Actos Bladder Cancer Trial: More Sanctions Against Takeda

Takeda Pharmaceuticals – the Japanese manufacturer of diabetes drug Actos – has been hit with sanctions at a trial in Las Vegas over the drug’s link to bladder cancer.  The lawsuit was brought by two women, Delores Cipriano and Bertha Triana, who have alleged that Actos caused bladder cancer they developed after taking the drug.

The trial began in February and, apparently, Takeda’s defense lawyers have engaged in what has been described as “very egregious”, “very disrespectful” conduct.

“[D]efense counsel has repeatedly engaged in disruptive and disrespectful behavior towards the court, which is well-documented in the record.  As a result, the court’s decision to impose sanctions is based on the aforementioned cumulative conduct of counsel in disobeying court orders and disrupting court proceedings.”

The noted that defense counsel had repeatedly violated the trial’s pre-trial evidentiary rulings.  Defense counsel’s conduct required Plaintiffs to make frequent, proactive, and timely objections.  While the objections were proper and necessary, it may have caused jurors to believe plaintiffs’ attorneys were “hiding evidence, disrupting the proceedings, prolonging the trial, or wasting the jury’s time.”

The court will instruct the jury regarding Takeda’s conduct prior to submitting the case.  The instruction will read:

Due to defense counsels’ repeated and persistent violations of this court’s orders, plaintiffs’ counsel has been forced to make consistent objections and numerous requests for bench conferences in order to address these violations during trial. By continuously violating this court’s orders, defense counsel has engaged in a pattern of misconduct that creates the risk that you, members of the jury, will be improperly influenced by this misconduct.

You should not and must not be prejudiced in any way against the plaintiffs by the fact that plaintiffs’ counsel has been forced to frequently and consistently make objections and request bench conferences. These objections were necessary to address defense counsel’s repeated violations of this court’s orders. Therefore, you are hereby admonished not to discuss or even consider the number of objections made by plaintiffs’ counsels, or the number of requests for bench conferences made by plaintiffs’ counsels because such objections and requests were necessary in order to ensure that this court’s orders were followed.

The Las Vegas court’s sanction order comes just weeks after a Federal District Court in Louisiana sanctioned Takeda for destroying documents from 46 employees and sales representatives.  Takeda’s destruction of documents is believed to have led to the $9 billion verdict against the company in the Actos bladder cancer lawsuit in Louisiana.

What is Actos?

Actos is a popular diabetes drug make by Japanese drug company, Takeda Pharmaceuticals and distributed in the US by Eli Lilly.  Actos (Pioglitazone HCl) is marketed under a variety of names, including Actos, Actoplus Met, and Duetact.

Actos has been Takeda most successful product – representing more than 25% of Takeda’s total revenue and with global sales of nearly $5 billion in 2010 ($3.78 billion in the U.S.).

However, despite Actos’ popularity and success, studies have now confirmed that Actos greatly increases the risk for bladder cancer.  According to a French study, a cumulative dose of greater than 28,000 milligrams and an exposure of longer than one year led to a substantial increase in bladder cancer, particularly in men.

The French Medicines Agency this summer suspended use of Actos while the European Union’s European Medicines Agency completed a risk/benefit analysis of the drug. In late July, the EMA confirmed an increased risk of bladder cancer, but determined that the benefit of Actos outweighed the risk for some patients and mandated a three- to six-month review of each individual patient.

In June 2011, the FDA released an Actos bladder cancer warning. The FDA’s new warning came on the heels of an interim analysis of an epidemiological study conducted by Takeda, the Japanese pharmaceutical company that manufactures Actos.

A backward look at Actos’ own label reveals a slow progression leading up to the current FDA warning. In 1999, as the drug was being tested, Takeda acknowledged that “[d]uring prospective evaluation … in clinical trials up to one year in duration, no new cases of bladder tumors were identified.” In addition, since testing had been done on animals for the drug, the product had added a caveat about the disconnect between animal testing and actual results on humans.

But in 2003, Takeda eliminated language that, “[t]he relationship of these findings in male rats to humans is unclear” from label. Precautions mentioned at this time were carcinogenesis, mutagenesis and impairment of fertility. Three years later, in 2006, data from two new studies was added, as an occurrence of .44 percent (drug) v. .14 percent (control) of bladder cancer was found, meaning patients taking Actos were three times more likely to develop bladder cancer.

More than a decade after Actos was first studied, in the summer of 2011, at the request of the FDA, detailed information about Actos’ link to an increased risk of bladder cancer was finally added, including a whole section on urinary bladder cancer.  Because the warning label was only recently changed, many people taking Actos may not realize that studies have linked prolonged use of Actos with bladder cancer.

Actos Lawsuits

The Louisiana lawsuit was the fourth Actos trial litigated to verdict, but first case tried in the federal multi-district litigation (MDL).  There have been two prior verdicts for plaintiffs in California and Maryland (though those results were later overturned) and defense verdict in Las Vegas.  The Allen case in Louisiana was the first federal bellwether case to be tried.  There remain about 3,000 Actos lawsuits pending in the federal MDL in the Western District of Louisiana.  Additional Actos lawsuits are pending in Cook County, Illinois (Chicago) and Las Vegas, Nevada.

Read More:

•  Litigation over Takeda’s diabetes drug Actos reaches crossroads [Missouri Lawyers Weekly]
• Actos Litigation: A comprehensive look at the litigation landscape for Takeda’s diabetes drug, as studies link its long-term use in some to bladder cancer [Forum Magazine]
• Study: Actos Diabetes Drug Doubles Bladder Cancer Risk
• Actos / Bladder Cancer FAQ

© Copyright 2014 Brett A. Emison

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