AndroGel Racketeering Lawsuits Over Marketing Tactics Dismissed

A federal judge has dismissed allegations of racketeering filed against the makers of AndroGel, the most popular testosterone drug currently on the market.

The complaint was originally brought against AbbVie and Abbott Laboratories, as part of a class-action lawsuit over its use of co-pay discount cards, alleging that the actions were illegal because they frustrated pharmacies’ contractual obligation to collect co-pays from the Plaintiffs’ insurance companies and because they tried to make the co-pay subsidies look like a secondary form of insurance.

The racketeering lawsuit also included charges in connection with the marketing of Humira, and was filed by the New England Carpenters Health and Welfare Fund, seeking class action status for third party payors who spent additional funds due to the co-pay subsidy programs run by the manufacturers of those drugs.

In an order (PDF) issued on September 25, U.S. District Judge Robert M. Dow, Jr. dismissed the racketeering charges, finding that the plaintiffs have not been able to show that the defendants entered into a specific enterprise for the intent of conducting a criminal act, according to requirements under the Racketeer Influenced and Corrupt Organizations (RICO) Act.

Androgel Injury Lawsuits

The decision comes amid a growing number of Androgel lawsuits filed in courts nationwide on behalf of former users of the popular testosterone gel, alleging that the drug maker withheld important safety information about the risk of heart attacks, strokes, blood clots and other injuries associated with use of the medication.

In the federal court system, the Androgel injury claims are centralized with other similar testosterone lawsuits filed against the makers of other low T treatments, such as Axiron, Testim, AndroDerm and others.

More than 200 complaints are currently consolidated as part of a federal MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Matthew F. Kennelly in the Eastern District of Illinois.

The litigation comes following a series of studies and the launch of a safety investigation launched by the FDA in January.

In November 2013, a study published in the Journal of the American Medical Association suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

Earlier this month, the FDA convened two advisory committees to evaluate the testosterone drug heart risks. The panels voted 20-to-1 to recommend that drug manufacturers be forced to conduct clinical trials, at the risk of civil penalties, to determine the heart attack risks of testosterone drugs.

The panels also called for label changes that would help reduce testosterone drug use by men suffering from age-related low T levels and would return the drug’s focus on men with hypogonadism caused by injury or disease affecting the testicles or certain parts of the brain.

It is ultimately expected that thousands of lawsuits over Androgel and other testosterone treatments will be filed in courts throughout the country in the coming months.