A man who developed bladder cancer while using the diabetes drug Actos has been awarded $9 billion in damages in a bellwether trial over allegations that manufacturers hid the risks of getting cancer from Actos.

The Actos settlement marks a huge victory for thousands of plaintiffs suing Takeda Pharmaceuticals and Eli Lilly & Co. over the carcinogenic side effects of Actos. U.S. District Judge Rebecca F. Doherty presided over the bellwether Actos trial, which will set a precedent for the more than 6,000 Actos cancer lawsuits pending in multidistrict litigation in Louisiana.

Plaintiffs Terrance and Susan Allen were awarded the Actos settlement on April 7 by a federal jury who sided with Mr. Allen’s claims that company executives knew that Actos caused bladder cancer in animals and humans due to preclinical trials, but hid this information from the public.

The Allens filed the Actos lawsuit in 2011 after Mr. Allen developed bladder cancer while taking the diabetes medication. The Allens alleged that Takeda know about the risk of Actos bladder cancer from animal testing even before applying for FDA approval of the drug, which was granted in 1999. Several years later, clinical trials in humans showed the same Actos bladder cancer risk.

Despite these findings, Takeda and Eli Lilly failed to include this cancer warning on Actos information packets, allowing them to rake in $16 billion in sales since its release, according to court records.

The jury ordered Takeda to pay $6 billion in punitive damages and Eli Lilly to pay $3 billion. Both companies will also split a payment of $1.5 million in actual damages to the plaintiffs.

Thousands of Actos Bladder Cancer Lawsuits Remain

So far in the litigation process, executives from either company have not admitted to any wrongdoing. In June 2011, the FDA alerted the public that using Actos could possibly lead to bladder cancer, after various injury reports were submitted to the FDA.

Like the Allens, thousands of plaintiffs with lawsuits pending in the Actos MDL are accusing Takeda and Eli Lilly of hiding crucial medical information regarding the side effects of Actos.  Allegedly, the companies had taken actions to conceal the fact that the drug may cause bladder cancer after one year of use.  Eli Lilly has been partnered with Takeda since 1999 to jointly produce and sell Actos, and the partnership lasted until 2006.

In most of these Actos lawsuits, including the Allens’, Takeda’s legal team tried to argue that the bladder cancer had been caused by other complications of the plaintiffs’ health, including age, gender and smoking habits.  Takeda also stated on their label that prolonged consumption of the drug could lead to potential harm.  In May 2013, Takeda had managed to persuade a California judge to dismiss a $6.5 million Actos settlement against the company using similar arguments.

Judge Doherty did not buy the argument, and said that the efforts the company had taken to hide the evidence of cancer from Actos further proved the plaintiffs’ case.  Before the federal bellwether trial began, Takeda had faced the possibility of a potential breach of duty to preserve evidence.

In 2002, Takeda had put a litigation hold on documents and electronic data related to pre-clinical and current research of Actos.  According to Judge Doherty, the destroyed documents were relevant to the plaintiffs’ claims, and would likely prove beneficial to their case.  Judge Doherty concluded that Takeda’s failure to preserve the evidence was likely to prejudice the plaintiffs.

The case is Allen, et al. v. Takeda Pharmaceutical Co. Ltd. et al., Case No. 6:12-cv-00064.

The Actos  MDL is In re: Actos (Pioglitazone) Products Liability Litigation, MDL No. 2299, both in the United States District Court of Western Louisiana.

— Additional reporting by Amanda Antell