Testosterone therapy product Androgel, made by Belgian company Besins Healthcare, has been the target of numerous lawsuits. The manufacturer has attempted to dodge a huge class-action suit in the U.S., but a federal U.S. judge blocked that evasion, forcing Besins to face up to the charges against it and its testosterone product.
AndroGel and the Problems with Testosterone Therapy
Besins is not the only manufacturer of testosterone products facing lawsuits. Multiple companies are being accused of marketing testosterone off-label—for uses unapproved by the U.S. Food and Drug Administration (FDA)—and that practice is illegal. While doctors may prescribe drugs for off-label uses, drug companies are not allowed to market them that way.
Testosterone is only approved by the FDA to be used for men with hypogonadism, unnaturally and dangerously low levels of this hormone. Drug companies like Besins, and the company that distributes it in the U.S., AbbVie, are being accused of inventing a condition, low-T, and marketing their products to treat it. As men age their levels of testosterone naturally decline, but this is not the same as hypogonadism.
Testosterone makers pushed their products to treat this natural decline, an off-label use. It also proved to be a dangerous use for testosterone. The potential side effects of supplementing side effects include some very serious ones like the formation of blood clots that cause heart attacks and strokes. Men have died using testosterone and the plaintiffs in the class action lawsuits are claiming that these men never needed testosterone products like AndroGel in the first place.
Besins and Personal Jurisdiction
Besins, a Belgian company, tried to get out of being held accountable in the class-action lawsuit against AndroGel by claiming that there was a lack of personal jurisdiction. The company argued that its contact with the U.S. was too minimal and did not meet the required standard for personal jurisdiction. A court did previously find that it may be difficult to establish personal jurisdiction, but pushed for further discovery. Personal jurisdiction is the requirement that there be a certain amount of minimum contact between the party in question and the forum of the court.
U.S. District Judge Matthew F. Kennelly just ruled in Illinois that Besins does in fact meet the requirements for establishing personal jurisdiction. The company has made more than $600 million in sales of AndroGel in the U.S. over the past 16 years and its employees have gotten updates about the U.S. market for AndroGel regularly over a similar period of time. The product has impacted and caused injury to people in Illinois. These points, according to Kennelly, are enough for personal jurisdiction and it means that Besins cannot maneuver itself out of the class-action lawsuit.
The class-action suit was filed in 2014 and includes more than 2,000 plaintiffs. There are also multiple defendants. These include AbbVie and Besins as well as Eli Lilly and GlaxoSmithKline, which also make testosterone replacement products. The class-action lawsuit will go forward, with Besins in the defendant pool, in spite of the company’s claims that it should not be a part of the case.