Discovery Moving Forward in Low T Drug Lawsuits

As a growing number of AndroGel lawsuits, Testim lawsuits and other claims involving heart problems from “Low T” drugs continue to be filed throughout the federal court system, the U.S. District Judge presiding over the litigation has issued initial discovery plan orders.

In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federal testosterone drug lawsuits before U.S. District Judge Matthew F. Kennelly in the Eastern District of Illinois for coordinated management during pre-trial proceedings.

All of the complaints involve similar allegations that plaintiffs suffered a heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism or other serious injury after using a testosterone replacement therapy, such as AndroGel, Testim, Axiron, Androderm or Depo-Testosterone.

Regardless of the manufacturer involved in the lawsuit or the specific Low T drug used by the plaintiff, the cases have been centralized as part of one MDL, or multi-district litigation, to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the witnesses, parties and the courts.

On August 25, Judge Kennelly issued a case management order (PDF), outlining the preliminary discovery plan and procedures in the litigation.

Each defendant in the MDL has been given 45 days to provide initial disclosures, including a list of people most knowledgeable about the marketing and development of their drugs, information about where relevant documents for the case are being stored and the names of their custodians.

In advance of a status conference scheduled for later this month, the parties have been directed to continue negotiations over the contents of a Plaintiff Fact Sheet (PFS), which will include case-specific questions and document requests that will need to be answered by each plaintiff who has filed a lawsuit. A separate Case Management Order concerning the PFS is expected to be issued at or slightly in advance of the September 2014 status conference.

On September 1, a protective order (PDF) was issued by Judge Kennelly, outlining how the parties must handle information and documents designated as confidential information, including certain internal documents received from the drug makers, as well as personal information on specific plaintiffs.

Testosterone Drug Lawsuits

There are currently only about 200 cases centralized before Judge Kennelly in the MDL. However, as low T drug lawyers continue to review and file additional complaints over the coming months and years, it is ultimately expected that several thousand lawsuits will be included in the litigation.

The litigation has emerged over the past nine months, following a series of studies that found a link between testosterone drugs and heart risks, as well as a January 2014 FDA announcement that indicated that the agency is reviewing the risk of cardiovascular problems among men taking any approved testosterone drugs.

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.

As part of the testosterone MDL, it is expected that Judge Kennelly will eventually select a small number of cases to serve as “bellwether” lawsuits to be prepared for early trial dates.

While the outcomes of these cases are not binding in other lawsuits, they are typically used to help the parties gauge how juries may respond to evidence and testimony that may be repeated throughout the litigation. The process may also influence eventual low T drug settlement negotiations with the various manufacturers.