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Wednesday, March 19, 2014

Jury in Actos Cancer Trial Told of Drug Company Misconduct

Jury in Actos Cancer Trial Told of Drug Company Misconduct

MARCH 11, 2014 By: Susan Green

The opening witness in the first “bellwether” Actos cancer trial told the jury about drug manufacturer Takeda’s pretrial misconduct.  The case is the first of several scheduled in the ongoing Actos Multidistrict Litigation (MDL) in federal court in Louisiana.

Terrence Allen and his wife’s lawsuit charges that Allen developed bladder cancer as a result of using Actos to treat diabetes between 2004 and 2011.  Plaintiffs argue that Actos manufacturer Takeda failed to disclose the link between Actos and bladder cancer.  Takeda claims that Allen’s cancer was not caused by the drug, and that the company provided proper notification of Actos’s risks.

Takeda’s pretrial misconduct 

Just before the Allens’ Actos cancer trial began on January 27, the judge ruled that Takeda had acted in bad faith by hiding or destroying evidence that the company should have given plaintiffs during the pretrial process.  The judge held that plaintiffs could reveal Takeda’s improper actions to the jury.  Thus plaintiffs’ first witness was an Actos employee, who testified about the company’s evidentiary misconduct.

The next witness was Dr. David Kessler, a physician who served as Commissioner of the FDA from 1990-1997.  Dr. Kessler told the jury that the FDA is required to determine that a drug is safe and effective before the agency can authorize that drug’s use in the United States.  Dr. Kessler described the types of data Takeda was required to obtain to demonstrate Actos’s safety and effectiveness, and explained what the manufacturer was obligated to show the FDA in order to obtain authorization for the drug.

Several medical experts then testified about the studies linking Actos use to a high risk of bladder cancer.  Takeda employees also took the witness stand to describe what the company knew about the connection between bladder cancer and Actos use.

Actos cancer trial details 

Millions of Americans have used Actos to treat their Type 2 diabetes since the FDA approved the drug in 1999.  In 2011, however, the FDA advised that use of Actos for longer than one year increased patients’ risk of bladder cancer by as much as 40% compared to patients who had never used the drug.  The FDA’s advice was based on results after five years of a planned ten-year study of over 193,000 diabetes patients.

Nearly 3,000 Actos cancer lawsuits were centralized in the Louisiana federal court as a way to streamline pretrial proceedings.  The MDL procedure allows the court to resolve pretrial issues common to all the lawsuits at one time.  Then the parties select a few representative or “bellwether” cases to go to trial.  The procedure often facilitates settlement, as defendants understand the likely outcome of the remaining cases, and try to minimize the time and expense of multiple separate trials.

On top of the thousands of cases pending in the MDL, many other patients have filed lawsuits in state courts around the country charging that Actos caused bladder cancer.  To date at least three cases have been concluded.  Two 2013 trials resulted in jury verdicts of $1.7 million and $6.5 million, although the verdicts ultimately were vacated.  A third trial led to a decision in favor of Takeda.

The Actos cancer trial in Louisiana will continue to draw attention as witnesses testify for both sides.  Based on the parties’ original estimates, the jury should begin its deliberations sometime in late March.

 


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