FDAnews
www.fdanews.com/articles/172273-court-reinstates-65-million-award-in-actos-cancer-lawsuit

Court Reinstates $6.5 Million Award in Actos Cancer Lawsuit

July 23, 2015

A California appeals court has reinstated a $6.5 million jury award against Takeda in a case involving its diabetes drug Actos, which announced in April that it would pay up to $2.4 billion to settle the majority of U.S. lawsuits involving the therapy.

In 2013, a jury found that Takeda failed to adequately warn Jack Cooper’s physician of the cancer risk with Actos (pioglitazone). Jurors awarded Cooper and his wife $6.5 million in damages. However, the judge threw out the award and ordered a new trial on the grounds that an expert’s testimony was unreliable and there was insufficient evidence without it.

In the ruling, the appeals court said the lower court erred in determining that an expert’s testimony is only admissible if it rules out all other possible causes of harm, even when there is no substantial evidence that other causes might be relevant.

The reversal is not a surprise, says Erik Gordon, a professor at the University of Michigan. In civil cases, plaintiffs have to prove by a preponderance of the evidence that an act caused unlawful damage, but don’t have to rule out every other possible cause of the damage, he says.

The ruling could make it easier for people to sue drugmakers over possible links between therapies they use and serious adverse effects.

Takeda is considering its options in Nancy Cooper v. Takeda Pharmaceuticals America, Inc., et al., including a request for a review by the California Supreme Court, spokeswoman Sandy Rodriguez says. — Jonathon Shacat