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Testosterone MDL Court Outlines Deadlines for Axiron Bellwether Trials

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In June 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed testosterone therapy lawsuits into one court in the Northern District of Illinois. Since that time, both sides have been busy collecting evidence and choosing a small number of cases that will represent the rest in the first few bellwether trials.

Early on, Judge Kennelly, who is overseeing the proceedings, ordered that the first several bellwether trials would involve only AndroGel. This is the most popular testosterone replacement drug, and is by far the drug most often named in plaintiffs’ lawsuits. The parties were scheduled to make their final selections on these cases—a total of eight—in August, with the actual trials scheduled to begin in July 2017.

Once these trials are completed, however, the court plans two more early trials. These will involve the next most popular drug in the litigation: Axiron.

The Difference Between Axiron and AndroGel

Axiron is the only underarm testosterone treatment on the market. Like AndroGel, it helps raise serum testosterone levels, and it’s actually made up of the same synthetic ingredient as AndroGel. The difference is that AndroGel comes in a clear gel-like solution that men rub onto the skin, usually on the shoulders, upper arms, or abdominal area. It is manufactured by AbbVie Inc.

Axiron, on the other hand, is a clear solution that comes in a pump bottle, and it’s meant to be used in the armpit area. It is manufactured by Eli Lilly and Company.

Once the initial bellwether trials for AndroGel are complete, the court will move on to early trials for Axiron. In a recent case management order, Judge Kennelly outlined the process for choosing these cases, with plans for them to go to court starting on January 29 and March 7, 2018.

Court Sets Deadlines for Choosing Axiron Bellwether Trials

The court ordered the parties to continue their discovery against Lilly. Meanwhile, by November 1, 2016, each party is to choose from the eligible pool of bellwether cases the following:

  • Four cases involving plaintiffs who suffered blood clot injuries.
  • Four cases involving plaintiffs who suffered cardiovascular injuries.

With each side choosing these cases, the end result will be 16 total cases. Then, by June 9, 2017, the parties will submit proposals for the selection of the final bellwether cases. By June 23, the court will select between two and four cases for actual trial, and will designate the order of those trials.

Once the cases are chosen, plaintiffs will proceed with disclosures of expert witness testimony, and will make any motions for summary judgment by November 21, 2017.

After AndroGel and Axiron, Generics to be Next

Once the AndroGel and Axiron bellwether cases have gone to trial, the court has stated that cases naming Actavis as a defendant will be next. In a recent case management order, they outlined the bellwether selection process for these cases, which will begin in March 2017.

Actavis is another pharmaceutical company, formerly known as Watson Pharmaceuticals, that produces a number of generic drugs, as well as over-the-counter medications and commercially branded products. In this litigation, it is named for its generic testosterone products.

The court has mapped out the process for choosing the initial Actavis trials, stating that there will be no more than 14 selected for the initial pool. Between two and four will be chosen for bellwether trials.