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Takeda denies hiding Actos cancer risks in Nevada trial

May 21, 2014

Takeda Pharmaceutical Co. didn’t hide the alleged bladder-cancer risks of its diabetes medicine Actos, a lawyer for the company told a jury in the sixth U.S. trial by patients who claim the drug caused their disease.

“There was no hiding of the ball,” Craig Thompson, a lawyer for the Osaka, Japan-based company, said Tuesday in his closing argument in Nevada state court in Las Vegas. “The Actos label accurately reflected what was available at the time.”

Actos was marketed for Takeda in the United States by Indianapolis-based Eli Lilly and Co. from July 1999 to March 2006 and in several other countries until 2011. Lilly isn’t a defendant in the Las Vegas trial but has been named in other lawsuits involving the drug.

A federal jury in Louisiana six weeks ago ordered Takeda and Lilly to pay more than $9 billion in damages to a former shopkeeper who developed bladder cancer after taking the drug. Takeda’s shares fell more than 5 percent in the wake of that award, which will probably be reduced. Lilly was ordered to pay $3 billion of that award, but said its agreement with Takeda indemnifies it from legal losses involving Actos.

The jury in the Las Vegas trial, which began deliberating Tuesday afternoon, was asked to determine whether Takeda is liable for the bladder cancer of two women, both in their 80s, who were diagnosed with the disease after they stopped taking the drug. The women’s lawyer asked the jury to award them $35 million and $25 million, respectively, in compensatory damages.

Takeda, Asia’s largest drugmaker, faces thousands of Actos lawsuits in the United States. Food and Drug Administration officials found in 2011 that an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems.

Appeal verdict

The company, which said it will appeal the Louisiana verdict, has prevailed in four other cases that went to trial.

Actos sales peaked in the year ended March 2011 at $4.5 billion and accounted for 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. Actos has generated more than $16 billion in sales since its 1999 release, according to court filings. Takeda now faces generic competition from Ranbaxy Laboratories Ltd.

Takeda officials failed to warn consumers and doctors adequately about the company’s research that linked Actos to bladder cancer, Robert Eglet, a lawyer for Delores Cipriano and Bertha Triana, told jurors Monday in his closing statement.

“A drug company is not allowed to put profits before patients’ safety,” Eglet said. “A drug company must tell the truth, the whole truth, and nothing but the truth about the risks of its products.”

Should jurors award compensatory damages, they also need to decide whether Takeda is liable for punitive damages. If so, the amount of any punitive damages will be decided at a separate one-day phase of the trial.

Nevada District Court Judge Kerry Earley instructed the jurors before the start of closing arguments that they could infer that evidence Takeda improperly destroyed may have been unfavorable to the company.

Plaintiffs’ objections

The judge also told the jurors that they shouldn’t be prejudiced against the plaintiffs’ lawyers because of the many times they raised objections to lines of questioning by attorneys representing Takeda. The objections were prompted by continuous violations of her orders, Earley said.

Thompson, Takeda’s lawyer, said that the plaintiff’s lawyers had failed to prove that Actos was the cause of Cipriano’s and Triana’s bladder cancers. Both women were no longer using the drug when they were diagnosed with the disease, he said.

“The central issue in this case is: Did this medication cause this disease in these women at the doses and lengths of time that they used it?” Thompson said.

The “best science” and the “best studies” have not confirmed that there is an increased risk of bladder cancer from Actos, Thompson told the jurors.

State juries

Last year, state juries in California and Maryland ordered Takeda to pay a total of $8.2 million in damages to former Actos users. Judges in both states threw out the verdicts. In December, state court jurors in Las Vegas rejected claims the company failed to properly warn consumers about the risks of Actos. An Illinois jury last week found Takeda wasn’t liable for the bladder-cancer death of a man who took the drug.

In April, jurors in Lafayette, La., ruled Takeda should pay $6 billion and Lilly $3 billion in punitive damages over the companies’ handling of the diabetes drug. U.S. District Judge Rebecca Doherty hasn’t decided yet how much to chop out of those awards to Terrence Allen, a former hardware store manager who blamed the drug for his bladder cancer.

In the current Las Vegas case, 81-year-old Cipriano and 80-year-old Triana were diagnosed with bladder cancer in 2012 after taking the medication. Triana, a retired seamstress, endured four surgeries to remove bladder tumors, according to the filings.

 

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