Sunday, January 15, 2012

Actos® Damages and Typical Settlements

The Type 2 diabetes drug Actos is one of a class of drugs known as thiazolidinediones and has recently been linked to an increased risk of bladder cancer, liver disease and cardiovascular issues. The FDA felt that the link between heart failure and Actos was serious enough to require increased warnings on the drug packaging concerning congestive heart failure. According to the Washington Post on 8/05/11, the first of what is expected to be literally thousands of lawsuits was filed alleging the use of Actos resulted in bladder cancer. Takeda Pharmaceuticals, a Japanese corporation is the manufacturer of Actos although it was jointly launched with the American company, Eli Lilly. Actos quickly became a top-seller of the giant pharmaceutical corporations, becoming the tenth best-selling drug in the United States in 2008 with sales over 2.5 billion dollars increasing to a staggering 4.3 billion in 2010.

In June of 2011, Takeda halted its sales of Actos in both France and Germany after receiving considerable pressure from health regulators in both those countries. New Zealand is currently in the process of pulling the drug as well. Since June, both the FDA and the European Medicines Agency have prudently issued warnings regarding the potential risk of bladder cancer for those taking the drug, but are allowing the continuation of sales pending further studies. The FDA has, however, warned doctors not to prescribe the drug for those who have a history of bladder cancer or who currently have bladder cancer.

Actos became a huge money-maker relatively quickly following its approval in 1999, then when Avandia—the only close competitor of Actos—was found in 2007 to sharply increase the risk of heart attacks, the sales of Actos nearly doubled. Actos is quite effective in controlling blood sugar and boosting the body’s insulin sensitivity, but it may have been prescribed too often prior to learning the extent of its more serious side effects. Takeda Pharmaceuticals has issued the mid-point results of their own study regarding the safety of Actos, and while the five year results showed no overall increased risk of bladder cancer, among those taking the drug in higher dosages or for longer than twelve months, the risk for bladder cancer jumps by as much as 40%. The FDA believes further studies are warranted before Actos is pulled from the shelves in America, however the flurry of lawsuits may make a difference in that decision.

Although there are already hundreds of potential lawsuits against the manufacturer of Actos, the Japanese company has thus far declined to comment other than issuing a statement reaffirming its commitment to keeping Actos available for those who need it. An April study published in the Journal of Diabetes Care found that those who had used Actos for longer than two years had a definite increase in their risk of bladder cancer. Advocates for the drug remind those who want to pull it from the market that approximately 28 cases of bladder cancer a year for every 100,000 people taking the drug is not that statistically significant. Those patients who have developed bladder cancer as a direct result of taking Actos may beg to differ.

The new safety issues which have risen regarding Actos and bladder cancer could potentially cost Takeda more than the payout for the lawsuits they will face. The Actos patent is set to expire in August of 2012, and not only will Actos fail to make the expected revenues in its final months prior to that time, the prospects for two more of Takeda’s experimental drugs may be severely dampened. Because one of those drugs is a combination drug containing both Actos and alogliptin while the other is straight alogliptin, it is fairly likely that the combo drug is out of the running due to the current safety concerns surrounding Actos.

Although it is not expected that the Actos bladder cancer litigation will hit the extreme levels of the Vioxx 2004 painkiller settlement—50,000 lawsuits and a $4.85 billion settlement—the makers of Avandia, a drug in the same class as Actos, have set aside over $400 million dollars for settlements. Many physicians switched their patients from Avandia to Actos believing it would be the safer choice however it is now being shown that it has many of the same dangers as well as the increased risk of bladder cancer. Actos attorneys are claiming Takeda knew many years ago of the increased risk of bladder cancer their drug could cause, yet did nothing to warn patients. A two-year animal study prior to the release of Actos showed that male rats developed tumors after receiving doses of Actos, yet the drug was pushed through in spite of those results, and launched with no warnings regarding potential bladder cancer risks.

Potentially thousands of those who were harmed by taking Actos could file lawsuits against Takeda and Eli Lilly, and it is expected that these suits could take years to fully resolve. These suits may include those who developed bladder cancer, those who suffered congestive heart failure or other heart issues, those who suffered osteoporosis and bone fractures, and those who developed macular edema from the drug. The initial estimates are that the “typical” settlement could be between $75,000 and $360,000 for those who were harmed by taking Actos for their Type 2 diabetes.

Author: Sullo & Sullo Attorneys

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