AbbVie faces $150M in damages in AndroGel trial
- AbbVie will have to pay out $150 million in punitive damages, but no compensatory damages, in the case of an Oregon man, Jesse Mitchell.
- Mitchell claimed the company was at fault over his near-fatal heart attack following use of the company's testosterone replacement gel AndroGel. Mitchell used the treatment for four years.
- AbbVie and other testosterone manufacturers are facing many more cases filed as part of multi-district litigation in Illinois.
AbbVie, then Abbott Laboratories, snagged rights to AndroGel from Solvay Pharmaceuticals back in 2010, and became one of the company's best-selling drugs by 2013, second only to Humira.
With AbbVie (Abbott)'s acquisition of the drug, came a large marketing push, including direct-to-consumer campaigns. The advertising of AngroGel, and other testosterone treatments, focused on a condition dubbed "low-T." While low levels of testosterone are known to occur in some men, particularly after treatments for prostate cancer, low testosterone levels are not considered common place. Yet, after the very convincing advertising campaigns and pushes to doctors, prescriptions for "low-T" skyrocketed, despite little evidence the condition existed in otherwise healthy men.
But, the "low-T" craze is now under both regulatory and legal threat. The FDA is cracking down on testosterone drugs, particularly off-label use. It has put in place class-wide labeling changes, including warnings about the risks of abuse and dependence. It also warned about reported serious adverse outcomes, including "heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity and male infertility."
And the legal backlash has begun too. Legal cases against AbbVie and other companies have been put together into a multi-district litigation in Illinois, claiming lack of warning over the risks, and deception through positive marketing. The first testimony was offered last month in a class action suit against six drugmakers.
AbbVie argued that Mitchell's heart attack owed more to weight, high cholesterol and smoking. Jurors ruled for AbbVie on claims of negligence and liability, but against the company on fraudulent representation. While Mitchell's case may not stand because the jurors didn't award compensation for injuries, it's just one of many thousands that are expected to hit the testosterone companies over the coming months. BioPharma Dive reached out to AbbVie for comment but the company has made no response.
"This verdict sends a very strong message to AbbVie, that its conduct in improperly marketing this drug to millions of off-label patients was wrong and warranted severe punishment," said Troy Rafferty of Levin, Papantonio, Mitchell, Rafferty & Proctor, lead counsel in the case.
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