Pharmaceutical

First testosterone trial begins

Low T1 First testosterone trial beginsMore than 2,000 plaintiffs from around the U.S. will be watching this week as the first testosterone trial gets underway in Chicago, according to the Cook County Record. It is the first of seven cases in the class action singled out as bellwethers. Thousands of plaintiffs filed suit against multiple drug manufacturers of testosterone replacement drugs saying the drugs increased their risk of life-threatening adverse effects including blood clots, stroke and heart attack.

As Beasley Allen previously explained, the U.S. Judicial Panel on Multidistrict Litigation established a multidistrict litigation (MDL) for testosterone replacement drugs in 2014 following a Food and Drug Administration (FDA) investigation confirming findings from two studies linking the drugs to significantly higher risk of stroke, heart attack and death.

The FDA also learned the drugs have been linked to dangerous blood clots in the legs, known as deep vein thrombosis, which can lead to pulmonary embolism. This finding led the agency to order manufacturers to update their safety labels with a new warning for the blood clotting condition.

The MDL is located in the U.S. District Court of the Northern District for Illinois, with Judge Matthew Kennelly presiding.

Plaintiffs also assert drug manufacturers, including AndroGel maker AbbVie, aggressively marketed their products to treat an industry-invented illness it called “Low T” and for off-label uses such as treating diabetes, AIDS, cancer, depression and anxiety. In May, Judge Kennelly ruled to allow the claims against the manufacturers’ advertising tactics to proceed.

The first six bellwether trials involve AbbVie’s Androgel.

Testosterone replacement therapy, Righting Injustice reports, is intended to treat men whose bodies don’t produce enough of the male hormone, or hypogonadism. However, drug makers marketed it as a remedy for symptoms of low testosterone, or “Low T,” such as low sex drive, fatigue, muscle loss and weight gain, Beasley Allen has described previously.

The industry rakes in at least $2 billion a year in sales fueled by marketing campaigns that targeted men with the symptoms of “Low T.” AbbVie alone paid more than $20 million to 191,555 doctors from August 2013 to December 2015 to promote AndroGel.

Beasley Allen reports that the remaining bellwethers are scheduled through April 2018.

Sources:
Cook County Record
Beasley Allen
Righting Injustice