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According to confidential sources and as reported in today’s Bloomberg News, Takeda Pharmaceutical Co. has indicated that it will pay more than $2.3 billion to settle the pending Actos lawsuits over bladder cancer claims. Asia’s largest drugmaker tentatively agrees to settle more than 8,000  Actos bladder cancer lawsuits in federal and state courts in the U.S.

This global settlement would still have to ratified by Takeda’s board of directors, a board meeting is set to occur soon. Any settlement deal would average about $275,000 for each case, and would be the first in the four year old litigation over the diabetes drug. If approved, the global settlement may be announced at the next federal court hearing which is set for May 22.

Tentative Actos Settlement Details

As is common in complex pharmaceutical ligation, a grid settlement matrix will be applied to the bladder cancer cases. Folks will be awarded points for their injury as a baseline, points will be deducted for pre-existing risk factors such as smoking, exposure to toxins known to cause bladder cancer and low cumulative dose of Actos. Folks with a higher cumulative dose will get more settlement than folks who took Actos for less than a year. Folks who had pre-existing bladder cancer will get less than folks who developed bladder cancer while on Actos.

Plaintiffs who developed severe metastatic spread of the disease or died as a result of the cancer, will get the highest settlement. The exact amount payable is still being worked out, and even if the settlement was announced today, plaintiffs can expect their settlement checks a year from now. It just takes that much time to enroll the plaintiffs into the settlement, review each person’s medical records and negotiate the amount to be paid back to the insurance companies, including Medicare and Medicaid to pay back the medical expenses incurred as a result of the cancer.

It is unclear, whether Takeda will cut off the settlement to those folks who developed or filed their injury cases after the December 2011 label change and FDA warning. This is known as Statute of Limitations, most states have a hard 2 year statute of limitations in personal injury cases, an injured person has to file their claim within 2 years of when they got injured or when they knew or should have known that the injury was a result of a defective drug or medical device.

Actos Bladder Cancer Lawsuits Continue to Increase

There are more than 4,000 federal personal injury, product liability lawsuits pending against Takeda Pharmaceuticals and Eli Lilly. The claims blame the companies for providing inadequate warnings about the risk of bladder cancer from Actos, a blockbuster type 2 diabetes drug.

Louisiana Federal Multi-district Litigation

Since December 2011, federal lawsuits have been centralized before U.S. District Judge Rebecca F. Doherty in the Western District of Louisiana, as part of an MDL, or Multi-District Litigation.

It is common in mass tort pharmaceutical and medical device cases, that small groups of cases are prepared for early trial dates, known as “bellwether” cases.

The first federal Actos trial ended in a record breaking $9 billion jury verdict last year. The jury found evidence that the drug makers deliberately destroyed documents about Actos and bladder cancer link. Takeda also deleted the files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives.

Judge Doherty post verdict, reduced the punitive damage award in the case to $37 million. The case is on appeal.

8,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 4,000 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. According to court documents, Takeda is exposed to another 4,500 claims in state courts in Illinois, West Virginia and Pennsylvania.

Takeda is blamed for not disclosing that that Actos use can lead to bladder cancer. All of the lawsuits allege that Takeda knew or should have know about the increased risk of bladder cancer and yet failed to alert patients, doctors and the FDA. The Japan-based drugmaker suggested the settlement thinking that it could avoid more huge verdicts and to put this litigation behind them. They will be getting off cheap if accepted.

Actos VerdictsThe most recent trial in Philadelphia, is the ninth Actos patient to take bladder-cancer claims before a jury, and the fifth case to score a victory against the Asian pharmaceutical giant. The company folks in Osaka, Japan will have to give serious thought to stop the hemorrhaging of money in the defense of these indefensible bladder cancer cases and go for a global settlement.

Several Actos bladder cancer cases have have been tried in state court, with multi-million damage awards awarded in many of the cases. Most recently, Takeda was hammered with a $3.6 million damage award in a Pennsylvania case, including $1.3 million in punitive damages designed to punish the drug makers.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).

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