Actos

  • Actos Medical Record Review & Outsourcing Services

Actos (pioglitazone) is an oral diabetes medicine of the thiazolidinedione (TZD) class used to treat Type 2 diabetes. Actos is manufactured by Japanese pharma giant Takeda Pharmaceutical and marketed by Eli Lilly, one of the largest drug companies in the U.S. (Eli Lilly stopped marketing Actos in 2006). It is available in 15mg, 30mg, 45mg and is prescribed once a day. Actos increases the body’s sensitivity to insulin and decreases the amount of sugar that is stored in the liver. It can only be prescribed to patients who can make their insulin. Though being effective in treating Type 2 diabetes, concerns about Actos arose over serious diseases like kidney disease, bladder cancer, and bone fractures. It was approved by the U.S Food and Drug Administration (FDA) in 1999, in a tablet form (15 and 30 mg) for oral administration. Actos is used alone or in combination with other diabetes medications. On August 17, 2012, the US FDA announced its approval of the first generic version of Actos.

Serious Alleged Injuries may include:

  • Increased Risk Of Bladder Cancer
  • Chronic Kidney Disease
  • Lactic Acidosis
  • Bone Fractures
  • Congestive Heart Failure

FDA Safety Warnings:

  • In 2007, the FDA also issued a black-box warning for congestive heart failure.

  • In a safety announcement published in June 2011, the FDA warned that patients using Actos can result in increased risk of bladder cancer. Long-term use of Actos is linked to several side effects and serious health complications, including bladder cancer that led to lawsuits against Takeda.

Legal Updates:

Defendants: Takeda Pharmaceuticals, Eli Lilly & Co.

Defendant Law Firm: Norton Rose Fulbright US LLP, Tucker Ellis LLP, and Bowman and Brooke LLP.

Allegations: Plaintiffs alleged that the drug manufacturer Takeda and the drug marketer Eli Lilly knew about the risk of bladder cancer and other side effects caused by the drug but failed to warn the public.

Plaintiff Steering Committee:
Paul J. Pennock - Weitz & Luxenberg

Richard J. Arsenault - Neblett Beard & Arsenault

A.J. De Bartolomeo - Girard Gibbs

Andy D. Birchfield - Beasley Allen

Christopher A. Seeger - Seeger Weiss

Daniel S. Robinson - Robinson Calcagnie

Dawn M. Chmielewski - Neblett Beard & Arsenault

Dianne M. Nast - Nast Law

Donald C. Arbitblit - Lieff Cabraser

Jayne Conroy - Hanly Conroy

Jerrold S. Parker - Parker Waichman

Neil D. Overholtz - Aylstock Witkin & Sasser

Nicholas J. Drakulich - Drakulich Firm

Orran Brown, Sr. Brown Greer - Brown Greer: Greer Lynn C

Stephen B. Murray - Murray Law Firm

Tara Tabatabaie Sill Law Group - Troy A. Rafferty, Levin Papantonio

Vance R. Andrus - Andrus Hood & Wagstaff

W. Mark Lanier - The Lanier Law Firm

W. James Singleton - Singleton Law Firm

Lawsuit Status:

2011: More than 10,000 Actos side effects lawsuits were filed against the drug maker Takeda Pharmaceuticals.

Nearly 4,000 federal cases were a part of the Multidistrict Litigation (MDL) in the U.S. District Court for the Western District of Louisiana in Lafayette. U.S. District Judge Rebecca Doherty (In Re: Actos (Pioglitazone) Products Liability Litigation, 11-MD-02299, U.S. District Court, Western District of Louisiana. About 4,500 cases were filed in various state courts including Illinois, Pennsylvania, California, and West Virginia. 

2015: About 5,000 federal multidistrict litigation (MDL) cases and 4,000 local, state and local Actos lawsuits were eligible for Actos settlement. Another 4,500 lawsuits were filed in state courts of Illinois, California, Pennsylvania, and West Virginia. Before Takeda announced its plan to pay $2.4B to settle Actos Lawsuits, nine cases went to trial. Takeda was ordered to pay more than $22 million by the trial juries to injured Actos users. 

2018: The Actos MDL was closed in April 2018 as the majority of the cases in the MDL were resolved in the settlement.  

MDL Status: Closed In April 2018

Important Verdicts And Settlement:

2014: In April 2014, plaintiff Terrence Allen, a former shopkeeper was awarded $9 billion in punitive damages and $1.5 million in compensatory damages by U.S. District Judge Rebecca Doherty in Louisiana as he was diagnosed with bladder cancer. The jury found Takeda 75 percent liable and Lilly 25 percent liable, awarding plaintiff with $6 billion in punitive damages against Takeda and $3 billion against Eli Lilly. Doherty stated that the original $9 billion damages award was excessive and violated the company's constitutional rights. She ordered Takeda to pay $27.6 million and Eli Lilly to pay $9.2 million a total of $36.8 million. 

 2015: Takeda settled about 9,000 Actos side effects lawsuits for $2.4 billion in 2015 without admitting any guilt and continued to believe the benefits of Actos outweigh the risk of cancer. Actos settlement became one of the largest Big Pharma settlements in the U.S. history. The settlement followed eight Actos jury verdicts. Before the opt-in deadline of September 11, 2015, the settlement amount was increased from $2.37 to $2.4B as a percentage of claimants exceeded. Average payments per person will be increased for more severe injuries, and reductions will occur where an individual had other likely causes of bladder cancer, such as smoking.

The U.S. District Court, overseeing Actos injury cases in the federal court nationwide issued an order recognizing that Takeda has agreed to settle all bladder cancer claims made against the company by Actos users provided three conditions are met:

  1.  They took Actos at some time prior to December 1, 2011,

  2.  They were diagnosed with bladder cancer on or before April 28, 2015, and

  3.  They are represented by counsel or retained counsel by May 1, 2015

    Scoring Actos Cases:

    1. A meticulous review of plaintiff's medical and pharmacy records of the entire treatment duration.

    2. A thorough comparative analysis in light of risk and adjustment factors are needed to achieve the desirable and most appropriate compensation.

Evidence:

  • Duration of Usage
  • Usage in Pharmacy Records
  • Indication of usage in Medical Records

Medical Record Review and claim validation of Actos case should take approximately 5 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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