Actos, the diabetes drug made by Takeda Pharmaceuticals and marketed by Eli Lilly, set a record for the largest settlement awarded by a jury ever for a prescription medication. Although that record amount was reduced and Takeda eventually settled for a smaller amount, it sent a message that harmful drugs and hiding information about risks of drugs would not go over well with juries and the plaintiffs looking for justice and compensation.
Takeda and Eli Lilly have made big money with Actos, a popular drug for treating type 2 diabetes, but some of the side effects have proven to be devastating. The risks of heart failure and bladder cancer led to the thousands of lawsuits over Actos and the record settlement. What really triggered Actos settlements was the evidence that Takeda knew about the risks and failed to communicate them while profiting from the drug.
Actos and Type 2 Diabetes
Actos is the generic drug pioglitazone and belongs to the class of drugs called thiazolidinedione. These medications are used to control blood sugar in people with type 2 diabetes. The condition is one associated with poor lifestyle choices like a bad diet and being overweight. The number of cases has risen quickly in the last couple of decades and drug companies like Takeda have rushed to develop drugs for this expanding market.
Type 2 diabetes occurs when insulin, the hormone excreted by the pancreas that controls blood sugar, is either produced less or the body becomes less sensitive to it. The result is chronically high blood sugar levels, which is dangerous over the long term and leads to organ damage and ultimately death. Drugs like Actos are supposed to be used along with exercise, diet changes, and weight loss to control blood sugar.
Actos works to do this on several different fronts: it decreases how much sugar is made in the liver, helps the body excrete more sugar, increases sensitivity to insulin, and reduces insulin resistance. The U.S. Food and Drug Administration (FDA) first approved Actos for treating type 2 diabetes in 1999. Since then some serious concerns have arisen over the drug’s safety and these have led to the record settlements.
Heart Failure and Bladder Cancer
Two of the most serious concerns over using Actos are congestive heart failure and bladder cancer. Heart failure is characterized by the heart being unable to efficiently pump blood. It is a type of heart disease that does not cause sudden death, like a heart attack, but ultimately it is a fatal condition.
The evidence that Actos contributes to heart failure comes from the fact that it causes fluid retention in the body. This worsens heart failure in people who already have it and can lead to the onset of heart failure in anyone with risk factors. Beginning in 2007 the FDA required that Actos carry a black box warning about heart failure.
The other big risk with using Actos, and the main reason for all the lawsuits and Actos settlements, is bladder cancer. The FDA issued a warning about it in 2011 that stated Actos users may have an up to 40 percent increased risk for developing bladder cancer. Some studies have shown an even greater risk, especially for those patients with other risk factors for bladder cancer. What became more problematic for Takeda during lawsuits is that clinical trials show that there was evidence for a bladder cancer risk, but that the company did not communicate it.
Lawsuits and Takeda Wrongdoing
Thousands of people who suffered some of the more serious side effects of using Actos, overwhelmingly bladder cancer filed lawsuits against Takeda. These plaintiffs and their lawyers claimed that Takeda knew about the risks of developing cancer from using Actos, but failed in its responsibility to communicate that risk to doctors, patients, and the FDA. Eli Lilly as the marketer of the drug has also been included in lawsuits and settlements.
During consolidated multidistrict litigation cases, or MDLs, against Takeda and Eli Lilly, evidence emerged that Takeda was guilty of wrongdoing in its failure to communicate risks. The jury in the largest MDL heard evidence that Takeda actually destroyed documents that proved it knew about the bladder cancer risk. This means that the company willingly hid important information so that they could promote Actos as safe and make more profits.
A Record Settlement, Reduced
In 2014 a federal jury in a huge Takeda and Eli Lilly MDL found that the evidence against the companies warranted Actos settlements. The jury awarded the plaintiffs the largest settlement in pharmaceutical history, a whopping $9 billion. As soon as the award was announced, experts started to claim that this settlement wouldn’t hold water, that the judge would be forced to reduce the amount because it was considered to be out of proportion with the damages caused to plaintiffs.
The original $9 billion settlement included $6 billion for Takeda and $3 billion for Eli Lilly. While the companies never admitted to any wrongdoing, in spite of the evidence, they did ultimately agree to a lesser settlement amount. The U.S. District Judge responsible for the MDL, which took place in Lafayette, Louisiana, slashed the original jury-awarded settlement to $36.8 million, but Takeda then offered $2.3 billion to the thousands of plaintiffs in the case.
Other Actos Settlements Tossed
In other cases against Actos, Takeda has come out on top with successful appeals of jury-awarded settlements. In a Maryland case in 2013, for instance, the jury gave the family of a man who died from bladder cancer a settlement judgement of $1.7 million. Takeda made a case that the man’s longtime smoking habit contributed to his death from bladder cancer, and succeeded in having the judge throw out the settlement.
In another case, a man from California had been awarded $6.5 million, but Takeda again succeeded in proving that the decision should be tossed. The company claimed that a doctor that testified as an expert witness was not reliable and that his testimony should not have contributed to the jury decision.
Takeda has seen some success in denying claims and appealing jury awards, but the $9 billion made an impact. It sent a message to drug companies that juries were willing to play tough with drug companies that put patients at risk. If you were harmed by Actos there may still be time for you to win a settlement to help pay for medical and other expenses. Let a lawyer’s expertise be your guide and help you decide what you can do to make your case and seek compensation from a drug company giant that has clearly put patients in harm’s way.