AndroGel Side Effects Caused Pulmonary Embolism, Lawsuit Claims

According to allegations raised in a product liability lawsuit recently filed against AbbVie, side effects of Androgel testosterone gel caused a Massachusetts man to suffer a severe and life-altering pulmonary embolism.

The complaint (PDF) was filed in the U.S. District Court for the Eastern District of Pennsylvania on January 27, by John F. Albana and his wife, Marianne.

Albana indicates that he began using the leading testosterone replacement therapy, Androgel, in July 2005, after he was diagnosed with hypogonadism at the age of 55. However, the lawsuit claims that the drug maker failed to adequately warn consumers and the medical community that Androgel may increase the risk of blood clots, heart attacks, strokes and pulmonary embolism.

About one year after he began using the testosterone gel, Albana indicates that AndroGel side effects caused him to suffer a pulmonary embolism, which typically involves a blood clot that breaks free in the body and lodges in the lungs. As a result of the pulmonary embolism from Androgel, Albana alleges that he has suffered severe pain and suffering, financial loss and permanent injury. His wife has presented claims for loss of consortium as a result of the impact the Androgel pulmonary embolism had on his ability to provide household services, financial support, companionship and attention.

“AndroGel may produce undesirable side effects to patients who use the drug, including but not limited to, myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism and death,” states the complaint. “In some patient populations, Androgel use may increase the incidence of myocardial infarctions and death by over 500%.”

The case joins hundreds of other Androgel lawsuits pending throughout the United States, each involving similar allegations that AbbVie aggressively promoted the medication while withholding important safety information from consumers and the medical community.

Albana indicates that if he had known about the risks and dangers of Androgel, he ever would have used the testosterone gel and would not have been subject to the potential side effects.

Testosterone Drug Side Effects

There are currently about 3,500 testosterone drug lawsuits pending throughout the federal court system involving problems with Androgel and other less popular “low T” treatments, such as Axiron, Testim, AndroDerm and others.

The cases are currently centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, for coordinated discovery and a series of early “bellwether” trials that are expected to begin next year.

Litigation over the testosterone blood clot risks emerged in November 2013, after a study published in the Journal of the American Medical Association (JAMA) found that certain men who began taking testosterone drugs following coronary angiography may be more likely to suffer cardiovascular events.

That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.

The FDA announced a warning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between testosterone drugs and heart problems. In addition, the agency encouraged doctors not to prescribe testosterone drugs for so-called “life-style” reasons, such as addressing decreased energy levels or sexual drive experienced by most men as they get older.

As part of the MDL proceedings before Judge Kennelly, a small group of Androgel lawsuits are currently being prepared for early trial dates. Known as bellwether cases, these trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.

Following a series of bellwether trials in the MDL, if Androgel settlements are not reached by AbbVie and other manufacturers of low testosterone drugs, a second series of bellwether trials are expected to begin involving the use of other drugs.