Earlier this month, AbbVie Inc. faced its first test trial in over 4,000 cases filed against the company for overselling testosterone replacement drug AndroGel and for failing to warn of its potential side effects. AndroGel is a topical treatment for low testosterone.
The first plaintiff, Jeffrey Konrad, suffered a heart attack in 2010 that he believes is linked to his use of AndroGel. He was prescribed the medication two months before his heart attack and claims he was not warned of the dangers associated with using the drug. Though Konrad survived the heart attack, AndroGel has been linked to four cases of fatal heart attacks.
AndroGel was approved by the FDA in 2000 to treat hypogonadism, a condition that causes a severe loss of testosterone. Shortly thereafter, AbbVie began marketing the drug to treat low testosterone in an $80 million marketing campaign that featured television ads promising immediate relief for men suffering from low energy and other ailments.
Plaintiffs claim that AbbVie unlawfully convinced patients and doctors that AndroGel would cure several symptoms of aging through their promotion of the product beyond its FDA-approved use. Plaintiffs also claim that AbbVie mislead doctors about the side effects and that the drug company had ignored studies that showed that AndroGel led to an increased risk of stroke, heart attack, blood clots and pulmonary embolism.
AbbVie Inc. countered that doctors had used testosterone replacement therapy to treat symptoms of aging for a decade before AndroGel was approved. They contend that they did not warn of the potentially dangerous side effects because studies proving that such risks existed were not released until nearly 15 years after the drug was approved by the FDA. The pharmaceutical company opposes notions that its marketing was deceptive because symptoms such as low energy and moodiness are also symptoms of hypogonadism.
According to Bloomberg News, in 2015 the FDA requested that AndroGel’s labeling include increased consumer safety warnings. This request came after a study was released suggesting that testosterone-replacement drugs increased the risk of stroke and heart attack by nearly 30 percent.
Jeffrey Konrad is seeking compensation for his medical bills, pain and suffering as well as punitive damages for AbbVie Inc. His case is the first in a series of test trials against AbbVie Inc. and will help determine if the pharmaceutical company should settle allegations against AndroGel.