AbbVie Inc. manufactures AndroGel 1% and AndroGel 1.62% — prescription testosterone gels applied to the skin daily. At its commercial peak around 2012–2014, AndroGel generated over $1 billion annually in U.S. sales, fueled by a massive "Low T" direct-to-consumer advertising campaign that encouraged men to self-diagnose testosterone deficiency based on symptoms of normal aging.
Clinical research — including a 2013 JAMA study of 55,000 VA patients and the FDA's own 2014 safety review — found significant cardiovascular risk in AndroGel users. The FDA issued a black box warning in 2015. MDL 2545 in the Northern District of Illinois consolidated over 10,000 cases against AbbVie alone. After multiple bellwether trials with mixed results, AbbVie reached a confidential global settlement estimated at $250M–$500M for its MDL inventory.
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Axiron (Eli Lilly) is an underarm testosterone gel marketed from 2011. Androderm (Actavis/Allergan, now Teva) is a transdermal patch. Both products are named in MDL 2545, and both defendants — unlike AbbVie — have not yet completed global settlement of their MDL inventory. Men who used Axiron or Androderm and suffered cardiovascular injuries may be in a strong position as these defendants move toward resolution.
Learn moreTestosterone therapy directly stimulates red blood cell production (erythropoiesis), raising hematocrit and blood viscosity — a known mechanism for DVT and pulmonary embolism. The FDA's 2015 black box warning specifically called out venous thromboembolism (VTE) risk. DVT/PE cases that resolved without permanent injury typically settle in the $15,000–$75,000 range; PE cases requiring hospitalization or with lasting effects may settle higher.
Learn moreThe primary defendants in MDL 2545 are AbbVie (AndroGel), Eli Lilly (Axiron), Actavis/Allergan/Teva (Androderm), Pfizer (Depo-Testosterone), and Endo Pharmaceuticals (Testim, Fortesta — now in Chapter 11 bankruptcy). AbbVie's MDL docket is largely resolved via confidential settlement. Eli Lilly and Actavis/Teva remain in active litigation. Endo plaintiffs must file through bankruptcy trust.
Learn moreThe four essential evidence categories are: (1) TRT prescription or pharmacy records showing product, duration, and dose; (2) medical records documenting your cardiovascular injury (hospital records, discharge summaries, cardiac catheterization or imaging results); (3) a timeline showing TRT use preceded the cardiac event; and (4) any hematocrit or CBC lab results from during TRT use. An attorney can help obtain records via medical release authorization at no cost to you.
Learn moreIn March 2015, the FDA required the strongest safety label — a black box warning — on all testosterone products for venous thromboembolism (VTE) risk, including DVT and PE. The FDA simultaneously restricted approved TRT uses to men with medical-condition hypogonadism only, excluding normal aging. The 2014 FDA Drug Safety Communication may trigger the discovery rule clock in some states. The 2015 black box warning is the most legally significant regulatory event in TRT litigation.
Learn moreStatutes of limitations for TRT lawsuits vary by state — typically 2–3 years from injury discovery. Florida reduced its SOL to 2 years effective March 2023. The 2014 FDA Drug Safety Communication may trigger the discovery rule clock in some states. Filing a Short Form Complaint in MDL 2545 provides tolling protection. Endo bankruptcy trust claims have court-set deadlines. If your cardiac event was more than 18 months ago, contact an attorney immediately.
Learn moreThe 2010 TOM Trial was stopped early due to excess cardiovascular events. A 2013 JAMA study found a 29% increased MI risk in TRT users. A 2014 PLOS ONE study found doubled MI risk in men under 65 with pre-existing heart disease within 90 days of starting TRT. The FDA acted in 2014 and 2015. Men who suffered heart attacks while on TRT may have a strong legal claim.
Learn more"Low T" — hypogonadism framed as a widespread treatable epidemic — was substantially created by pharmaceutical industry disease-awareness campaigns beginning around 2008. AbbVie spent hundreds of millions on direct-to-consumer AndroGel advertising. Eli Lilly and Actavis ran similar campaigns for Axiron and Androderm. The campaigns targeted men experiencing normal aging symptoms — fatigue, reduced libido, mild mood changes — that had never previously been treated as a medical condition requiring daily hormone therapy.
Learn moreMDL 2545 — In re: Testosterone Replacement Therapy Products Liability Litigation — is pending in the Northern District of Illinois (Chicago). AbbVie's MDL inventory is largely resolved via confidential global settlement. Eli Lilly (Axiron) and Actavis/Teva (Androderm) cases remain in active negotiation. Endo (Testim/Fortesta) claims require Endo bankruptcy trust filing. New individual cases continue to be filed in both federal and state courts.
Learn moreThe four primary qualifying injuries are: heart attack (myocardial infarction), stroke (ischemic or hemorrhagic), deep vein thrombosis (DVT), and pulmonary embolism (PE). Polycythemia that caused or contributed to a cardiovascular event may also qualify. Injury must have occurred during or within 6 months of TRT use, and you must have used a qualifying TRT product for at least 30 days.
Learn moreAbbVie reportedly settled its MDL 2545 inventory for an estimated $250M–$500M (confidential terms). Individual per-plaintiff values: DVT/PE without permanent injury ($15K–$75K), heart attack with recovery ($75K–$250K+), stroke or disability ($200K–$600K), wrongful death ($250K–$1M+). Bellwether verdicts ranged from $150K to $140M (later reduced on appeal). Remaining defendants Eli Lilly and Actavis/Teva continue negotiations.
Learn moreTestosterone Therapy Lawsuit
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.
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