Testosterone Lawsuits

Background information on Testosterone lawsuits, settlements and litigation updates published between 2014 to 2018.

Testosterone Lawsuit Overview

The testosterone therapy litigation involved claims that popular hormone replacement products, such as AndroGel, Testim, and Axiron, increased the risk of heart attacks, strokes, and blood clots in men.

Marketed by companies including AbbVie, Endo Pharmaceuticals, and Eli Lilly, these drugs were promoted as treatments for “Low T,” a term widely used to describe symptoms of fatigue and aging. However, thousands of men alleged that they were misled into using testosterone therapies that had never been proven safe for age-related hormone decline, leading to life-threatening cardiovascular complications.

As reports of heart-related injuries grew, lawsuits were filed nationwide claiming that drug makers aggressively marketed testosterone replacement therapy without conducting adequate long-term safety studies. Plaintiffs argued that the companies knew or should have known about the potential cardiovascular dangers but failed to include proper warnings on product labels. In 2014, the U.S. Food and Drug Administration launched an investigation, later requiring label changes to reflect risks of heart attack and stroke associated with testosterone use.

The federal cases were centralized into multidistrict litigation (MDL No. 2545) in the Northern District of Illinois, where coordinated discovery and bellwether trials took place. Several early verdicts resulted in large jury awards against AbbVie, prompting widespread settlements. By 2018, most of the litigation was resolved through a global settlement exceeding $1 billion.

Testosterone Litigation Updates

June 20, 2018: Testosterone Bellwether Trial Schedule Issued for Remaining Cases

The federal court overseeing testosterone replacement therapy litigation released a new bellwether trial schedule to address remaining claims involving multiple manufacturers. The order aimed to conclude trials efficiently after several settlements and verdicts narrowed the docket.

May 7, 2018: Androderm Lawsuits Selected for Bellwether Trials

A group of lawsuits involving the testosterone patch Androderm was selected for early bellwether trials to test key claims against Actavis. The cases focused on allegations that the product caused heart attacks, strokes, and blood clots in men treated for low testosterone.

April 24, 2018: Trial Date Set for AndroGel Testosterone Lawsuit in Federal MDL

The U.S. District Judge presiding over the testosterone multidistrict litigation (MDL) scheduled another AndroGel trial for May 2018. The case followed a string of bellwether verdicts in which juries found AbbVie liable for failing to warn about cardiovascular side effects.

February 2, 2018: Testosterone Injury Settlement Reached in Axiron Claims

Eli Lilly agreed to resolve lawsuits over its Axiron testosterone gel, joining other manufacturers in negotiating settlements. The agreements came after several bellwether outcomes established patterns of liability and potential jury damages.

January 18, 2018: Federal Judge Establishes Waves for Testosterone Drug Trials

The MDL judge issued a new pretrial order dividing remaining testosterone therapy cases into trial “waves” for expedited proceedings. The order reflected progress toward concluding the massive litigation involving over 6,000 filed cases.

November 17, 2017: Axiron Bellwether Trial Cases Selected in Testosterone Litigation

The court finalized selections for the first bellwether trials involving Eli Lilly’s Axiron testosterone gel. The trials were designed to evaluate whether juries found the company responsible for marketing the drug without proper cardiovascular risk warnings.

September 26, 2017: Testosterone Settlement Discussions Continue After Jury Verdicts

Following mixed results in several bellwether trials, parties involved in the testosterone MDL entered continued settlement talks. The discussions aimed to resolve thousands of remaining claims involving AndroGel, Axiron, Testim, and other Low-T treatments.

August 3, 2017: Axiron Bellwether Trials Scheduled in Testosterone Drug Litigation

The court announced trial dates for bellwether cases involving Axiron, marking a shift toward evaluating claims beyond AbbVie’s AndroGel. These trials were intended to assess whether liability findings would extend to other manufacturers in the MDL.

July 19, 2017: AndroGel Punitive Damages Ruling Issued by Federal Court

A federal jury awarded punitive damages against AbbVie in one of the AndroGel bellwether trials, finding that the company’s marketing was misleading. Although the initial compensatory damages were minimal, the verdict underscored jurors’ concerns about corporate conduct.

May 31, 2017: Testosterone Settlement Master Appointed to Oversee Resolution Process

The court appointed a settlement master to facilitate negotiations between plaintiffs and multiple testosterone drug makers. The appointment signaled an approaching resolution phase following several key trial outcomes.

February 14, 2017: AndroGel Bellwether Discovery Schedule Established

A detailed discovery plan was approved for upcoming AndroGel bellwether trials. The order outlined deadlines for depositions, expert reports, and dispositive motions as litigation entered its most active trial stage.

September 28, 2016: Test Case Selections Finalized in Testosterone Drug Litigation

The MDL court selected a group of representative cases involving multiple Low-T drugs for early test trials. These bellwethers were intended to evaluate evidence on heart attack, stroke, and blood clot risks associated with testosterone therapy.

August 16, 2016: Axiron Bellwether Trial Selections Announced

Eli Lilly’s Axiron lawsuits were formally included in the federal bellwether trial process. The selected cases centered on men who suffered cardiovascular injuries allegedly caused by testosterone use promoted for non-medical age-related decline.

March 9, 2016: AndroGel Bellwether Cases Selected for Federal Trials

The MDL judge selected specific AndroGel lawsuits for the initial round of federal jury trials. The cases focused on AbbVie’s alleged failure to warn about cardiac risks and its marketing of the drug for “Low-T” symptoms unrelated to medical necessity.

October 31, 2015: Court Rules on Generic Testosterone Lawsuits Dismissal

A federal judge dismissed lawsuits involving generic testosterone drugs, ruling that they were preempted by federal law. The decision narrowed the scope of litigation to brand-name manufacturers like AbbVie, Actavis, and Eli Lilly.

August 26, 2015: AndroGel Bellwether Schedule Released

The court overseeing the testosterone MDL released the trial calendar for AndroGel bellwether cases. The first trials were scheduled for 2017 to test whether AbbVie concealed heart attack and stroke risks linked to its popular Low-T gel.

February 22, 2015: Generic Testosterone Ruling Further Narrows Federal Litigation

A federal judge reaffirmed earlier rulings dismissing claims against generic manufacturers. Plaintiffs were permitted to proceed only against brand-name producers under failure-to-warn theories.

October 6, 2014: AndroGel Bellwether Trial Pool Identified

The MDL judge identified 32 AndroGel lawsuits to serve as a pool for early bellwether trials. Each case involved common allegations of heart attacks or strokes caused by testosterone therapy marketed for age-related symptoms.

July 15, 2014: Low Testosterone Drug Lawsuits Consolidated in Federal MDL

The U.S. Judicial Panel on Multidistrict Litigation centralized all Low-T lawsuits before Judge Matthew Kennelly in the Northern District of Illinois. The MDL included claims involving AndroGel, Axiron, Testim, and other testosterone replacement therapies.

May 14, 2014: Court Rejects Bifurcation in AndroGel Testosterone Trials

The MDL judge denied AbbVie’s request to separate liability and damages phases for upcoming trials. The ruling ensured that juries would hear full evidence in each case regarding both product risks and corporate conduct.

March 3, 2014: Testosterone Preemption Challenge Filed by Drug Makers

Defendants in the testosterone MDL filed motions arguing that federal preemption should bar certain state-law claims. Plaintiffs countered that the companies had independent duties to warn of cardiovascular dangers.

July 28, 2013: Testosterone Bellwether Process Proposed for Coordinated Litigation

Plaintiffs’ attorneys submitted a plan for selecting representative bellwether cases to streamline the growing MDL. The proposal aimed to identify key injury types and manufacturer patterns to guide trial strategy.

September 10, 2012: AndroGel Bellwether Trials Scheduled

The court set preliminary trial dates for early AndroGel lawsuits, establishing the timeline for discovery and evidence exchange. These early proceedings helped define key expert testimony on testosterone’s link to cardiovascular events.

May 28, 2012: Testosterone Leadership Counsel Appointed

The MDL court named lead counsel to coordinate litigation efforts among hundreds of plaintiffs suing testosterone drug manufacturers. The leadership team was tasked with organizing discovery and managing settlement discussions.

February 24, 2012: Initial MDL Status Conference Held in Testosterone Litigation

The first case management conference was held to address pretrial procedures, evidence preservation, and discovery coordination. Attorneys and the court outlined a roadmap for handling complex scientific issues surrounding testosterone safety.

February 4, 2012: Low-T Drug Lawsuits Consolidated in Northern District of Illinois

Federal judges centralized all testosterone-related lawsuits in the Northern District of Illinois, consolidating claims over heart attack, stroke, and blood clot injuries. The ruling was expected to improve efficiency and avoid duplicative discovery.

January 6, 2012: Motion Filed to Consolidate Testosterone Drug Lawsuits Nationwide

Plaintiffs requested that all federal testosterone lawsuits be consolidated into a single multidistrict litigation (MDL). The motion cited common claims that Low-T therapy caused cardiovascular injuries and was marketed for unapproved uses.

December 19, 2011: AndroGel MDL Sought Over Heart Attack and Stroke Risks

The first motion to establish coordinated pretrial proceedings was filed as lawsuits began to mount against AbbVie over its AndroGel testosterone gel. Plaintiffs alleged that the company failed to warn men of increased cardiovascular risks linked to use of the drug.

Testosterone Verdicts and Settlements

July 13, 2018: AndroGel Settlement Agreement Developing in Testosterone Litigation

AbbVie entered into settlement discussions to resolve remaining AndroGel lawsuits following multiple bellwether verdicts. The negotiations aimed to conclude thousands of claims alleging that testosterone therapy caused heart attacks and strokes.

April 16, 2018: Androderm Trial Vacated as Settlement Talks Advance

A scheduled bellwether trial over Actavis’ Androderm testosterone patch was vacated after reports indicated ongoing settlement negotiations. The move reflected broader efforts to bring the multidistrict litigation closer to resolution.

March 5, 2018: Androderm Settlements Reached in Testosterone Replacement Therapy Cases

Actavis agreed to settle several Androderm lawsuits involving allegations that its testosterone patch caused cardiovascular injuries. The terms were not publicly disclosed, but the settlements marked progress toward winding down litigation across multiple manufacturers.

December 4, 2017: Testim Lawsuits Settled as Testosterone Drug Cases Wind Down

Endo Pharmaceuticals reached agreements to settle lawsuits involving its Testim testosterone gel. The company joined AbbVie and Eli Lilly in negotiating resolutions following years of bellwether trials in the federal MDL.

October 17, 2017: AndroGel Defense Verdict Returned in Latest Bellwether Trial

A federal jury returned a defense verdict for AbbVie in one of the final AndroGel bellwether cases, finding insufficient evidence that the drug caused the plaintiff’s heart attack. The result followed several mixed outcomes in prior trials.

September 7, 2017: Second AndroGel Bellwether Verdict Favors Plaintiff

A jury ordered AbbVie to pay $3.2 million in compensatory damages after finding the company failed to adequately warn about heart attack risks linked to AndroGel. The verdict followed earlier rulings that awarded substantial punitive damages against the manufacturer.

June 21, 2017: Testim Gel Settlements Reached Following Early Trial Outcomes

Endo Pharmaceuticals reached a series of settlements resolving lawsuits over its Testim testosterone gel. The agreements followed the first bellwether verdicts and reduced the number of active claims in the MDL.

May 9, 2017: Jury Awards $140 Million in Punitive Damages Against AbbVie

A federal jury awarded $140 million in punitive damages against AbbVie in one of the first testosterone bellwether trials, finding that the company fraudulently marketed AndroGel. The landmark verdict was later appealed but highlighted the litigation’s momentum.

February 22, 2017: Defense Verdict Issued in AndroGel Bellwether Trial

AbbVie prevailed in a bellwether case after a jury found no link between AndroGel and the plaintiff’s cardiovascular injuries. The ruling represented the first defense win for the manufacturer amid a series of mixed outcomes.

December 6, 2016: AndroGel Jury Awards $150 Million in Punitive Damages

A federal jury awarded $150 million in punitive damages against AbbVie, finding that the company misrepresented the safety of its AndroGel testosterone therapy. The verdict became one of the largest in the MDL before being later overturned on appeal.

September 7, 2016: Jury Returns Defense Verdict in Testim Bellwether Trial

Endo Pharmaceuticals secured a defense verdict in a Testim testosterone gel bellwether trial after jurors concluded the company was not liable for the plaintiff’s injuries. The decision marked the first major defense win in the coordinated proceedings.

August 2, 2016: AndroGel Verdict Issued in Favor of Plaintiff

A federal jury found AbbVie liable for misleading marketing of AndroGel and failing to warn about cardiovascular risks, awarding both compensatory and punitive damages. The verdict served as a key reference point for ongoing settlement talks.

July 7, 2016: Mistrial Declared in First Testosterone Bellwether Lawsuit

The first federal bellwether trial involving testosterone replacement therapy ended in a mistrial after jurors failed to reach a unanimous verdict. The case was retried later that year, leading to one of the earliest major plaintiff verdicts in the MDL.

Testosterone Warnings and Regulatory Actions

February 4, 2020: New Testosterone Guidelines Narrow Appropriate Use

The Endocrine Society released updated testosterone prescribing guidelines emphasizing that therapy should be limited to men with clinically confirmed hypogonadism. The update came after years of concern that testosterone drugs were being overprescribed for age-related fatigue and sexual dysfunction.

April 2, 2018: Testosterone Guidelines Recommend Additional Hypogonadism Testing

Medical experts called for stricter diagnostic testing before initiating testosterone therapy, citing ongoing evidence of cardiovascular risks. The new guidelines aimed to reduce unnecessary prescriptions that exposed men to avoidable health complications.

May 24, 2017: FDA Warns Against Testosterone Abuse and Misuse

Federal regulators issued a warning highlighting the risks of testosterone abuse, particularly among athletes and bodybuilders. The agency noted serious side effects including heart attack, stroke, liver toxicity, and psychiatric issues associated with non-medical use.

July 1, 2015: FDA Requires Joint Studies on Testosterone Heart Risks

The FDA ordered drugmakers to conduct coordinated clinical trials evaluating the cardiovascular safety of testosterone replacement therapies. The decision followed years of research suggesting increased heart attack and stroke risks.

March 3, 2015: FDA Adds Stronger Heart Risk Warning to Testosterone Labels

The FDA required manufacturers to update testosterone drug labeling with warnings about potential heart attack and stroke risks. The agency also restricted approved uses to men with true hormonal deficiencies rather than age-related testosterone decline.

April 17, 2014: European Medicines Agency Issues Statement on Testosterone Safety Review

The EMA announced it would continue monitoring potential cardiovascular side effects associated with testosterone therapy but found no immediate evidence warranting withdrawal. Regulators urged doctors to prescribe the drugs cautiously.

March 14, 2014: European Regulators Link Testosterone to Possible Heart Problems

The EMA launched a formal investigation into reports suggesting testosterone drugs may increase the risk of heart attacks in older men. The inquiry reflected growing international concern following FDA warnings in the U.S.

February 5, 2014: FDA Warns Against Overuse of Testosterone Supplements

The FDA cautioned consumers against using over-the-counter testosterone boosters or unapproved supplements marketed for energy and libido. Officials said the products may pose cardiovascular and liver risks similar to prescription versions.

January 30, 2014: FDA Demands Long-Term Studies on Testosterone Heart Dangers

Federal regulators mandated large-scale clinical trials to assess whether testosterone therapies elevate heart attack or stroke risk. The requirement followed several published studies linking testosterone use to increased cardiovascular events.

May 9, 2013: FDA Warns of Risks from Testosterone “Booster” Products

The agency issued a consumer alert on the dangers of testosterone overuse, particularly when obtained without medical supervision. Officials emphasized that misuse could result in blood clots, mood swings, and cardiovascular problems.

April 8, 2013: FDA Orders New Blood Clot Warnings for Testosterone Drugs

The FDA required all testosterone replacement therapies to carry warnings about deep vein thrombosis (DVT) and pulmonary embolism (PE). The decision followed reports linking testosterone use to life-threatening clotting events.

February 25, 2013: Drugmakers Oppose FDA Black Box Warning for Testosterone Heart Risks

Manufacturers pushed back against proposals for a black box warning, arguing that the cardiovascular data were inconclusive. Regulators ultimately opted for less severe label changes while continuing safety reviews.

January 21, 2013: European Officials Launch Investigation Into Testosterone Risks

European regulators began reviewing cardiovascular events associated with testosterone therapy after reports of heart attacks among older users. The findings were expected to influence global prescribing practices.

November 13, 2012: FDA Considers Adding Black Box Warning for Heart Risks

U.S. health officials debated whether to include a black box warning on testosterone drug labels after early studies linked the therapy to cardiac events. Industry resistance delayed the update until further research was completed.

October 29, 2012: European Review Targets “Low T” Drug Marketing Practices

Regulators in Europe began investigating aggressive marketing of testosterone drugs for non-medical “Low T” symptoms, raising ethical and safety concerns. The move mirrored scrutiny already building in the U.S.

March 3, 2011: FDA Investigates Testosterone Heart Attack and Stroke Reports

The FDA launched a formal review after receiving a surge in adverse event reports involving heart attacks and strokes among men using testosterone products. The investigation marked the beginning of widespread regulatory focus on Low-T risks.

January 28, 2011: FDA Requires Clinical Studies on Testosterone Therapy Safety

Following early safety signals, the FDA ordered drugmakers to perform controlled studies assessing cardiovascular outcomes among testosterone users. The order reflected growing evidence that the drugs could trigger serious heart complications.

January 13, 2011: FDA Opens Review of Heart Attack and Stroke Risks Linked to AndroGel

Federal regulators announced an official investigation into testosterone replacement therapies after mounting reports of heart attacks and strokes among middle-aged men. The review later led to widespread label changes and litigation.

Testosterone Lawsuit Examples

May 24, 2016: Wrongful Death Lawsuit Alleges AndroGel “Not Safe for Human Use”

A widow filed a wrongful death lawsuit claiming her husband suffered a fatal heart attack after using AbbVie’s AndroGel. The complaint alleged the company failed to warn about cardiovascular risks and marketed the drug for age-related fatigue without FDA approval.

June 18, 2015: AndroGel Lawsuit Filed Over Heart Attack, Stroke, and Blood Clots

A man filed suit against AbbVie after experiencing serious cardiovascular complications allegedly caused by AndroGel testosterone therapy. The lawsuit joined the growing MDL over claims that the drugmaker ignored known health risks.

August 27, 2014: Depo-Testosterone Lawsuit Filed Over Heart Problems

A lawsuit was filed against Pfizer over its injectable testosterone drug, Depo-Testosterone, alleging the treatment led to a heart attack. The case expanded litigation beyond gels and patches to include other testosterone delivery systems.

August 26, 2014: Androderm Patch Lawsuit Filed Over Low-T Treatment Risks

A man filed a lawsuit claiming Actavis failed to warn about the dangers of its Androderm testosterone patch, including heart attacks and strokes. The case accused the company of promoting the drug for lifestyle purposes rather than medical necessity.

July 14, 2014: AndroGel and Axiron Death Lawsuit Filed by Widow

A wrongful death claim was brought against AbbVie and Eli Lilly after a man’s fatal cardiovascular event allegedly linked to testosterone gel use. The suit claimed the companies concealed safety data to protect profits from their popular Low-T drugs.

July 10, 2014: Fortesta Heart Attack Lawsuit Filed Against Endo Pharmaceuticals

A plaintiff alleged he suffered a heart attack due to the use of Fortesta testosterone gel, accusing the manufacturer of failing to warn users about cardiovascular dangers. The case became part of a surge of filings nationwide.

April 11, 2014: Androderm Lawsuit Filed Over Stroke Linked to Testosterone Patch

A man filed suit against Actavis after suffering a stroke he attributed to Androderm use. The complaint claimed the manufacturer promoted the drug for unapproved age-related testosterone decline despite knowing of potential heart and stroke risks.

March 28, 2014: Wrongful Death Lawsuit Filed Over Testim Testosterone Therapy

The family of a deceased man filed a wrongful death lawsuit against Endo Pharmaceuticals, alleging the company’s Testim gel caused a fatal cardiovascular event. The complaint joined the early wave of testosterone-related claims filed nationwide.

March 25, 2014: AndroGel Heart Attack Lawsuit Filed Against AbbVie

A man filed suit after suffering a heart attack allegedly linked to AndroGel use, claiming AbbVie failed to disclose studies showing elevated cardiovascular risk. The case added to growing concerns that Low-T drugs were being overprescribed to older men.

March 21, 2014: Testim Gel Lawsuit Filed Over Stroke and Low-Treatment Risks

A lawsuit was brought against Endo Pharmaceuticals alleging that the plaintiff suffered a stroke after using Testim testosterone gel. The case claimed inadequate warnings about the risk of clotting and cardiovascular injury.

March 12, 2014: AndroGel Blood Clot Lawsuit Filed Over Deep Vein Thrombosis

A man filed a lawsuit after developing DVT allegedly caused by AndroGel, accusing AbbVie of failing to warn users about the risk of blood clots. The claim became one of several early cases citing similar injuries.

February 28, 2014: AndroGel Lawsuits Filed Over Heart Attacks From Testosterone Gel

Multiple lawsuits were filed against AbbVie over its testosterone replacement drug AndroGel, alleging the product caused serious cardiovascular injuries. Plaintiffs claimed the company misrepresented the drug’s safety in its “Low-T” marketing campaigns.