Congestive Heart Failure Leading to the Actos® Lawsuit

Billions of dollars in settlements and courtroom awards have already been paid to Actos® plaintiffs, and litigation against the Japanese manufacturer, Takeda Pharmaceuticals, is still ongoing. If you or a loved one suffered heart failure or another complication after taking Actos®, the time to seek help from a pharmaceutical attorney is now. Please schedule your free case evaluation with a member of our legal team today.

About Actos®

Introduced to the U.S. market in 1999, Actos® (pioglitazone) was considered a good alternative to Avandia, which had been tied to an increased risk of heart attack. Both of these type 2 diabetes drugs are insulin sensitizers in the thiazolidinediones (TZD) class of medications, which work to reduce the body’s resistance to insulin. Actos® attaches to cell receptors to rid the blood of excess glucose, and also inhibits the liver from producing and secreting glucose into the bloodstream.

With improved insulin sensitivity, it is easier for patients to maintain their blood sugar levels within a normal range. Together with proper diet and exercise, these types of medications are intended to help patients avoid long-term diabetic complications.

Initial clinical trials for Actos® had also shown a potential link to heart failure. Shortly after its release, elevated numbers of cardiac complications began to be reported in Actos® patients.

Following the drug’s release, thousands of doctors began to switch their patients’ prescriptions from Avandia to Actos®. There had been numerous reports of cardiac events in patients taking Avandia, and medical studies confirmed the increased risk. An estimated 50,000 lawsuits were filed, and billions of settlement dollars have been paid by GlaxoSmithKline to compensate Avandia plaintiffs.

However, initial clinical trials for Actos® had also shown a potential link to heart failure. Shortly after its release, elevated numbers of cardiac complications began to be reported in Actos® patients.

Actos® and Congestive Heart Failure

Heart failure, or congestive heart failure (CHF), is different from a heart attack, which occurs suddenly after a coronary artery is blocked. In a heart attack, blood flow is stopped by a blood clot or plaque build-up, preventing the heart muscle from getting oxygen and nutrients.

Heart failure occurs when the pumping action of the heart becomes gradually less efficient. The heart is working, but not as efficiently as it should, causing blood to move more slowly throughout the body. Pressure on the heart then increases, which further weakens the cardiac muscle. Weakened blood flow can decrease kidney function, causing fluid and sodium retention.

A variety of medical conditions can lead to congestive heart failure. Diabetics are more susceptible to the condition, but this class of medications is thought to increase the risk. A joint statement issued by the American Heart Association and American Diabetes Association in 2003 warned physicians about the link between TZDs, fluid retention, and congestive heart failure.

A 2007 study that ran in the Journal of the American Medical Association (JAMA) concluded that “serious heart failure is increased by pioglitazone, although without an associated increase in mortality.”

If you have been injured by a defective drug, Speak with an Attorney

The U.S. Food and Drug Administration (FDA) announced a black box warning for Actos® and other TZD labels regarding heart failure in 2007. The warning stated that the FDA’s adverse event reports found cases of significant weight gain and edema in TZD patients and “continuation of therapy has been associated with poor outcomes, including death.” The FDA advised that patients should be closely monitored for signs of heart failure, and some should consider alternative treatments.

The symptoms of heart failure may include:

• Water retention – This is experienced as swelling (edema) in your ankles, legs or abdomen, and there may also be an increased need to urinate at night. Swelling in the abdomen may make you feel nauseated and decrease your appetite.
• Congestion in the lungs – Fluid accumulation in the lungs can cause shortness of breath. You may first notice it when you are active, and then may find it increasingly hard to breathe while relaxing. Lying flat in bed can exacerbate the problem.  
• Dizziness – When the heart is pumping insufficiently, there is less blood flow to the brain. You may experience lightheadedness or even confusion.
• Fatigue and weakness - Lower blood flow can affect major organs and muscles, which can make you feel weak tired.
• Rapid heartbeat or irregular heartbeat – When the heart is beginning to fail, it often responds by beating faster to pump more blood. You may feel a faster beat or an alternating rapid and slow rhythm.

Patients who suspect potential heart failure should call their doctor immediately or seek urgent medical care. Surgery can prevent further damage to the heart and improve functioning. Implantation of a left ventricular assist device (LVAD) can help the heart pump blood more efficiently. In the most severe cases, a heart transplant may be required.

Legal Response and Supporting Evidence

Many Actos® patients filed lawsuits after experiencing heart failure, bladder cancer, and other serious complications. There have been multiple wrongful death claims, including that of a Texas man, who filed a lawsuit after his wife passed away from congestive heart failure. She had been taking Actos® for several years before being diagnosed with a heart condition.

Federal Actos® lawsuits from all over the country have been consolidated into multidistrict litigation (MDL). In April 2015, Takeda agreed to a $2.37 billion settlement for 9,000 MDL and state cases.

Legal evidence shows that Takeda was aware of the potential danger from Actos®. During the company’s initial clinical trials, an increased risk of heart failure was indicated. One study compared data between patients who took Actos® and those who took a placebo. Researchers found a statistically significant increase in rates of heart failure among patients taking pioglitazone. Additionally, a post-marketing study conducted over several months compared Actos® to another diabetes medication, glyburide. The data showed that 4.7 percent of glyburide patients were hospitalized overnight with heart failure. However, Actos® patients were hospitalized for the same condition more than twice as often.

Dr. Ge said she was asked to under-report cases of congestive heart failure and bladder cancer to the FDA’s adverse event reporting system.

To date, there have been two whistleblower lawsuits that have called the ethics of Takeda executives into question, and shown evidence that the company had knowledge of the potential dangers associated with the drug. A former Takeda medical reviewer, Dr. Helen Ge, filed a case in Massachusetts that accused the company of purposely downplaying links between Actos® and associated complications.

Dr. Ge said she was asked to under-report cases of congestive heart failure and bladder cancer to the FDA’s adverse event reporting system. All pharmaceutical manufacturers are required to keep this database updated with reports of patient complications. Dr. Ge stated that Takeda’s medical reviewers were instructed not to report hundreds of congestive heart failure incidents, and when she complained, her contract was terminated.

The other whistleblower case was filed by a prospective employee who claimed that Takeda told him in a series of job interviews about plans to promote Actos® for the off-label treatment of prediabetes. The FDA had not approved the drug for this purpose, and Takeda officials allegedly stated that doctors were being paid to prescribe the medication to patients with prediabetic symptoms.

Contact a Qualified Actos® Attorney

Actos® claimants are still coming forward and seeking restitution for their injuries and other losses. If you are an Actos® patient who has suffered a complication, you may be entitled to significant compensation. Please contact our legal team today to schedule a free consultation and learn about your legal options.