There is currently testosterone side effect litigation pending, and plaintiffs in these testosterone lawsuits are waiting for proceedings to advance. The United States Food and Drug Administration are not waiting, announcing that there will be labeling changes for all prescription testosterone therapies for treating testosterone levels. The newly approved testosterone labels will see changes in two sections: the Warning section, and the Abuse and Dependence section.
The Controlled Substances Act Schedule III includes anabolic androgenic steroids. The FDA believes these drugs pose an abuse risk, where users frequently take such drugs at levels higher the prescribed. Abusing drugs like these is known to correlate to severely negative effects, which include hostility, male infertility, toxicity of the liver, and heart attack and failure. The FDA made an October 25th, 2016 announcement that the newly approved warning labels would emphasize the possibility of abuse of testosterone drugs. It would also give guidelines to prescribers regarding how essential it is that they follow through with any patients they suspect of abusing these particular medications.
The FDA has approved steroids for the treatment of low testosterone levels if they’re the result of particular medical conditions. Steroids are sometimes prescribed in an off-label manner though, to treat individuals who have ‘low-t’ or low testosterone, even when this might not be definitively linked to a specific medical condition. The manufacturers of certain testosterone therapies have had lawsuits filed against them, in which the plaintiffs allege that men did not get an appropriate warning about negative consequences and risks of the drugs to treat low testosterone levels, particularly the links between testosterone prescriptions and cardiac issues.
There have been around sixty-six hundred lawsuits consolidated into the pretrial proceedings for MDL 2545, per Testosterone Replacement Therapy Products Liability Litigation. As discovered and laid out the Amended Case Management Order #14, the judge in charge, Matthew F. Kennelly, has decided that June 5th, 2017 will be the start date for the initial bellwether trial. That case is just one of six bellwether cases involving the maker of Androgel, AbbVie. The following five suits will each being approximately a month after the previous one concludes. Experts anticipate the final trial to get going on October 23rd, 2017.
The use of bellwether trials serves a purpose, which is to represent an entire class of plaintiffs. Bellwether trials are undertaken so that both sides get opportunities to see the arguments each side might make in following trials, as well as garner a sense of how both courts and juries respond to such claims and arguments.
A lawsuit filed by plaintiff Jeffry Konrad is likely to be among the first bellwether lawsuits. Konrad claims that despite no previous history of heart issues, he had a myocardial infarction at the age of 49. The timing of this has been reportedly just two months following the time he started using AndroGel for treating testosterone levels.