Testosterone replacement drugs, such as AndroGel made by AbbVie, have been under scrutiny in recent years after complaints that they increase the risk of heart attack and blood clots surfaced. Victims have started lawsuits against the manufacturer and many of those have been consolidated in multidistrict litigation. The first eight lawsuits, which will act as bellwether trials, are set to begin soon after multiple delays.
Testosterone and Heart Attacks
Testosterone is a natural hormone, and in men its levels decline with aging. In some cases a decline in testosterone may occur because of some underlying condition and this can be treated with testosterone replacement therapy. Having abnormally low testosterone levels is called male hypogonadism and it can cause symptoms like fatigue, sexual dysfunction, and muscle weakness.
Therapy that replaces natural testosterone with synthetic hormones can help many men, but it comes with side effects too. There is a major concern, and evidence from both individual cases and studies, that testosterone replacement products like AndroGel can cause blood clots and heart attacks.
The risks have been reported by individuals and their doctors, but have also been confirmed in studies showing heart attacks and blood clots are more prevalent in men using testosterone than those in control groups. In one study, the research had to be stopped early because the men being given testosterone were suffering high numbers of adverse events including heart attacks.
Selection of Bellwether Cases Faced Delays
The bellwether trials against AbbVie and AndroGel are being selected from among many cases that were consolidated into a multidistrict litigation (MDL). The MDL was consolidated in 2014 in a court in the Northern District of Illinois under Judge Matthew F. Kennelly. Since then there have been delays in actually beginning the bellwether trials that would test the arguments of both sides.
Much of the delay has come from AbbVie, which has fought to have many of the over 2,000 claims against AndroGel dismissed. The company has also delayed the trials be pushing to have a direct say in which are selected for the bellwether. AbbVie claims that it is concerned about the fairness of the process, while the lawyers involved are claiming that the company is exerting to much influence over how the trials proceed.
Bellwether Trials Finally Moving Forward
Both sides finally agreed on terms for selecting the trials for the bellwether cases and Judge Kennelly agreed. The updated guidelines stated that the cases selected must either involve blood clots and blood clotting injuries or cardiovascular injuries. The selected cases also had to come from a pool of cases that had fact sheets completed by June 15, 2015.
The bellwether cases have now been selected, and assuming they survive continued scrutiny, will begin in 2017. The first case set to go to trial early next year is brought by plaintiff Jeffrey Konrad whose claim includes that using AndroGel caused him to suffer a myocardial infarction. He was hospitalized and had a stent implanted. Following the Konrad case, the rest of the eight bellwether cases will go to trial.
These cases will give the court a good idea of how the arguments of both the plaintiffs and the defendant will hold up. The arguments that the plaintiffs are making is that AbbVie knew there were risks of blood clots and heart attacks associated with its testosterone product, and that it failed to warn patients and doctors of those serious, potentially life-threatening risks.