Men who used AndroGel, Axiron, Androderm, or other testosterone replacement products and suffered cardiovascular injuries — including heart attack, stroke, or blood clots — may qualify for compensation through MDL 2545 or individual state court litigation.
Litigation Timeline
TOM Trial Stopped Early — First Major Safety Red Flag
The Testosterone in Older Men with Mobility Limitations (TOM) trial, published in the New England Journal of Medicine, was stopped early due to a significantly higher rate of cardiovascular adverse events in the testosterone group compared to placebo — including heart attacks, strokes, and deaths. This was the first major clinical signal that TRT carried serious cardiovascular risk in older men.
JAMA Study: 30% Increased MI Risk in TRT Users
A large retrospective cohort study published in JAMA, analyzing over 55,000 men in the VA Healthcare System, found a statistically significant 29% increase in myocardial infarction risk in men who filled a testosterone prescription. The findings intensified scrutiny of TRT safety and supported the growing body of litigation evidence.
FDA Drug Safety Communication: Cardiovascular Risk Review Announced
The FDA issued a Drug Safety Communication announcing a class-wide safety review of all approved testosterone products for cardiovascular risk. The FDA required manufacturers to update labeling and stated it was evaluating the risk of stroke, heart attack, and death. This date is significant for the discovery rule — it is the first official government acknowledgment that cardiovascular risk existed for TRT users.
MDL 2545 Established in Northern District of Illinois
The Judicial Panel on Multidistrict Litigation consolidated TRT personal injury cases into MDL 2545 before Judge Matthew Kennelly in the U.S. District Court for the Northern District of Illinois (Chicago). The MDL would eventually consolidate over 10,000 cases at peak, making it one of the largest pharmaceutical MDLs of the 2010s.
FDA Requires Black Box Warning for Venous Thromboembolism on All Testosterone Products
The FDA required all testosterone product manufacturers to add a black box warning — the FDA's strongest safety warning — specifically addressing the risk of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Simultaneously, the FDA restricted approved uses of testosterone therapy to men with hypogonadism caused by underlying medical conditions, explicitly excluding normal age-related decline.
Endo Pharmaceuticals Files Chapter 11 Bankruptcy
Endo International plc filed for Chapter 11 bankruptcy protection, impacted by multiple mass tort liabilities including TRT litigation inherited from Auxilium Pharmaceuticals (acquired 2015). Claims against Testim and Fortesta were channeled into bankruptcy trust proceedings. Affected plaintiffs must now file proofs of claim with the Endo bankruptcy trust rather than through MDL 2545, under deadlines set by the bankruptcy court.
Notable Verdicts & Settlements
The first bellwether trial in MDL 2545 resulted in a plaintiff verdict for a man who developed deep vein thrombosis while using AndroGel. The jury awarded approximately $150,000 in compensatory damages. This initial verdict established that juries could find AbbVie liable for TRT-related blood clot injuries and encouraged plaintiffs' attorneys to continue pursuing the MDL.
The second MDL 2545 bellwether trial — involving a plaintiff who suffered a myocardial infarction while using AndroGel — resulted in a defense verdict for AbbVie. The defense successfully argued that the plaintiff's pre-existing cardiovascular conditions were the primary cause of the heart attack, not TRT use. This verdict highlighted the causation challenge in MI cases with significant comorbidities.
A jury awarded over $140 million in punitive damages in a 2018 MDL 2545 bellwether trial against AbbVie. The award was the largest verdict in the litigation and reflected jury findings that AbbVie engaged in egregious marketing misconduct. The award was subsequently reversed on appeal and substantially remitted, but the verdict demonstrated the potential for significant punitive exposure and drove AbbVie's global settlement negotiations.
A fourth bellwether trial in MDL 2545 again resulted in a defense verdict for AbbVie. Defense arguments focused on plaintiff's significant pre-existing cardiovascular risk factors and lack of direct causation evidence linking AndroGel specifically to the cardiac event. The mixed bellwether record (2 plaintiff wins, 2 defense wins) complicated global settlement valuation.
AbbVie reportedly reached a confidential global settlement resolving the substantial majority of its MDL 2545 case inventory — estimated by plaintiffs' attorneys at $250M–$500M total. The exact terms remain undisclosed. The settlement covered non-bellwether AndroGel cases consolidated in MDL 2545. Individual plaintiff amounts varied by injury severity. Cases involving Eli Lilly (Axiron), Actavis/Teva (Androderm), and Endo successor entities were not included.
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