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
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: 919.546.8788.