Articles Posted in Testosterone

Testosterone is approved to treat hypogonadism
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.

Testosterone Litigation
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

Last Thursday a jury in Chicago found that AbbVie, Inc., the manufacturers of the testosterone product Androgel, must pay the plaintiff, Jeffrey Konrad, over $140,000,000.00 for injuries he suffered after using the company’s testosterone product. The jury found that AbbVie did not adequately test the testosterone roll-on gel product and misrepresented its safety to patients and doctors.

The Second Testosterone Bellwether Trial

Testosterone MDL in ChicagoMr. 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.

A few weeks ago I wrote about an Androgel testosterone case being tried in Illinois. We now have the verdict, and the result is, well, a mixed bag. Still, on balance, it must be viewed as a win for plaintiffs, and a major rebuke for companies like AbbVie, Inc. who aggressively market their prescription drugs for off-label uses. After all, at the end of trial the jury awarded the plaintiffs $150 million in punitive damages for fraudulent misrepresentation.

Androgel testosterone trial
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.

An important trial is taking place over testosterone in Illinois. As part of the testosterone prescription multidistrict litigation, manufacturer AbbVie, Inc. is defending itself against claims that Androgel, a roll-on testosterone product, caused the heart attack of Jesse Mitchell in 2012 after years of taking the prescription medication. Let’s take a look at that case:

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

AbbVie's Androgel TestosteroneIn 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.

Testosterone Lawsuits in Chicago Illinois

So you are a man in your early fifties, and around four years ago you were prescribed testosterone to treat what you were told was “Low-T” (or low testosterone–I’ve already written on this subject). Sadly, two years ago you suffered a pretty awful heart attack, and your doctor took you off the testosterone replacement therapy and stated that he believed the testosterone was a significant cause of your heart attack. Four months later you found a good attorney who agreed to review your case, and six months after that your attorney filed suit in federal court in Raleigh, North Carolina. So far so good (well, except for the heart attack). Then two months later you discovered that your case had been “transferred” to federal court in the North District of Illinois in Chicago.

So What Just Happened?

Your case was transferred from your home federal district court to the multidistrict litigation (“MDL”) court that has been designated to consolidate cases like yours in one central court with one primary federal judge as a way to process more efficiently the hundreds of claims against the testosterone manufacturers.

For testosterone lawsuits such as yours, that MDL is “MDL 2545 (In re Testosterone Replacement Therapy Products Liability Litigation).” Judge Matthew F. Kennelly is the presiding federal judge of MDL 2545.

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1. If You Develop Harmful Side Effects, Stop Taking Testosterone.

Of course I am no doctor, but this is the safe and correct call. If you suffer a heart attack, you won’t have any choice, as you will most likely be incapacitated; but even with less serious side effects like anxiety or sexual dysfunction, the unwanted condition is a red flag that testosterone may not be right for you. Therefore I suggest you stop taking the drug and schedule an immediate appointment with your doctor.

In fact, I would say that even if you have no symptoms, you should ask your doctor (or a doctor who did not prescribe testosterone in the first place) if you should stop testosterone replacement therapy. As we saw in the last post, in one study men receiving testosterone were almost five times more likely to suffer a heart attack than were men in the study taking a placebo. And beyond heart attacks, other side effects include the growth of breasts on men, skin irritation, and depression (not to mention the strange side effects testosterone can have on your family members and pets).

Testosterone Side Effects
Part 2

In the last post we looked at the introduction of testosterone replacement therapy (TRT) on the marketplace and the huge marketing efforts that sold billions of dollars’ worth of the hormone therapy in the last ten years. The pharmaceutical companies targeted men of a certain age (typically forty and older) who may (or may not) have actually suffered from a collection symptoms: fatigue, low energy, weight gain, loss of sexual interest. The “disease” was labelled Low-T, and although doctors say this condition is real, it is not nearly as common as the drug companies would have had us believe. One study from Great Britain found that just 0.1 percent of men in their forties suffered from Low-T combined with sexual symptoms, 0.6% of men in their fifties, 3.2% of men in their sixties, and 5.1% of men in their seventies. Despite these (startlingly) low numbers, the drug companies sold billions of dollars’ worth of testosterone. Then many of these men—and even their family members and pets—began having alarming side effects.

Study Shows Increased Risk of Heart Attacks

Part 1

Can you imagine the excitement from the marketing department when the drug company chemists walked in and said: “all right everyone, we have a new product, an easy-to-use roll-on gel that will increase a man’s energy, improve muscle tone, help him lose weight, and reawaken his sexual interest.” I’ve never taken a marketing class in my life, and I could sell that product.

And sell it the drug companies did. Billions of dollars of it. I’m sure most of you recall the commercials about testosterone replacement therapy (TRT) from a few years ago. If not you can still find them on YouTube. The commercials and the advertising campaigns targeted men from early middle age through old age, and made some statement similar to this:

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