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Takeda Announced Settlement of $2.4 Billion
April 28, 2015 - Takeda Pharmaceutical agreed to pay $2.4 billion to settle thousands of Actos bladder cancer lawsuits.
Actos (pioglitazone) is an oral diabetes medication in the class of drugs known as the thiazolidinediones (TZD). Diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Takeda’s Type 2 Diabetes drug, Actos (pioglitazone), grew in popularity after use of Avandia, GlaxoSmith Kline’s controversial drug, was severely restricted in the United States because of concerns of an increased risk of heart attack and heart failure. By late 2011, Avandia was no longer available through retail pharmacies. And then came Actos.
Waiting one day after Avandia received restrictions from the FDA, Takeda began a new advertising campaign for its diabetes product Actos. Boasting taglines such as “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke,” diabetes sufferers quickly shifted from Avandia to Actos. However, like Avandia before it, the safety issues surrounding Actos have come to the attention of the FDA and have left the public questioning whether there is a diabetes drug worth the risk.
On June 15, 2011, the FDA issued a Drug Safety Warning with regards to an increased bladder cancer risk associated with the use of the diabetes drug, Actos. This warning came after a review of data from a five-year interim analysis of an ongoing study of Actos by Takeda.
In the same year, Takeda was named in more than 10,000 Actos-related lawsuits.
The results showed that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer amongst those who had used the drug the longest. Independent researchers discovered that Actos users have a 40% higher chance of developing cancer after they have taken the drug for longer than a year. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
Prior to the FDA warning – several European Markets, France and Germany, suspended the use of Actos, citing concerns over an increased risk of patients developing bladder cancer.
Studies continued to point toward Actos bladder cancer risks. On July 5, 2013, an international independent study was published finding Actos to be “probably carcinogenic.”
On June 2013, 23 experts from nine countries met at the International Agency for Research on Cancer (IARC) to assess the carcinogenicity of fourteen drugs and herbal products. After a detailed review of one large randomized controlled study, four cohort studies, and three case-controlled studies, the Agency determined that pioglitazone (the active ingredient in Actos) should be classified as “probably carcinogenic” to humans based on the evidence that it causes bladder cancer.
Takeda had profited from sales of Actos in the U.S. of over $3 billion in 2009 and just under $3 billion in 2010.
Possible side effects associated with Actos include:
A 2008 Swiss medical study was the first to uncover a link between Actos and bone fracture, finding that the drug could cause a double or triple risk of bone fracture in patients.
In 2010, Actos was linked to 243 cases of heart failure and 121 heart attacks.
What are diabetics supposed to do? Is there a drug to help with the suffering that doesn’t set them up for new injuries? What drugs can they safely turn towards to alleviate their struggles? Sadly, it appears there is no clear answer at this time. Given the history of diabetes drugs, diabetics have to seriously question and monitor the release of new diabetes medications, especially when the FDA is already requesting additional research.
Today’s diabetic must be informed. If you are a diabetic, your focus should remain on your health. It is always advisable to discuss any risks and concerns with your physician.
The Actos bladder cancer lawsuit is largely inactive. As of January 2018, only 18 cases remained in the federal court in Louisana. TorHoerman Law is no longer accepting Actos cases. If you have any questions, contact us.
TorHoerman Law, one of the lead negotiators in $2.4 billion settlement deal with Takeda, released a press release announcing the completion of a historic Actos bladder cancer lawsuit settlement. Read the Press Release Here.
February 11, 2014 - In preparation of the first Actos trial in Chicago, Judge Deborah Dooling heard oral arguments from both parties on Takeda Pharmaceutical's Motion for Partial Summary Judgment based upon federal preemption. Ken Brennan of TorHoerman Law argued for the Plaintiffs and cited numerous cases and regulations for the conclusion that federal law did not prevent Plaintiff’s Failure to Warn claims under Illinois Law. After hearing the arguments, Judge Dooling went through a very lengthy analysis of Defendants motion and the arguments made by both sides before ruling that Defendants Motion was denied.
February 3, 2014 - The first Actos multidistrict litigation case began in the US District Court, Western District of Louisiana with opening statements in the case of Terrence Allen, a man who was diagnosed with bladder cancer in January 2011 after taking Actos pursuant to a prescription starting in June 2006.
Mr. Allen's lawsuit claims that despite bladder cancer findings in animal model studies and other pre-clinical evidence, Takeda failed to adequately conduct complete and proper testing prior to filing for and obtaining FDA approval for Actos. Furthermore, according to Mr. Allen's complaint, Takeda concealed and failed to completely disclose its knowledge that Actos was associated with or could cause bladder cancer or its knowledge that it had failed to fully study and test regarding that risk.
Mr. Allen’s attorneys argued that as a result of Takeda's actions, Mr. Allen was unknowingly put at risk for, and ultimately diagnosed with, bladder cancer.
January 14, 2014 - Judge Doherty denied a Motion for Partial Summary Judgment filed by Takeda Pharmaceuticals. In ruling for the plaintiffs, Judge Doherty found that the plaintiffs did, in fact, satisfy their burden to show that the facts and circumstances of this case warrant the Actos cases to move forward towards a day in court.
In the Motion for Summary Judgment, defendants argued that since the FDA approval of Actos in 1999, there had been many discussions between the FDA and Takeda concerning the warning that was placed on the Actos label. While this may be an accurate statement, the court denied the motion for summary judgment and noted that despite multiple conversations, it is still the duty of the drug’s manufacturer to appropriately warn the public about the potential dangers of the drug. Since Takeda could have submitted stronger warning language to the FDA with regards to the risk of bladder cancer when they became aware of these risks but failed to do so, preemption does not apply. Furthermore, since plaintiffs have presented evidence of a link between Actos and bladder cancer, the cases consolidated in the MDL will now be able to move forward to the next step in the litigation.
December 16, 2013 - A jury found in favor of Takeda in the third Actos trial heard in Las Vegas Nevada. In the prior two trials, Takeda was found guilty of a negligent failure to warn.
After hearing about this verdict, Tor Hoerman, a co-lead counsel in the Cook County Actos litigation said:
My sympathy goes out to Mr. Alsabagh and his family. In any litigation like this, there will be some losses under certain factual scenarios. This loss does not change the fact that Actos increases the risk of bladder cancer. This unfortunate verdict does not dissuade us in the least in our effort to achieve justice for the thousands that have been afflicted by bladder cancer as a result of this drug.
In addition to the courts, a number of governmental and independent agencies have looked at the safety of Actos and are beginning to speak up.
September 25, 2013 - In the second Actos case to go to trial, attorneys representing the family of a former U.S. Army translator who died of bladder cancer after taking Actos, argued that Takeda put sales over safety when they failed to warn consumers about the risk of bladder cancer associated with Actos.
Specifically, attorneys representing the family of Diep An stated that Takeda executives "knew the value of the drug and they knew the risks" it posed, and consciously chose not to warn the Plaintiff or his doctors so that Takeda could continue its efforts to "sell, sell, sell" Actos. (An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland)
During this Actos case, attorneys further argued that Takeda valued Actos so highly that the company completely disregarded concerns about bladder cancer and continued to put their product on the market for several years. In fact, according to Mr. An's attorneys, Takeda officials knew by 2005 at the latest that studies had shown a link between Actos and cancer. However, because of the wide success of Actos, the company deliberately chose not to issue a warning until six years later.
Arguments made in Mr. An's case are similar to those made in the first Actos trial. A clinical pharmacologist in the first trial testified that there were “multiple emails from different levels of Takeda management…[that] indicate the product came first.” More specifically, this expert testified about an August 2005 email from a Takeda executive addressing regulatory concerns that Actos might cause bladder cancer. The email stressed that the "worst-case scenario" would be for regulators to require the inclusion of a bladder cancer warning in the Actos label. Because Takeda was more interested in profits than safety, they chose not to warn consumers at all until six years later, thereby posing a risk of bladder cancer to millions of Actos users.
July 5, 2013 - An international independent study has found Actos (pioglitazone) to be "probably carcinogenic." In June 2013, 23 experts from nine countries met at the International Agency for Research on Cancer (IARC) to assess the carcinogenicity of 14 drugs and herbal products. After a detailed review of one large randomized controlled study, four cohort studies, and three case-controlled studies, the Agency determined that pioglitazone (the active ingredient in Actos) should be classified as probably carcinogenic to humans based on the evidence that it causes bladder cancer.
April 26, 2013 - A California state court jury has reached a verdict for the plaintiff in the first Actos trial in the country. The verdict comes after almost two months of trial, and jury deliberations that lasted more than a week. The jury ruled Takeda failed to warn plaintiff, Jack Cooper, of the risks of bladder cancer. Cooper and his wife were awarded $6.5 million in damages.
June 18, 2013 - India banned the use of Pioglitazone (Actos), Takeda's blockbuster diabetes drug. The ban includes all combination products that contain Pioglitazone. Regulators cited safety concerns over bladder cancer and heart failure as the reasons for the ban.
August 13, 2012 - According to a study published in the Journal of the National Cancer Institute, one of the major classes of diabetic drugs increases patients' risk of bladder cancer. Patients treated with either Actos or Avandia for five or more years had a two-to-three-fold increase in the risk of developing bladder cancer when compared to those who took another class of diabetes medications called sulfonylurea drugs.
June 13, 2012 - A study, published in The Archives of Internal Medicine, suggested that diabetes drugs such as Avandia and Actos could cause eye problems in those who take them. The study observed over 100,000 people with Type 2 diabetes for nearly a decade.
The results demonstrated that those who used either Avandia or Actors have an increased risk of developing diabetic macular edema (DME), a condition in which the retina thickens and swells, was roughly two to three times higher. Overall, about 1.3 percent of diabetes drug users developed the disease while only 0.2 percent of those who were not on one of the medications did. Combinations with insulin, a common practice for diabetes drug users, seemed to increase this risk even more.
Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye (an area on the retina) and cause it to thicken and swell, which consequently may distort a person's central vision (the section of the eye that controls the sharpness in straightaway vision).
Iskandar Idris, an author of the study and a consultant in diabetes and endocrinology in England, said that persons taking Avandia or Actos should get their vision checked regularly.
While the study was not able to pinpoint what exactly it is in the drugs that may cause the damage, Dr. Idris believes that it may have something to do with the greater sodium and fluid retention or changes in blood vessels caused by the drugs.
May 31, 2012 - Dr. Laurent Azoulay, Ph.D., of McGill University in Montreal, and colleagues published an article in the online British Medical Journal that showed patients who had taken pioglitazone at any time were found to have an 83% higher risk of bladder cancer. According to Dr. Azoulay, this risk increased for patients who had taken the drug for longer than two years and whose cumulative dosage exceeded 28,000mg.
May 21, 2012 - A preliminary study performed at the Tehran University of Medical Sciences suggested that adding pioglitazone (Actos) to a commonly prescribed anti-depressant, citalopram (Celexa), boosts the effects of antidepressants in patients, whether they have diabetes or not. Although this study was performed on only 40 patients, the conclusion of the study suggested that it will be repeated using a larger group of patients and may lead to new uses for the diabetes drugs, Actos.
Does it make sense to look for additional uses for a drug that has gathered this much negative attention?
Takeda Pharmaceutical, the manufacturer of Actos, faced a large number of lawsuits of individuals who believe they got bladder cancer as a result of their Actos usage. These lawsuits come from individuals who took Actos for Type 2 diabetes because there were very few options available for treating their disease. To then increase the market of Actos users to include those without Diabetes but who have a major depressive disorder would be to ignore the guidance of regulatory agencies in the U.S., Canada, and Europe.
And, to make matters worse, Celexa, a selective serotonin reuptake inhibitor prescribed commonly as an anti-depressant, has been linked to a wide range of birth defects. It seems completely irresponsible to combine two drugs with so such serious and varied side effects and to increase the number of people exposed to risks such as these.
April 19, 2012 - Health Canada followed their previous warning with a change in labeling to indicate the link to bladder cancer. Ontario Public Drug (OPD) Program also took the additional step of limiting patient access to Actos.
The ODB Program provides coverage for over 3,800 drug products that are listed in the ODB Index or formulary. If a drug is not listed in the ODB formulary, patients are required to submit a request for the unlisted drug which then becomes part of the Exceptional Access Program (EAP) and the Executive Officer makes decisions regarding its funding on a case by case basis. Effective April 24, 2012, Actos has been moved to the "exceptional access" list. This change comes at the midway point of Takeda’s 10-year study which Health Canada believes to be pointing to a real link between Actos and bladder cancer.
According to Dr. David Jurlink, head of the division of clinical pharmacology at the University of Toronto:
At this point, there is little need to resort to this drug, unless a patient has done extraordinarily well on it in the past. I personally would not be comfortable using it as a long-term therapy because bladder cancer is…not something that’s reversible. It is not a skin rash that goes away when you stop the drug.
March 1, 2012 - The Illinois Supreme Court approved the transfer and consolidation of all Illinois Actos cases to the court of Judge Deborah Dooling in Cook County. Given the complexity and resource demands that the "mass tort" (multiple plaintiffs injured in a similar fashion by a defective product) case will require, the consolidation of these cases was intended to allow the litigation to move forward in an organized and timely manner.
Anyway, some of the pending Actos cases were filed and handled in federal court under a federal consolidation called multidistrict litigation (or "MDL"). The MDL procedure is utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States.
Multidistrict Litigation Established for Federal Claims in Louisana
December 29, 2011 - The Judicial Panel on Multidistrict Litigation (JPML) established an MDL for all federal claims alleging injury caused by Actos. The MDL was assigned to Judge Rebecca F. Doherty of the U.S. District Court for the Western District of Louisiana.
November 18, 2011 – Avandia was removed from retail pharmacies. The FDA mandated an access program because of safety concerns. On November 18, Avandia became available only through specially certified pharmacies participating in the program. Healthcare providers will also have to enroll in the access program if they want to continue to prescribe Avandia. The providers must also enroll each patient in the access program in order for the patient to start receiving or continue receiving Avandia. The FDA ordered Avandia's manufacturer, GlaxoSmithKline, to send "Dear Health Care Provider" letters to prescribers to make them aware of current Avandia information.
June 15, 2011 – The FDA issued a new warning of increased bladder cancer risk associated with the use of the diabetes drug Actos (pioglitazone). The warning came after a review of data from a five-year interim analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceutical Co.
The results showed that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
The FDA issues warnings such as the one on Actos as a result of clinical reviews of information provided in a database called the Adverse Event Reporting System (AERS). These reports come to the FDA from three places – physicians, the public and from the drug manufacturer.
Prior to the FDA warning – several European markets, France and Germany, suspended the use of Actos, citing concerns over an increased risk of patients developing bladder cancer.
2007 - Studies revealed that GlaxoSmithKline's popular diabetes drug, Avandia, increased the risk of heart attack, cardiovascular disease, stroke, and death. Consequently, this led to the FDA requiring Avandia to use a black box warning to alert consumers of the risks. These warnings were still not enough.
Last Modified: July 23rd, 2019 @ 03:04 pm
Takeda Pharmaceutical Co, the manufacturer of Actos (pioglitazone), made more than $16 billion on its blockbuster drug, Actos, prior to it going generic in August 2012. While Takeda's internal Actos studies uncovered links to bladder cancer as early as 2004, the company didn't alert U.S. regulators until seven years later, according to the Actos bladder cancer lawsuit that was filed against Takeda.
At this time, TorHoerman Law is no longer pursuing cases involving Actos and bladder cancer.
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