Before 2008, testosterone replacement therapy was a relatively niche treatment for men with documented primary hypogonadism — a genuine medical condition involving failure of the testes to produce testosterone due to injury, disease, or genetic disorder. The "Low T" marketing revolution transformed TRT into a blockbuster lifestyle drug by reframing normal aging — mild fatigue, reduced libido, modest weight gain — as symptomatic of a diagnosable, treatable deficiency.

The campaign worked spectacularly from a commercial standpoint: AndroGel sales grew from approximately $150 million annually in 2006 to over $1 billion by 2013. But the clinical evidence for benefit in non-hypogonadal men was thin, and cardiovascular safety was never established for this expanded population. Plaintiffs' attorneys argue that manufacturers knew — from emerging studies and their own clinical data — that cardiovascular risk existed, but suppressed this information to protect market share. The FDA's eventual black box warning validated these allegations.