Drug maker AbbVie, Inc. has scored a legal victory in the third bellwether trial focused on its testosterone-replacement drug AndroGel. In late January, a federal jury in Illinois denied an Arizona plaintiff’s claim that his pulmonary embolism was due to his use of the drug.
In two previous AndroGel trials, juries have awarded sizable monetary awards to the plaintiffs. The first of those was recently overturned and the second has been appealed by AbbVie.
These three cases — as well as a fourth earlier in 2017 that was dismissed — are only the beginning of the low-testosterone litigation. About 6,000 such claims have been consolidated in federal court, with these initial cases serving as indicators of sorts for those to come later.
In these bellwether cases, as well as across the expansive field of future plaintiffs, claims focus on the notion that low testosterone drugs such as AndroGel lacked sufficient warning labels and were marketed to patients inappropriately. Drug maker AbbVie, meanwhile, continues to cite AndroGel’s approval by the U.S. Food and Drug Administration and says its labeling and marketing are appropriate.
Third Time’s A Charm (But Not For the Plaintiff)
Arizonan Robert Nolte began using AndroGel in 2012 to address a drop in testosterone levels. He continued using the medication for a few months.
Nolte stopped using AndroGel after he suffered a pulmonary embolism. He blames the drug for the event. During the recent trial, a physician from the Yale School of Medicine testified that Nolte was correct on that point.
Like other plaintiffs claiming injury due to AndroGel, Nolte’s legal team argued in court that the drug’s risks had been misrepresented and that AbbVie had overly marketed the drug for off-label use.
The Chicago jury disagreed, however, deciding that Nolte’s injury was not due to his use of AndroGel. The verdict is a discouraging turn of events for the thousands of other low-testosterone plaintiffs awaiting their day in court.
The verdict also differs from two previous verdicts in the bellwether cases that led up to Nolte’s case. In July of 2017, a jury awarded $150 million to plaintiff Jesse Mitchell, who attributed a heart attack to AndroGel. A few months later, another jury awarded $140 million to plaintiff Jeffery Konrad, who also suffered a heart attack.
AbbVie appealed both rulings. And in December, a federal judge in Chicago overturned the initial $150 million ruling.
In his decision, Judge Matthew Kennelly noted that the overturn was tied to the jury’s finding that AndroGel was not to blame for the plaintiff’s injury. The jury had based its award, which was entirely punitive, on the plaintiff’s argument regarding inappropriate labeling and marketing. Kennelly termed the original decision to be “logically incompatible.”
A new trial for Mitchell has been scheduled for March. The plaintiff’s attorney said at the time that he was looking forward to it — but now the case will hit the courtroom following a litigation victory for AbbVie.
Marketing, Warning Labels & Heart Attacks
The low-testosterone therapy AndroGel was approved by the FDA in 2000. It reached peak sales a few years ago, and had fallen back to $675 million in sales by 2016.
AndroGel is approved to treat a condition called hypogonadism, or a reduced functioning of the gonads. However, the drug is marketed to treat the much broader sounding condition of “low-testosterone.”
In claims filed against AbbVie, plaintiffs typically cite what they consider to be the overly broad marketing of low-testosterone medication, as well as warning-label inadequacies. Specifically, they hold up the marketing campaign entitled “Is It Low-T?,” which encouraged men experiencing lower energy levels to consider low-testosterone medication. This campaign, plaintiffs contend, serves as an example of the pharmaceutical industry’s attempt to draw from the deeper pool of aging patients experiencing testosterone drops, which is natural for men their age.
After patients began raising concerns about the effects of low-testosterone medications such as AndroGel, attributing injuries such as heart attacks to the drug, the FDA in 2014 convened an advisory committee to consider cardiovascular risks associated with testosterone replacement therapy. The next year, the FDA acted on the committee’s recommendation and ordered AbbVie to place additional warnings on AndroGel’s labeling.