There have been two major developments in testosterone replacement therapy litigation in the past week. Last Thursday Eli Lilly & Co., the maker of the testosterone product Axiron, announced to Judge Matthew Kennelly in Illinois that an agreement had been reached to settle claims by people injured by Axiron testosterone. In the second development, the same judge tossed a jury verdict awarding $150,000,000.00 in punitive damages to a man who suffered a heart attack while taking Androgel testosterone.

Let’s take a quick look at both litigation developments:

Axiron Testosterone Global Settlement

Two bellwether trials in the Axiron testosterone litigation had been scheduled for January and March 2018. In one case, a plaintiff alleged that Axiron had caused his heart attack. In the second case, the plaintiff alleged that the testosterone product had caused deep vein thrombosis (DVT). These two cases were going to be the first trials over injuries sustained by Axiron in the multidistrict litigation, or MDL. Nevertheless, on December 21, 2017 Eli Lilly announced to the judge that a framework for settling all Axiron lawsuits had been reached by the executive committees for the plaintiffs and defendants.

The terms of the proposed settlement were not announced. The judge gave both sides forty-five (45) days to finalize the terms of the settlement. The Axiron testosterone cases are part of more than 6,000 lawsuits brought against several testosterone makers, including Eli Lilly, AbbVie, and Auxilium.

On the strength of this settlement announcement, Judge Kennelly postponed the upcoming Axiron bellwether trials and all trial deadlines. In a way this is a shame, as several bellwether trial verdicts give all sides a clear picture of how juries view the harm done. Of course, there is serious risk on both sides in trying these cases. If a jury awards a huge amount of damages, the defendant company will eventually pay more in the larger settlement. If several juries find no link to the product and the injury, the plaintiffs suffer. We will not get to see what juries thought of the Axiron testosterone product at this point.

I will update you here as soon as the Axiron Master Settlement Agreement is released.

Androgel: $150,000,000 Jury Award Set Aside

I must admit I saw this coming. I essentially predicted it. I wrote about Mr. Mitchell’s large punitive damages award in August, which you can read here. You may recall that I pointed out then the serious problem with the jury’s verdict: that it awarded punitive damages without any award for compensatory damages. As I explained months ago, to support an award for punitive damages, there usually must be some award for actual damages. Think of this way: in order for a plaintiff to qualify for a punitive damages award, that plaintiff must show that he has been directly harmed by the product, even if the harm is minimal.

In this case, Mr. Mitchell suffered serious harm: a heart attack. However, the jury could not agree that the heart attack was caused by the Androgel testosterone. Nevertheless, the jury did believe that AbbVie, Inc., the maker of Androgel, should pay for its fraudulent misrepresentation. The jury agreed with Mitchell’s claim that AbbVie targeted middle-aged men with misleading marketing that Androgel could treat low testosterone and improve lives. The jury then awarded a huge punitive damages award, with no underlying compensatory damages award. The jury appeared to find that AbbVie should be punished for fraudulent marketing, even though it could not connect Androgel to Mitchell’s heart attack.

As I said then, this was a “glaring problem” with the jury’s verdict. And Judge Kennelly, last Friday, tossed out the award altogether. He wrote that it was illogical to assert “simultaneously” that Mr. Mitchell had been damaged and not damaged. The judge wrote that the verdict was “internally inconsistent.” He makes a point.

Plaintiff Jesse Mitchell will get a new day in court. Judge Kennelly ordered a new trial in the case, although a new trial date has not been set. But again, as I wrote above, there is risk for all sides in any trial, and Mr. Mitchell’s case is an excellent example of this risk.

If you took any testosterone product in the past and suffered injuries, give me a call ((919) 830-5602) to discuss your potential case.

The Second Testosterone Bellwether Trial

Mr. Konrad was in his late forties when he began using Androgel in 2010. He was prescribed testosterone to treat a decrease in his testosterone levels. Two months later he suffered a heart attack. He filed suit years later, alleging that AbbVie knew about the link between testosterone use and heart attacks but sold the product anyway, and without sufficient warnings. The jury did not find that Mr. Konrad proved the connection between his use of Androgel and his heart attack. Other factors, such as Mr. Konrad’s obesity, high blood pressure, and family history, could have caused his heart attack. Nevertheless, the jury found that AbbVie was liable for damages based on AbbVie’s negligence and misrepresentation.

After a two week trial, the jury awarded Mr. Konrad $140,000.00 in compensatory damages and $140,000,000.00 in punitive damages. Compensatory damages represent payment for actual losses, to compensate a plaintiff for a proven physical injury or financial loss. In Mr. Konrad’s case, according to reports, the jury awarded $40,000.00 for repayment of medical expenses following his heart attack. The remaining $100,000.00 award represented pain and suffering damages, which you can read more about here.

Punitive damages are a different animal. This category of damages is meant, quite simply, to punish, and the message the jury sends is essentially this: you defendants hurt this person, and your actions were intentional or at least reckless, and you need to be punished financially for your extremely bad behavior. A jury typically can award any amount for punitive damages (after all the point is to punish), though many states have laws capping the amount defendants ultimately must pay in punitive damages.

This is the second straight testosterone trial where the jury awarded a huge amount of punitive damages. I wrote about the first bellwether trial and the large punitive damage award here.

AbbVie announced that it would appeal last week’s jury verdict. This always happens when, as here, plaintiffs win big.

Androgel has been on the market since 2000. In 2004 it began to be sold for “off-label uses”; namely, to treat men with low testosterone. It is now one of the most popular TRT products on the market. Last year AbbVie sold $675 million worth of Androgel testosterone.

In 2015, after many years of complaints (and many heart attacks), AbbVie finally added a warning about the risk of heart attacks to its Androgel drug label.

Studies Show Increased Risk of Heart Attacks From Testosterone

Studies have shown a relationship between testosterone use and the increased risk for heart attacks. In 2010 The New England Journal of Medicine published the results of a study on the effects of testosterone replacement therapy. More than two hundred men with a mean age of seventy-four were studied over a six-month period. In the study the group undergoing testosterone replacement therapy had higher rates of dermatological, respiratory, and cardiac events that the group receiving a placebo. The study revealed that twenty-three men receiving testosterone had “cardiovascular-related adverse events” compared with five in the placebo group. This is a remarkable finding: those men receiving testosterone were almost five times more likely to suffer a heart attack or other heart issue than were the men taking sugar pills. The findings were so alarming that the study had to be terminated early, most likely because it would have been unethical to keep having men take testosterone with such an elevated potential for heart attacks and other health problems.

What is Testosterone?

Testosterone is a naturally occurring hormone vital to the development of masculine characteristics and male growth. It is mainly produced in the testicles (though women produce smaller amounts of testosterone). Testosterone increases during male puberty; it operates to deepen the male voice and increase muscle mass; it also functions to increase facial and body hair, and to spark the sex drive. It’s the thing that helps the boy become the man (at least physically).

Testosterone can also be produced synthetically. FDA-approved testosterone products include gel or patches applied to the skin, an injection, and another method of delivering testosterone through application to the upper gum or inner cheek. The FDA has approved these products for men who “who lack or have low testosterone levels in conjunction with an associated medical condition.” Examples of an “associated medical condition” include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.

Physicians Recommend Lifestyle Changes Instead of Testosterone Use

Many physicians have been skeptical of the need for testosterone replacement therapy. Many doctors advise that the first thing a man should do when he believes he may suffer from low testosterone is to lose weight, exercise, get more sleep, and get retested after making these lifestyle changes. In many cases, these positive changes will increase testosterone levels naturally. Testosterone levels in men typically fall by only one or two percent per year after age forty, which is not alarming. Most physicians and other experts believe there is no epidemic of low testosterone among men.

More than 6,000 lawsuits have been filed against manufacturers for injuries allegedly caused by testosterone. More trials will follow, and I will keep you posted here. Call me any time if you have specific questions: (919) 830-5602.

Mitchell v. AbbVie Inc. (1:14-cv-09178)

In 2007 Jesse Mitchell visited his doctor complaining of a constellation of symptoms, including fatigue and depression. He was 44. The doctor ran tests, discovered low testosterone levels, and prescribed Androgel, an easy-to-use roll-on testosterone product manufactured and (aggressively) marketed by AbbVie, Inc. Mitchell applied the roll-on testosterone to his upper body for several years. In 2012, at the age of 49, he had a massive heart attack. From trial and media reports, the heart attack permanently damaged his heart and almost killed him.

Mr. Mitchell and his wife filed suit, alleging that AbbVie sold Androgel without warning men adequately about the increased risk for heart attacks. The plaintiffs’ legal team has put on its case for more than a week now. Yesterday an expert for the Mitchells, Dr. Hossein Ardehali, testified that in his expert opinion there was a connection between use of testosterone products like Androgel and the increased risk of heart attacks. He also specifically connected Jesse Mitchell’s 2012 heart attack to his use of Androgel. Dr. Hossein is a cardiologist at Northwestern University.

The drug company’s defense, as it often turns out to be, is that the FDA did not see a serious problem with Androgel and did not require further testing. Manufacturers often blame the FDA, saying in effect, “don’t blame us; the FDA should have caught the problem.” (This is one vital reason the FDA should always be run by thoughtful, smart, consumer-protective department heads.) In the Mitchells’ case, defense lawyers have argued that no studies have shown a direct link between use of Androgel and heart attacks, and that is why the FDA did not require warnings about heart attacks until recently.

So there is the issue for the jury: how much evidence of a link between testosterone and heart attacks is enough? How many men who use Androgel need to have heart attacks before a connection is made? The defense will answer that question this way: sufficient causation requires more than the number of men who have had heart attacks so far. The plaintiffs will argue in response that the number of heart attacks in men using Androgel is sufficient to show a dangerous connection between use of the drug and heart attacks.

The jury will decide the matter, as least with respect to Jesse and Kimberly Mitchell, in the next week or so. I will keep you updated as always. If you are currently taking Androgel or some other testosterone product, you may want to check out my blog post: Seven Things You Should Do If You Were Harmed By Testosterone.

A Little Background on Testosterone Litigation

The lawsuits against testosterone drug companies have increased in the past several years. Currently more than 4,000 men and families have filed suit. On June 6, 2014, the Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) site in the federal District Court for the Northern District of Illinois, with Judge Matthew Kennelly presiding. The MDL has been expanded to include lawsuits against the makers of Androgel, Axiron, Fortesta, and Delatestryl, all different testosterone products.

What is Testosterone?

Testosterone is a naturally occurring hormone which is important to the development of masculine characteristics and male growth. It is mainly produced in the testicles. Testosterone production increases during male puberty, and the hormone works to deepen the male voice and increase muscle mass; it also functions to increase facial and body hair, and to spark the sex drive. It’s the thing that helps the boy become the “man” (at least physically).

Testosterone can also be produced in laboratories. The FDA has approved these products for men who “who lack or have low testosterone levels in conjunction with an associated medical condition.” (My emphasis.) Examples of an “associated medical condition” include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.

What Is Hypogonadism?

Hypogonadism is a medical condition which occurs when a man’s body is unable to produce enough testosterone because of an underlying problem with the testicles and/or parts of the brain that regulate the testicles, such as the hypothalamus and pituitary gland. When testosterone levels fall below a certain this range, the levels are considered to be low. But that still doesn’t automatically mean the man needs to begin TRT. In fact, many doctors discourage taking testosterone except in serious, isolated cases.

Studies Show Increased Risk of Heart Attacks

In 2010 The New England Journal of Medicine published the results of a study on the effects of testosterone therapy. More than two hundred men with a mean age of seventy-four were studied over a six-month period. In the study the group undergoing testosterone replacement therapy had higher rates of dermatological, respiratory, and cardiac events that the group receiving a placebo. The study revealed that twenty-three men receiving testosterone had “cardiovascular-related adverse events” compared with five in the placebo group. This is a remarkable result: those men receiving testosterone were almost five times more likely to suffer a heart attack or other heart issue than were the men taking sugar pills.

Three other studies in 2013 and 2014 indicated an increased risk of heart attacks in those men taking prescription testosterone.

FDA Requires Revisions to Testosterone Warning Labels

In a September 2014 hearing, an FDA advisory panel voted to require revisions to the labels of testosterone drugs. The revision would emphasize that the product should be prescribed only to those men suffering from serious testosterone deficiencies, and not to men who are dealing with the normal decrease of hormone levels that occur with the aging process. The panel also noted that recent studies showing an increase in heart attacks and strokes among some users of testosterone should induce those drug companies to conduct further studies on the risks of TRT.

On March 3, 2015, the FDA required further label revisions to warn of the “possible increased risk of heart attacks and strokes associated with testosterone use.”

The information in this post was gathered from the FDA and other media and news sources.