Generic Testosterone Drug Lawsuits Dismissed Based on Federal Preemption

The U.S. District Judge presiding over all federal testosterone drug lawsuits has determined that cases involving Depo-Testosterone, Testopel and generic versions of popular low-T medications are pre-empted by federal law.  

There are currently more than 2,700 product liability lawsuits pending in the federal court system involving allegations that various drug makers failed to adequately warn about the potential side effects of testosterone replacement therapy, which have been linked to reports of heart attacks, strokes, deep vein thrombosis, pulmonary embolism and other injuries.

The federal testosterone litigation is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL, or “Multi-District Litigation, regardless of which low T drug allegedly caused the plaintiff’s injury.

While most of the cases are Androgel lawsuits, Testim lawsuits, Axiron lawsuits or Androderm patch lawsuits, which are the most widely used testosterone drugs on the market, a number of cases have been filed on behalf of individuals who received Depo-Testosterone injections, Testopel pellets or other generic testosterone drugs.

Preemption of Generic Testosterone Cases

In an order (PDF) issued earlier this month, Judge Kennelly granted a motion to dismiss all lawsuits over Depo-Testosterone and Testopel, finding that those brand-name medications are actually generic testosterone drugs, and that the failure to warn claims are pre-empted by federal law.

In a controversial 2011 U.S. Supreme Court ruling, known as Pliva v. Mensing, generic drug makers were provided immunity from failure to warn lawsuits, with the Supreme Court ruling that federal regulations pre-empt the state law warning requirements.

Since generic drug makers are required to carry the same warning labels as the brand name medications they copy, the Supreme Court found that it would be an impossible standard to hold manufacturers liable for failure to warn about risks associated with generic medications, even if they are aware that the existing label is inadequate. The highly criticized decision has resulted in the dismissal of hundreds of lawsuits over generic Reglan, Accutane and other products.

When a generic version of a drug is approved, the FDA usually names the brand-name version of that drug as the reference-list drug (RLD), meaning it is the drug that all the generics have to duplicate. However, the FDA gave Depo-Testosterone and Testopel RLD status, even though they were generics, because the original drugs they copied were no longer on the market at the time.

In response to a motion to dismiss filed by Pfizer and Auxilium, the makers of Depo-Testosterone and Testopel respectively, plaintiffs’ argued that because the testosterone drugs were the reference-list drugs that other manufacturers were required to copy, the manufacturers should not be exempt from liability for failure to warn under Pliva v. Mensing.

In a memorandum opinion issued on November 9, Judge Kennelly rejected the plaintiffs’ argument and granted the motion to dismiss generic testosterone drug lawsuits. Judge Kennelly noted that the FDA recently itself said it did not see the designation of an RLD that way, and that generic drugs given RLD status still had the same labeling restrictions as other generic drugs.

The original motion to dismiss was also filed by Actavis over their generic testosterone replacement therapy products, but Judge Kennelly noted that plaintiffs voluntarily dismissed all cases involving Actavis products, thus the only claims still at issue were the Depo-Testosterone lawsuits and Testopel lawsuits.

Status of Remaining Testosterone Drug Litigation

The ruling does not impact the hundreds of additional claims pending over problems with Androgel, Axiron, Testim, Androderm or other brand-name testosterone drugs.

As part of the centralized pretrial proceedings in the MDL, Judge Kennelly has ordered that a small group of Androgel cases be prepared for early trial dates, which are expected to begin in 2017. Known as bellwether cases, these trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be offered throughout a number of different lawsuits over testosterone drugs.

All of the complaints raise nearly identical allegations, indicating that the drug makers knew or should have known about the potential testosterone heart risks, yet continued to promote the medications for men without any true need for the drugs, withholding warnings and information from consumers and the medical community.

The litigation has emerged since several studies published in recent years identified a potential link between low testosterone drugs and heart attacks.

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.

Following the Androgel bellwether trials, Judge Kennelly has indicated that a second round of cases will be scheduled involving other testosterone drugs, such as Axiron, Testim and Androderm.

While the outcomes of these early bellwether cases will not be binding on other plaintiffs, they may influence potential testosterone drug settlements for men who have suffered heart attacks, blood clots or other side effects.