Law360, New York (October 17, 2014, 6:13 PM ET) -- The first trial in West Virginia state court over allegations that Takeda Pharmaceutical Co. Ltd.'s widely prescribed diabetes drug Actos causes bladder cancer begins Monday, featuring the same plaintiffs firm that has taken Actos cases to trial in four other states and secured three pro-plaintiff verdicts.
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Actos Verdict: Jury Orders Takeda, Eli Lilly To Pay $9 Billion In Damages

Reuters

Posted: 04/08/2014 12:28 am EDT Updated: 04/08/2014 10:59 am EDT

April 8 (Reuters) - A U.S. jury ordered Takeda Pharmaceutical Co Ltd to pay $6 billion in punitive damages and Eli Lilly and Co to pay $3 billion in a case claiming that cancer risks to the diabetes drug Actos were concealed, the plaintiffs' lawyer said.

The lawyer, Mark Lanier, said there was "stunned silence" in the packed courtroom following the announcement of the damages.

The jury in Lafayette, Louisiana also ordered the payment of $1.475 million in compensatory damages in the suit.

Takeda's shares in Tokyo tumbled 8.4 percent to 4,415 yen following news of the verdict.

The case number is 11-MD-2299. (Reporting by Daniel Levine in San Francisco; Writing by Edmund Klamann)

BY DANIEL LEVINE AND EDMUND KLAMANN

SAN FRANCISCO/TOKYO Tue Apr 8, 2014 1:36pm EDT

 (Reuters) - Takeda Pharmaceutical Co Ltd said it would contest $6 billion in punitive damages imposed by a jury in the United States in a case that accused Japan's largest drugmaker of concealing cancer risks associated with its Actos diabetes drug.

Eli Lilly and Co, Takeda's co-defendant in the case, was ordered to pay $3 billion in punitive damages by the jury in Louisiana on Monday. It also awarded $1.475 million in compensatory damages.

Legal experts said it was unlikely that such a large award would stand after challenges in court by both companies. Eli Lilly and Takeda have said they would dispute the verdict, which could include appeals to a higher court or filing motions asking the trial judge to set aside or reduce the verdict.

"Although there's no mathematical bright line" to determine how high is too high when it comes to punitive damage awards, federal appeals courts generally scrutinize the ratio of punitive to compensatory damages, preferring those that fall into the single-digit range, according to Professor Catherine Sharkey, a tort law expert at New York University School of Law.

Punitive damages are meant to discourage companies from bad conduct. Compensatory damages are meant to pay victims for their actual losses. With a ratio of more than 6,100 to 1 of punitive to compensatory damages, the Actos award could be highly vulnerable.

"It's definitely the case that the U.S. Supreme Court has signaled to lower courts that they should be restraining very large punitive awards," Sharkey added.

Lilly, which co-promoted Actos from 1999 to 2006, said in a press release it will be indemnified by Takeda for its losses and expenses around the litigation based on the terms of its agreement with Takeda.

Takeda's shares fell as much as 8.8 percent to an eight-month low in Tokyo trading on Tuesday after the verdict. The stock ended 5.2 percent lower at 4,572 yen.

Lilly shares fell 0.2 percent, or 12 cents per share, to $58.50 per share in New York Stock Exchange trading.

The massive award was met with "stunned silence" in the Lafayette, Louisiana, courtroom, plaintiffs' lawyer Mark Lanier said.

Lanier acknowledged it was not certain whether the damages award would be sustained.

"Nobody has gone out and bought a new home," Lanier said.

"This is a conservative judge and a conservative court and she's very 'balls and strikes.' We're not under any grand illusion."

The $9 billion in punitive damages awarded by the jury against Takeda and Eli Lilly exceed the $5 billion penalty that a jury in Alaska imposed on Exxon Mobil Corp for the Exxon Valdez oil spill in 1989.

The U.S. Supreme Court ruled in 2008 that the previous Exxon Valdez award had been "excessive." The company was ultimately ordered to pay $500 million. That and other rulings have been read as limiting punitive damages in federal cases.

Lanier said the jury deliberated for only an hour and 10 minutes to deliver its verdict finding liability on all 14 questions, and 45 minutes longer to come out with the multibillion-dollar punitive damages.

The allocation of liability for compensatory damages was 75 percent for Takeda and 25 percent for Lilly, according to Lilly.

Takeda said judgments were entered in Takeda's favor in all three previous Actos trials, while this was the first federal case to be tried in a consolidated multidistrict litigation comprising more than 2,900 lawsuits.

Last May, a U.S. judge had nullified a separate jury verdict for $6.5 million against Takeda after ruling that the plaintiffs failed to offer any reliable evidence that Actos had caused cancer.

Germany and France suspended use of the drug, a multibillion-dollar seller, in 2011 because of concerns about a possible link to cancer.

The case is In Re: Actos Products Liability Litigation Case U.S. District Court, Western District Louisiana, No. 6:11-md-2299.

Jury in Actos Cancer Trial Told of Drug Company Misconduct

MARCH 11, 2014 By: Susan Green

The opening witness in the first “bellwether” Actos cancer trial told the jury about drug manufacturer Takeda’s pretrial misconduct.  The case is the first of several scheduled in the ongoing Actos Multidistrict Litigation (MDL) in federal court in Louisiana.

Terrence Allen and his wife’s lawsuit charges that Allen developed bladder cancer as a result of using Actos to treat diabetes between 2004 and 2011.  Plaintiffs argue that Actos manufacturer Takeda failed to disclose the link between Actos and bladder cancer.  Takeda claims that Allen’s cancer was not caused by the drug, and that the company provided proper notification of Actos’s risks.

Takeda’s pretrial misconduct 

Just before the Allens’ Actos cancer trial began on January 27, the judge ruled that Takeda had acted in bad faith by hiding or destroying evidence that the company should have given plaintiffs during the pretrial process.  The judge held that plaintiffs could reveal Takeda’s improper actions to the jury.  Thus plaintiffs’ first witness was an Actos employee, who testified about the company’s evidentiary misconduct.

The next witness was Dr. David Kessler, a physician who served as Commissioner of the FDA from 1990-1997.  Dr. Kessler told the jury that the FDA is required to determine that a drug is safe and effective before the agency can authorize that drug’s use in the United States.  Dr. Kessler described the types of data Takeda was required to obtain to demonstrate Actos’s safety and effectiveness, and explained what the manufacturer was obligated to show the FDA in order to obtain authorization for the drug.

Several medical experts then testified about the studies linking Actos use to a high risk of bladder cancer.  Takeda employees also took the witness stand to describe what the company knew about the connection between bladder cancer and Actos use.

Actos cancer trial details 

Millions of Americans have used Actos to treat their Type 2 diabetes since the FDA approved the drug in 1999.  In 2011, however, the FDA advised that use of Actos for longer than one year increased patients’ risk of bladder cancer by as much as 40% compared to patients who had never used the drug.  The FDA’s advice was based on results after five years of a planned ten-year study of over 193,000 diabetes patients.

Nearly 3,000 Actos cancer lawsuits were centralized in the Louisiana federal court as a way to streamline pretrial proceedings.  The MDL procedure allows the court to resolve pretrial issues common to all the lawsuits at one time.  Then the parties select a few representative or “bellwether” cases to go to trial.  The procedure often facilitates settlement, as defendants understand the likely outcome of the remaining cases, and try to minimize the time and expense of multiple separate trials.

On top of the thousands of cases pending in the MDL, many other patients have filed lawsuits in state courts around the country charging that Actos caused bladder cancer.  To date at least three cases have been concluded.  Two 2013 trials resulted in jury verdicts of $1.7 million and $6.5 million, although the verdicts ultimately were vacated.  A third trial led to a decision in favor of Takeda.

The Actos cancer trial in Louisiana will continue to draw attention as witnesses testify for both sides.  Based on the parties’ original estimates, the jury should begin its deliberations sometime in late March.

Great news for folks injured by Actos diabetes drug. As most people know the first federal Actos trial is set to start on Monday February 3rd. The jury has been picked and is ready to go into a marathon trial expected to last several weeks.

Takeda Pharmaceutical Co., the manufacturer of the type 2 diabetic drug, Actos, must let a jury hear claims that it intentionally destroyed files related its Actos diabetes drug. The federal judge overseeing the trial has made this ruling, to allow this evidence and jury instruction, known as a Spoliation of Evidence. The jury is allowed to infer that the destroyed documents were damaging to the company.

Takeda Allegedly Intentionally Destroyed Key Documents

U.S. District Judge Rebecca Doherty said, Takeda admitted they can’t find files compiled by 46 current and former employees involved with the development, marketing and sale of Actos, including those of two directors. Some files were deleted from company computers after executives warned employees to retain Actos-related material.

“The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing,” Doherty wrote in a January 27 court filing.

Takeda Under Fire

Takeda, Asia’s largest drug maker, is preparing for the federal-court trial in Lafayette, Louisiana, about a month after it scrapped development of another diabetes drug when research linked it to liver damage.

To punish the company, the judge will let lawyers for an Actos user suing Takeda over his bladder cancer tell jurors about the document destruction at his trial. The judge stopped short of awarding the plaintiff a default judgment over his case, stating that was too severe of a punishment.

Takeda Downplayed Actos Bladder Cancer Concerns

Plaintiffs allege that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. and misled FDA regulators about its risks.

Actos Blockbuster Drug

Sales of Actos 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 Bloomberg.
Actos has generated more than $16 billion in sales since its 1999 release, according to court filings.

Federal Court MDL

The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette). Allen’s case is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, U.S. District Court, Western District of Louisiana (Lafayette).

Posted by Shezad Malik MD JD
February 1, 2014 11:31 AM

Today, the jury selection was underway in the first federal bellwether trial to take place involving allegations that the side effects of Actos caused bladder cancer.

Plaintiff Allen Alleges Damages from Actos

This first federal Actos bellwether trial by Terrence Allen and his wife, Susan, will be the first one out of 2,700 pending lawsuits. Allen took Actos from 2004 until 2011, when he was diagnosed with bladder cancer.

The plaintiffs allege that Takeda Pharmaceuticals failed to warn patients and doctors about the elevated risk of bladder cancer with long-term use of the diabetes drug, and withheld this important safety information. Allen maintains that if he and his physicians had known about the risk of bladder cancer, he would have not taken the drug.

Federal MDL Consolidation

U.S. District Judge Rebecca F. Doherty, is presiding over the centralized federal Actos MDL (multidistrict litigation) in the U.S. District Court for the Western District of Louisiana. Trial is expected to last about six weeks.

The Allen case is a “bellwether” trial, designed to help the parties determine how juries are to respond to similar scientific evidence and testimony throughout other Actos bladder cancer lawsuits.

Actos Trial Outcomes

Three Actos cases have gone to trial in various state courts. In May 2013, a California jury found that Takeda liable for increased Actos bladder cancer risk and awarded $6.5 million in damages, but, the trial judge reversed the verdict after excluding the plaintiffs’ expert witness testimony.

In September 2013, a Maryland jury found that Takeda liable for the Actos risks, and awarded the plaintiff $1.77 million in damages. But the jury also found that the plaintiff failed to exercise reasonable care for his own health, which cancelled the negligence of Takeda and so the verdict was reversed.

In December 2013, a Nevada jury, found for the defense, after evidence was presented that the plaintiff also used generic versions of Actos from online pharmacies.

It is expected that if the plaintiffs are successful in this trial, then it may pave the way for a global settlement.

Posted by Shezad Malik MD JD from "The Legal Examiner"
January 27, 2014 10:06 PM

• With the outcome of thousands of lawsuits potentially at stake, the first bellwether Actos cancer trial is scheduled to begin soon in U.S. District Court for the Western District of Louisiana. This trial is expected to set the tone for future Actos litigation, as plaintiffs, defendants and their attorneys get an early taste of how juries might respond to testimony and evidence. Over 3,000 plaintiffs with complaints currently pending in federal court against Actos manufacturer Takeda will be watching this first bellwether trial with interest to see how their cases might eventually resolve.

Actos is a type 2 diabetes drug that, according to product liability lawsuit complaints, significantly raises the risk of bladder cancer in patients who use the drug for more than 12 months. Plaintiffs who developed cancer after using Actos allege that Takeda never adequately warned them of the risk.

Bellwether case selected out of thousands

The first Actos bellwether trial was selected by representatives for both plaintiffs and defendants out of more than 3,000 Actos bladder cancer lawsuits currently filed in federal court, and thousands more expected to join them. The trial is scheduled to begin on January 27, 2014. The plaintiffs in this complaint, Terrance Allen and his spouse, allege Allen’s use of Actos to treat type 2 diabetes from 2004 to 2011 led to a bladder cancer diagnosis in 2011.

The plaintiffs plan to show in their trial that Actos was a direct cause of his bladder cancer, and thatTakeda failed to warn consumers about the potential risk associated with their drug.

Actos was approved by the FDA to treat type 2 diabetes in 1999. The drug has been used for long-term management of diabetes, as it was in Allen’s case. However, studies have now shown long-term use of Actos can significantly increase a person’s risk for bladder cancer.

History of Actos side effects

In 2011, the FDA reported results from the first half of a 10-year study that showed patients who took higher doses of Actos for one year or longer increased their risk for bladder cancer by as much as 40%. The agency published those results in a safety communication on its website and alerted the medical community and consumers that the warning would also be added to the product’s label. However, many individuals who took the drug and developed bladder cancer prior to the 2011 warning have filed lawsuits against Takeda, claiming the company failed to provide proper warnings about their product.

In December, 2011, eleven cases involving Actos side effects were transferred to the U.S. District Court in Louisiana and coordinated into multidistrict litigation. Also referred to as MDL, multidistrict litigation is assigned when there is a growing number of complaints involving common questions of fact. The coordination is designed to make early trial proceedings more efficient and convenient for plaintiffs, defendants and witnesses.

Growing MDL numbers

Since the MDL was established, the case number has grown to more than 3,000 in coordinated proceedings. In addition, there are hundreds more Actos lawsuits pending in state courts across the country. Three of those cases have already been decided. Two ended in favor of the plaintiffs, including jury awards of $1.7 million and $6.5 million, although one verdict was thrown out by the judge because of a technicality of law, and the other is on appeal. The third was decided in favor of the defendant.

Despite these early rulings, this first bellwether trial will be the one to truly set the stage for future Actos litigation. The judge overseeing these trials, Judge Rebecca Doherty, will preside over all pretrial proceedings, including motions and discovery proceedings. Bellwether trials are also often the catalysts to begin settlement negotiations between plaintiffs and defendants.

As the court, plaintiffs and defendants continue to prepare for this first Actos lawsuit trial on January 27, thousands of eyes will be on the Western District of Louisiana to determine how Actos litigation might proceed in the future.

Reporter Whitney Taylor

The nation’s third trial of an Actos lawsuit involving allegations that long-term use of the Type 2 diabetes drug can cause bladder cancer is now underway in the Eighth Judicial District Court of Nevada for Clark County. The lawsuit was brought on behalf a patient who began taking Actos before bladder cancer warnings were added to the drug’s label in 2011.The complaint accuses Takeda Pharmaceuticals of concealing knowledge of an association between Actos and bladder cancer until the company was forced to make the 2011 label change. The jury hearing the Actos lawsuit is expected to begin deliberations by the middle of December.

Actos Lawsuits 
Court records indicate that more than 3,000 Actos lawsuits involving bladder cancer allegations have been filed in courts around the country. More than 2,500 of those claims are pending in a multidistrict litigation now underway in U.S. District Court, Western District of Louisiana. That litigation’s first bellwether trials are scheduled to begin next year

According to court documents, two other Actos lawsuits have gone to trial at the state level, both of which ended with jury decisions favoring plaintiffs. However, a $6.5 million verdict awarded to a Plaintiff in California Superior Court in April was set aside by the judge overseeing the case, and is currently on appeal. (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court)

A second trial involving Actos and bladder cancer concluded in Maryland State Court in September, with $1.7 million being awarded to the family of a man who died of the disease. However, according to court records, the judge presiding over that trial overturned the verdict in accordance with Maryland law because the jury also found that the decedent’s decades-long smoking habit contributed to the development of the disease.

According to court documents, the Actos litigation began to grow after the U.S. Food & Drug Administration (FDA) warned in June 2011 that use of the drug for 12 months or more had been associated with an increased risk of the disease. At that time, the FDA ordered Takeda Pharmaceuticals to add new warnings to the Actos label about its potential to cause bladder cancer.

Long-term users of Actos who have been diagnosed with bladder cancer may be eligible to file an Actos lawsuit against Takeda Pharmaceuticals.

For more information on ACTOS, contact Foulston Law

Bloomberg News

By Jef Feeley - Mar 5, 2013 11:01 PM CT

Takeda Pharmaceutical Co. (4502), Asia’s biggest drug maker, put sales of its Actos diabetes drug ahead of concerns about consumer safety, a witness testified in the first trial over claims the medicine caused cancer.

In 2005 e-mails discussing whether regulators in the U.S. and Europe might seek warning labels about Actos’s potential links to bladder cancer, Takeda officials emphasized protecting the product rather than its users, Howard Greenberg, a clinical pharmacologist, said in state court in Los Angeles yesterday.

“There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg told jurors in the first day of testimony about Jack Cooper’s claims over Actos.

Testimony in the trial comes about a month after Osaka, Japan-based Takeda won U.S. regulatory approval for Nesina, a replacement for Actos, which lost patent protection last year. Actos sales peaked in the year ended March 2011 at $4.5 billion for Takeda, accounting for 27 percent of the company’s revenue at the time, according to data compiled by Bloomberg.

The U.S. Food and Drug Administration approved Actos for the U.S. market in 1999 and the drug later became the world’s best-selling diabetes treatment.

European Regulators

Health regulators in Germany and France ordered Actos pulled off the market in 2011 after an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems.

Takeda executives said in a Feb. 11 statement the Actos study regulators reviewed is continuing and final results should be available next year. Other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased, Takeda said.

Cooper, a retired cable splicer for Pacific Bell, was diagnosed with bladder cancer in 2011, according to court filings. He took Actos for more than four years. His lawyer told jurors in opening statements that Cooper had been in “good shape” before he started on the medication, regularly walking five miles, repairing his own roof and going deep-sea fishing with his grandchildren.

Takeda’s lawyer countered in her opening statement that Cooper’s history as a smoker and his gender put him at higher risk for developing bladder cancer. The disease is the fourth-most common cancer among men after prostate, lung and colon cancer, according to the Bladder Cancer Advocacy Network.

Internal Documents

Greenberg, testifying as an expert for Cooper, said he reviewed internal Takeda documents to prepare for his testimony, according to an online feed from Courtroom View Network. Greenberg said he formerly worked as a drug researcher for companies such Bristol-Myers Squibb Co. (BMY) and Johnson & Johnson (JNJ)’s Janssen Pharmaceuticals unit.

Among the files Greenberg reviewed was an August 2005 e-mail from Takeda executive Kiyoshi Kitazawa on regulators’concerns about Actos’ cancer links, the pharmacologist said.

In the e-mail, Kitazawa highlighted Actos’s value for colleagues who had analyzed what regulators might do in the wake of research showing that users may be at higher risk of getting bladder cancer. Takeda officials were worried that regulators would demand that the company add warnings about the illness to Actos’s label, according to the e-mail.

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Kitazawa said.

Worst-Case

Takeda officials said that the “worst-case scenario”would be for regulators to mandate the inclusion of a bladder cancer warning on Actos’s label, according to the e-mail. Kitazawa urged colleagues to seek a “positive outcome” on the warning issue from “regulatory authorities,” the e-mail shows.

Under cross examination by Takeda lawyer Bruce Parker, Greenberg acknowledged that employee e-mails may not indicate the drugmaker’s corporate policies on issues such as patient safety. “I’d agree with that,” the pharmacologist said.

The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).

The Foulston Law Office is following the latest developments in the Actos trial currently in progress in Los Angeles. According to a Bloomberg News article published on March 6th, a clinical pharmacologist has testified that Takeda Pharmaceutical appeared to care more about product sales than patient safety.  This critical testimony suggests that Takeda knew the risk factors of Actos but failed to warn patients and their doctors.

Actos is a Type 2 diabetes medication that is the subject of thousands of lawsuits alleging that the drug caused bladder cancer. Users of this drug should be aware that there is a substantial amount of evidence indicating that drug may increase their risk of bladder cancer.

The Foulston Law Office offers free legal advice to Actos patients who feel that they were injured by use of this drug.

According to Bloomberg News, clinical pharmacologist, Howard Greenberg, testified  in Los Angeles state court in the case (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles). In his testimony, Greenberg said that emails in 2005 revealed that Takeda officials cared more about protecting Actos than protecting patients; the emails discussed whether or not a warning label would be required by US and European regulators over a link to bladder cancer. “There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg stated. One of the emails he reviewed in preparation for his testimony was written by Takeda executive Kiyoshi Kitazawa, who emphasized how valuable Actos was for the company and noted the implications of what regulators might do in light of research showing that the drug is linked to bladder cancer. “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Kitazawa wrote.

Plaintiff, Jack Cooper, was diagnosed with bladder cancer after taking Actos for over four years. His lawsuit is one of thousands filed over the drug, and alleges that Takeda knew about the cancer risks but failed to warn the public. Bloomberg News reports that Actos sales peaked at $4.5 billion as of March 2011; this accounted for 27 percent of Takeda’s total revenue at that time.

Actos was approved in 1999 and was once the world’s best-selling Type 2 diabetes drug, notes Bloomberg News. In 2011, the U.S. Food and Drug Administration (FDA) updated the safety label on Actos to warn that the drug may increase the risk of bladder cancer after one year of use.

A number of Actos lawsuits are pending in the U.S. District Court for the Western District of Louisiana as part of the multidistrict litigation (MDL) entitled In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299). Judge Rebecca Doherty is presiding over the litigation.

For more information on this topic, please contact the Foulston Law Office.