.


“These data findings suggest that focusing safety initiatives on a few medicines that commonly cause serious, measurable harms can improve care for many older Americans,” said lead study author Dr. Daniel Budnitz, director of CDC’s medication safety program. “Blood thinners and diabetes medicines often require blood testing and dosing changes, but these are critical medicines for older adults with certain medical conditions.”


“Of the thousands of medications available to older patients, a small group of blood thinners and diabetes medications caused a high proportion of emergency hospitalizations for adverse drug events among elderly Americans,” Budnitz added.


“The most significant finding of this study was the thousands of medicines available to older Americans, it’s really a small group that causes two-thirds of the hospitalizations,” he tells WebMD. The blood thinner warfarin, insulin, oral anti-platelets such as aspirin, and oral diabetes drugs led the list. “Both blood thinners and diabetes medicines are critical drugs that can be lifesaving,” Budnitz says. He also said that “these are medications that you do need to pay attention to,” making sure the dose and timing are correct, among other measures. High-risk medications, such as narcotics, only account for about 1% of the hospitalizations, as found by the researchers.


To sum it up, the medications most often responsible for emergency hospitalizations for adverse drug incidents in people ages 65 and older were: warfarin, insulins, oral antiplatelet agents, and oral hypoglycemic agents. Whether taken alone or in combination with other medications, these drugs accounted for 33%, 14%, 13% and 11% of the hospitalizations, respectively. Better management could help avoid thousands of emergency admissions for adverse drug events in older adults every year, according to the research. The researchers estimated that 265,802 visits to the E.R. for adverse drug incidents occurred from 2007 to 2009 in adults aged 65 and older. More than one third of these visits (or nearly 100,000) required hospitalization.


This is an important study, and will benefit tens of thousands of Americans, especially as Americans are living longer.  The rate of chronic conditions increases and people need to take more medications.  Since blood thinners and diabetes medications are critical medications for many older adults, careful monitoring and awareness will be crucial in managing the safety and well-being of our aging population.


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Beware of the Toxic Tushie Injector!

November 26, 2011

(November 26, 2011) Oneal Ron Morris, a transgendered, self-proclaimed doctor, charged a victim $700 for a series of injections that were promised to enhance the 30 year old victim’s rear end.  The procedure was performed in a residential home in the Miami Gardens neighborhood.  This should have been the first red flag.  No real surgeons perform any procedures on patients in a home.  The procedure was so agonizing for the victim that she requested he discontinue at once.  She went to two hospitals to seek help but never told them the cause of her pain.


A second suspect, Corey Eubanks, was arrested yesterday.  Police say Eubanks assisted Morris. Both suspects are charged with assisting a fake doctor accused of leaving patients with life-threatening injuries from a buttocks-enhancement procedure that involved injecting a toxic variety of household and automotive chemicals into their bodies.


Eubanks, 40, of Hollywood, was charged with 2 counts of unlicensed practice of a healthcare professional with serious injuries, and 2 counts of acting as a principal of the crime. Morris’ clients believed they were getting a backside enhancement. What they really got, according to police, were injections of cement, mineral oil, Fix-a-Flat (a tire repair material), and SuperGlue. This was established following initial lab analysis conducted by medical personnel. The injections left all victims quite ill, most ending up in the hospital. “Injection sites were bleeding and puss was excreting,” said the report quoted by NBC.


At the end of the second woman’s procedure, Morris covered injection sites with cotton ball dabbed in SuperGlue. When the victim called Morris twice after the procedure with health concerns, Morris first recommended soaking in Epsom salt and then suggested she “tell the hospital she had MRSA (a staph infection resistant to most antibiotics) and the MRSA treatment would resolve her symptoms,” the affidavit said. The woman who was told to do salt soaks underwent surgery twice at Memorial Hospital West in Pembroke Pines to remove cysts and a lymph node, according to police. She also received two blood transfusions and needed home healthcare for four months. Both victims eventually recovered.


As a result of the national and international media attention that Morris’ arrest has received, many other possible victims have come forward alleging Morris performed similar procedures on them also resulting in life-threatening injuries.



Police suspect that Morris is part of a network of scam artists who prey on people who want to change their appearance but can’t afford to pay for traditional cosmetic surgery.


In a time where the entire country is in a recession, it is apparent that people will go to lengthy measures to save a buck or two. But in the long run, other people are out to take advantage of anyone they can, and it proves detrimental. These “victims” were just looking for a boost to their self-image, but instead, they were left with reminders (both physically and emotionally) of their bad decisions. Is this justice?


one of the victims

Danger Lurks In Your Pantry

November 24, 2011

(November 24, 2011) Get up. Go into your pantry and look to see if you have any canned food items. Chances are, you do! A new study in the Journal of the American Medical Association has shown over a 1,000 percent increase in urinary BPA in humans who consumed canned soup everyday over a five-day period.  It isn’t just canned soup, but any canned food items, for that matter.


BPA, or bisphenol A, has been linked to reproductive problems, diabetes, heart disease, and obesity in humans, and has the potential to cause problems during development in fetuses and young children. BPA has most recently been found detrimental in plastic bottles, and it seems as though canned food items are hopping on board.  BPA is used in many products to prevent corrosion, but the risks of consuming products with BPA might outweigh the benefits.


The study shows that canned foods contain an even higher amount of BPA than the amounts in plastic bottles, and has prompted warnings for consumers of these canned soups. This study included 75 people, with an average age of 27. One group ate 12 ounces of canned soup everyday for lunch, and the other group ate 12 ounces of fresh soup. BPA was detected in 77 percent of the people who ate fresh soup, and all of the people who ate canned soup.


Canned Foods Contain BPA

It has been reported that these spiked BPA levels leave the body within hours after consumption, but more research is still being conducted.


Some manufacturers have already taken BPA out of their cans, but the rest of them should follow these footsteps.  BPA has already been banned in Europe and Canada, and while some baby products sold in the U.S. are BPA-free, it is still not regulated by the government.


While the FDA claims that the daily BPA exposure we receive does not appear to be toxic, they maintain that there is some concern about the potential effects it has on the brain, behavior, and prostate gland in fetuses, as well as infants and young children.


So before you reach for the can-opener for that “Mmm, Mmm, Good” Campbell’s, maybe you should make some soup from scratch.

Merck Will Pay $950 Million in Vioxx Settlement

November 23, 2011

(November 23, 2011) Merck pharmaceutical company will pay $950 million to settle criminal and civil charges relating to the unapproved promotion of the painkiller Vioxx, as per the U.S. Justice Department.


The Justice Department alleged that Merck promoted the drug for treatment of rheumatoid arthritis prior to approval by the FDA for this condition in 2002. Merck agreed to pay a $321 million criminal fine and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce, as stated by the Justice Department in a news release.


Merck also is paying $426 million to the federal government and $202 million to state Medicaid agencies. These payments will settle civil claims that its illegal marketing caused many doctors to prescribe Vioxx and bill the government where they otherwise would not have prescribed the painkiller. Physicians are free to prescribe drugs as they see fit, but pharmaceutical companies are prohibited from marketing any drug for uses except those approved by the FDA as being safe and effective. It is irresponsible of these pharmaceutical companies to ignore FDA rules and regulations that strive to keep the available medicines and treatments safe and effective. It is clear that the federal government no longer tolerates this behavior, and even though this is a multi-billion dollar industry, a $950 Million verdict is not pocket change by any means. Hopefully this will result in changes by these pharmaceutical companies.


In 2007, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claimed they or a loved one suffered cardiac injury or death following use of Vioxx. Investors are also suing Merck claiming it played down Vioxx risk and danger and cost them billions of dollars in stocks after Vioxx was removed from the market. As of yesterday, Merck shares declined, dropping .97% to $33.81.


It is about time that these pharmaceutical companies are held accountable for their negligence and greed. But how many large settlements will it take for every pharmaceutical company to fall in line?

Sanofi’s Multaq Causes Stroke or Even Death

November 17, 2011

(November 17, 2011) Paris-based Sanofi funded a study, which was published in the New England Journal of Medicine, showing there were 21 deaths from cardiovascular causes in the Multaq group compared with 10 deaths among those receiving placebo.


Sanofi’s Multaq was approved in 2009 to treat patients with intermittent racing of the heart.  However, studies have shown that in a trial of 3,236 patients, those given Multaq had a significant rise in stroke and heart failure rates. Doctor’s had hoped Multaq’s ability to reduce deaths, strokes, and hospitalizations in patients with occasional atrial fibrillation would also help those with more serious forms of the condition.  These study findings contradict those hopes.  Stuart Connolly, from the Population Health Research Institute in Hamilton, Ontario said, “We have had a healthy suspicion of anti-arrhythmic drugs for many years, but we had thought this drug didn’t have the same risks.”  “We are now getting the message that this drug has the potential to harm as well,” he said. “It seems this drug acts very differently depending on which type of patient receives it.”


The U.S. Food and Drug Administration are reviewing Multaq’s safety profile.


It was recently decided by France’s top medical authority, the Haute Autorite de Sante, that Multaq should be withdrawn from the list of drugs reimbursed by the state-run health system.  HAS said in July that Multaq, known chemically as dronedarone, was not sufficiently effective.  As of December 1, 2011 France will stop reimbursement of Multaq, Sanofi’s irregular heart beat drug, according to a notice published in the government’s official bulletin. A Sanofi sppkesman said the company disagrees with the decision, stating that France is the only country in Europe who has decided to stop reimbursement of Multaq.  Europe’s drug regulator restricted the use of Multaq in September stating that the drug should only be prescribed after all alternative treatments have been considered.


In July, EU and US regulators widened their review into whether or not Multaq causes cardiovascular disease.  This came after a probe into a possible link between Multaq and liver failure.  This more involved review was prompted by Sanofi’s decision to stop a late-study clinical trial of Multaq when it noticed a “significant” rise in cardiovascular side effects such as heart attacks and strokes.


Before these involved studies, analysts predicted Multaq’s potential annual sales to exceed $1 billion.


It would seem to me to stick with the rapid heart beats as opposed to taking a drug that causes heart attack, stroke or possibly even death. Feel free to comment on this blogpost.

Merck Settles Vioxx Claims for $4.85 Billion

November 15, 2011

(November 15, 2011)


Merck has agreed to pay $4.85 billion to settle claims that it misled state officials regarding the safety of its painkiller Vioxx.  Merck agreed to pay an undisclosed sum to Florida, New York and South Carolina to resolve suits alleging they failed to disclose the risks of Vioxx adequately before stopping sales in 2004. (Similar settlements have already been reached in lawsuits from Alaska, Kentucky, Mississippi, Montana, Oklahoma and Utah).


Merck recalled the popular painkiller, Vioxx, in September 2004, after a study showed it doubled the risk of heart attack and strokes in patients taking it for more than 18 months.  Former Vioxx users also criticized Merck for downplaying the drugs’ health risks and manipulating studies in order to help promote sales.  Despite the fact that Merck officials countered that Vioxx was not the cause of users’ heart attacks, strokes and other cardiovascular side effects, and that they had properly warned doctors and consumers about its risks, Merck paid $4.85 billion to resolve more than 27,000 lawsuits over their drug. Pretty costly mistake, if you ask me!


New York governor, Andrew Cuomo, who was the state’s attorney general in 2007, sued Merck, seeking tens of millions of dollars in restitution for money spent on Vioxx prescriptions through state health-care programs.  The following year, Bill McCollum, Florida’s attorney general at the time, followed with a similar suit, seeking $80 million in reimbursements.


The state officials claim that Merck’s misleading statements about Vioxx’s safety lead doctors to write thousands of prescriptions for the drug and state Medicare and Medicaid programs into paying for them.


Merck announced this month that it agreed to pay $49.5 million to settle suits filed on behalf of former and current employees of Merck over losses to their retirement funds tied to the company’s handling of Vioxx. Merck said in filings with the U.S. Securities and Exchange Commission that it paid the money to resolve allegations of executives violating legal duties by making false and
misleading statements about Vioxx. Yet if these were just allegations about false statements, do you really think they’d agree to cough up nearly $5 billion?!


Merck said it would still defend all claims not included in the settlement. Since the withdrawal of Vioxx, Merck has won 11 court cases over the drug and lost five.


Conover, an analyst at Morningstar, estimates Merck could be facing 1,000 to 2,000 outstanding claims and could face more than $1 billion in additional costs.  It has been noted that litigation over Wyeth’s Phen-Fen diet drug is now only slowly coming to a close after ten years in the courts and more than $21 billion in settlement costs.


So many plaintiffs will want to address Merck on an individual basis in hopes of seeking higher compensation.  Even with
the major litigation drag, their stock has outperformed their peers on the American Stock Exchange pharmaceutical index this year, rising 25%.


Even though Merck has agreed to pay such a large settlement in this major legal battle, this is only a third of its market value in 2004!  These pharmaceutical companies care about one thing and one thing only: their profit.  So many men and women lost their lives and many of the “lucky” ones were left with chronic, debilitating cardiac ailments.  Maybe the large settlements will set an example for other pharmaceutical companies and they will be more conscientious about safety and not just their pocketbooks. But then again, if companies like Merck are willing to pay millions (or, in this case, billions) of dollars to “resolve false allegations”, then what lesson does this really teach them? It seems as though billions in court fees and settlements are merely pocket change to the “bad guys.” Is this justice?


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