Selection of Androgel Lawsuits for Bellwether Trials to be Reviewed with MDL Judge

Parties involved in the federal testosterone replacement therapy litigation have submitted competing proposals regarding the process for selecting a group of AndroGel lawsuits to be prepared for a series of early trial dates. 

There are currently more than 1,750 testosterone lawsuits pending throughout the federal court system, all involving similar allegations that the manufacturers failed to adequately warn about the risk that men may suffer a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other injury.

Since June 2014, cases filed against various manufacturers of different testosterone drugs have been centralized 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, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

Most of the complaints filed to date have been brought against AbbVie over their Androgel treatment, which is the most widely used testosterone replacement therapy.

As a result, Judge Kennelly has established a “bellwether” program that calls for a group of cases where AbbVie is the only defendant to go through case-specific discovery in preparation for a series of six trial dates that will begin next year to help the parties gauge how juries may respond to certain evidence and testimony that will be offered throughout many different cases.

Judge Kennelly originally called for the parties to each “identify” 16 lawsuits for bellwether discovery, including eight cases involving heart attacks and eight involving a thromboembolism clotting injury, such as deep vein thrombosis, pulmonary embolism or other clotting cases. This pool of 32 lawsuits will later be reduced down to six cases that will go to trial between October 2016 and April 2017.

The selection of these 32 cases is not due until October 31, 2015. However, the parties were directed to submit proposals for the exact selection process this month, and there are vast differences between the positions of plaintiffs and the drug maker.

In a memorandum (PDF) submitted by the Plaintiffs’ Steering Committee (PSC) on August 10, attorneys appointed to leadership positions on behalf of plaintiffs in the litigation argue that the court should stick with the original plan, allowing each side to select 16 cases, with the court later selecting the six that will go to trial.

Plaintiffs submitted a proposed Case Management Order that details the parameters for the pool of cases from which bellwether candidates should be considered and provides a process for replacing cases if the parties select duplicate claims or if any of the cases are voluntarily dismissed or settled.

In a competing proposal (PDF) submitted by AbbVie, the maker of Androgel argues that the Court should adopt a new plan and pick the 32 cases that will go through case-specific discovery, and then have the final six cases selected by the parties.

“AbbVie believes this Court should take an active role in the selection of the 32 representative discovery cases and should not simply leave it up to the lawyers to choose their favorites from the pool,” wrote the drug maker in their memorandum. “Rather than being relegated to a purely administrative formality, this decision should be regarded as one of the most important in the case, as it will define the arena of facts that will be used in the AbbVie-only pretrial and trial proceedings. Accorded that significance, the selection process should be guided by data, use available statistical methods and apply objective criteria.”

Plaintiffs maintain that AbbVie’s proposal “seeks to unwind” most of the provisions previously outlined by Judge Kennelly. They also argue that AbbVie’s proposal to engage in full fact discovery and expert workup for all 32 cases will negatively impact and delay the trial schedule.

The parties are expected to review the submissions regarding the bellwether selection process with Judge Kennelly during a status conference set for Friday, according to a joint agenda (PDF) submitted yesterday.

While the outcomes of these early bellwether trials are not binding on other cases, they will be closely followed by those involved in the litigation, as they may influence eventual testosterone settlement negotiations that would avoid the need for hundreds of individual cases to go before juries throughout the U.S.

In addition to cases against AbbVie, Judge Kennelly is also presiding over Axiron lawsuits, Testim lawsuits, Androderm lawsuits and cases involving other testosterone replacement drugs.

Following the Androgel trials, a second group of bellwether trials are expected involving lawsuits pending against other manufacturers, which would likely not begin until the second half of 2017.