Challenges Ahead for Takeda Pharmaceuticals, Despite Judge's
Nullification of Jury Verdict
Thursday, May 2, 2013
A $6.5 jury award against Takeda Pharmaceuticals for failing to warn a California man and his physician of the risk of bladder cancer associated with Takeda’s diabetes drug Actos was overturned Friday by the presiding judge. But Takeda’s troubles may be just beginning.
Trial Exhibit Provides Insight into Jury Verdict
Monday, April 29, 2013
In its complaint against Actos manufacturer Takeda Pharmaceuticals, counsel for plaintiff Jack Cooper alleged that Takeda acted negligently in the selling, advertising, marketing and promotion of its diabetes drug by failing to warn physicians and consumers of the risk that Actos could cause bladder cancer. Jurors in the trial that concluded Friday agreed, awarding $6.5 million dollars to Cooper and his wife.
New Details Emerge in $6.5 Million Verdict against Actos Maker
Monday, April 29, 2013
During the trial, plaintiff’s counsel Michael Miller argued that Takeda had known of research linking Actos to bladder cancer since at least 2004, but to protect their profits ($4.5 billion in 2011 from Actos sales), the company consistently thwarted the numerous Food and Drug Administration’s attempts to revise the drug’s product label to notify doctors and patients of the risk. Studies also suggested that the risk was increased the longer one took the diabetes drug, making the timing of a label change even more significant. Cooper began taking Actos (pioglitazone) in late 2006. It wasn’t until 2011 that a bladder cancer warning was finally added to the label.
Jury Says Actos Causes Bladder Cancer, Awards $6.5 Million in First Actos Trial
Friday, April 26, 2013
A Los Angeles jury has awarded $6.5M to Jack Cooper, a California man who claimed his bladder cancer was the result of the Actos medication he was taking for his diabetes.
Mr. Cooper’s case was the first Actos bladder cancer case to go to trial and was given priority because his doctor had given him only a few months to live. This verdict will set the bar for the thousands of other plaintiffs’ cases waiting to go to trial.
Jurors Hear Closing Arguments in First Actos Trial
Tuesday, April 16, 2013
In closing arguments yesterday, Mr. Cooper’s attorney told jurors that Takeda was aware of the bladder cancer risk as early as 2004 (Cooper began taking Actos in September 2006) but carried out a carefully executed plan, revealed in emails and other internal documents, to hide the risk in order to protect a drug that was making $1.6 billion a year.
Expert Alleges Study of Diabetes Drug Actos Hid Vital Data
Saturday, March 30, 2013
In a report filed with the court, plaintiff’s expert James Morrison stated that a prominent clinical trial involving Actos, known as the PROactive study and published in The Lancet in October, 2005, demonstrated a link between the drug and bladder cancer – a link that Takeda concealed in its Lancet paper.
Four More Diabetes Patients Allege Actos Linked to Bladder Cancer
Wednesday, March 27, 2013
Baum, Hedlund, Aristei & Goldman has filed a new Actos bladder cancer lawsuit on behalf of four plaintiffs and three of their spouses against Japanese drug manufacturer Takeda Pharmaceuticals and its subsidiaries, alleging that the diabetes medication caused their bladder cancer. Eli Lilly, which launched Actos along with Takeda in 1999, is also listed as a defendant in the bundled complaint.
New Allegation in Ongoing Actos Trial: Takeda Blocked FDA Efforts
to Add Bladder Cancer Warning to Actos Label
March 15, 2013
Following meetings with Takeda, the FDA sought to add language to the Actos label stating that “a receptor-mediated mechanism for tumor induction cannot be ruled out” with PPAR agonists. Takeda resisted, claiming that “current evidence was insufficient to justify the proposed label change.”
Takeda Employs “Just Following Orders” Defense in Actos Bladder Cancer Trial,
Places Blame on Federal Regulators
Thursday, March 14, 2013
Depositions taken by Takeda of two key plaintiff’s witnesses suggest that the drug maker may employ a “just following orders” strategy in its defense, arguing it did everything the Food and Drug Administration (FDA) required in terms of the Actos label, and therefore, if the label did not fully convey the bladder cancer risk associated with Actos, the FDA, not Takeda, should be held liable.
Drug Regulation Expert Testifies Against Takeda Regarding
Emails Which Discussed Actos Bladder Cancer Risk
Monday, March 11, 2013
Dr. Howard Greenburg, an expert in pharmacology and drug regulation, was questioned about internal Takeda emails that he says demonstrate the drug maker’s intent to forestall label changes that would have warned of an Actos-bladder cancer link, a change that Takeda knew would seriously damage sales of its top selling drug.
Actos Manufacturer Surveyed Doctors about Bladder Cancer in 2003,
Internal Documents Show
Tuesday, March 5, 2013
One of the central allegations in the ongoing Actos bladder cancer trial is that Actos manufacturer Takeda has long known that its diabetes drug caused bladder cancer in patients but chose not to warn consumers or the medical community.
First Actos Bladder Cancer Trial Underway in Los Angeles
Friday, March 1, 2013
Attorneys have delivered their opening statements in the first Actos bladder cancer trial which is currently underway in California state court. The Actos case, brought by plaintiff Jack Cooper against Osaka, Japan-based Actos manufacturer Takeda Pharmaceuticals, began on February 19, 2013 at the Central Civil West Courthouse, Superior Court of California in Los Angeles. It is the first trial of thousands of similar pending lawsuits alleging that the blockbuster diabetes drug Actos led to an increased risk of developing bladder cancer.
Opening Statements for First Actos Bladder Cancer Trial
Establish Timeline of Alleged Negligence
Thursday, February 28, 2013
The attorney for a California man who claims he developed terminal bladder cancer as a result of taking the diabetes drug Actos delivered opening remarks in California state court on Thursday, February 28. The case is the first of thousands of similar Actos bladder cancer lawsuits nationwide to go to trial. Plaintiff’s attorneys used their opening statement to lay out a timeline of actions taken by Actos manufacturer Takeda Pharmaceuticals that demonstrate a consistent effort to conceal from doctors and patients scientific evidence linking Actos to bladder cancer.
FDA's Surprising Approval of Diabetes Drug Nesina
Tuesday, February 5, 2013
Takeda Pharmaceuticals, the manufacturer of diabetes drug Actos (pioglitazone), saw sales of the drug plummet by over 50 percent at the end of last year. The dramatic drop in sales was mainly due to U.S. and European regulatory agencies issuing safety warnings linking Actos to an increased risk of bladder cancer.
Now that the patent on Actos has expired, Takeda is apparently looking for other sources of revenue. Actos, once one of the most widely-prescribed drugs in the world, has been replaced by Nesina (alogliptin), and Takeda has high hopes for its success. Surprisingly, the U.S. Food and Drug Administration approved Nesina, along with combination drugs Kazano and Oseni, the latter of which contains pioglitazone.
New Study Confirms Actos Linked to Increased Risk of Bladder Cancer
January 28, 2013
A new study published in the January edition of Diabetic Medicine confirms myriad other studies in recent years linking diabetes drug Actos (pioglitazone) to an increased risk of developing bladder cancer. The study, which looked at data from over 215,000 patients taking Actos, showed that "the hazard of developing bladder cancer was significantly higher in patients using pioglitazone." The elevated hazard ratio of 1.23 compared to control groups in the study led researchers to advise doctors against prescribing the drug to certain patients.