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The U.S. District Judge presiding over all federal testosterone lawsuits has issued a case management plan that outlines the process for the first bellwether cases, which could result in the first Androgel trials going before juries in late 2016 and early 2017.
Since June 2014, all product liability lawsuits filed throughout the federal court system involving injuries allegedly caused by side effects of testosterone replacement treatments have been centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.
All of the complaints raise similar claims that men suffered a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other injury after using a testosterone gel, cream, patch, injection or other therapy, alleging that the drug makers failed to adequately research the drugs or warn about the potential risks associated with testosterone treatments.
Given common questions of fact and law, the litigation is consolidated as part of a federal MDL, or multidistrict litigation, regardless of which drug manufacturer or specific treatment was used. However, most of the cases are Androgel lawsuits pending against AbbVie, as that product was the most popular “Low T” treatment on the market in the U.S.
As part of the coordinated pretrial proceedings before Judge Kenelly, it has been expected that a small group of cases will be prepared for early trial dates, known as “bellwether” cases, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.
In a case management order (PDF) issued November 6, Judge Kennelly outlined the process for selecting a group of bellwether lawsuits that only involve the drug maker AbbVie as a defendant. These claims will will go through case-specific discovery and culminate in a series of six trial dates that are expected to begin about one-per-month between October 2016 and April 2017.
Judge Kennelly’s order comes after the parties each submitted competing proposals regarding the testosterone bellwether process. The Court’s final schedule more closely reflects the proposal submitted by the plaintiffs, which called for the first trials to begin in mid-2016. AbbVie attorneys did not want the first trials to start until late 2017.
Androgel Bellwether Trials
According to the bellwether plan, lawsuits filed against AbbVie will be divided into two tiers, with eight cases selected from each injury group that will be eligible for the first trial dates.
The first tier will involve lawsuits that allege the plaintiff suffered a pulmonary embolism, deep vein thrombosis or other blood clot injury from Androgel or another AbbVie testosterone drug. The second tier will involve cardiovascular cases, where plaintiffs allege that they suffered a heart attack from Androgel or another AbbVie drug.
Judge Kennelly has directed the parties to submit proposals regarding the selection process and parameters for these two tiers of cases by July 11, 2015. The final group of 16 cases will be identified by October 31, 2015, and the discovery phase of the bellwether process will begin.
Between November 1, 2015 and January 15, 2016, core bellwether discovery will be conducted, including a maximum of four depositions per side for each case, which are designed to help the parties assess the cases and provide the Court with information necessary to select which specific cases will be scheduled for the first six trial dates.
Following selection of the final trial cases in the testosterone MDL, additional fact and expert witness discovery will be completed, with any dispositive motions for summary judgment or challenges to the admissibility of expert opinions due by August 1, 2016.
The first three AbbVie bellwether trials are scheduled to begin on October 31, 2016, December 5, 2016 and January 9, 2017, involving claims over thromboembolism (TE) clotting injuries. These cases will be followed by a second series of trial dates set to begin on February 13, 2017, March 20, 2017 and April 24, 2017, which will all involve cardiovascular injuries.
While the outcomes of these early trial dates will not be binding on other cases against AbbVie or other drug makers, the process of preparing the cases and the findings of the jury may influence any potential testosterone settlement agreements that may be reached to avoid hundreds of individual trials throughout the country.
Testosterone Drug Litigation
According to the latest case list (PDF) released by the JPML on October 15, there are currently at least 223 testosterone lawsuits filed in federal courts throughout the country that have been transferred to Judge Kennelly to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
As testosterone injury lawyers continue to review and file cases in the future on behalf of men throughout the United States who used these popular treatments, it is ultimately expected that several thousand lawsuits will be included in the MDL.
In addition to Androgel cases filed against AbbVie, Judge Kennelly is also presiding over Testim gel lawsuits against Auxillian, Axiron gel lawsuits against Eli Lilly, Androderm patch lawsuits against Actavis, Depo-Testosterone injection lawsuits against Pfizer and other claims involving similar products marketed in recent years for treatment of “Low T.”
Nearly all of the cases have been filed since the publication of two studies about a year ago, which raised concerns about the heart risks of Androgel and other testosterone treatments.
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.
The FDA launched its own testosterone investigation shortly after the release of this research. indicating that the agency is reviewing the cardiovascular risks among men taking any approved testosterone drugs to determine what regulatory actions may be necessary.
Two FDA advisory committees met this summer to evaluate the available data and voted 20-to-1 to recommend that the drug makers be forced to conduct additional clinical trials to evaluate the potential heart risks. The panels also recommended that the FDA restrict use of the widely used medications to men actually suffering from testosterone deficiencies caused by hypogonadism or another medical condition.
In recent years, testosterone drugs have grown from a niche treatment into a $2 billion industry following aggressive marketing that has promoted the drugs for age-related drops in testosterone levels, which are occur as all men get older.