Testosterone Drug Makers to Challenge Generic Lawsuits on Preemption Grounds

Lawyers involved in the federal testosterone lawsuits are scheduled to meet today with the U.S. District judge presiding over the litigation.

According to a status report filed before the conference, several generic drug makers indicate that they intend to file motions to dismiss cases involving use of their products, arguing that the plaintiffs are barred from pursuing compensation if they received generic testosterone replacement products.

There are currently about 1,500 product liability lawsuits filed throughout the federal court system involving men who allege that inadequate warnings were provided about the risk of heart attacks, strokes and other injuries that may be caused by side effects of testosterone drugs.

While most of the complaints involve lawsuits over Androgel, Testim, Axiron or other name-brand medications, some of the cases involve injuries suffered by users of generic testosterone replacement therapy.

In recent years, generic drug makers have sought to insulate themselves from liability for injuries caused by side effects of their medication, even when the manufacturers know about risks that are not disclosed on the warning label. Known as federal preemption, generic pharmaceutical companies have argued that they are protected from failure to warn lawsuits since FDA regulations currently require their warning labels to be the same as those provided with the name-brand drug they copy.

A controversial 2011 U.S. Supreme Court ruling, known as Pliva v. Mensing, upheld the pre-emption argument, resulting in the dismissal of previous lawsuits filed over generic Reglan, Accutane and other products. The Supreme Court found that it is an impossible standard for generic drug makers to comply with federal regulations and state law warning requirements. Therefore, many individuals who have suffered injuries from known side effects of medications have been prevented from seeking any damages, just because they were given a generic.

With several generic testosterone drugs on the market, primarily involving older injection products, some of the manufacturers named in recently filed lawsuits plan to move to dismiss the cases on the ground that plaintiffs’ claims are preempted under the doctrine of impossibility preemption.

“The parties are meeting and conferring regarding a proposed briefing schedule and page limits for the briefs, for which they intend to request the Court’s approval (if they are able to reach agreement) or the Court’s guidance (if they are not able to reach agreement),” according to a joint status report (PDF) filed by the parties on April 16. “The parties also will seek the Court’s guidance with regard to a hearing date for oral argument on the motion.”

Androgel, Testosterone Drug Injury Cases

Since June 2014, the federal testosterone litigation has been centralized for pretrial proceedings before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois to avoid duplicative discovery into common issues raised in the complaints, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

All of the complaints involve nearly identical allegations, indicating that drug makers failed to adequately warn about the heart risks with testosterone drugs, which several studies have recently suggested may cause some users to suffer a heart attack, stroke, pulmonary embolism, deep vein thrombosis or sudden death.

Over the past year, hundreds of lawsuits have been filed in U.S. District Courts nationwide, or directly into the federal MDL (Multidistrict Litigation) before Judge Kennelly. As testosterone drug lawyers continue to review additional cases, it is ultimately expected that several thousand complaints will be involved in the litigation.

As part of the coordinated pretrial proceedings before Judge Kennelly, a small group of Androgel lawsuits are being prepared for trial. Known as “bellwether” cases, a series of six trials are scheduled to begin about one-per-month between October 2016 and April 2017.

A separate bellwether track has been established for early test trials involving other testosterone drugs, which are not expected to begin until at least mid-2017.

These early trial dates are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, with the cases selected serving as representative samples of other claims.

While the outcome of any early bellwether trials will not be binding on other lawsuits, the process is designed to help parties evaluate the strengths and weaknesses of their cases, potentially facilitate in testosterone drug settlements that will avoid the need for individual trials to be scheduled nationwide.

According to an agenda (PDF) for today’s status conference, Judge Kennelly is also expected to review with the parties status of discovery in the bellwether cases, the product of documents and adverse event reports from the drug makers and the coordination of the federal litigation with state court cases.