Pharmaceutical

Testosterone lawsuits blame makers for failing to warn of drug’s risks

androgel pump 435x435 Testosterone lawsuits blame makers for failing to warn of drugs risksAbbVie won the latest testosterone side effects lawsuit alleging its testosterone replacement therapy AndroGel caused a man to suffer debilitating blood clots, but the two previous plaintiffs wins with verdicts totaling nearly $300 million suggest the fight has only just begun.

AbbVie’s AndroGel has enjoyed the lion’s share of sales in the once-booming testosterone replacement therapy market. The hormone treatment was approved by the Food and Drug Administration (FDA) in 2000 for the treatment of hypogonadism, a condition in which there is a testosterone deficiency due to a genetic defect, illness or trauma.

But AbbVie began aggressively promoting the drug for off-label use of so-called Low T, an age-related drop in the male hormone that the company said results in low libido, weight gain and muscle loss. The company’s direct-to-consumer ads lured many men to their doctors’ offices to ask for the drug by name. It paid off in skyrocketing sales for AbbVie.

But studies began to emerge that showed that testosterone treatments increased the risk for blood clots, heart attacks and strokes, some of which could be fatal. Men across the country began filing lawsuits alleging AbbVie and manufacturers of other testosterone replacement therapies did not adequately warn of the cardiovascular risks with using the product.

About 7,000 lawsuits have been filed against testosterone makers, the vast majority of which – about 4,500 – name AbbVie’s AndroGel. The lawsuits filed in district courts across the country have been consolidated before Judge Matthew Kennelly in Chicago federal court. Three of the four bellwether trials that have been completed to date involved AbbVie.

Another 200 lawsuits are pending in Cook County Circuit Court, many of which name AbbVie. The first bellwether trial among those lawsuits involved a 66-year-old man who blamed AndroGel for his heart attack. AbbVie won that case but the man’s attorneys are seeking a new trial in order to present evidence on the internal decision-making behind the company’s sales tactics, which was not permitted in the initial trial.

Source: Chicago Tribune