Actos. In Re: Actos (Pioglitazone) Products Liability Litigation. U.S. District Court, Western District of Louisiana. Mass Tort - Pharmaceutical

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1 Actos Case Caption: MDL Jurisdiction: MDL Docket: Case Type: In Re: Actos (Pioglitazone) Products Liability Litigation U.S. District Court, Western District of Louisiana 6:11-md-2299 Mass Tort - Pharmaceutical Summary Actos is a prescription Type II diabetes drug. Defendants named in the litigation are Takeda Pharmaceuticals and Eli Lilly and Company. Plainitffs allege that they purchased and ingested Actos believing it to be safe based upon the promotions, advertising, marketing and labeling by Defendants. Further, Plaintiffs contend that the ingestion of Actos posed significant safety risks due to design defects and inadequate testing, which risks included the development of bladder cancer. On December 29, 2011, the Actos litigation was consolidated as a multi-district litigation ( MDL ) in the United States District Court for the Western District of Louisiana, assigned to Hon. Rebecca F. Doherty. In an effort to coordinate the MDL Actos cases with those in state court, Judge Doherty created a webpage designed specifically to provide information to the state court judges. See Actos has only one active ingredient, pioglitazone, and is part of a class of drugs known as thiazoldidinediones ( TZDs ). TZDs are oral anti-diabetic agents that decrease insulin resistance. The other TZDs are Avandia (rosiglitazone) and Rezulin (troglitazone). After the FDA-approval of Actos in 1999, Takeda Pharmaceuticals North America and Eli Lilly and Company jointly launched the drug into the U.S. market. Takeda and Lilly partnered together in mutual cooperation and agreement to promote and market Actos until After 2006, Takeda took over marketing Actos (Lilly continued to receive residual royalties from Actos sales until 2009). In 2007, the FDA and manufacturers of TZDs agreed to add stronger warnings of the risk of heart failure after taking certain drugs approved to treat Type II diabetes. The information was included in the form of a black box warning (the FDA s strongest form of a warning). In an alert specific to Actos, the FDA stated that Actos might cause or exacerbate congestive heart failure in some patients. Nevertheless, in 2010, Actos was the 11 th top selling drug in the U.S, with sales exceeding $2.6 billion and in March 2011, sales of the drug peaked at $4.5 billion. In June 2011, the FDA issued a warning informing the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA based its conclusion on data from a 5-year interim analysis of an ongoing 10-year epidemiological study. The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone. Counsel Financial September 2015

2 In June 2013, 23 experts from 9 countries met at the International Agency for Research on Cancer (IARC) to assess the carcinogenicity of fourteen drugs and herbal products. After a detailed review of one large randomized controlled study, 4 cohort studies, and 3 case controlled studies, the Agency determined that pioglitazone should be classified as probably carcinogenic to humans based on the evidence that it causes bladder cancer. Moreover, the British Journal of Clinical Pharmacology published a study in December 2013 that linked the use of TZDs, including Actos, to the development of bladder cancer. Researchers discovered that there was an increased risk of bladder cancer in patients with the highest doses of pioglitazone and in patients who either took Actos between 12 and 24 months or more than 24 months. In addition, the researchers noted that there was a higher overall risk of bladder cancer in patients who used Actos than those who used Avandia. Nevertheless, specific causation is an issue in this litigation as demonstrated by the three trials detailed below. Whether each plaintiff s bladder cancer is actually caused by Actos will be impacted by whether the plaintiff has a pre-existing medical condition, is a smoker, or took the generic-form of the drug (released in 2012). Another issue for plaintiffs counsel is the learned intermediary doctrine. Pursuant to the learned intermediary doctrine, manufacturers of prescription drugs discharge their duty of care if they adequately warn healthcare providers of the risks associated with the drug. Provided below is a summary of some of the Actos trials and subsequent decisions as of August 2015: Case Jurisdiction Date Award Notes Cooper v. Takeda Cal. Super. Ct. - Los Angeles Aug-15 $6,500,000 Verdict. Judge ordered the trial court to enter judgment for Plaintiff in accordance with the jury verdict of April 26, An v. Nieberlein Md. Cir. Ct. - Baltimore Alsabagh v. Takeda Nev. Dist. Ct. - Allen v. Takeda U.S. Dist. Ct. W.D. La. Whitlatch v. Takeda Ill. Cir. Ct. - Cook Sept-13 $1,700,000 Verdict. Judge overturned the verdict because of Maryland s contributory negligence law. Dec-13 - Verdict. Defense was found to have properly warned of the drug s risks. Apr-14 $9,000,000,000 Verdict. Judge refused to overturn the jury award, however, amended the judgment to $36.8 million from $9 billion. May-14 - Verdict. Plaintiff was a former smoker. Triana v. Takeda Nev. Dist. Ct. - Cipriano v. Takeda Nev. Dist. Ct. - May-14 - Verdict. Jury found plaintiff did not meet their burden of proof. May-14 - Verdict. Jury found plaintiff did not meet their burden of proof. Wisniewski v. Takeda Pa. Ct. of Oct-14 $2,050,000 Verdict. Counsel Financial September

3 Common Pleas - Philadelphia Myers v. Takeda W.Va. Cir. Ct. - Berkeley Nov-14 $155,000 Verdict. Award was for spoliation of evidence. Jury found Actos was not unsafe and that Takeda was not negligent. In Cooper v. Takeda Pharmaceuticals America Inc., CGC , California Superior Court, a Los Angeles court returned a verdict in favor of the plaintiff for $6.5 million. The verdict was vacated because the judge held that the medical expert failed to establish that Actos was the cause of the plaintiff s bladder cancer. However, that decision has since been reversed and the $6.5 million verdict has been reinstated. In September 2013, a Baltimore jury returned a verdict for $1.7 million in favor of the plaintiff. See An v. Nieberlein, 24- C , Circuit Court for the City of Baltimore, State of Maryland. The judge in that case also vacated the award, finding that in accordance with Maryland s contributory negligence law, the decedent s decades-long smoking habit contributed to the development of bladder cancer (if a plaintiff is found even 1% liable in Maryland, the plaintiff cannot recover). In Alsabagh v. Takeda Pharmaceuticals America, Inc., et al., A C, Nev. Dist., County, the jury found that defendants were not liable and that company officials had properly warned the plaintiff s doctor of the risk associated the drug. In the first bellwether Actos trial, Allen v. Takeda Pharmaceuticals America, Inc., et al., No. 6:12-cv-0064, U.S. District Court, Western District of Louisiana, the jury awarded the plaintiffs, Terrence and Susan Allen, the sixth largest verdict in U.S. history, slapping Takeda Pharmaceuticals with $6 billion in punitive damages and the drug s co-promoter Eli Lilly & Co. with $3 billion, as well as held each company liable for approximately $1.5 million in compensatory damages. Allen had been diagnosed with bladder cancer after taking Actos from 2007 until On July 26, 2013, the Allens case was chosen to be the first pilot bellwether trial in the Actos MDL. On January 27, 2014, on the date Allens trial was set to commence, Judge Doherty ruled that Takeda Pharmaceuticals had destroyed evidence that would have been relevant to Allen s lawsuit. The Court thereafter issued an order allowing evidence of Takeda s intentional destruction of documents and electronic data to go before the jury. On August 28, 2014, Judge Doherty declined to overturn the Louisiana jury s award of over $9 billion, but in October, the Judge reduced the judgment amount, ordering Takeda to pay $27.6 million and Eli Lilly to pay $9.2 million, for a total award of $36.8 million. Defendants are appealing the award. The first trial in the Illinois Actos docket resulted in a defense verdict on May 15, See Whitlatch v. Takeda Pharmaceuticals America, Inc., No. 12-L-6087, Illinois Circuit Court, Cook County. In April 2001, William Whitlatch was prescribed Actos to treat his diabetes. He was diagnosed with bladder cancer in 2005, and as a result, died in December of On May 22, 2014, a Nevada state court jury returned a unanimous defense verdict in a two-plaintiff Actos trial. See Triana v. Takeda Pharmaceuticals America Inc., No. A C and Ciprano v. Takeda Pharmaceuticals America Inc., No. A , Nev. Dist. Ct., County. Counsel Financial September

4 In October 2014, a Pennsylvania state court jury awarded $2 million to a woman diagnosed with bladder cancer as a result of taking Actos. Wisniewski v. Takeda Pharmaceuticals America Inc., No , Philadelphia County Court of Common Pleas. In November 2014, a West Virginia state court jury ordered Defendants to pay $155,000 in compensatory damages after finding that the companies intentionally destroyed files about the development and marketing of Actos. Nevertheless, the jury held in favor of Takeda concerning claims that the drug manufacturer was negligent, or that Actos was unsafe. See Myers v. Takeda Pharmaceuticals America Inc., No. 13-C-315, West Virginia Circuit Court, Berkeley County. Procedural Status On April 29, 2015, the MDL Court announced that the parties had negotiated an agreement to establish an Actos Resolution Program to resolve all Actos bladder cancer claims pursuant to a Master Settlement Agreement dated April 28, The Master Settlement Agreement establishes a settlement administration program that provides funding to eligible claimants who have both filed and unfiled claims, including those pending as of the date of the agreement: 1. In Re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, a federal multi-district litigation venued in the United States District Court for the Western District of Louisiana; 2. Any other federal court proceedings, either pending in that court or awaiting transfer to the MDL; 3. In re Actos Related Cases, No L , venued in the Circuit Court of Cook County, Illinois, County Department, Law Division; 4. In Re Actos Product Liability Cases Coordinated Proceeding, JCCP No. 4696, venued in the California Superior Court, Los Angeles County, California; and 5. Any other state court proceedings pertaining to actions, disputes, and claims asserted against Defendants regarding the use of ACTOS Products. Under the Master Settlement Agreement, Takeda will create a qualified settlement fund of $2.37 billion contingent upon participation by 95% of the eligible plaintiffs. The total fund will rise to $2.4 billion if 97% of eligible plaintiffs participate. To be eligible for payment from the fund, a claimant must have used Actos on or before December 11, 2011 and been diagnosed with cancer of the bladder, renal pelvis, or ureter. Individual settlements are determined by the use of a point matrix is a system, similar to what was used in the Vioxx litigation. The system provides points to each plaintiff based certain factors, including injury, treatment, age, duration of product usage, timing of product usage and other risk factors leading to the development of bladder cancer. Factors that can reduce a plaintiff s total number of points, and thus, negatively impact the amount awarded, include consumption of less than 16,200 mg of Actos, obtaining a diagnosis more than five years after discontinuing the use of Actos, or a history of smoking or exposure to toxic substances. Of the total fund, $50 million is set aside for Extraordinary Injury claims. Such claims involve economic damages of $200,000 or more, claimants with minor children at time of injury, or other extenuating circumstances not otherwise accounted for on the point matrix. Counsel Financial September

5 The entire Settlement Agreement is subject to a walk away provision if less than 95% of all eligible claimants do not opt into the settlement. In that event, Takeda can elect to void its obligations under the settlement. Conversely, if the 95% threshold is reached, Takeda is bound by all of the terms and conditions. On September 12, 2015, counsel for Takeda and co-lead counsel for the plaintiffs announced the Master Settlement Agreement is final. For more information concerning the Actos settlement of bladder cancer claims: See DISCLAIMER: All materials or information on the Counsel Financial web pages, including, without limitation, the summaries of mass tort litigation, are derived from public record only. Nothing contained herein is confidential or subject to attorney/client and/or work product privileges. Counsel Financial s analysis, commentary, and research is expressed in good faith and believed to be true and accurate, but there can be no assurance or guaranty that the contents of the information presented is true and accurate, or that further events have not transpired since this publication. Information on Counsel Financial s web pages is subject to change without prior notice. Counsel Financial September