A federal judge hearing the bellwether lawsuit for "low-T" drug marketing decided the plaintiff’s case was suffering from a lack of support for some of its claims.
U.S. District Judge Matthew Kennelly said the plaintiffs couldn’t support their contention the drugs had a “negligent design defect,” tossing those claims, the Cook County Record reports. But the judge denied AbbVie’s effort to dismiss off-label marketing claims that contend the drugs not only didn’t work, but increased patients’ risk of heart attack.
"Plaintiffs here have presented evidence sufficient to permit a reasonable jury to find that AbbVie had knowledge that its advertisements contained false or misleading statements," Kennelly ruled recently.
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The decision came in the cases of six plaintiffs against AbbVie’s testosterone replacement drug Androgel, that are set to go to trial next month in Chicago and which will serve as a test for about 2,000 other cases in class-action litigation against AbbVie and other testosterone drug makers, including Eli Lilly and GlaxoSmithKline.
The judge also agreed to limit the testimony of six medical experts lined up by the plaintiffs to testify.
The cases began popping up in 2014 after studies suggested the class of drugs, which includes Eli Lilly's Axiron and GlaxoSmithKline's Testim, might be tied to increased risks of heart attack or stroke.
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Up to that point the drugs were big sellers, led by AndroGel, which became a $1-billion-plus hit, driven by AbbVie’s ad campaign that popularized the term “low-T” and talked up the benefits of taking a testosterone replacement to relieve fatigue and improve sexual function.
AndroGel sales started plummeting in 2014 after the FDA ordered drugmakers to note the cardio risks on their labels and to spell out that the drugs were approved only to treat hypogonadism, a serious testosterone deficiency.
AbbVie and others have defended their drugs as supported by clinical and safety data.
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Recent studies have been mixed on the risks of taking a testosterone replacement. One showed the drugs contributed to a build-up of plaque in the heart, an early sign of heart disease. Another that followed men with the androgen deficiency found that those taking the testosterone replacements actually had a lower risk of heart attack than patients who never took the drugs.