A federal jury in Lafayette, La., last month ordered Takeda Pharmaceutical Co., based in Osaka, Japan, and its partner, Eli Lilly & Co, based in Indianapolis, Ind., to pay a combined $9 billion in punitive damages. The jury determined the drug makers hid cancer risks associated with their Actos diabetes medicine from the public. The drug has been linked to the development of bladder cancer. This was the first federal trial in this litigation.
Mark Lanier of the Lanier Law Firm based in Houston, Texas, was the lead attorney for the Plaintiffs at trial. Paul J. Pennock of Weitz & Luxenberg PC and Richard J. Arsenault of Neblett Beard & Arsenault also represented the Plaintiffs in the lawsuit, Terrence Allen and his wife Susan. Mr. Allen developed bladder cancer after using Actos.
In addition to the punitive damages, the jury also awarded the Allens $1.5 million in compensatory damages. The punitive damages are to be paid as follows: Takeda was ordered to pay $6 billion, while Lilly will pay $3 billion. Beasley Allen lawyer Andy Birchfield, who is head of the firm’s Mass Torts section, had this to say about the trial:
Thousands of people have bladder cancer as a result of the egregious conduct of these drug companies regarding Actos. As long as potential drug sales are wildly lucrative, companies will face the temptation to ignore or hide serious safety concerns. This verdict sends a clear message for companies to beware; there is accountability in the courts.
Andy was appointed to the Plaintiffs’ Steering Committee (PSC) by U.S. District Judge Rebecca Doherty, who is in charge of the Actos multidistrict litigation (MDL), and presided over the Alden case. The PSC heads up and supervises the Actos MDL. As a member of the PSC, Andy assisted in pretrial preparation for the Allen trial.
Actos lawsuits filed in federal courts have been consolidated under Judge Doherty in U.S. District Court for the Western District of Louisiana. Lawsuits claim Takeda and Eli Lilly misrepresented and omitted information it held about Actos and “actively concealed its risks.” The lawsuits also claim Plaintiffs were not adequately warned about Actos risks and could have taken several safer alternative drugs had they known about the health risks posed by Actos.
Actos is prescribed to treat Type 2 diabetes. The U.S. Food and Drug Administration (FDA) began a review of Actos and cancer risk in September 2010, when the agency issued a safety announcement suggesting a potential risk with Actos. The FDA reported in its data summary that the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure. The FDA later updated its safety label for Actos to state that the use of the drug for more than one year may be associated with an increased risk of bladder cancer. In June 2011, the FDA issued a warning for Actos.
This bellwether trial for allegations the companies hid the cancer risks of diabetes drug Actos to keep sales high was the first federal jury decision in multidistrict litigation against Asia’s largest drug company and its American partner Eli Lilly. Eli Lilly partnered with Takeda to market the drug from 1999 to 2006. The companies, which jointly marketed the drug, were the only Defendants in the case.
The jury found Takeda hid the results of clinical studies it has known about since before the drug was approved by the FDA that showed that using the drug can cause bladder cancer. Mr. Allen, a former shopkeeper in New York, sued the company in 2011, saying the company’s executives knew the drug caused bladder cancer in animals and humans, but kept it hidden from the public because the drug was profitable for the company.
The Allens alleged that even before Takeda applied for approval from the FDA, it knew from the results of animal testing that the drug could cause bladder cancer, according to the original complaint. Later, in the early 2000s, clinical trials in humans had shown it would induce the cancer. But the executives at Takeda said nothing, and instead made more than $16 billion in sales since Actos’ release. The drug represented more than a quarter of Takeda’s total sales in 2011, at its peak. In June of that year, the FDA alerted the public that use of the drug for longer than a year could cause bladder cancer, and the agency discouraged doctors from prescribing it to patients with active bladder cancer.
Thousands of lawsuits have been filed related to the drug’s carcinogenic side effects. More than 6,000 of them were sent to multidistrict litigation in Louisiana. Takeda’s lawyers argued that bladder cancer wasn’t caused by Actos, but by other factors, such as age, gender and smoking habits. Takeda claims it properly warned consumers as the information became better understood that prolonged consumption of the drug could be harmful.
Before the federal bellwether trial began, Takeda faced the possibility of sanctions for a potential breach of duty to preserve evidence. Takeda put a litigation hold on documents and electronic data related to Actos in 2002, yet repeatedly destroyed emails and other documents with information about the drug during much of the next decade. Judge Doherty, who is overseeing the multidistrict litigation, made a ruling on Jan. 27 that said the documents Takeda destroyed were relevant to the Plaintiffs’ claims and would likely prove beneficial to their case. Takeda’s failure to preserve the evidence was likely to prejudice the Plaintiffs, she said in the order.
Eli Lilly was accused of perjury during the trial when a former employee was said to have lied on the stand during testimony. The Allens on March 3 sought a default judgment against Eli Lilly for willfully disobeying the court’s authority during the trial, which has been ongoing since Feb. 3. The motion for sanctions targets the testimony of Ronald Hoven, a former senior director for global marketing at Eli Lilly. According to the Plaintiffs, Hoven “expressed a stunning lack of knowledge” about the company’s marketing of Actos during hours of testimony before the jury. The result in this important case had to get the attention of the bosses at the two drug companies. We will see if it changes their attitude toward the Actos’ victims.
Sources: Reuters and Bloomberg News
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