Men who use the testosterone replacement therapy (TRT) product AndroGel face an increased risk of stroke and heart attack, according to the results of a new study. Androgel warning labels list a number of serious side effects including high blood pressure, blood clots in the legs, and ‘serious problems’ for patients with pre-existing heart, kidney or liver disease.
What is AndroGel?
Manufactured and marketed by Abbvie (a subsidiary of Abbott Laboratories), AndroGel is an androgen used for replacement therapy in men with testosterone deficiency. AndroGel 1% was approved by the U.S. Food & Drug Administration (FDA) in 2000, and 1.62% strength was approved in 2011. The product is a gel formulation offered for topical use, and has gone through a number of label changes over the years.
AndroGel Linked to Cardiac Side Effects
Testosterone replacement therapy is more profitable today than ever before, with sales of prescription patches, topical gels and creams topping $2 billion in 2012 alone. The TRT industry is expected to hit $5 billion within the next five years, due in large part to an aggressive marketing campaign that pushes AndroGel on middle-aged men.
Men in this age range face naturally-occurring diminished testosterone levels, and many turn to prescription treatments to reinvigorate themselves. However, a recent study published in the Journal of the American Medical Association (JAMA) indicates that men who use testosterone boosters like AndroGel are 30% more likely to suffer a stroke or other severe cardiac complications than non-users. Researchers found testosterone supplements to be correlated with an increased risk for:
- Stroke – Occurs when a blood clot gets stuck in the brain, restricting the supply of oxygen
- Pulmonary embolism (PE) – Blood clot lodged in the lungs
- Deep vein thrombosis (DVT) – Blood clot in the legs
- Venous thromboembolism (VTE) – Combination of PE & DVT
- Heart attack
- Deep vein thrombosis – Blood clot in the legs
- Arrhythmia – an irregular heartbeat
- Transient ischemic attacks – commonly referred to as ‘mini-strokes’
- Brain damage
These AndroGel complications can cause tremendous suffering, not only for the man affected, but for each of his family members as well. Additionally, the medical costs associated with AndroGel injuries are likely to be staggering, and may threaten the entire family’s financial future. This is why you may wish to consider legal action if you’ve been adversely affected by AndroGel side effects.
Update: 1000’s of AndroGel Lawsuits Nearing Settlement
January 3, 2019 – AbbVie Inc. has been ordered to pay $3 million over a lawsuit filed by an Oregon man who claimed that the product caused him to have a heart attack.
The complaint belongs to an ongoing multidistrict litigation (MDL) filed against BIG Pharma manufacturers over their testosterone replacement therapy (TRT) products.
A federal jury in Illinois found AbbVie Inc. liable for failing to adequately warn of the severe cardiovascular complications linked to use of its AndroGel supplement, ordering the company to pay Plaintiff Jesse Mitchell, who claimed the product contributed to his development of a heart attack, $3 million in damages. The ruling marks closure of Mitchell’s second trial over AndroGel; he was awarded $150 million in that dispute, only to have the award turned over by U.S. District Judge Matthew Kennelly, who found the verdict to be “logically incompatible.”
During the first trial, the jury found AbbVie guilty of fraudulent misrepresentation, handing down the massive penalty in large part as punitive damages against the company for what it saw as continued negligence, rather than compensating Mitchell for his injuries.
To date, nearly 7,000 federal testosterone lawsuits have been added into mdl 2545 in the Northern District of Illinois, the vast majority of which have been filed over AndroGel.
Jury Rules in Favor of Plaintiff in Retrial, Awards $3 Million to Heart Attack Victim
March 27, 2018 – A jury in Chicago on Monday ordered AbbVie Inc. to pay more than $3 million to a man who had a heart attack after taking AndroGel. While still considered a significant victory for plaintiff Jesse Mitchell, the $3 million is a far cry from the $150 million he was awarded during the first trial in December, which was tossed after U.S. District Judge Matthew Kennelly determined the verdict was “logically incompatible.”
AbbVie Failed to Study AndroGel Side Effects, Plaintiff Alleges
September 25, 2017 – AbbVie Inc. neglected its duty to adequately test AndroGel to see whether the testosterone supplement increased the risk for heart attack, attorneys for a man suing the company told a jury last week.
By the time Plaintiff Jeffrey Konrad had his heart attack in April 2010, AbbVie had been warned several times that a major study was needed to determine the cardiovascular health risks associated with AndroGel, Konrad’s attorneys alleged. However, the drugmaker never did the study, and even worked to expand the supplement’s approval for the treatment of additional conditions, the complaint states.
AbbVie countered that there is no evidence backing up Konrad’s allegations, which are nearly identical to the claims in thousands of other lawsuits alleging injuries from AndroGel and other similar testosterone products.
However, Konrad’s attorney noted several studies which in fact did show a link, including one involving older men that was stopped early after a large number of volunteers reported suffering adverse cardiovascular events. The drugmaker had a responsibility to address the risk if AndroGel was going to be introduced to the market, the suit claims.
Konrad was 49 when he went to his doctor complaining about fatigue and difficulty recovering after running a 5K. After testing his testosterone levels, the physician wrote him a prescription for AndroGel, and 2 months later he had a heart attack, according to the lawsuit.
He filed suit shortly thereafter, claiming that AbbVie wilfully ignored evidence of a link between heart attacks and testosterone replacement therapy (TRT) while marketing AndroGel for age-related declines in testosterone, an “off-label” use not approved by the U.S. Food & Drug Administration (FDA).
The case originally went to court in June, but ended in a mistrial after one of Konrad’s attorneys got sick.
Chicago Jury Orders AbbVie to Pay $150 Million Over AndroGel Side Effects
July 27, 2017 – AbbVie Inc. must pay $150 million to an Oregon man who accused the company of failing to adequately warn about the safety risks of its AndroGel testosterone booster, a federal jury in Chicago has decided.
Plaintiff Jesse Mitchell blamed AndroGel for a heart attack he suffered in 2012 after taking the supplement for 4 years, according to the Chicago Tribune. The jury awarded Mitchell $150 million in punitive damages, meant to punish AbbVie for failing to provide adequate warnings or instructions on AndroGel, but did not award damages to compensate him for any personal injury.
“We expect the punitive damage award will not stand,” AbbVie spokeswoman Adelle Infante said in an email.
The lawsuit, filed back in 2014, was the first of thousands of similar claims alleging injuries from AndroGel to reach trial. AbbVie sold about $675 million worth of the testosterone supplement last year alone.
AbbVie argued that Mitchell had other risk factors that could have caused his heart attack, such as a history of smoking, high blood pressure and high cholesterol, among other things, according to court documents.
Sales of AndroGel have dropped sharply since health officials called for tougher warning labels. The supplement generated $675 million in sales last year, compared with more than $1.1 billion in 2012, according to Bloomberg. AbbVie maintains that AndroGel is safe and does not increase the risk of either blood clots or heart attack.
First AndroGel Bellwether Ends in Mistrial
June 19, 2017 – The first attempt to hold AbbVie Inc. responsible for the side effects alleged from its AndroGel testosterone supplement has ended in a mistrial after the lead plaintiff’s attorney suffered from heart problems.
Barely one week after Plaintiff Jeffrey Konrad brought before a jury his allegations that AndroGel caused him to have a heart attack in 2010, U.S. District Judge Matthew Kennelly called the trial off.
The mistrial was called due to health problems suffered by the plaintiff’s lead attorney, according to Law360. Court documents indicate that the man was hospitalized with heart complications on June 10 and underwent an unspecified procedure, but has since been released and is now recovering back home.
The defense objected to the mistrial, saying there were other lawyers who could fill in. However, Kennelly said that he wouldn’t try the case without the lead attorney, according to court transcripts.
The Konrad Bellwether trial is expected to begin again in September.
AbbVie is facing about 4,200 lawsuits that have been centralized as part of a multidistrict litigation (MDL No. 2545) in the U.S. District Court for the Northern District of Illinois.
AbbVie Rejects Evidence in AndroGel Bellwether Trials
As the first bellwether trials over the alleged side effects of AndroGel are set to get underway, drugmaker AbbVie has filed a request with an Illinois federal judge to reject evidence related to the company’s alleged misconduct.
The AndroGel multidistrict litigation (MDL No. 2545) currently includes about 7,000 lawsuits filed against manufacturers of more than a dozen testosterone supplements.
Plaintiffs allege that the supplements were marketed to treat normal symptoms of aging — an “off-label” use not approved by the FDA — without regard for the potential health risks posed by the medications.
The first bellwether trial is scheduled to begin on Monday for plaintiffs Jeffrey Konrad, Jana Conrad, Jesse Mitchell and Kimberly Mitchell.
Both parties filed documents over the weekend agreeing that the trial should not be bifurcated into a liability phase and a damages phase. However, where the plaintiffs presented for review an array of evidence of “willful and wanton conduct” on the part of AbbVie, the drugmaker rejected the evidence, arguing that numerous items filed under seal had no place in the trial.
The proffer “includes evidence that is inadmissible to prove liability or entitlement to punitive damages,” AbbVie said. “Plaintiffs’ proffer also fails to acknowledge that they are seeking to introduce certain limited evidence that, if at all admissible, would be so only for purposes of punitive damages, such as evidence of AbbVie’s net worth.”
All of the complaints involve similar allegations that testosterone supplements caused serious side effects including heart attack, stroke, and blood clots. Judge Kennelly has ordered that each of the first 6 bellwether trials must involve use of AndroGel. Trials for other testosterone boosters, such as Testim and Axiron, are set to begin later this year.
FDA Requires Heart Attack, Stroke Warning to be Added to AndroGel Labels
March 3, 2015 – FDA issued a press release today announcing label changes that will be applied to all approved prescription testosterone supplements. The updated labeling warns that testosterone has been linked to heart attack, stroke, and other severe cardiovascular side effects, and that the supplements should not be prescribed to men for the sole purpose of treating symptoms associated with the normal aging process. Click here to learn more.
FDA Black Box Warning on AndroGel
In September of 2009, the Food & Drug Administration required that a black box warning be placed on AndroGel labels stating that children exposed to the product could experience changes in genital size, pubic hair or libido, and become unusually aggressive. Two years later, in March 2011, another warning was issued stating that AndroGel users should wait at least five hours before showering or swimming after applying the product. Then in November 2011, a Medication Guide was issued that discussed the earlier black box warnings, but which failed to warn of potential cardiac side effects such as heart attack, stroke and death.
AndroGel Side Effects
Severe side effects of AndroGel include:
- Heart attack
- Blood clot
- Pulmonary embolism
- Transient ischemic attacks
- Sudden death
Other, more moderate side effects may include:
- Hair loss
- Trouble sleeping
- Change in sexual desire
- Redness/swelling of the skin
- Change in skin color
Men Receiving Testosterone Prescriptions Without Test
The JAMA study mentioned above also reported that approximately 25% of men who were issued prescriptions for testosterone replacement therapy were granted the prescription without having blood tests to check their testosterone levels. The study also that found men who took testosterone boosters were nearly 30% more likely to suffer a heart attack, stroke, or die suddenly compared to men who did not take the supplements.
Testosterone and Prostate Cancer
Two recent studies found that testosterone raised the risk of prostate tumors and worsened the effects of carcinogenic chemical exposure in laboratory rats. Researchers administered testosterone to the animals through slow-release implants. Before the rats were dosed, some were injected with the carcinogenic chemical N-nitroso-N-methylurea. Among the rats that received testosterone without this chemical, 10 to 18% developed prostate carcinomas. When rats were exposed to testosterone and the carcinogen, 50 to 71% developed prostate cancer. Rats that were exposed to the carcinogenic chemical but not testosterone did not develop the disease.
“This research demonstrates that testosterone on its own is a weak carcinogen in male rats,” said study author Maarten Bosland from the University of Chicago. “When it is combined with cancer-causing chemicals, testosterone creates a hospitable environment for tumors to develop. If these same findings hold true in humans, there is serious cause for public health concern.”
Type 2 Diabetics with “Low T” may have Increased Risk of Heart Disease: Study
A recent study conducted in Argentina found that men who have low testosterone levels — along with type 2 diabetes — have an increased risk of developing heart disease compared to diabetics with normal T levels. Researchers at Universitario Sanatorio Guemes Hospital identified a link between low concentrations of testosterone and atherosclerosis, a cardiovascular disease that occurs when artery walls thicken due to the accumulation of white blood cells. Click here to learn more.
Testosterone Warning Labels Updated to Reflect Addiction Risk
January 18, 2017 – The warning labels of all prescription testosterone supplements is being updated to include information about a risk of abuse and dependence. FDA also warned that high doses of testosterone can lead to serious adverse events affecting the heart, liver, brain, mental health and endocrine system.
First AndroGel Heart Attack, Blood Clot Lawsuits To Go To Trial Late 2016: Judge
Coordinated litigation involving injuries allegedly caused by AndroGel continues to move forward in Illinois federal court, with early trials tentatively scheduled to begin in late 2016. A case management plan created by the judge overseeing the litigation outlines a process by which bellwether trials will be selected and a potential calendar for trial dates. Click here to learn more.
Bellwether Trials Selected in AndroGel MDL
September 2, 2016 – U.S. District Judge Matthew Kennelly has selected 8 lawsuits to move forward as bellwether trials in the testosterone MDL in the Northern District of Illinois. Of the 8 suits designated as bellwether trials, 4 allege claims of myocardial infarction (heart attack) or stroke, and 4 involve venous thromboembolism (VTE). All 8 cases, however, involve injuries alleged from AndroGel.
Indiana Woman Seeks Damages in AndroGel Wrongful Death Lawsuit
March 30, 2016 – An Indiana woman whose husband allegedly died from a heart attack after using AndroGel has filed a product liability lawsuit against AbbVie Inc. and Abbott Laboratories.
According to the lawsuit, which was filed January 20 in the U.S. District Court for the District of Pennsylvania, the deceased was about 55 years old when his doctor prescribed him AndroGel for hypogonadism – a medical condition that causes low testosterone (“Low T”) levels.
Plaintiff alleges that neither her husband nor his physician were aware of the risks associated with AndroGel — heart attack, stroke, blood clots and pulmonary embolism — because the manufacturers failed to adequately warn about these risks. As a result, the deceased could not have been aware “of the true risks associated with the use of AndroGel,” according to the lawsuit.
Unfortunately, about 4 years later, on Jan. 20, 2014, the man had a fatal heart attack. Plaintiff claims AndroGel was the cause of death, stating that it resulted in significant pain and suffering, financial loss, and permanent injury both to herself and her husband.
Plaintiff further contends that AbbVie and Abbott launched a massive marketing campaign in which they suggested that common symptoms of aging and lifestyle choices — increased body fat, moodiness and listlessness — were actually caused by low testosterone, and that men should talk to their doctors about the benefits of AndroGel.
As a result of this aggressive marketing campaign, sales of testosterone boosters have more than doubled since 2006, with forecasts indicating a potential tripling by next year. However, a number of studies have linked these supplements to an increased risk of heart attack and stroke, including one in 2010 that was stopped early because a large number of men suffered adverse events after using the products.
In 2013, a study found that testosterone replacement therapy (TRT) increased the risk of cardiovascular events by approximately 30%, and another study published the next year determined that testosterone use doubled the risk of heart attack in men over the age of 65, and in younger men who had a pre-existing history of heart disease.
AbbVie and Abbott failed to add new warnings to the labeling of AndroGel despite the studies’ findings, leaving unsuspecting men at risk for serious injury and death, according to the lawsuit. Plaintiff is alleging inadequate warnings, fraud, violation of Indiana’s consumer sales act and wrongful death. She seeks both compensatory and punitive damages in excess of $150,000.
AndroGel Bellwether Trial Selection Amended
June 2, 2015 – The court overseeing the federal AndroGel litigation has amended the Case Management Order governing selection for the upcoming bellwether trials, which may provide insight into how juries will rule in similar cases.
The amended order, which was issued last Friday in the U.S. District Court, Northern District of Illinois, directs the parties to submit a Proposed Case Management Order by August 10, which outlines parameters for selecting AndroGel plaintiffs in 2 tiers of lawsuits: 1) clotting injuries, and 2) cardiovascular complications such as heart attacks.
The Order further specifies that only cases for which a plaintiff’s fact sheet has been completed on or before June 15 are eligible to be selected as bellwether candidates. The first of 6 trials are scheduled to begin on October 31, 2016. The litigation is: In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 254.
AndroGel Lawsuit Allegations
- AbbVie misrepresented AndroGel as safe and effective
- Marketing campaigns ignored potential risks of AndroGel treatment
- AbbVie placed sales ahead of adequate warnings
Additional Resources & Information
- First Status Conference Scheduled in Testosterone Lawsuit Multidistrict Litigation
- Judicial Panel Denies Pfizer’s Attempt to Exclude Depo-Testosterone Lawsuits from Consolidation
- FDA Requests Blood Clot Warnings on Labels of Testosterone Supplements
- Public Citizen Calls for Black Box Warning on Testosterone Supplements
- Pfizer Argues Testosterone Lawsuits Should Be Limited to Gel Formulations
Do I Have an AndroGel Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AndroGel Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Again, if you or a loved one has been injured by AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.