Terminally Ill Plaintiffs Will Give Early Testimony, Actos MDL Judge Orders

Plaintiffs who developed bladder cancer after using Actos and who have filed lawsuits against Takeda Pharmaceuticals face a quandary: they may not still be alive by the time their cases go to trial. Statistics from the American Cancer Society reveal that the five-year survival rate for patients with Stage IV (advanced) bladder cancer is only 15 percent. For Stage III cancer the five-year survival rate is 46 percent, and for Stage II, it is 63 percent.

With this in mind, Judge Rebecca F. Doherty, who is overseeing the Actos MDL in the Western District of Louisiana, presented a case management plan on January 8, 2013 that includes an order that will enable terminally ill Actos plaintiffs to give early testimony, before their cases go to trial.

Guidelines for testimony of terminal patients

The judge’s order states that counsel must give notice to the lead counsel for the opposing side as soon as possible after learning that the health of a plaintiff or witness “has deteriorated to the point that his or her competency or survival is at risk,” and must also include a letter from the plaintiff’s or witness’ doctor confirming the diagnosis and deteriorating health. The judge then included guidelines for recording testimony from such plaintiffs and witnesses.

In litigation, it is common to allow early depositions from plaintiffs who are elderly or infirm, but this situation is unusual because of the huge number of plaintiffs suffering from a life-threatening illness, namely bladder cancer.

Background on Actos litigation

Actos (pioglitazone) was approved by the FDA in 1999 to treat Type 2 diabetes. In 2005, a study found a link between use of Actos and increased risk of bladder cancer. In 2010, the FDA announced that it would be investigating evidence of the connection between bladder cancer and Actos to evaluate the potential risk. Early in 2011, the American Diabetes Association published another study that also found a link between bladder cancer and Actos.

In June 2011, the FDA issued a public safety announcement warning that use of Actos for longer than 12 months may increase the risk of developing bladder cancer, and ordered that warning to be added to the Actos label. The warning came after the agency reviewed the five-year results of an ongoing 10-year epidemiological study of Actos side effects.

The same month, sales of Actos were suspended in France and Germany because of the risk of Actos bladder cancer. However, there has been no such Actos recall in the United States.

Following the FDA warning, many patients took the step of filing an Actos bladder cancer lawsuit. Such lawsuits allege that Takeda knew or should have known of the risk of Actos bladder cancer, but failed to warn the public and the medical community. In December 2011, an Actos MDL was established in the Western District of Louisiana to consolidate Actos lawsuits at the federal level. Altogether, there are currently more than 1,000 Actos cases pending in state and federal courts, and that number is expected to grow.

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