Actos Settlement Alert

Actos (pioglitazone HCl), also marketed as Actosplus Met and Duetact by Eli Lilly and Takeda Pharmaceuticals, is used as an adjunct therapy to diet and exercise to improve glycemic control in Type 2 diabetics.   Unfortunately, recent studies indicate that Actos may be responsible for catastrophic side effects.  Continuous use of Actos by type 2 diabetics can lead to life-threatening urinary bladder cancer.

Takeda Pharmaceutical Signs Off on the $2.4 Billion Dollar Settlement for Bladder Cancer Lawsuits

Takeda Pharmaceutical Co, the manufacturer of Actos (pioglitazone), profited as much as $16 billion on Actos by 2012.   By 2004, Takeda already knew from internal Actos research and studies that there was a link between the diabetic drug and lethal bladder cancer.  Takeda continued to sell the drug without reporting the devastating side-effects to patients, nor did it live-up to its duty of care to warn the FDA.

Nearly 10,000 Actos lawsuits were filed for those victims who were exposed to the damaging effects of the drug.

If you are one of the millions of people that took the diabetes medication Actos, and you developed bladder cancer, you may be awarded compensation by filing an Actos Lawsuit.

These Actos bladder cancer cases are divided between Chicago Actos Bladder Cancer Cases, Merrimack New Hampshire Cases, and the Actos lawsuits consolidated in federal court under an MDL (multidistrict litigation)

The lawyers at Oliver-Zhang Law represent victims in the Actos Lawsuit and Settlement against Takeda Pharmaceutical and Eli Lilly.

Actos Bladder Cancer Risk and Ban in Europe

The U.S Food and Drug Administration (FDA) issued public safety information on June 15, 2011 that the use of pioglitazone (Actos) for at least two years and in high doses may be associated with an increased risk of bladder cancer.  These findings are based on the 5-year review of an ongoing 10-year epidemiological safety study on pioglitazone.  Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing products (Actos, Actoplus Met and Duetact). The Patient Medication Guide for these medications will also be revised to include information of the increased risk of urinary bladder cancer for patients who were on Actos the longest and took the highest cumulative dose of Actos.

Actos was banned in Europe due the risk of diabetic patients developing bladder cancer.

Touted as a Type2 Diabetes drug that is effective in controlling blood sugar, Actos grew in popularity after the use of Avandia by GlaxoSmith Kline became severely controlled in America due to serious side-effects of heart attacks and heart failures.  Takeda had profits from sales of Actos in the U.S of over $3 billion in 2009 and just under $3 billion in 2010.

New Studies Found Significant Increased Actos Bladder Cancer Risk

Recent studies continue to indicate that Actos is a substantial factor in increasing the risk of bladder cancer.

On June 2013, the International Agency for Research on Cancer (IARC) assessed 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 concluded that a positive association has been observed between pioglitazone (the generic name for Actos) and cancer of the bladder, and classified it as probably carcinogenic to humans based on the evidence that it causes bladder cancer.  According to the IARC,

Total worldwide sales of pioglitazone were US$ 3.34 billion in 2012, with 71% occurring in the USA (US$ 2.37 billion). Other nations with significant sales of pioglitazone included Japan (US$  322 million), India (US$  106 million), United Kingdom (US$  71 million) and Italy (US$ 66 million) (IMS Health, 2012a) . . .  Based on these same data, approximately 600 000 patients in the USA were taking pioglitazone in 2012 (IMS Health, 2012b).

Nearly across all study designs and geographical regions worldwide, risk ratios that ranged from 1.2 in the observational studies to a nearly threefold statistically significant increase, or 300% increase in bladder cancer was found in the randomized controlled trial.

Our Actos Bladder Cancer Attorneys at Oliver-Zhang Law believe that Eli Lilly and Takeda Pharmaceutical knew about the significant risk of Actos bladder cancer, but still marketed Actos to patients with diabetes as safe and effective, leading to serious injuries and deaths.

Our lawyers at Oliver-Zhang Law fight for fair compensation for our clients, especially when drug companies have hidden serious, known drug risks in order to make money despite injuring you and your loved ones.  Contact our Actos bladder cancer attorneys before September 11, 2015 at Oliver-Zhang Law for a free consultation to see if you are eligible to be a part of the Actos Bladder Cancer Lawsuit and Settlement.  This is a no charge, no-obligation review of your medical history to see if you are eligible for the Actos Bladder Cancer Lawsuit & Settlement.  Unless we recover compensation for you, our representation of you in your Actos bladder cancer lawsuit is always free.

We are located in Washington, D.C., and represent clients from the District of Columbia, Maryland, Virginia, and nationwide.


In March 2011, the European Medicines Agency (EMA) launched a formal probe into the potential link between Actos and the increased risk of bladder cancer. An increase in spontaneous reports from the field prompted the EMA to “review all available data thoroughly, including published data . . . and will assess their impact on the balance of risks and benefits of these medicines.”

French authorities (Agence Francaise De Securite Sanitare Des Produits De Sante or AFSSAPS) suspended the use of Actos and another diabetes medication also made by Takeda Pharmaceuticals, Competact, citing to data showing that the medications may raise the risk of bladder cancer.  This order for doctors to stop prescribing Actos and Competact comes in the wake of a French study of public insurance data, which “confirms a slight increase in the risk of bladder cancer in patients treated with pioglitazone.”

The German drug regulators (Bundesinstitut furArzneimittel und Medizinprodukte or BfArM) followed close behind and also suspended the use of the diabetes drug, Actos.

What are the signs and symptoms of urinary bladder cancer you should know?  The most common symptoms are:

  • Painless Hematuria (bleeding in the urine not associated with pain on urination). Most often, the bleeding is gross (visible to the naked eye) and episodic.
  • Painful Hematuria: Microscopic hematuria (bleeding only be visible under the microscope) or gross blood in the urine may be associated with pain due to blockage of the urine by formation of blood clots.

There may be no symptoms or blood in the urine for prolonged periods of time between episodes, misleading the patient into a false sense of security.  Some types of bladder cancer may cause irritating symptoms with little or no bleeding.

  • Frequency, Urgency & Burning Associated with Urination: Some patients may have urinary frequency (urinate small amounts in short intervals), urgency (inability to hold urine) or dysuria (burning sensation while passing urine).  These symptoms occur in patients with high-grade, flat-urothelial cancers called CIS or carcinoma-in-situ.
  • Advanced Bladder Cancer: In advanced bladder cancer cases, patients may present with distended bladder due to obstruction by a tumor at the bladder neck, flank pain due to obstruction of urine flow from the kidney to the bladder by the growing tumor mass in the bladder, bone pain or cough due to the spread of cancer cells to the bones and lungs.

The law firm of Oliver-Zhang Law help clients in cases involving Actos and Avandia.  If you know of a person who has taken Actos or Avandia and suffered bladder cancer, we may be able to help them recover from the Actos settlement.  Contacting one of our experienced legal or medical professionals is your first step to obtaining a settlement and holding the drug companies accountable for your injuries.

Actos Bladder Cancer Trials and Victories for Plaintiffs

In April 2014, a Louisiana jury in federal court punished Takeda and Eli Lilly & Co. with a $9 billion dollar punitive damages verdict.

Terrence Allen, et ux v. Takeda Pharmaceuticals North America, Inc. was the first case, or what’s called a bellwether case, to go to trial in the federal Actos multidistrict litigation (MDL).

Apparently, that the jury agreed with the attorneys representing victims of Actos bladder cancer that Takeda and Eli Lilly put profit before safety and that this conduct is negligent, reckless, and unacceptable.  There was also indication that Takeda destroyed documents and emails relevant to the case.   The successful Actos litigation shows that the jury agreed that drug companies have a legal duty to warn against the risk of bladder cancer.  Had Takeda or Eli Lilly adequately warned about Actos bladder cancer risks, many patients with diabetes, including Mr. Allen, would never have taken it.  This gave incentive for the drug companies to settle the remaining bladder cancer cases.

The testimony at trial showed that Takeda management  focused on the sale of Actos rather than on patient safety.  Takeda management argued that the “worst-case scenario” would be for FDA to require a warning on the Actos label that informed of the bladder cancer risk.  In 2011, this “worst-case scenario” warning label ultimately was mandated by the FDA.  However, six years have then passed, after tens of thousands of diabetic patients who took Actos suffered bladder cancer.

Actos Bladder Cancer Lawyers, Oliver-Zhang Law will continue to update about the pending Actos lawsuits as well as settlements.

 Actos Breaking News

The New York Times, April 28, 2015

Takeda Pharmaceutical has agreed to pay $2.4 billion to settle thousands of lawsuits from patients and their family members who said that the company’s diabetes drug Actos caused bladder cancer, it announced on Tuesday.

FiercePharma, April 28, 2015

Takeda is preparing to pony up $2.3 billion to settle lawsuits accusing the Japanese pharma of hiding diabetes med Actos’ cancer risks. But according to some experts, that’s a steal.

If the company’s directors sign off on the deal, it’ll wipe the legal slate clean of 8,000 suits and offer a payment exceeding $287,000 per case to those who sign up for the settlement program, Bloomberg reports. Former Actos patients looking for more compensation will be able to continue litigating their claims.

Takeda Pharmaceuticals has agreed to pay $2.4 billion to settle the Actos bladder cancer lawsuits in a global settlement agreement. The Actos bladder cancer settlement is the largest single mass tort settlement for a drug that is still currently on the market., May 7, 2015

According to the agreement reached and filed in the Western District Court of Louisiana, compensation “will be calculated for each plaintiff based on factors that include the extent of their injuries and cumulative dosage.” . . . .

Type 2 diabetes patients who were prescribed an Actos medication, including Actos, ACTOplus Met, ACTOplus Met XR, or Duetact, before December 1, 2011, and who were diagnosed with bladder cancer before April 28, 2015 may be eligible to participate in the settlement.

Some accounts, including Bloomberg News, indicate the settlement could be as much as $296,000 for eligible individual plaintiffs, depending on their age, smoking history, exposure to toxins, etc.

FDA required long term studies for diabetes drugs continue to show significant side effects and many are questioning the FDA’s stance on approving diabetes drugs based solely on blood sugar reduction.  Diabetes drug lawyers are filing cases and talking to people who believe they were harmed through their use of Onglyza, Byetta, Januvia, Victoza and other diabetes drugs.

Actos bladder cancer lawyer report that Takeda Pharmaceutical Co. was ordered by a jury Thursday to pay more than $2.3 million in damages to a former teacher who blamed the company’s Actos diabetes drug for causing his bladder cancer.

Takeda Pharmaceutical Co. (4502) was ordered by a jury to pay $155,000 over its destruction of documents about its Actos diabetes medicine after the panel concluded the missing files blocked a man from proving his claims that the drug caused his cancer.

The first trial in West Virginia state court over allegations that Takeda Pharmaceutical’s widely prescribed diabetes drug,  Actos causes bladder cancer began this week. This is the eighth case to go to trial where a plaintiff claims the blockbuster diabetes drug caused their bladder cancer.

Takeda Pharmaceutical Co. (4502) was ordered by a jury to pay more than $2 million to a woman who claimed the company’s Actos diabetes medicine caused her bladder cancer, in the latest of thousands of lawsuits involving the drug to go to trial.

Takeda Pharmaceutical Co., in the first federal trial in the U.S. over claims it hid the cancer risks of its Actos diabetes medicine, was ordered by a jury to pay $6 billion in punitive damages.

This morning in preparation of the first Actos trial in Cook County (Chicago, Illinois) 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.

This first bellwether trial in the Actos Louisiana MDL began this week.  Before trial began, the court entered a scathing order that described in detail systemic destruction of evidence by drug maker Takeda Pharmaceuticals.

Today begins the first Actos MDL case in the US District Court, Western District of Louisiana. Jury was selected on Friday and today begins 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.