A federal jury has handed a win to North Chicago-based drugmaker Abbvie, as it continues to seek to fend off a mass of legal claims accusing the company’s testosterone replacement therapy drug, Androgel, of causing heart attacks and other cardiovascular conditions.
On June 14, the Chicago jury found Abbvie not liable for any of the medical conditions plaintiff Robert Rowley claimed Androgel had caused him to suffer. The jury also decided Abbvie’s marketing of Androgel, and the product’s labeling, was not deceptive, and did not constitute fraud, as Rowley’s legal team had alleged.
U.S. District Judge Matthew F. Kennelly presided over the trial, as he has the four other so-called bellwether trials held to date against Abbvie, as the court works through the consolidated mass action against several of the country’s largest drugmakers over the alleged effects of testosterone replacement therapy drugs, like Androgel.
Nancy Mismash
Rowley, of Utah, and his wife, Sherrie, had filed suit in 2015 against Abbvie, and four other pharmaceutical manufacturers, claiming his use of Androgel had caused him to develop deep vein thrombosis, a condition in which a blood clot forms in the veins, typically in the legs. Rowley claimed he began to suffer the condition in April 2013, about a year after he began to take the testosterone drug.
Rowley’s claim was filed in Utah federal court by attorney Nancy A. Mismash, of the firm of Robert J. Derby & Associates, of Salt Lake City. However, the lawsuit was consolidated in Chicago with thousands of other similar cases from across the U.S. by a federal judicial panel, which handles such so-called multi-district litigation, or MDL.
Since 2014, such cases have streamed into federal courts, alleging the testosterone drugs harmed many who took them, increasing their risks of heart attacks and other conditions. The lawsuits allege the companies downplayed or skipped over those risks in marketing their products, which the suits allege the company advertised as effective in treating a variety of conditions, including diabetes, AIDS, cancer, depression, anxiety and a condition called “andropause” or “low T.” The lawsuits allege the drugmakers invented andropause and low T to boost sales of their drugs.
Other companies named as defendants in the action include Eli Lilly & Co., Endo International, GlaxoSmithKline and Pfizer, among others.
To gauge how juries might respond to the claims, the judge selected eight of the cases to move forward to trial. The outcomes of these trials could determine if and how the companies may ultimately settle the more than 25,000 cases now pending in the MDL.
Rowley’s case was among those selected to serve as a “bellwether” trial.
The trial began June 5.
In a motion filed during the trial, Abbvie asserted Rowley’s claims concerning Abbvie’s marketing and labeling of Androgel can’t hold up, as the label content is controlled by the U.S. Food and Drug Administration, and that label, which discusses risks arising from taking a particular drug, was approved as recently as 2011. Abbvie asserted the two years between the FDA’s approval of that label and Rowley’s alleged injury was not enough time for the company to learn enough new “significant safety information” about potential risks associated with taking Androgel to justify asking the federal agency to rewrite the label’s warnings.
The company also asserted Rowley’s fraud and misrepresentation claims couldn’t be sustained under Utah state law, nor could Rowley demonstrate Androgel caused his condition, nor that any statements from Abbvie caused him to take Androgel.
The verdict is the third such win for Abbvie in its five bellwether trials, to date. In trials in January and May, juries similarly found in favor of Abbvie on all counts.
In the first two bellwethers, juries found Abbvie not liable for the plaintiffs’ heart attacks and other conditions, yet still awarded judgments worth $150 million and $140 million to the plaintiffs, finding Abbvie had misled doctors and consumers about Androgel. Abbvie has challenged those verdicts, winning a new trial in the $150 million verdict. A jury in the retrial still awarded the plaintiff, Jesse Mitchell, of Oregon, $3.2 million. Abbvie has also contested that verdict, asking Judge Kennelly to toss out the verdict, or again order a new trial.
Published reports indicate Eli Lilly, Endo, GSK and Auxilium Pharmaceuticals have agreed to tentative settlements to end much of the testosterone replacement therapy drug-related litigation against them.
In addition to Mismash, the Rowleys are represented by attorneys Seth A. Katz and Meghan C. Quinlivan, of the firm of Burg, Simpson, Eldredge, Hersh & Jardine P.C., of Englewood, Colo.; Stephanie O'Connor, of the firm of Douglas & London P.C., of New York; and T. Matthew Leckman, of Pogust Braslow & Millrood LLC, of Conshohocken, Pa.
Abbvie is represented by attorneys of the firm of Goldman Ismail Tomaselli Brennan & Baum LLP, of Chicago, and Dechert LLP, of Princeton, N.J.