TRT Likely Good for Heart If You Have Low T
Testosterone Litigation Update
TRT Likely Good for Heart If You Have Low T
How are all those lawsuits going, the ones against testosterone marketers for not disclosing heart risks?
Back in January 2014, the U.S. Food and Drug Administration (FDA) announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”1 The FDA’s investigation was prompted by two studies purporting to show an increased risk of cardiovascular events in men prescribed testosterone therapy. Plaintiff’s lawyers seized the moment, filing numerous lawsuits on behalf of men who claimed they suffered injuries, including heart attack, stroke, deep vein thrombosis, and pulmonary embolism, as a result of testosterone replacement therapy (TRT). In June 2014, the U.S. Judicial Panel on Multidistrict Litigation transferred and consolidated the cases to the Northern District of Illinois as “In Re: Testosterone Replacement Therapy Products Liability Litigation” and assigned the cases to Judge Matthew F. Kennelly.2
The majority of cases are against AbbVie, Inc. and Abbott Laboratories (collectively, “AbbVie”). They currently face approximately 4,510 cases over injuries allegedly caused by their TRT drug AndroGel®.3 The plaintiffs argue that although TRT drugs are considered safe and effective by the FDA for the treatment of “classical hypogonadism” caused by certain medical conditions, AbbVie falsely represented in their marketing and promotional materials that TRT is safe and effective for the treatment of “age-related hypogonadism” (low testosterone levels and “associated signs and symptoms resulting from the normal aging process”).4 The plaintiffs also allege that AbbVie failed to provide proper warnings of the risk that using TRT could increase blood-clotting injuries in the veins and cardiovascular injuries like heart attacks and strokes.
To date, three of the TRT cases against AbbVie have been tried to a jury as “bellwether” cases— “test trials” (pun intended) to help explore how verdicts might be rendered in the other cases and to help guide settlement figures.5 The first case that went to a jury verdict, Mitchell v. AbbVie, lasted 13 days and resulted in a verdict for Mitchell on the fraudulent misrepresentation claim. However, the jury awarded him no money in “compensatory” damages for his injuries but awarded $150 million dollars in “punitive” damages as punishment to AbbVie for its conduct! In December 2017, the court concluded that the jury’s findings were “logically incompatible,” vacated the verdict and awards, and ordered a new trial.
In Konrad v. AbbVie, a federal jury found in favor of the plaintiff and ordered AbbVie to pay $140,000 in compensatory damages and $140 million in punitive damages.6 AbbVie plans on appealing the decision. The most recent TRT case to be tried was Nolte v. AbbVie, in which the jury found that AbbVie was not liable for the pulmonary embolism that the plaintiff suffered.7
Although cases against AndroGel® make up the bulk of the TRT litigation, there are many cases against other TRT drugs. In 2014, over 1,000 cases were filed against Pfizer’s injectable TRT drug Depo®-Testosterone (testosterone cypionate). The cases alleged that Pfizer failed to warn about cardiovascular risks in connection with Depo-T. In 2015, Judge Kennelly dismissed these cases, holding that the plaintiffs’ claims were preempted by the FDA’s approval of Depo-T’s label. In January 2018, the Court of Appeals affirmed the decision, stating, “Pfizer may not unilaterally change the FDA-approved language on Depo-T’s label. A lawsuit under state law that seeks to recover damages for Pfizer’s failure to do so is preempted by federal law.”8
While thousands of cases are still pending litigation, certain companies have chosen to settle prior to trial. In December 2017, Eli Lilly and Company settled approximately 400 cases related to its TRT drug Axiron® and in January 2018, Endo’s Auxilium Pharmaceuticals settled a case related to its TRT drug Testim®.9
Bottom line: just because someone on TRT has a heart attack doesn’t mean the TRT had anything to do with it. Millions of men have heart attacks, and the vast majority were not on TRT. The few studies claiming to link testosterone with heart problems run contrary to 40 years’ worth of research, as reviewed in many past editions of this column. While some men may not be good candidates for TRT, the body of evidence shows that TRT is quite good for the hearts of most men suffering from low testosterone. I’ll keep you posted on this hot legal topic as further cases are resolved!
Rick Collins, JD, CSCS [www.rickcollins.com] is the lawyer that members of the bodybuilding community and nutritional supplement industry turn to when they need legal help or representation. [© Rick Collins, 2018. All rights reserved. For informational purposes only, not to be construed as legal or medical advice.]
References:
1. www.fda.gov/downloads/Drugs/DrugSafety/UCM383909.pdf
2. www.jpml.uscourts.gov/sites/jpml/files/MDL-2545-Initial_Transfer-05-14.pdf
3. www.businessinsider.com/r-abbvie-wins-us-trial-in-lawsuit-over-androgels-risks-2018-1?r=UK&IR=T
4. Memorandum Opinion and Order on post-trial motions in Mitchel v. AbbVie, No. 14 C 9178, In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545.
5. http://definitions.uslegal.com/b/bellwether-case/
6. www.drugwatch.com/2017/10/10/abbvie-loses-140-million-androgel-verdict/
7. www.businessinsider.com/r-abbvie-wins-us-trial-in-lawsuit-over-androgels-risks-2018-1?r=UK&IR=T
8. www.leagle.com/decision/infco20180119099
9. www.drugwatch.com/testosterone/multi-district-litigation/
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