AndroGel Testosterone-Replacement Defective Drug Bellwether Trials Set to Start
In August 2016, eight lawsuits were filed by people who used the testosterone-replacement therapy, AndroGel. In those lawsuits, the plaintiffs claim they experienced a number of adverse effects, including heart attacks, blood clots and strokes. These suits were approved to go to trial in 2017. United States District Judge Matthew Kennelly has approved four heart attack and four blood clot cases to serve as bellwether trials. After the conclusion of these trials, the thousands of additional plaintiffs with pending lawsuits against the drug’s manufacturer will be able to gauge the viability of their cases.
What is AndroGel?
You may have seen the commercials about AndroGel, the testosterone-replacement drug manufactured by Abbott Laboratories and massively marketed to the public by AbbieVie. The ads made promises about how the testosterone-replacement gel could restore lost sex drive, vitality and vigor to men. However, these symptoms occur as a natural consequence of aging in men, and the synthetic testosterone-replacement drugs did not always live up to the marketing hype. In fact, they have been linked to an increased risk of heart attack, stroke and death in those who took the drug. These symptoms occurred in men who had prior heart problems and those who did not have previous heart or cardiovascular problems.
AndroGel was approved in 2011 by the U.S. Food and Drug Administration for the treatment of men who were experiencing symptoms of low testosterone. In 2011 there were millions of prescriptions written for low testosterone drugs. AndroGel was just one of about a half dozen brands. The drug and others like it have since proven to cause some serious adverse effects, which has caused thousands of men to sue drug manufacturer, Abbott Labs and AbbieVie, the subsidiary that markets the drug. Plaintiffs allege that the drug maker failed to provide adequate warning to consumers about the risk of cardiovascular events associated with taking the drug.
In 2014, the FDA issued the first safety alert with regard to testosterone-replacement therapy drugs and their cardiovascular risks. Then in 2015, the FDA issued a Drug Safety Communication, which required all manufacturers of testosterone drugs to revise their labels to include a warning about the possible increased risk of heart attack and stroke. It is interesting to note that that the safety communication also said that the, “benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.” An important fact that those ads promising a quick solution to age-related low testosterone levels unfortunately left out.
In 2017, the bellwether cases will go to trial while the other plaintiffs will watch and see the outcome of those eight cases. If they prove to have favorable outcomes, then additional plaintiffs might move ahead with their lawsuits, if not and if there are enough cases, they might opt for a class action or multidistrict litigation (MDL), which is a legal process designed to make processing so many similar product liability cases through the courts as efficient as possible given that they share similar claims and the same defendants.
Christopher T. Nace works in all practice areas of the firm, including medical malpractice, birth injury, drug and product liability, motor vehicle accidents, wrongful death, and other negligence and personal injury matters.
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