The testosterone-replacement drug AndroGel is the subject of litigation again, with the latest bellwether trial taking place, again, in an Illinois federal courtroom. The trial began in early January, just weeks after a judge overturned a jury award from earlier in this bellwether series.
This most recent trial involves Robert Nolte and his wife Genienne, who filed a lawsuit against AbbVie Inc., the manufacturer of AndroGel, in 2014. After using the drug, Nolte suffered a pulmonary embolism.
The Noltes are not alone in claiming injury due to the use of AndroGel, as well as other low-testosterone medications. Their case is in the company of about 6,000 other such lawsuits consolidated in federal court.
Two juries have awarded damages to plaintiffs thus far. The first was for the amount of $150 million and the next was for $140 million. The first award, however, was overturned in December and awaits a retrial.
Low-T, High Risk
AndroGel is a hormone-replacement drug that is marketed to men who may be experiencing lower levels of testosterone. The drug — and other similar medications — are also being blamed for heart attacks among patients using the medications.
First approved by the U.S. Food and Drug Administration in 2000, AndroGel is a big seller for AbbVie. It racked up $675 million in sales in 2016, and that’s down from its peak a few years earlier.
But the drug is also increasingly the subject of lawsuits, with patients citing insufficient warning labels and broad marketing campaigns. Further, in 2014 an FDA advisory panel’s recommendation resulted in additional warnings on the medications labeling concerning cardiovascular risks.
Nolte’s current case in Illinois is considered the third in a series of bellwether trials concerning AndroGel. The two previous trials have each resulted in sizable jury awards. There was also another earlier trial, but it ended in a mistrial.
In July of last year, a jury awarded Jesse Mitchell $150 million. The plaintiff attributed his heart attack to the use AndroGel.
In Mitchell’s case, the jury did not find that AndroGel was responsible for the heart attack, but rather that AbbVie had misrepresented the risk of the medication. AbbVie, of course, appealed
A few months later, in October, AbbVie suffered another litigation loss, this time to the tune of $140 million. This time the jury did link the medication to the plaintiff, Tennessee resident Jeffrey Konrad’s, heart attack.
In Konrad’s case, the plaintiff also specifically cited the marketing of low-testosterone medications. Whereas AndroGel is approved to treat a condition called hypogonadism, or a diminished functionality of the gonads, the plaintiff argued that the drug was marketed more broadly in an effort to target aging men with lowering testosterone levels, thus drawing a much deeper pool of patients; he cited the marketing campaign titled “Is It Low-T?”
AbbVie has appealed this second ruling as well. In the appeal, the drug maker challenges the assertion that its warning labels were insufficient and marketing over broad
Overturning $150 Million Punitive Damages Decision
In late December, the first jury award in an AndroGel case was overturned. U.S. District Judge Matthew Kennelly in Chicago found the original ruling to be “logically incompatible.”
Judge Kennelly’s assertion was based on the original jury’s finding that AndroGel was not to blame for the plaintiff’s injuries. The jury had instead stressed the company’s inappropriate marketing tactics and warning labels.
In that case, the first among this bellwether series, the plaintiff was not awarded any compensatory damages. The entire $150 million award was punitive.
Judge Kennelly pointed to that incongruence specifically.
“The irreconcilable conflict between the jury’s finding of liability on the fraudulent misrepresentation claim and award of zero compensatory damages requires a new trial on this claim,” Kennelly wrote in his decision.
The judge scheduled a new trial to begin March 5. The plaintiff’s attorney, Christopher Seeger, said his team was looking forward to the retrial.
But first, the Noltes are getting their turn in the Illinois courtroom. So far in this third bellwether trial in the low-testosterone series, a physician from the Yale School of Medicine has testified that the plaintiff would not have suffered his pulmonary embolism except for his use of AndroGel.