Pharmaceutical

AndroGel verdict sends message to testosterone makers

androgel pump 435x435 AndroGel verdict sends message to testosterone makers AbbVie may have skirted claims that its testosterone replacement therapy AndroGel caused a man’s heart attack in the first trial to reach a verdict, but drug company was slapped with $150 million in punitive damages for misleading advertising, according to Law360. The jury’s action sends a strong signal to drug makers about deceptive direct-to-consumer advertising.

Plaintiff Jesse Mitchell sued AbbVie, blaming his heart attack on AndroGel. His lawsuit cited studies that indicated testosterone treatments could increase the risk of heart attacks, strokes, blood clots and death. Mitchell also had other health problems that may have contributed to his injuries.

But where jurors took issue was at the aggressive advertising that AbbVie launched to lure men into using the treatments. Mitchell’s lawsuit claimed that AbbVie invented a condition – Low T – and told men that testosterone therapy could improve symptoms such as low libido, weight gain and mood swings.

The effort paid off for AbbVie and other manufacturers of testosterone treatments. Sales of AndroGel and other testosterone treatments skyrocketed. The Food and Drug Administration (FDA) eventually had to reign in testosterone makers by requiring them to update labels on testosterone treatments to better clarify that the drugs are only for men with hypogonadism, a condition in which men do not produce enough testosterone due to disease or defect.

The misleading advertising issue will likely come up again for AbbVie – as well as other testosterone makers – who face more than 6,000 lawsuits consolidated in a multidistrict litigation in Illinois federal court. The next AndroGel trial is scheduled for September.

Source: Law360