Overview: A clinical pharmacologist is among the first to testify in the Actos trial currently underway in Los Angeles. According to Bloomberg, Howard Greenberg told jurors yesterday that Takeda was more focused on protecting their product rather than patients. The diabetes medication is the subject of thousands of lawsuits alleging that it caused bladder cancer. The lawsuit of Jack Cooper, who developed bladder cancer after four years of using the drug, is the first to go to trial in Los Angeles Superior Court.
- A clinical pharmacologist testified in court yesterday that Takeda emphasized product sales over patient safety
- The lawsuit of Jack Cooper is the first to go to trial in state court in Los Angeles
- In 2011, the FDA updated the safety label on Actos to warn about the increased risk of bladder cancer after one year of use
Product: Actos (pioglitazone)
Manufacturer: Takeda Pharmaceutical
Side Effects & Complications
- Bladder cancer
- Heart attacks
- Congestive heart failure
Takeda Focused on Protecting Actos Rather than Patients, Witness Says
Bloomberg reports that clinical pharmacologist Howard Greenberg testified yesterday in the case of Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles). His testimony focused on Takeda emails from 2005 in which company officials discussed the protecting the product over patients. “There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg said. He reviewed internal Takeda documents to prepare for his testimony. One of these documents was an August 2005 email written by Takeda executive Kiyoshi Kitazawa, who stated that “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,” Kitazawa emphasized what regulators might do in light of research linking the drug to bladder cancer; he urged colleagues to seek a “positive outcome” on the warning issue from regulators, Bloomberg notes.
Actos Lawsuits Allege Bladder Cancer
Jack Cooper’s lawsuit is the first of thousands to go to trial. Cooper was diagnosed with bladder cancer after taking the drug for over four years, and alleges that the medication caused the cancer. His lawsuit is also one of many to allege that Takeda knew about the risks of bladder cancer but failed to warn the public. His case is being tried in California state court, but a number of other lawsuits are pending in the U.S. District Court for the Western District of Louisiana as part of the multidistrict litigation (MDL) entitled In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299). Judge Rebecca Doherty is presiding over the litigation. Jerrold S. Parker, founding partner of Parker Waichman LLP, serves on the Plaintiff’s Steering Committee.
The U.S. Food and Drug Administration (FDA) updated the Actos label in 2011 to warn that use of the medication may increase the risk of bladder cancer after one year. The drug has been pulled off the shelves in France and Germany at the request of those countries’ regulators.