Abbvie Testosterone Lawsuit | 2022 Update and Look Back

In June 2019, AbbVie’s AndroGel testosterone lawsuits settled for $775 million. (Our lawyers are still taking testosterone lawsuits in 2022. Just no longer involving this testosterone supplement.)

Lawsuits had been filed claiming that the makers of Androgel, AbbVie, failed to warn thousands of men about the potential side effects of the drug. These side effects include heart attacks, blood clots, stroke, and even sudden death in extraordinary cases. As the litigation wheels start turning here, AbbVie is trying to gum them up with objections to slow down the process. You could say everything is going according to plan…

What Is AndroGel?

Androgel is a form of testosterone replacement therapy (TRT). The purpose of testosterone is to increase levels of testosterone in the blood of humans. So TRT is a process to supplement our naturally occurring levels of testosterone. Why? Because some men have low testosterone production (and some just want more).

AndroGel is a synthetic testosterone gel formulation. The gel formulation was developed to give transdermal delivery of testosterone continuously for 24 hours.

Androgel Lawsuits

If you are reading this you probably already know this. But let’s recap. There were about 7,000 lawsuits against AbbVie percolating around the federal court system.

The various suits alleged that the makers of Androgel, AbbVie, neglected to warn thousands of men about the serious side effects of the “Low-T” treatment drug.

This drug has certainly been a big hit, understandably so, considering that it promises men physical enhancement to counteract the forces of aging. But thousands of lawsuits allege that low-T drugs can lead to heart attack, stroke, pulmonary embolism, deep vein thrombosis, or other injuries, prompting men across the U.S. to sue AbbVie and the other manufacturers for not being adequately warned of the risks.

That really is what this is about. No one — at least not many people — was calling for a low-T recall. The risk might outweigh the benefit for some, although probably not many of us. It is about giving patients and doctors a choice. Tell us what can happen and let us make the call. They are giving this warning now. They should have given it to us before. That is what these lawsuits were about.

These Testosterone Lawsuits

The gist of the lawsuits was the argument that testosterone therapy in men increases the risk of a major cardiovascular event through rheological, biochemical, and coagulation system effects that can alter the integrity of blood flow within the coronary artery or cerebrovascular circulations. Accordingly, as we have been saying, the drug company has a duty to warn of this problem. This is especially true for men who had preexisting cardiac conditions associated with increasing levels of atherosclerotic burden.

The lawsuits against AbbVie are substantially similar in that they focus on this failure to warn of the risks of these low-T drugs.

As a result, the cases were consolidated as “Multi-District Litigation” (MDL) before Judge Matthew Kennelly in the Northern District of Illinois. One thing that the parties have been directed to do in the preliminary phases of MDL is exchange fact sheets, which contain specific information about each claim. This allows bellwether cases to be selected, which are the first cases that eventually go to trial. Bellwether cases give the parties the opportunity to dip their feet in the water to gauge how jurors will react to various aspects of each case.

Androgel Verdict in 2017: $150,000,000.

In October 2017, the judge presiding over the federal MDL class action has ordered the parties to meet to then provide an update of settlement negotiations. Will this lead to an Androgel class action settlement? Maybe. This is how mass tort cases get to a global settlement. The plaintiffs hit with big verdicts and the drug company began looking at getting rid of the uncertainty on their balance sheets of so much litigation.

Since then, there have been some wins and losses on both sides. What we have learned is that the juries buy into some of these cases and not others. This is the best kind of litigation to get settled.

The Fact Sheet Dispute

One thing to remember though: lawyers cannot always play nice. The attorneys for AbbVie recently submitted objections to the fact sheets alleging all manner of incorrectness. They suggested that some of the fact sheets were not filed on time and/or contained deficiencies. We are talking about a lot of plaintiffs so there is some truth to their allegations. Not everyone complies as quickly as they should. But 90% of these were done correctly and on time. (This was not written in 2022.)

Opinion: AbbVie Does Not Want to Take a Case to Trial

[I wrote this part – the rest of this – in 2015. I was, at least in part, wrong.]

But this is always the case. Conveniently, they want to delay the bellwether process. What does this mean? Delaying trials. Why? This is what defense lawyers do. I don’t think AbbVie has any real intention of trying these cases. They would like to see other non-AbbVie cases go forward first.

Anything to stall and delay and avoid test getting tried. Because if a case goes to trial and AbbVie takes a hit, it is a stain on this new company… and the price of settlements will keep going up. They think they are better off stalling and they might be right. But hopefully, Judge Kennelly will hold their feet to the fire. A delay in some fact sheets has nothing to do with getting a small group of cases ready for trial. Plaintiffs’ lawyers know this, defense lawyers know this — everyone knows the score.

With roughly 300 complaints currently pending before U.S. District Judge Mathew Kennelly, and several thousand expected to be filed before all is said and done, Judge Kennelly of the Northern District of Illinois has appointed four testosterone drug attorneys to serve as liaisons with state courts where dozens of additional cases are pending. In an effort to increase coordination of the litigation, the role of the state-federal court liaisons will be to promote better coordination for the rapidly accumulating host of testosterone lawsuits being filed.

2023 Update: This is an old blog post. But there are still testosterone lawsuits in 2023. Eli Lilly and Co. faces a wrongful death lawsuit in a Washington state court filed in August 2023, following the death of a 39-year-old man from a severe heart attack, which is claimed to be a result of the pharmaceutical company’s testosterone replacement drug, Axiron. Axiron is prescribed to men who have low testosterone levels due to various medical conditions, such as aging, injury, or certain diseases. It helps raise testosterone levels to within the normal range but it may come with significant cardiovascular risks.

What’s It All About?

Testosterone products, prescribed to treat low testosterone (“Low T”) in men, have become popular among young men seeking physical enhancement, as well as older men who want to counter signs of aging. The problem? In simple terms, low testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men 65 years of age and older, even those who have had no heart problems.

Recent concerns include the increased risk of deep vein thrombosis (DVT) which can lead to life-threatening complications including pulmonary embolisms. DVT is where the body develops blood clots in the deep veins, most commonly in the legs. These blood clots can break off and travel through the body, resulting in potentially life-threatening complications. But there is a growing concern that these products have serious side effects and long-term risks, particularly related to the heart.

Men who have used one or more of these supplements or low testosterone products, who then suffer cardiac arrest, stroke, other heart-related issues, and side effects are beginning to file lawsuits contending they were not properly warned of the risks. All the complaints involve nearly identical allegations that these products caused a heart attack, stroke, pulmonary embolism, DVT, or other injuries.

Lawsuit Status

The lawsuits name products such as Androgel, Axiron, Testim, Androderm, and Depo-Testosterone, though the majority of the cases filed involve Androgel. Manufactured by AbbVie Inc., a drugmaker that spun off Abbott Laboratories in 2013, Androgel has 60% of the testosterone replacement therapy market. With this in mind, Judge Kennelly has outlined a case management plan for Androgel, separate from that which will guide litigation against the other defendants.

In a case management order issued on December 19th, Judge Kennelly indicated that a group of non-Androgel cases will prepare for early trial dates, known as bellwether lawsuits, to go before a jury in mid-2017. Slightly further along, the first Androgel trials are expected to begin by late 2016. Bellwether lawsuits, common in complex pharmaceutical litigation, are designed to help the parties gauge how juries may respond to certain evidence and testimony, reduce duplicative discovery common to the lawsuits, and avoid conflicting pretrial rulings from different judges. While not binding on other claims, the process hopefully helps to facilitate settlements and avoid the need for individual trials. Should that not happen, the cases may be remanded back to the U.S. District Court where the case was initially filed for an individual trial date.

Axiron

Axiron is a prescription medication used in the treatment of low testosterone levels in men, a condition known as hypogonadism. This drug is produced by Eli Lilly and Company and is applied topically, typically under the arm, once daily.

Here are some things to know about Axiron:

Indication: Axiron is used for men with low T levels that come with age, injury, or disease. The drug is designed to raise testosterone levels back to a normal range.
Application: The medication comes in a liquid form that is applied directly to the skin, usually under the armpit. It should be applied at approximately the same time every day, typically in the morning. Users need to allow it to dry completely before dressing.
Dosage: The prescribed dosage of Axiron varies depending on the individual’s specific medical condition and testosterone levels. Doctors determine the appropriate dosage for each patient.
Effectiveness: Axiron works for many men. That has never been the issue. It can certainly increase testosterone levels in many men with low testosterone. Improved symptoms may include more energy, improved mood, enhanced muscle mass, and increased libido… things men want to look and feel younger.
Potential Side Effects: Like many medications, Axiron can have side effects, which may include skin irritation at the application site, and increased red blood cell count (polycythemia),. The bigger concern in the minds of many is the increased risk of cardiovascular complications.
Monitoring: Men using Axiron need regular monitoring by their healthcare provider to ensure the treatment is working effectively and safely. This may involve blood tests to check testosterone levels and evaluate any potential side effects, including cardiovascular complications.

Testosterone Class Action History

The Testosterone Litigation Multi-District Litigation (MDL) was established in the Northern District of Illinois on June 6, 2014, by the Judicial Panel on Multidistrict Litigation (JPML). The Testosterone Replacement Therapy (TRT) multidistrict litigation (MDL) was created on June 6, 2014, by the Judicial Panel on Multidistrict Litigation (JPML). The MDL was assigned to Judge Matthew Kennelly in the Northern District of Illinois.

The lawsuits involved allegations that testosterone replacement therapy drugs, including AndroGel, Testim, Axiron, and others, caused serious cardiovascular side effects, including heart attacks, strokes, and blood clots. The plaintiffs claimed that the drug manufacturers, including AbbVie Inc., Eli Lilly and Company, and Endo Pharmaceuticals Inc., failed to adequately warn about the risks associated with TRT.

AbbVie has faced six cases that went to trial, winning four and losing two. The company was initially ordered to pay $140 million in one trial but that did not survive an appeal.

As of 2023, over 7,000 lawsuits had been filed and transferred to the MDL. In January 2018, AbbVie Inc. agreed to settle over 4,000 cases for $140 million, which was considered a bellwether for the remaining cases. The settlement was made without any admission of liability or wrongdoing by AbbVie. The remaining cases were later dismissed or transferred back to their original courts for trial.

Case Status: Where Are We Going?

As I said, everyone now expects the lion’s share of these cases to settle. We are just waiting to see what the settlement compensation amounts are for these cases. I’m also interested in seeing how many victims who are bitter at the amount of money they will receive opt out of the settlement and keep pushing forward.