Articles Tagged with Androgel

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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.

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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

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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.

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Medical device and prescription drug jury verdicts come rapid fire, with a few cases being tried at any given moment across the country. Below is a recap on three recent jury verdicts involving Ethicon pelvic mesh, the blood-thinning drug Xarelto, and the testosterone drug Androgel.

Pelvic Mesh (September 7, 2017)

Pelvic Mesh
Last week a Philadelphia jury awarded a seriously injured woman $57.1 million in damages caused by defective Ethicon TVT pelvic mesh. This was the largest verdict for a pelvic mesh lawsuit against Ethicon, Inc. and Johnson & Johnson (the parent company of Ethicon). The award included $7.1 million in compensatory damages, which encompasses pain and suffering damages, as well as a huge $50 million award for punitive damages.

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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.

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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.

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Prescription MedicationsI have to say, there are times I just don’t want to hear any more alarming news. But recently I stumbled upon a disturbing database of payments made by drug and medical device manufacturers to physicians. It can be horrifying to imagine that your doctor or surgeon is getting huge amounts of money from drug companies or device makers, for any reason.  Now imagine that the payments were hundreds of thousands of dollars, or millions. It just doesn’t pass the smell test. Think about it: if a surgeon gets $250,000.00 per year from a medical device manufacturer, do you think the surgeon is likely going to “choose” to implant devices made by the fee-paying medical device manufacturer?

ProPublica is the nonprofit organization who maintains the database. Recently nonprofit organization updated its database of doctors across the country who were paid by medical device manufacturers or drug makers in 2015. ProPublica also compiled statistics on the amount of money drug companies spent promoting certain prescription medications and medical devices. The numbers are staggering. Let’s take a look at a few of the prescription medications on ProPublica’s list that I’ve written about on this site:

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