Anabolic androgenic steroids (AAS) are included in Schedule III of the Controlled Substances Act. According to the FDA, such drugs are at risk of abuse, with users often taking the drugs at higher than prescribed doses. Such abuse of the drugs is associated with serious adverse effects, including heart attack, heart failure, hostility, liver toxicity and male infertility. On October 25, 2016, the FDA announced that the new warning will highlight the potential for testosterone abuse, and advise prescribers about the importance of following up with patients if they suspect patients are abusing the medications.
Steroids are approved by the FDA to treat low testosterone that is caused by certain medical conditions. It is often prescribed off-label, however, to treat men who have low testosterone (sometimes referred to as "Low-T") that is not linked to any medical condition. Lawsuits have been filed against the makers of some testosterone therapies, alleging men were not properly warned about the risks associated with using the medication, including an alleged link between testosterone therapy and heart problems.
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Bellwether trials are intended to be representative of the class and are undertaken to give both sides a chance to see what arguments the other side will make in subsequent trials, and get a sense of how the courts and/or juries will respond to the claims.
Among the first of the bellwether lawsuits to be heard will likely be the lawsuit filed by Jeffry Konrad. Konrad alleges he suffered a myocardial infarction at age 49, even though he had no history of heart problems. His myocardial infarction reportedly occurred around two months after he began using AndroGel.
The Konrad lawsuit is case number 1:15-cv-00966.