Expert Witness Randall Tackett, a pharmacologist and toxicologist at the University of Georgia, said Takeda should have issued stronger warnings about the risks associated with Actos, including labeling changes and so-called dear-doctor letters.
An expert witness testifying on behalf of a woman who claims she developed bladder cancer after taking the diabetes drug Actos told a Philadelphia jury on Thursday that Takeda Pharmaceuticals Co. Ltd. had worked to suppress information about the cancer risks associated with the medication.
Randall Tackett, a pharmacologist and toxicologist at the University of Georgia tapped to testify on behalf of plaintiff Frances Wisniewski, testified that Takeda had urged a putative partner in the drug’s development in the early 1990s to say that it had backed away from the project due to concerns over the drug’s efficacy and not because of data showing potential health risks.
Tackett pointed to correspondence between Takeda and the Upjohn Co. in 1993 in which Upjohn said it was backing out of the drug’s development due to concerns about the drug’s safety. In response, Takeda asked that Upjohn to claim instead that it was not proceeding with development because it didn’t believe the drug would be effective enough at treating diabetes.
“What this basically does, in my opinion, is remove the concern for the margin of safety and focuses on the fact that they wanted Upjohn to say that the drug didn’t work as well as they would like. That’s a big difference from saying there was a concern over the margin of safety,” Tackett testified. “A prudent drug company should have the patients’ safety at the forefront. You shouldn’t have someone decreasing or minimizing the concern over safety.”
Wisniewski, a suburban Philadelphia resident, filed suit in the Philadelphia County Court of Common Pleas in July 2012 alleging that she was diagnosed with bladder cancer in August 2011 after taking Actos for seven years. Trial in the case commenced earlier this month.
Actos was launched jointly by Takeda and Eli Lilly & Co. in 1999. However, the complaint said that the company was aware through preclinical studies prior to the medication’s approval by the U.S. Food & Drug Administration that incidences of tumors had been reported in male rats who took the drug.
Studies conducted subsequent to the drug’s launch likewise showed a higher incidence of bladder cancer in patients taking Actos.
Tackett said that the information should have led to Takeda issuing stronger warnings about the risks associated with the drugs, including labeling changes and so-called dear-doctor letters.
“As soon as there is any reasonable association with a particular adverse event, that would be something you’d want to have communicated to the physician or the prescriber,” he said.
On cross-examination, Goodell DeVries Leech & Dann LLP’s Robert Limbacher said that it was very important to distinguish between an association with incidences of cancer and actual causation.
“Association does not mean the same thing as causation. Sometimes articles talk about association and sometimes they talk about causation,” he said. “You’ve got to be really careful about distinguishing those two.”
He also said that while Tackett’s testimony focused on Takeda’s reputed conduct in developing the drug and responding to safety concerns, it had nothing to do specifically with the injuries alleged by Wisniewski.
Actos has served as a major source of revenue for Takeda, according to courts records. Wisniewski’s complaint said that the company earned $4.8 billion in revenue from sales of the drug in 2011 and that it was the tenth-best selling medication in the country in 2008.
However, the company was slapped with $6 billion in punitive damages by a federal jury in April in a product liability case brought by a former New York shopkeeper who claimed that company executives knew the drug caused bladder cancer in animals and humans but kept mum because the drug was profitable.
‘Eli Lilly was hit with $3 billion in punitive damages in the case, which was heard as part of multidistrict litigation in Louisiana.
A judge in the case denied a set of post-trial motions by the companies in August seeking judgment as a matter of law or a new trial.
Wisniewski’s attorneys are expected to wrap up their case on Friday. Defense arguments, meanwhile, are expected to conclude the week of Oct. 6 before the case is sent to a jury.