Testosterone Lawsuits Begin, Outcomes Split

Chicago, ILThe makers of a testosterone supplement that only carries FDA approval for hypogonadism (severely depleted testosterone) but nonetheless has been heavily marketed to treat a largely manufactured disease, won their day in court at the end of last month when a jury in state court found in favor of AndroGel manufacturer AbbVie. The decision translates to a loss for the plaintiff, who alleged in his testosterone lawsuit that his heart attack was associated with his use of AndroGel.

Plaintiff James Couch became interested in advertisements for AndroGel as a response to so-called ‘Low-T.’ The manufacturer claimed that depression and lethargy could be related to a drop in testosterone levels – and that use of AndroGel could boost an individual’s energy and foster a return to vitality. Couch alleged in his testosterone side effects lawsuit that there was no inference to the normal depletion of testosterone with age, and that use of testosterone supplements in otherwise healthy men carried a risk for testosterone heart attack.

The plaintiff went to his doctor and asked to have his testosterone levels checked out. Couch was provided with a prescription for AndroGel in February, 2013 and later that year suffered a heart attack, after which he received a defibrillator implant to help regulate his damaged heart.

Couch filed his testosterone lawsuit – one of hundreds housed in state court in Illinois – about six months following his heart attack, asserting that AbbVie knew about the increased risk for testosterone heart attack and testosterone stroke but withheld those risks from consumers, and declined to study the link. Couch made claims for strict liability, negligence, breach of implied warranty, negligent misrepresentation and willful and wanton conduct.

However, following a two-week trial the jury dismissed the plaintiff’s claims and found in favor of the manufacturer. In their defense, AbbVie noted that Couch was seen to have refilled his prescription for AndroGel only once before he stopped using it altogether. He suffered his heart attack two months after stopping use of testosterone, according to Court documents.

Court records also showed that attorneys for the plaintiff were not allowed to present years of marketing materials which were alleged to reflect how AbbVie sought to expand the market for AndroGel.

That evidence was allowed in the first bellwether trial for AndroGel in federal court as part of multidistrict litigation. In that case, plaintiff Jess Mitchell claimed his heart attack was related to his use of AndroGel for ‘Low-T’ and accused AbbVie of misrepresentation. He asserted that AbbVie claimed that testosterone replacement therapy was safe and effective, when in fact it was not.

The jury in the federal trial determined, at the end of July that use of AndroGel did not cause Mitchell’s heart attack and thus did not award compensatory damages. However, unlike the state trial the jury awarded $150 million in punitive damages on the misrepresentation claim.

The next federal trial in the AndroGel MDL is scheduled for this month (In re: Testosterone Replacement Therapy Products Liability Litigation, Case No. 1:14-cv-01748, in the US District Court for the Northern District of Illinois). Ahead of the start of that trial – and perhaps with a view to how the state trial turned out – AbbVie has requested that marketing materials not be allowed as evidence in the second federal trial, as it was in the first.

“The precise impact of that evidence was demonstrated in a verdict that found no compensable loss, but went on to award punitive damages that were tethered to nothing,” AbbVie said of the Mitchell verdict (Mitchell et al. v. AbbVie Inc. et al., Case No. 1:14-cv-09178, US District Court for the Northern District of Illinois).

As for the Couch trial, AbbVie had this to say in their motion: “The impact of that ruling also is clear – the trial was focused on the claims at issue and the jury’s verdict was not overshadowed by an unconstitutional and collateral finding that AbbVie should be punished for conduct that had nothing to do with the plaintiff.”

There are about 150 testosterone lawsuits in state court in Illinois, with the next lawsuit prepared but as yet without a start date. Couch plans to appeal the verdict in his state court trial.

The Couch testosterone lawsuit is Couch v. AbbVie Inc., Case No. 2014-L-005859, in the Circuit Court of Cook County, Illinois.

Testosterone supplementation has long been approved by the US Food and Drug Administration (FDA), but only for an indication involving hypogonadism, which is the term used for dangerously low levels of testosterone in men. Such extremely low levels of natural testosterone are thought to be dangerous to a man’s health and thus, testosterone supplementation carries more benefits than risk for the intended patient.

However, testosterone has never been approved for vanity use in men seeking a so-called fountain of youth and having found one in testosterone supplements. In otherwise healthy men, who may not be aware that testosterone levels ebb and flow with age and even according to the time of day, use of testosterone supplements can pose a risk to the cardiovascular system, or so it has been alleged. Research has suggested that testosterone supplements can multiply red blood cells, thickening the blood when patients are at an age when thinner blood is needed to travel through veins shrinking with age and plaque build-up. Testosterone heart attack or testosterone stroke can sometimes lead to testosterone death.