While one of their competitor drugmakers must seek to undo jury verdicts worth nearly $290 million over testosterone replacement therapy drugs, drugmaker Auxilium has received a clean bill from a jury in its first court test over claims it and other similar drugmakers should be made to pay for alleged misleading marketing that led men to take the drugs, and suffered heart attacks as a result.
On Nov. 16, a federal jury in Chicago found in favor of Auxilium Pharmaceuticals LLC, turning back a lawsuit brought by a man, identified as Steve Holtsclaw, who has alleged his use of Auxilium’s drug Testim produced a clotting condition, which led to a heart attack.
Holtsclaw, represented by a team of attorneys from across the country, had asserted he and his doctor were not aware of the cardiovascular risk of taking Testim, because Auxilium did not properly label their product to warn of such serious health risks.
In their verdict, the jury said it did not believe Auxilium should be found liable for the man’s heart attack, and should also not be sanctioned for falsely marketing its products.
That verdict stands in contrast to two verdicts delivered earlier this year against North Chicago-based AbbVie. In those cases, plaintiffs had leveled virtually the same allegations against AbbVie over its marketing of its testosterone replacement therapy drug, Androgel.
In those trials, juries found AbbVie not liable for causing the plaintiffs’ heart attacks, the jurors said they believed AbbVie did mislead doctors and patients concerning the safety of the drugs, and the conditions the drugs could be used to treat.
For that, jurors found AbbVie should be on the hook for damages of at least $140 million in each case.
AbbVie has challenged those verdicts, saying they don’t believe the law allows jurors to order them to pay such steep awards for the alleged misdeeds for which the juries declared them liable.
Since 2014, Auxilium and AbbVie have been among group of pharmaceutical companies facing untold amounts of potential damages amid a massive nationwide class action involving thousands of plaintiffs, who have claimed testosterone replacement therapy drugs caused clotting issues and heart attacks, among other health problems. Other companies named as defendants in the actions include AbbVie, Besins, Eli Lilly and GlaxoSmithKline.
The lawsuits, which were filed in various courts across the country, were consolidated in Chicago federal court under Judge Kennelly.
The drugs at issue were all approved by the U.S. Food and Drug Administration to treat testosterone deficiency. However, plaintiffs alleged the drugmakers misled doctors and the public with marketing designed to lead people to believe the drugs could also be used to treat a wide variety of other conditions, including “andropause” or “low T,” an allegedly nonexistent condition invented by the drugmakers.
To test the claims and evidence in court, the judge and litigants selected several of the cases for so-called “bellwether” trials.
AbbVie faced the first two bellwethers, and Auxilium has now completed the third, with another soon to follow.
The drugmakers have consistently argued the labeling and marketing claims should be dismissed, as the labeling for such drugs is controlled by the FDA. But time and again, those motions have been set aside by the judge.
In the Holtsclaw case, for instance, Judge Kennelly said he believed Holtsclaw’s doctor’s “frequent contacts with Testim sales representatives and (the doctor’s) admission that he relies upon Auxilium for accurate information about Testim’s risks and benefits.”
“… The Court concludes that a reasonable jury could infer (the doctor) relied on Auxilium’s representation to form his belief that Testim was safe and effective for the treatment of age-related hypogonadism,” Kennelly wrote, rejecting Auxilium’s attempts to short-circuit the trial in late October.
The trial began Nov. 6 in Chicago.
Holtsclaw is represented in the action by attorneys with the firms of Herman, Herman & Katz LLC , of New Orleans; Ross Feller Casey Llp, of Philadelphia; Burg, Simpson, Eldredge, Hersh & Jardine PC, of Englewood, Colo.; Pogust Braslow & Millrood LLC, of Conshohocken, Pa.; and McCorvey Law LLC, of Lafayette, La.
Auxilium is represented by attorneys with the firms of Arnold & Porter Kaye Scholer LLP, of New York and Chicago.