Endo International has finally made a move to resolve thousands of complaints regarding life-threatening injuries stemming from Testim and its other male replacement hormone therapy drugs, reaching a significant testosterone settlement this past week that will affect 1,300 cases.
The plaintiffs in these testosterone lawsuits allege that Endo and its Auxilium Pharmaceuticals subsidiary concealed their products’ serious cardiovascular risks to drive sales. Furthermore, the companies even helped invent a condition known as “Low-T” to further expand market share. This marketing ploy exposed countless more innocent people to serious cardiovascular risks. These men faced heart attacks, blood clots, strokes, and other severe cardiovascular problems to satiate these companies' endless greed. The testosterone settlement takes care of a sizable portion of the Northern District of Illinois federal multidistrict litigation (MDL). But, Endo still does not admit any wrongdoing despite overwhelming evidence to the contrary.
Endo formally announced the master testosterone settlement agreement June 11. In response, the judge overseeing the federal MDL has issued case management order to specify guidelines in approaching participation in the testosterone settlement. District Judge Matthew F. Kennelly ordered, among other things, any future and existing cases electing not to participate in the settlement must produce certain information within specified timeframes. The order also addressed expedited discovery on plaintiffs and a disposition motion practice for certain defenses. Furthermore, Judge Kennelly also limited discovery solely to Endo. Further details of the testosterone settlement continue to remain confidential.
Behind the Testosterone Settlement
The FDA only approved testosterone replacement medications, including Axiron, AndroGel, and Testim, to treat hypogonadism or low testosterone secondary to an injury or medical condition. The manufacturers have never demonstrated that these drugs are safe or effective for men with decreasing testosterone levels as part of the normal aging process. However, this did not stop their marketing departments from creating a whole new condition that would encapsulate the entire aging male population.
AbbVie led the charge, expending a great deal of resources to create the “Low T” market in what has been called “the mother of all disease mongering.”
The symptoms of Low T are merely the predictable results of simply getting older. Testosterone manufacturers pounced on middle-aged masculine insecurities despite that much of this expanded market had elevated cardiovascular risks. Because of the Low T campaign, testosterone sales skyrocketed from $324 million in 2002 to nearly $2.3 billion in 2012. Meanwhile, the drug manufacturers actively concealed many of the drugs’ serious cardiovascular side effects to enhance marketability.
In March 2015, the FDA ordered testosterone therapy manufacturers to include the possible increased risk of heart attacks and strokes on the drugs’ labels. Several months later, the agency ruled that the labels also needed to include the risk of venous thromboembolism.
Testosterone Litigation, Verdicts, and Settlements
There are almost 6,000 testosterone lawsuits pending in the Northern District of Illinois federal litigation. The majority of these claims involve AbbVie’s AndroGel testosterone gel. The first federal trial over serious cardiovascular harm from AndroGel concluded in July 2017. The jury ruled in favor of the plaintiff to the tune of $150 million in punitive damages for false advertising. However, awarding punitive damages without their obligatory compensatory counterpart is unprecedented. Consequently, the court overturned the verdict and ordered a retrial. The plaintiff eventually received $3 million in damages from the retrial jury.
In October 2017, the second Androgel trial concluded with the jury awarding the plaintiff $140,000 in compensatory damages. The jury also levied $140 million in punitive damages. However, jurors have sided with AbbVie in the two most recent bellwether trials. The most recent of which concluded Thursday.
In January, Eli Lilly & Co. agreed to a testosterone settlement to resolve all Axiron lawsuits pending in the federal litigation. However, the court has not disclosed the details of this settlement.