A medical reviewer who worked for the manufacturer of the drug Actos, has filed a whistleblower lawsuit claiming that the drug company knowingly hid adverse events associated with the embattled diabetes drug.
The lawsuit alleges that Takeda Pharmaceuticals North America, Inc., concealed Actos heart failure risks. The suit goes on to contend that as a result of the concealment, doctors prescribed the drug more than they would have had they known the risks, which ultimately cost federal and state health programs hundreds of millions of dollars.
The whistleblower alleges that Takeda didn’t properly report all congestive heart failure adverse events related to Actos to the U.S. Food and Drug Administration (FDA). Between 2007 and 2010, the suit alleges that the Japanese drugmaker didn’t count hundreds of reports of non-hospitalized and non-fatal congestive heart failure cases as “serious” adverse events — thus, avoiding having to report them as such to the FDA.
The whistleblower, who worked for Takeda in 2008, alleges her contract was terminated when she complained about the underreporting of the congestive heart failure events. The suit also alleges that Takeda attempted to sway medical reviewers’ opinions concerning the potential dangerous side effects of the drug.
In June of 2011, Takeda stopped selling Actos in Germany and France. Both the FDA and the European Medicines Agency have issued warnings about the drug’s possible link to bladder cancer.
Takeda will not comment on the allegations since the lawsuit is still pending.
The Florida Actos attorneys at Farah & Farah will be keeping close tabs on this lawsuit as it evolves. If you suspect you are suffering from congestive heart failure or bladder cancer linked to Actos use, please give us a call at (800) 533-3555 to learn more about your legal rights and options. The call is free and confidential.
Sources: http://www.law360.com/productliability/articles/317049/takeda-hid-diabetes-drug-s-heart-risks-ex-reviewer-says;http://www.prweb.com/releases/2012/3/prweb9296926.htm
By Eddie Farah on February 6, 2012 -
Actos is a diabetes medication that is the subject of hundreds, if not thousands, of lawsuits. The problem is that when Actos, also known as pioglitazone, is used for a prolonged time period it is found to increase the risk of developing bladder cancer. In France, the sales of Actos have been suspended and sales are seriously curtailed in Germany, but Actos is still sold in the U.S. despite some pretty serious U.S. Food and Drug Administration (FDA) warnings.
In the U.S., the drug was considered a blockbuster, delivering record profits to Japanese drugmaker Takeda Pharmaceutical Industries with $2.5 billion in sales in 2010. An American subsidiary, Takeda Pharmaceuticals North America (based in Illinois), is now where a number of lawsuits have been filed and should be heard.
There are so many lawsuits filed that the Judicial Panel on Multidistrict Litigation (MDL) decided to consolidate many Actos lawsuits pending in federal courts around the country in one area – the U.S. District Court for the Western District of Louisiana. Judge Rebecca F. Doherty will oversee the discovery process and coordinate sharing, which is what is learned in discovery among all of the plaintiff lawyers. This is also a way to cut down on conflicting rulings that can be issued from various courts and to more quickly resolve the Actos lawsuits. The cases can still be tried individually on their own merits, though they are often settled depending on the outcome of a few select, or bellwether, trials.
Since the FDA warning, sales have slowed and the FDA is now reviewing data about the link to bladder cancer.
The Florida Actos attorneys of Farah & Farah are talking to patients who have taken Actos and are suffering the complications, such as bladder cancer. With emotional, medical, and financial challenges ahead, we are bringing defective product cases forward to seek compensation for individuals who have suffered complications from taking Actos. Call our law offices at 1(800) 533-3555 for a complimentary consultation on your injury and find out what we can do to help.
By Eddie Farah
By Eddie Farah on January 26, 2012 -
Last month, the outstanding Actos lawsuits pending in federal courts around the country were consolidated before Judge Rebecca F. Doherty in U.S. District Court for the Western District of Louisiana. That decision was made by the U.S. Judicial Panel on Multidistrict Litigation (JPML), a federal panel that decides how to handle the massive number of personal injury cases that result from the same defective product. The JPML determined there were common questions of law among the thousands of plaintiffs to merit the consolidation of pretrial proceedings. This saves plaintiffs money in that their lawyers can all share information gathered from Asian drug maker Takeda Pharmaceutical Co. and its co-defendant, Eli Lilly & Co.
A question yet to be answered is whether the drug maker and distributor withheld adequate warning from doctors and consumers, thereby failing to give users informed consent about the potential risk for bladder cancer.
When used for more than one year, Actos (pioglitazone) may increase the risk of bladder cancer. According to the U.S. Food and Drug Administration (FDA), a review of data found those patients who had taken the drug for the longest period of time had the highest risk of bladder cancer.
Actos is still sold in the U.S., but sales have been suspended in France and Germany after users developed bladder cancer after long-term use of the drug. Actos is used by patients to lower the blood sugar level in patients suffering from type 2 diabetes. During the first 10 months of 2010, about 2.3 million patients filled a prescription for a drug containing Actos. Doctors have been warned not to prescribe Actos to patients who have active bladder cancer.
If you have suffered adverse side effects from using Actos, the Jacksonville Actos attorneys with Farah & Farah can help you obtain compensation for your injuries and health problems. Please call (800) 533-3555 for a consultation with our law team.
By Eddie Farah
Public Citizen, in its Worst Pills, Best Pills publication, reports that on August 4, 2011, the U.S. Food and Drug Administration (FDA) revised the warning on the type 2 diabetes drug, Actos, to include a warning about an increased risk of Actos bladder cancer. Actos, made by Takeda Pharmaceuticals, is also known as pioglitazone. It is available as a standalone drug, or can be combined with the diabetes drug metformin or with glimepiride.
It wasn’t that long ago that another drug in the same family, Rezulin, was taken off the market because of living toxicity. Actos is also part of the same family, which also includes Avandia, and it can carry an elevated risk of heart attack and failure, as well as eye abnormalities and bone fractures. Even before the bladder cancer risk was known, the advocacy group Public Citizen had put Actos on its ”Do Not Use” list because the risks seemed to outweigh the benefits, especially considering there are longer term and safer drugs available such as metformin (Glucophage).
A ten-year study on pioglitazone is underway and is being conducted by the Kaiser Permanente Northern California health plan. Last April, half way through the study, investigators found an increased risk of bladder cancer among patients who had taken the drug the longest or who had taken the highest dosage. France has already suspended sales there as a result of the increased risk for bladder cancer, estimated by the FDA to be 27.5 cases of bladder cancer for every 100,000 patients.
Initial arguments in the defective product cases involving Actos should begin to be heard in December 2011. The pharmaceutical litigation attorneys in Florida of Farah & Farah are talking to patients who have taken or are currently taking this dangerous drug. We will offer anyone who’s been associated with this drug a complimentary consultation with an experienced product liability attorney.
