AndroGel Deep Vein Thrombosis (DVT) Lawsuit Filed Over Low Testosterone Treatment

One of the latest in a growing number of Androgel lawsuits filed against AbbVie alleges that a man using the low testosterone treatment suffered a deep vein thrombosis (DVT) only a few months after he started applying the popular gel.

The complaint (PDF) was filed by Donald Roberts in the U.S. District Court for the Eastern District of Pennsylvania on January 28, and will soon be transferred to the federal multidistrict litigation (MDL) where several thousand similar lawsuits over Androgel and other testosterone drugs are currently pending in the federal court system.

Roberts indicates that he was prescribed Androgel for treatment of hypogonadism in November 2009, at the age of 45. Only about three months later, in February 2010, Roberts indicates that side effects of Androgel caused him to suffer a DVT, which is a blood clot that develops in the deep veins of the leg. This poses a serious health risk, since the blockage of vital arteries can restrict blood flow to the heart, lungs or brain, and may cause a heart attack, stroke, pulmonary embolism or sudden death.

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As a result of the deep vein thrombosis from Androgel, Roberts indicates that he experienced pain, suffered financial loss and has been left with permanent injury.

Like other lawsuits filed against AbbVie, Roberts claims that the drug maker purposely downplayed the blood clot risk with Androgel, including the risk of users suffering a deep vein thrombosis, pulmonary embolism, heart attack or stroke.

“Plaintiff would not have elected to use Androgel if he knew of the true risks associated with use of Androgel,” Roberts states in the complaint. “In other words, Plaintiff would not have used Androgel if he knew the true risk of development of a heart attack, stroke, pulmonary embolism, deep vein thrombosis and/or death.”

Androgel Litigation Over Health Risks

Roberts’s case is one of about 3,500 low testosterone drug lawsuits filed in U.S. District Courts nationwide, which have been centralized as part of an MDL before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, for coordinated discovery and pretrial proceedings.

Litigation over the testosterone blood clot risks emerged in November 2013, when 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 injury settlements are not reached by AbbVie and other manufacturers of low testosterone drugs, hundreds of individual cases may be remanded back to U.S. District Courts throughout the country for individual trial dates.


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