Actos is among a class of drugs known as thiazolidinediones, used in the treatment of Type 2 diabetes. Both Actos and Avandia were approved in 1999, and although Avandia has suffered under claims that it caused serious side effects such as edema, fractures and heart failures, Actos escaped accusations of harm until very recently. While Actos was on the FDA’s 2002 list of products which were required to report incidences of heart failure on the label, its sales continued to skyrocket, netting Takeda Pharmaceuticals over three billion dollars in 2010 alone.
A 2010 study even gave Actos a boost as it seemed to lend credence to the fact that Actos was a much safer alternative to Avandia. Other studies disagreed, showing that Actos, especially when taken for longer than a year or in higher dosages came with a significantly increased risk of bladder cancer—as much as 40%. Since Takeda’s Actos patent is set to expire in August of 2012, it is believed the company will experience a sharp drop in sales, not to mention a significant number of lawsuits among those who believe Takeda knew of the increased risk of bladder cancer yet failed to warn those taking the drug.
The cases of bladder cancer in those taking Actos continue to pour in. Just this June medical regulators in Germany and France suspended sales of Actos due to its potential risk of causing bladder cancer. This study found a 22 percent higher risk of serious bladder cancer in those taking Actos as compared to those who were not taking the drug. The bladder cancer risk appeared to be the highest in those who had received a cumulative dosage of 28,000 mg or more throughout the period of study. Yet another study which looked at the Adverse Event reports to the FDA between the years 2004 and 2009 suggested that those who took Actos faced a “disproportionate” risk of developing bladder cancer. In fact, from a half a million side effect reports, a full fifth of those involved bladder cancer among those taking Actos.
When the artery which supplies blood to the heart muscle becomes blocked, your heart can no longer receive the oxygen-filled blood it needs. When the heart is unable to receive that oxygen-rich blood, the heart muscles are damaged which can lead to death or other health problems such as congestive heart failure. Some of the studies done on Actos show it definitely has the capacity to cause congestive heart failure or other cardiovascular diseases as well as to create a significantly increased risk of bladder cancer, particularly in those taking the drug for longer periods of time.
Many of those who are suffering from congestive heart failure do not suspect they are experiencing problems with their heart. The earliest symptoms can be shortness of breath, a chronic cough, or feelings of being unable to get a deep breath. If you have a history of asthma, COPD or emphysema, the person may believe they are simply experiencing a worsening of the underlying condition. Those who have no history of breathing difficulties may believe they have the flu or a case of bronchitis. Those who are suffering from congestive heart failure may be unable to tolerate even the mildest physical exertion and may feel chronically fatigued. Should congestive heart failure worsen, fluid can accumulate in the lungs, interfering with the ability of oxygen to get into the blood. Fluid retention and swelling of the extremities may be noted, particularly in the evening or after sitting or standing for a prolonged period of time.
Actos is not recommended for use by anyone who has a history of cardiovascular problems or edema, and can cause significant fluid retention in diabetes patients, especially when used in conjunction with insulin. Any person who has had symptoms of heart failure, including a rapid weight gain, fluid buildup or shortness of breath should talk with their physician before taking Actos. If Actos has been a part of your diabetes treatment and you have developed congestive heart failure, time is definitely of the essence. Of course you should first take care of your health, then you should seek out a qualified attorney who is cognizant of the risks and facts surrounding the use of Actos.
The manufacturers of Avandia, Glaxo-Smith Kline, have already set aside over 400 million dollars for settlements due to harm caused patients who used the drug and that figure will likely increase as the suits continue to be filed. Actos, a product of a Japanese corporation, Takeda Pharmaceuticals, was believed to be the safer alternative to Avandia. In 2008, Actos was the tenth best-selling drug in the United States with sales of over 2.4 billion dollars, and by 2010 that figure was well over 3 billion dollars. Unfortunately, the summer of 2011 brought results from several research studies done on Actos which show that it is possibly as damaging as Avandia, though perhaps in different ways.
Actos was released in 1999 as a drug which increased the body’s sensitivity to insulin, rapidly rising in popularity over the past twelve years. It is estimated that the sales of Actos alone garnered Takeda as much as $4.3 billion in 2010, making it one of the ten best-selling drugs in the United States. Prior to the release of Actos, studies were done on animals which showed a direct correlation between Actos and the formation of tumors. Disregarding these results, Takeda forged ahead with the release of Actos. Takeda took the initiative to conduct a decade-long study regarding the safety of Actos, and the mid-point results showed that while overall there appeared to be no increase in the risks for bladder cancer, for those taking the drug for longer periods of time than twelve months or in high dosages, the risks could increase by as much as 40%.
As a result of the identification of the risks of bladder cancer, French drug regulators recalled Actos while Germany mandated that Actos not be prescribed to new patients. New Zealand is in the process of a recall, however the FDA has taken a more relaxed “wait and see” attitude, stating they will not recall the drug until the results of further studies are in. Recent months have seen dozens of individuals all across the United States filing lawsuits regarding the bladder cancer risk associated with the use of Actos. Results of one study states that 22, 512 patients who have taken Actos have reported side effects and that .22% of those subsequently developed bladder cancer.
Although Actos has not yet been recalled in the United States, it is not necessary that it be recalled in order for those damaged by the drug to file a lawsuit for injuries suffered. Legal action is the most expedient way to recover compensation, not only for your medical expenses, but for your pain and suffering as well. When your doctor prescribes a drug for a medical condition, you should not have to wonder if it has been properly studied prior to being released to the public. It is believed that Takeda Pharmaceuticals was well aware of the potential ill-effects of the drug prior to its release, as animal studies resulted in tumors developing in the rats treated with Actos.
The first wave of what many believe to be the tip of the iceberg in Actos lawsuits was filed in August, 2011. A fifty-four year old woman who took Actos for over a decade was diagnosed with bladder cancer in 2009. Nancy Rios may end up having her bladder removed and undergoing chemotherapy and perhaps radiation as well.
In Los Angeles two cases were filed against the manufacturers of Actos, both alleging that they not only developed serious bladder cancer as a side effect of taking the drug but also that Takeda knew the risks involved and did not warn them of those risks. Both residents of Los Angeles County, Roger Pike and Stanley Cook took Actos for several years. Their complaints include the fact that due in part to scientific studies done on animals Takeda was well aware of the increased risk of bladder cancer among humans taking the drug.
The complaints accuse Takeda of neglecting to conduct complete and proper testing of side effects before releasing it, and assert that several years following the approval of Actos clinical evidence surfaced which showed a definitive link between bladder cancer and Actos use and this evidence was willfully concealed from patients and doctors who prescribed Actos. Both Cook and Pike are seeking general, special, exemplary and punitive damages as well as compensation for injuries, pain, suffering, mental anguish and diminished enjoyment of life. Pike also seeks compensatory amounts for his wife claiming she was bereft of love, comfort, attention and loss of services and support from her husband.
Plaintiff Betty Thomas is filing suit on behalf of her mother, Maude Kinard, also in Los Angeles County, alleging her mother developed bladder cancer as a direct result of taking Actos as a treatment of her Type 2 diabetes. The bladder cancer eventually led to Maude Kinard’s death, therefore Thomas is alleging that Actos is not only designed defectively but also that manufacturer Takeda Pharmaceuticals was negligent in its marketing and sales of Actos, knowing full well of the increased risks of bladder cancer among those taking the drug. This particular lawsuit accuses Takeda of underplaying the seriousness of the health risks and offering only vague or inadequate warnings. Maude Kinard took Actos for six years, developing bladder cancer in 2006 which precipitated her death in 2008.
Paul McMahan of Minnesota claims Actos caused his bladder cancer and further states that both Takeda and Eli Lilly and Company were well-aware of the risks of bladder cancer from the time the drug was approved in 1999. In spite of the fact that Actos was shown to cause tumors in male rats that were given the drug, it was approved, and marketed with no warnings regarding bladder cancer risk. It was not until September of 2010 that the FDA finally issued a safety warning regarding the connection between Actos and bladder cancer.
A class action lawsuit aggregates many individual lawsuits into one lawsuit where the claimants have an injury in common, with a single representative member of the class representing the whole. Class actions offer the advantages of greater efficiency in trying the case and can lower litigation costs, although in some cases class action settlements can result in lower recoveries for individual class members and higher attorney fees.
Actos lawsuits are currently being represented on an individual basis by law firms. No Actos class action lawsuits have yet been filed. The injuries suffered by each Actos patient from bladder cancer and other complications will be different for each patient, so that it is not likely that a large number of claims will be similar enough to be successfully aggregated into a single class representative.
Later this year the United States Judicial Panel on Multidistrict Litigation is expected to decide whether the Actos litigation, which currently includes more than 50 individual lawsuits, should be centralized before one judge. If the cases were to be consolidated they would be handled similarly to a class action suit during pretrial litigation and discovery, however if no resolution were reached, each bladder cancer lawsuit would be handled individually during trial. Actos was taken by millions of people over the past twelve years, resulting in a potential class action suit which could include hundreds—or even millions—of injured plaintiffs.
Hundreds of patients who took Actos and were diagnosed with bladder cancer are expected to contact a highly experienced law firm regarding Actos exposure within the next year. Sullo & Sullo, LLP understands the trauma of developing a disease after taking a drug they believed to be safe. While the laws regarding defective drugs are quite complex, our legal team is up to the challenge and would like the opportunity to evaluate your specific case in order to determine whether or not you have a solid case against the manufacturers of Actos. Treating bladder cancer, if it is treatable, can result in huge medical expenses, time lost from work and even a diminished quality of life. If you took Actos for longer than twelve months and have been diagnosed with bladder cancer, you may be eligible to file an Actos lawsuit, so call our firm today for a consultation.
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