As with so many other harmful drugs, the use of testosterone went off the rails when companies pushed the drug’s use for off-label purposes. Although testosterone replacement therapy was approved to treat just two specific conditions, companies eventually pushed their products to treat all kinds of other conditions, uses never approved by the FDA. According to the Third Amended Master Long-Form Complaint filed in the testosterone multi-district litigation (MDL 2545), it was this aggressive off-label marketing and label-expansion that led to many unnecessary injuries, suffering, and thousands of lawsuits.

FDA Approves Testosterone For Treatment of Two Conditions

In 1953 the FDA first approved a version of synthetic testosterone to treat two conditions: (1) primary hypogonadism and (2) hypogonadotropic hypogonadism. Since that time the FDA has not approved testosterone to treat any other diseases or conditions.

• Primary hypogonadism

This is a condition where the man’s testicles fail to function in certain important ways. Specifically, the man’s body fails to produce sufficient amounts of testosterone. Primary hypogonadism can occur in childhood or later in life. If it happens in childhood, the child may not fully develop sex organs, may not grow body hair, and may fail to move normally through puberty. If hypogonadism occurs in adulthood, the man may suffer from erectile dysfunction, infertility, decreased body hair and muscle mass, loss of bone mass or density, and other problems. The FDA noted that primary hypogonadism may be specifically caused by undescended testicles, rotated or twisted testicles, inflammation in the testicles (orchitis), surgical removal of a testicle, or vanishing testicles. (And yes, it pained me to write out that list.)

• Hypogonadotropic hypogonadism

This is a form of hypogonadism which is caused by a problem with the pituitary gland or the hypothalamus (a part of the brain that regulates the pituitary gland and other bodily functions). Basically, hypogonadotropic hypogonadism (let’s call it HH) occurs when a lack of hormones fails to activate the testicles, and thus little or no sex hormones are released. HH can be caused by damage to the pituitary gland or to the hypothalamus from injury, surgery, tumor, infection, or radiation. It can also be caused by genetic defects, chronic disease, drug abuse, nutrition problems, or even stress. The symptoms of HH are like those of primary hypogonadism.

Over the years the FDA approved many different testosterone products for use to treat these two conditions. But only these two conditions. The FDA never approved the use of testosterone for use to treat erectile dysfunction, low energy, depression, lack of sexual interest, “Low-T,” or any other condition unless it was a diagnosed symptom of the two types of hypogonadism discussed above.

The business problem for the companies selling these products is that the population of men suffering from hypogonadism is not significant. The population of men suffering from low sex drive, low energy, loss of muscle mass, or erectile dysfunction, however, is much, much larger. Find a way to sell to that larger group and these companies can make much more money.

Aggressive Off-Label Marketing and Label Expansion

According to the Master Complaint (MDL 2545), companies marketed testosterone for off-label use. In addition, the companies are alleged to have exploited ambiguities in the product labeling to expand the permitted uses for testosterone beyond treatment of hypogonadism.

According to the Complaint, drug manufacturers attempted to blur the lines between hypogonadism and a condition referred to as “Low-T.” Many people have heard of the term Low-T, but it does not actually appear to be a condition recognized by the scientific or medical community. The Master Complaint alleges that AbbVie, Inc., maker of the testosterone product “Androgel,” represented that Low-T was an “acquired form of hypogonadism.” Low-T (whatever it is) is not the same as hypogonadism, and therefore use of testosterone to treat Low-T is an off-label and unapproved use. Other testosterone makers–including Eli Lilly, Endo, Auxilium, Pfizer, and Actavis–also pushed off-label uses and blurred the lines between hypogonadism and other conditions. This effort by the drug companies was intended to expand the reach of the approved uses for testosterone. The companies used ambiguities in the drug label to advocate for treatment of other conditions and thus sell much more of the product than it would if it were only sold to those men actually suffering from hypogonadism.

Once these connections were made, the target population of testosterone users expanded rapidly, from one million to five million and eventually up to twenty million men. Let me be very clear: twenty million men do not suffer from hypogonadism. Rather, as the years marched along more men without a diagnosis of hypogonadism but who may have suffered from an isolated condition such as low energy or reduced sex drive may have been prescribed testosterone. This medication is very potent and comes with significant risks and potentially nasty side effects (such as heart attacks, stroke, and blood clots), and it should be taken only if there is a serious underlying condition such as hypogonadism.

If you have taken testosterone, or otherwise have interest in this subject, I encourage you to read the Amended Master Complaint in the testosterone MDL. If you have suffered an injury after taking testosterone, call me.

Note: This post was written after review of court filings and news reports. Please note that the makers of testosterone dispute some of the points made in the Master Complaint and in this article.

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.

Just to recap, Androgel is a roll-on testosterone product. Jesse Mitchell began taking Androgel in 2007 after doctors ran blood tests and found that Mitchell’s testosterone levels were quite low. In 2012, at the age of 49, Jesse Mitchell had a massive heart attack. From what I’ve read, the heart attack almost killed him.

Mitchell and his wife sued AbbVie in 2014, claiming the company marketed and sold Androgel without properly warning men about the increased risk for heart attacks. During the trial an expert for the Mitchells testified that in his opinion there was a connection between Mitchell’s 2012 heart attack and his extended use of Androgel.

AbbVie’s defense was that the FDA did not see a serious problem with Androgel and did not require further testing, so the drug maker should not be to blame. In addition, the defense argued that Mitchell’s team simply did not establish “legal causation” between Mitchell’s use of Androgel and his heart attack. Among other things, AbbVie noted that Mitchell was obese, suffered from high blood pressure and bad cholesterol levels, and was a smoker. If this health description is accurate, these “bad facts” can derail an otherwise strong plaintiffs’ case.

The Verdict

The jury did not accept the argument that plaintiffs had proven the connection between Jesse Mitchell’s use of testosterone and his heart attack. Thus, the drug maker “won” on the claims of negligence. After the verdict an AbbVie spokesperson stated that the “jury found that Androgel did not cause any damage.” Let me stop here and note that this is not what the jury found. Finding, for example, that someone is “not guilty” is not the same thing as finding them “innocent.” Similarly, in a civil case against AbbVie, the verdict can be read only as indicating that the plaintiffs did not meet their burden of proof of establishing causation between the use of Androgel and Mitchell’s heart attack. It does not mean that the jury believed Androgel caused no damage. In any event, many observers of the trial believe that Mitchell’s poor health played a large part in preventing the jury from finding the connection between use of testosterone and the heart attack. It’s quite possible that a plaintiff with fewer health issues would have been able to establish the legal causation for the heart attack. We will certainly see in future bellwether trials.

Nevertheless, the jury did find that AbbVie was liable for fraudulent misrepresentation. Mitchell argued in this separate claim that AbbVie intentionally targeted middle-aged men with misleading marketing that claimed AndroGel could successfully treat a condition called “Low T” or low testosterone. Many medical experts agree that the symptoms of Low T are simply normal signs of the male aging process. It is undisputed that a healthy nineteen year old man will produce more testosterone than a healthy fifty year old man. Lower testosterone levels among middle-aged men–most doctors will say–do not require testosterone replacement therapy (TRT) with products like Androgel. Jesse Mitchell further argued that the FDA had never approved AndroGel for treatment of Low T.

The jury found that AbbVie had fraudulently misrepresented the use of the drug Androgel, then awarded the plaintiffs $150,000,000.00 in punitive damages. That is a really big number. Particularly coming as it does after the jury found that plaintiffs had not proven the connection between Androgel and the heart attack. Clearly, the jury did not like AbbVie’s aggressive marketing of Androgel for off-label uses.

The glaring problem with this verdict is that the punitive damages were awarded without any award of compensatory damages. In most states, there must be some compensatory damage award to permit an additional award of punitive damages. It goes like this: “we (the jury) find that you hurt the plaintiff–at least a little–and we also find that you should be punished for your really bad acts.” Sometimes when a jury decides that the defendant was a bad actor but they cannot agree on actual damages to the plaintiff, the jury will award nominal compensatory damages, such as a single dollar, to pave the way for a much larger punitive damages award. Even a damages award of $1.00 can shield a large punitive damages award post-trial attack. A punitive damages award alone, however, often will not stand.

So the chance that this punitive damages award is upheld in post-trial motions or on appeal is not great. It may well be that Jesse Mitchell and his family walk away with nothing.

Testosterone Multidistrict Litigation

The lawsuits against testosterone drug companies have grown in the past few years. Currently more than 6,000 men and families have filed suit. On June 6, 2014, the Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) site to consolidate cases against testosterone manufacturers. The MDL is situated in the U.S. District Court for the Northern District of Illinois, with Judge Matthew Kennelly presiding. The MDL has been expanded to include suits against AbbVie, Inc. (Androgel), Eli Lilly & Co. (Axiron), and Endo Pharmaceuticals, Inc. (Fortesta, Delatestryl).

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.” Testosterone can also be produced in laboratories. FDA-approved testosterone replacement therapy (TRT) products include a gel applied to the skin like Androgel, an injection, a patch (also applied to the skin), 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.” The problem is, several studies have shown an increased risk in heart attacks in men who use testosterone products.

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

If you have been using prescription testosterone and have had heart issues or other health problems, I would advise that you see your doctor promptly, and if you think you may have a civil case against the drug maker, give me a call ((919) 830-5602) and we will figure it out.

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

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.