Androgel Adverse Event Investigation Files Must Be Produced by AbbVie

The U.S. District Judge presiding over all federal testosterone injury lawsuits has determined that AbbVie must turn over information about hundreds of adverse event investigations into problems linked to side effects of Androgel. 

There are nearly 6,000 Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits and other claims pending throughout the federal court system involving problems with testosterone replacement therapy, which have been linked to reports of heart attacks, strokes, blood clots and other serious injuries.

Given the common questions of fact and law raised in the cases, complaints filed in U.S. District Courts nationwide are centralized for discovery and pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL or multidistrict litigation. The process is designed to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated proceedings, Judge Kennelly previously established a “bellwether” process, where a small group of cases filed against AbbVie, the makers of Androgel, are being prepared for early trial dates, since that testosterone gel is the most widely used of the “low T” drug on the market.

The first Androgel trials are expected to begin in June 2017, which may help gauge how juries will respond to evidence and testimony that will likely be repeated throughout the litigation.

After addressing a discovery dispute at a recent status conference, Judge Kennelly issued a docket entry (PDF) on June 22, ordering AbbVie and it’s former parent company, Abbott Laboratories, to produce drug safety and investigation files related to 269 adverse event reports submitted to the FDA.

The order came in response to a motion (PDF) filed by plaintiffs in May, which indicated that the drug makers have resisted turning over their full files.

“These back−up materials for defendants’ reports to the FDA are relevant regarding, if nothing else, what defendants knew about adverse effects potentially associated with their products and when they knew it,” the court determined. “There is, to be sure, burden associated with production of these materials, including the need to redact patient−identifying and some other information, but defendants have not shown that the burden is undue given the relevance of the information and the overall scope of this litigation.”

Judge Kennelly indicates that the question of whether the relevant file will turn out to be admissible evidence at trial is a separate matter that will be considered by the Court in the future.

The Androgel bellwether trials are designed to be representative of other claims in the litigation, and will be closely watched by lawyers involved in the litigation, as they may influence eventual testosterone settlements with AbbVie and other drug makers.

Following a series of trials against AbbVie, Judge Kennelly has previously indicated that a second group of cases will be prepared for trial involving other “low T” drugs, such as Axiron, Testim, Androderm and others. If the bellwether process fails to result in settlement of a large number of cases, or another resolution for the litigation, Judge Kennelly could begin remanding hundreds of individual cases back to U.S. District Courts nationwide for further trial dates.