AndroGel Lawsuit: FTC Seeks Board of Directors Documents in Suit Against AbbVie

Published on July 19, 2016 by Sandy Liebhard

The Federal Trade Commission (FTC) wants access to documents from the board of directors for AbbVie, Inc. According to a report from Law360.com, the Commission is pursuing a so-called pay-for-delay lawsuit involving the company’s AndroGel testosterone treatment.

The FTC went to court 2014, alleging that AbbVie filed sham lawsuits against certain generic drug makers in order to block generic versions of AndroGel from coming to market. On June 30^th, the Commission filed a motion with the U.S. District Court, Eastern District of Pennsylvania, seeking certain AbbVie board materials, including non-privileged marketing and sales documents presented to the company’s board from 2009 through the present. According to the motion, AbbVie has been stalling on the matter for months.

“Because AbbVie has engaged in a ten-month-long cat and mouse game about whether to produce this discrete set of easily identifiable documents, and now has refused to do so, AbbVie should be ordered to produce the requested documents within ten days,” the motion states.

For its part, AbbVie claims that the Commission’s request is “overly broad, unduly burdensome, and not reasonably calculated to lead to the discovery of admissible evidence.”

AndroGel Products Liability Litigation

The pay-for-delay case is not the only AndroGel-related legal matter to embroil AbbVie. In fact, the company is currently named a defendant in thousands of testosterone lawsuits filed on behalf of men who allegedly suffered heart attacks, strokes and other cardiovascular complications due to their use of the low-T therapy drug. The majority of these claims have been centralized in the U.S. District Court, Northern District of Illinois, along with similar lawsuits involving Axiron, Testim and other drugs in the same class.

In March 2015, the U.S. Food & Drug Administration (FDA) announced that new information would be added to the labels of all low-T therapies, including AndroGel, regarding a possible association with an increased risk of heart attack and stroke. The agency also directed the  drugs’ makers to modify the labels to clearly state that prescription low-T therapy has never been proven safe and effective for  the treatment of age-related symptoms in men.