According to Bloomberg, the first trial against Takeda Pharmaceutical over the diabetes drug Actos could soon be in the hands of a jury. Takeda faces a huge number of lawsuits claiming that its drug Actos is defective and dangerous. The Bloomberg article says that over 3,000 product liability lawsuits have already been filed against Takeda.

This first trial involves a case filed against Takeda in California. While some cases have been filed in state courts, all the cases against Takeda filed in Federal Courts have been consolidated before a Judge in the Western District of Louisiana for pre-trial purposes. Our office in Alabama has been involved in that litigation.

I have written previously about the problems in our safety system related to the approval of drugs such as actos and the similar medication avandia. I have also written several times about medical devices, such as transvaginal mesh, that are marketed to innocent consumers without adequate testing.

This first actos trial revealed significant evidence of the manufacturer’s efforts to persuade the Food and Drug Administration (FDA) not to increase the warning on the drug’s label. Here is an internal email among Takeda executives concerning the FDA that was cited in the article:

Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.

It appears that Takeda was much more concerned with the $1.6 billion in annual actos sales, than it was the devastating injuries being reported by patients prescribed the medication here in Alabama and throughout the United States. In closing argument, the plaintiff’s attorney told the jury that Takeda possessed studies revealing links to bladder cancer as early as 2004 but did not disclose the information until 7 years later. This case will be followed closely.

The purpose of the FDA is to protect us from dangerous drugs, defective medical products, and unsafe food. However, the safety and approval process has lost its focus on protecting citizens. Instead, it has become a system where safety is often delayed or denied while dangerous products needlessly cause death or severe personal injury.