Litigation

Takeda To Pay Up To $2.4 Billion To Settle About 9,000 Actos Bladder Cancer Claims

LAFAYETTE, La. — (Mealey’s) Takeda Pharmaceutical Co. Ltd. will pay up to $2.4 billion to settle the “vast majority” of Actos bladder cancer lawsuits in the United States, the company, plaintiff attorneys and the multidistrict litigation court said April 28 (In Re:  Actos [Pioglitazone] Products Liability Litigation, MDL Docket No. 2299, No. 6:11/md-2299, W.D. La., Lafayette Div.). 

In an April 28 press release, Takeda said it will pay $2.37 billion into a settlement fund if 95 percent of the current litigants opt into the settlement but said that will rise to $2.4 billion if 97 percent or more opt in.  

In an April 28 press release, Richard J. Arsenault of Neblett, Beard & Arsenault in Alexandria, La., co-chair of the MDL Plaintiffs’ Executive Committee, said the settlement “is intended to resolve nearly 9,000 bladder cancer claims.”  As of April 15, the Judicial Panel on Multidistrict Litigation said there are 4,302 cased pending in the MDL. 

Dosage, Smoking Affect Awards   

Arsenault said awards “will be determined using case-specific factors, such as cumulative dosage and smoking history, along with the extent of injury.”  The range of awards was not immediately available. 

On April 28, U.S. Judge Rebecca F. Doherty of the Western District of Louisiana, where the MDL is located, issued an order stating that the Master Settlement Agreement covers cases in the MDL, in other federal courts, in coordinated Actos dockets in Illinois and California, in any other state court and any unfiled claims.  She said the Actos Resolution Program settlement will cover alleged injuries occurring between Dec. 1, 2011, and April 28, 2015. 

Eligible plaintiffs and claimants who haven’t filed lawsuits have until July 13 to elect to participate in the resolution program by submitting an opt-in package.  The claims administrator may grant a 30-day extension with the parties’ agreement.

 Takeda Walk-Away Rights

Takeda may terminate the settlement within 45 days of the final opt-in extension if too few claimants participate. 

Claimants have 90 days following the effective date of the resolution program to submit claim packages seeking an award. 

Enrollment in the resolution program is irrevocable, the judge said. 

Gary J. Russo was appointed special master to hear motions to dismiss claims that fail to comply with the terms of the agreement. 

MDL Judge Orders Claims Census

The settlement agreement can be found online at www.actosofficialsettlement.com

Also on April 28, Judge Doherty ordered primary plaintiffs’ counsel to provide a “census of claims,” whether filed or unfiled. 

Judge Doherty also granted a joint motion to stay MDL discovery and to adjourn all deadlines. 

The MDL judge also ordered nonparticipating federal plaintiffs to preserve records and prima facie evidence of usage, injury and causation. 

Takeda Denies Liability

In its statement, Takeda said it believes that the Actos claims are without merit and said the company does not admit liability.  It noted that Actos remains on the market. 

Eli Lilly and Co. co-marketed Actos with Takeda and is a co-defendant in some cases.  It is not known if the settlement resolves claims against Lilly. 

Seven Actos bladder cases have gone to trial with mixed results.  Plaintiffs won four verdicts, but two of them were overturned.  Takeda won three defense victories. 

$9B MDL Verdict

The most notable verdict came in the first MDL bellwether trial, where the jury in April 2014 returned a verdict of $9 billion, mostly in punitive damages.  The MDL judge later remitted the punitive damages to $36 million. 

Takeda appealed that verdict to the Fifth Circuit U.S. Court of Appeals.  That court recently granted the parties an extension for briefing. 

The large punitives verdict is believed to be the result of spoliation of evidence by Takeda.  The MDL court separately found that Takeda acted in bad faith by failing to preserve evidence or destroying evidence and ordered the defendant to reimburse plaintiffs for expenses and fees related to spoliation motions. 

Since then, plaintiffs have attempted to introduce spoliation evidence into trials with mixed results. 

State Trial Verdicts

In February, a Pennsylvania state court jury awarded a plaintiff $2.3 million.  In June, Takeda won defense verdicts in two trials in Nevada and Illinois. 

Takeda won its first defense verdict in a January 2014 Nevada state court trial. 

In September 2013, a Maryland state court jury awarded a plaintiff $1.7 million.  The judge vacated the verdict because of the state’s contributory negligence standard. 

In May 2013, a California state court jury awarded a plaintiff $6.5 million.  That verdict was also vacated after the trial judge, in a post-verdict ruling, excluded the plaintiff’s causation expert. 

Miller Firm Not Participating

Michael Miller of The Miller Firm in Orange, Va., who has tried several state court Actos cases, told Mealey Publications that “The Miller Firm is not affected by these settlements.  We have trials against Takeda scheduled June 8 and June 15 as well as more Actos trials later this year.” 

Actos is an oral drug prescribed to help lower blood glucose in people with type 2 diabetes.  Plaintiffs allege that the drug causes bladder cancer and that Takeda failed to adequately warn doctors and patients about that risk. 

Takeda said it will take a $2.7 billion charge against earnings in the fourth quarter of fiscal year 2014 to cover the settlement and defense costs for remaining cases “and for other related litigation. 

The MDL plaintiffs are represented by Paul J. Pennock of Weitz & Luxenberg in New York and Arsenault. 

Takeda is represented in the MDL by Sara J. Gourley of Sidley Austin in Chicago and David R. Dugas of McGlinchey Stafford in Baton Rouge, La.

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