Health Care and Eli Lilly and Co. and Health Care Businesses and Health Care & Life Sciences and Health Care & Insurance

Lilly consolidated into testosterone drug lawsuit

June 9, 2014

Abbott Laboratories, AbbVie Inc. must face lawsuits consolidated in federal court in Chicago that claim they hid the risks of using the testosterone-replacement drug AndroGel, a panel of judges ruled Friday.

The market for testosterone replacement drugs, which include AndroGel and Axiron, made by Indianapolis-based Eli Lilly and Co., is worth $1.6 billion annually. The consolidation will encompass all suits against makers of testosterone-replacement pills, including Lilly, the panel said in its order.

Lilly had $178.7 million in Axiron sales in 2013.    

Abbott and AbbVie, a company Abbott spun off last year, are both based in the Chicago area, and “a significant number” of AndroGel suits already are pending before U.S. District Judge Matthew Kennelly there, the panel said. Kennelly will oversee pretrial information exchanges as part of the case consolidation.

The decision to collect the AndroGel cases before Kennelly comes after the U.S. Food and Drug Administration said it will re-examine the safety of testosterone-replacement drugs after studies showed the medicine posed an increased risk of heart attack and stroke.

“Abbott separated its research-based pharmaceutical business into a new public biopharmaceutical company called AbbVie in January 2013,” Scott Stoffel, an Abbott spokesman, said in an e-mailed statement. “With the separation, the U.S. commercial rights and associated responsibilities for AndroGel passed to AbbVie.”

Dirk Van Eeden, a spokesman for North Chicago, Ill.-based AbbVie, said the company supported the consolidation “in the interest of consistency and efficiency.”

Low T

While only about 45 AndroGel cases have been filed in federal courts around the U.S. so far, Kennelly may wind up overseeing thousands once suits against other manufacturers are filed and consolidated with the ones against Abbott and AbbVie, the Panel on Multidistrict Litigation said.

Abbott and AbbVie have been accused in patient suits of starting an $80 million marketing campaign in 2012 to promote AndroGel for a condition known as Low T. Television ads encouraged men complaining of low energy and lack of sexual drive to take the testosterone-boosting medicine, according to the plaintiffs.

Other companies that sell testosterone-boosting medicines, such as Pfizer Inc. and Actavis Inc., opposed consolidating cases over their products with the AndroGel suits against Abbott and AbbVie, the panel said.

Common questions

The panel said the lawsuits involve common questions of fact, and centralizing them in Chicago will promote efficiency.

Putting all the cases before Kennelly will help speed the litigation, said Alex MacDonald, a Boston-based plaintiffs’ lawyer representing patients who took the medicines. MacDonald sued Abbott and AbbVie in federal court in Boston last month on behalf of a former AndroGel user who suffered a stroke while taking the testosterone supplement.

“Testosterone supplements are a lifestyle drug that treat a contrived condition by subjecting men to deadly risks of heart attacks and strokes,” MacDonald said in an e-mail Friday.

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