Actos is a prescription Type 2 diabetes drug that has only one active ingredient, pioglitazone, and is part of a class of drugs known as thiazoldidinediones (“TZDs”). TZDs are oral anti-diabetic agents that decrease insulin resistance. The other TZDs are Avandia (rosiglitazone) and Rezulin (troglitazone).
After the FDA-approval of Actos in 1999, Takeda and Eli Lilly jointly launched the drug into the U.S. market. In 2006, Takeda took over the marketing Actos (Eli Lilly continued to receive residual royalties from Actos sales until 2009).
In 2007, the FDA and manufacturers of TZDs agreed to add stronger warnings of the risk of heart failure after taking certain drugs approved to treat Type 2 diabetes. The information was included in the form of a black box warning (the FDA’s strongest form of a warning). In an alert specific to Actos, the FDA stated that Actos might cause or exacerbate congestive heart failure in some patients. Nevertheless, in 2010, Actos was the 11th top selling drug in the U.S, with sales exceeding $2.6 billion and in March 2011, sales of the drug peaked at $4.5 billion.
In June 2011, the FDA issued a warning informing the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA based its conclusion on data from a 5-year interim analysis of an ongoing 10-year epidemiological study. The 5-year results showed that “although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone.”
In June 2013, 23 experts from 9 countries met at the International Agency for Research on Cancer (IARC) to assess the carcinogenicity of fourteen drugs and herbal products. After a detailed review of one large randomized controlled study, 4 cohort studies, and 3 case controlled studies, the Agency determined that pioglitazone should be classified as probably carcinogenic to humans based on the evidence that it causes bladder cancer.
Moreover, the British Journal of Clinical Pharmacology published a study in December 2013 that linked the use of TZDs, including Actos, to the development of bladder cancer. Researchers discovered that there was “an increased risk of bladder cancer in patients with the highest doses of pioglitazone and in patients who either took Actos between 12 and 24 months or more than 24 months.” In addition, the researchers noted that there was a higher overall risk of bladder cancer in patients who used Actos than those who used Avandia.
Plaintiffs in the litigation involving Actos allege that they purchased and ingested Actos believing it to be safe based upon the promotions, advertising, marketing and labeling by the defendants. Further, the plaintiffs contend that the ingestion of Actos posed significant safety risks, including the development of bladder cancer, due to design defects and inadequate testing.
On December 29, 2011, the federal Actos cases were consolidated into a multi-district litigation in the Western District of Louisiana, assigned to Hon. Rebecca F. Doherty. Several thousand cases were also filed in state courts, mainly in California and Illinois.