Takeda Pharmaceuticals, the manufacturer of Actos (pioglitazone), is defending claims that the company knew or should have known through prior research that the diabetes drug significantly increased the risk of bladder cancer and other severe health complications. Plaintiffs who’ve filed an Actos lawsuit contend that the medicine is inherently dangerous, defectively manufactured and put on the market with inadequate warnings of bladder cancer risks.
The product liability lawyer team at EKJ Law is currently reviewing cases of diabetes patients who developed bladder cancer or heart problems after taking Actos as prescribed by their doctor. Drug companies have a duty to clearly and comprehensively warn the public about the dangers associated with their pharmaceutical products. If manufacturers fail in this duty, and/or their products are shown to be the direct cause of harm in patients, then the companies can be held liable for damages.
If you or a loved one has developed life-altering complications from Actos, the lawyers at Edelman, Krasin & Jaye will fight assiduously to make sure you are fully compensated according to the laws out into place to protect drug side effects victims. Call us today for a free and honest evaluation of your case.
Side effects of Actos
Actos is a type of thiazolidinedione (TZD) drug and functions as an insulin sensitizer, helping decrease glucose released by the liver thereby stabilizing blood sugar levels. It is meant to be used in conjunction with a healthy diet and exercise regimen and is used by millions of Americans who suffer from Type 2 diabetes mellitus.
The product label states that normal side effects include headaches, muscle aches, swelling or fluid retention, but thousands who have taken pioglitazone under the supervision of their doctors have reported life-threatening reactions, ranging from congestive heart failure to cancer of the bladder.
Since entering the U.S. marketplace in 1999, Actos has quickly become one of Takeda’s top selling pharmaceuticals, earning the manufacturer billions in revenue. However, Actos side effects have also become the topic of escalating litigation, as patients seek recourse for physical injuries and economic losses that they argue were a direct result of their Actos use.
FDA warning on Actos and bladder cancer
For thousands of Actos patients throughout the country, their first warning of bladder cancer risks came in the form of an FDA safety notification, issued in 2011. The federal agency cautioned that pioglitazone exposure for 12 months or longer was associated with a 40 percent increased risk for bladder cancer.
The FDA’s actions were based on the interim findings of a ten-year study, and would later bolster allegations raised in Actos claims filed state and federal courts.
Unfortunately for many, this Actos warning was belated, as patients sought surgery, chemotherapy and other treatments in their battle with cancer. Further research published in the British Medical Journal found that Actos use heightened cancer risks by 83 percent.
Despite overwhelming evidence of increased cancer risks, Actos remains available in the United States, though it has been recalled in both France and Germany.
Takeda accused of concealing Actos side effects
Among allegations raised in lawsuits against Takeda, plaintiffs say that Actos has caused them to suffer other debilitating and potentially fatal side effects.
Serious side effects of Actos include:
- Congestive heart failure
- Bone fractures
- Lactic acidosis
- Bladder cancer
In 2007, the FDA mandated its strongest possible warning for a medication, and ordered a black box label on Actos for the risk of heart failure.
Plaintiffs who have bladder cancer claim that Takeda hid their knowledge of Actos risks, as pre-market animal trials had found cancerous tumors in rats that were given pioglitazone. The drug giant is charged with failing to adequately warn health care providers and the general public about the causal link between Actos and bladder cancer, effectively placing profits over consumer safety.
Despite heated litigation and hundreds of claimants leveling similar allegations, Takeda continues to deny any wrongdoing, and defends the safety of Actos.
Actos litigation continues to mount nationwide
Due to the growing number of Actos lawsuits, legal proceedings were coordinated for pretrial proceedings on both the state and federal level:
- Federal multidistrict litigation (MDL 2299) — established in the Western District of Louisiana and presided over by Judge Rebecca F. Doherty
- California mass tort—proceeding in Los Angeles Superior Court, CA and managed by Judge Kenneth R. Freeman
- Illinois mass tort—Cases are being heard by Judge Deborah Dooling in Cook County
Bloomberg News estimates that Takeda may soon face as many as 10,000 product liability lawsuits regarding Actos, and court dockets show 8,000+ cases pending under MDL and in state courts.
Actos lawsuit trials and verdicts
Takeda will face its first bellwether trial on January 27, 2014 in Louisiana federal court. This trial could pave the way for potential settlements for thousands of unknowing patients who developed bladder cancer after exposure to Actos. The second bellwether case for MDL 2299 is slated to commence in April 2014, and will be overseen by U.S. District Judge Rebecca Doherty.
Two prior Actos cancer lawsuits that went before juries in state courts resulted in multi-million verdicts for the plaintiffs. California plaintiff Jack Cooper won $6.5 million in damages, but the award was vacated by the court, as was another $1.7 million verdict for the family of a Maryland man named Diep An, who died from his bladder cancer. Despite these setbacks, the plaintiffs’ attorneys plan to appeal, as Takeda continues to defend its controversial drug in thousands of other lawsuits throughout the nation.
File an Actos lawsuit in New York
Serving victims of personal injury and products liability since 1952, the law firm of Edelman, Krasin & Jaye boasts a team of talented personal injury attorneys who have the expertise and legal skills necessary to take on Big Pharma and succeed. If you or someone you love has been diagnosed with bladder cancer after taking Actos, legal help is available.
Call our offices at 800-469-7429 to speak with a product liability lawyer who will help determine if you’re eligible to recover damages in an Actos lawsuit. A favorable jury verdict or pretrial settlement can help offset the economic burdens of medical bills, lost wages and diminished earning capacity, while offering financial stability along with a measure of justice. The initial consultation is free and our team only collects a fee if you win your case.
- WebMD Health News, Diabetes Drug Again Linked to Bladder Cancer http://www.webmd.com/cancer/news/20120531/diabetes-drug-actos-again-linked-to-bladder-cancer
- CBS News, Actos banned in Europe after diabetes drug tied to cancer, http://www.cbsnews.com/8301-504763_162-20070492-10391704.html
- FDA Safety Communication on Pioglitazone-Containing Medicines http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders
- United States District Court for the Western District of Louisiana, Honorable Rebecca F. Doherty, N RE: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, http://www.lawd.uscourts.gov/welcome-web-site-mdl-no-2299
- Bloomberg, Takeda Failed to Properly Warn About Actos, Jury Rules, http://www.bloomberg.com/news/2013-09-26/takeda-failed-to-properly-warn-about-actos-jury-rules.html