About 6,000 cases pending in the testosterone multidistrict litigation allege use of testosterone products led to blood clots, heart attack, stroke and sudden death. So far, two trials over AbbVie Inc.’s AndroGel have ended in jury verdicts against the company totaling $290 million.
If you took a prescription testosterone product and suffered cardiac side effects or stroke, you may be eligible for compensation.
Testosterone lawsuits claim men who used testosterone replacement therapy suffered from heart attack, stroke, blood clots and sudden death.
The lawsuits, which involve the makers of popular products such as AndroGel and Depo-Testosterone, have been consolidated into a multidistrict litigation, a legal process courts use to manage many similar cases.
To date, more than 25,000 lawsuits have been filed against AbbVie, Eli Lilly & Co., Pfizer Inc., Endo International and other testosterone-product manufacturers. Four cases have gone to trial.
Juries ordered AbbVie to pay $150 million and $140 million to two men who used AndroGel and suffered heart attacks. A third AbbVie trial ended in favor of the drugmaker in January 2018. Another jury ruled in favor of Endo International’s Auxilium unit. In December 2017, an Illinois federal judge threw out the $150 million verdict. That case is scheduled to be retried in March 2018.
Jury verdicts could affect settlement negotiations going forward for the more than 6,000 remaining cases. So far, Eli Lilly, Endo International, Auxilium Pharmaceuticals and GlaxoSmithKline have reached tentative global settlements involving hundreds of cases.
Attorneys continue to accept new cases on behalf of men who used testosterone products and then experienced heart attack, stroke or blood clots called pulmonary embolism and deep vein thrombosis.
Surviving spouses or relatives may also be eligible for compensation if their loved ones’ use of testosterone products led to sudden death.
Testosterone litigation is ongoing, meaning men who believe they suffered heart attack, stroke, pulmonary embolism or deep vein thrombosis as a result of using testosterone products, such as AndroGel, can still sue the products’ manufacturers.
The litigation is in the bellwether trial phase. This means a few representative cases are going to trial first. The outcome of these cases could decide the fate of 6,000-plus lawsuits still pending.
These trials are scheduled to continue in 2018.
The U.S. Judicial Panel on Multidistrict Litigation created the testosterone multidistrict litigation, or MDL, in June 2014 as a way of streamlining the pretrial proceedings for many similar lawsuits against makers of testosterone products.
The panel ordered that 45 lawsuits pending in four districts be consolidated and moved to the Northern District of Illinois. U.S. District Judge Matthew F. Kennelly is overseeing the MDL, formally called MDL-2545 IN RE: Testosterone Replacement Therapy Products Liability Litigation.
The number of lawsuits in the MDL reached more than 25,000, according to the U.S. District Court Northern District of Illinois website. As of Feb. 15, 2018, a total of 6,444 remained pending.
Of the 226 MDLs across the U.S., the testosterone MDL is especially complicated, with the fourth most pending actions, according to the U.S. Judicial Panel on Multidistrict Litigation’s February 2017 MDL statistics report.
Men who used testosterone products as prescribed by a doctor and suffered heart attack, stroke, pulmonary embolism or deep vein thrombosis may be eligible for compensation through a lawsuit. Relatives of men who died suddenly after using these products may also be eligible.
Thousands of testosterone lawsuits filed in federal court all make the same allegation: Manufacturers of testosterone products put healthy men in danger by marketing the hormone to treat sexual dysfunction, age-related fatigue and other symptoms that go beyond the use approved by the U.S. Food & Drug Administration.
Testosterone replacement therapies were approved for use in the treatment of a medical condition known as hypogonadism, but drugmakers widely marketed the products for off-label use for a condition they allegedly invented and call “Low T.”
Lawsuits accuse makers of testosterone products of marketing the products as safe and effective for this off-label use, when in fact, the products reportedly provide little or no benefit for men without hypogonadism and the drugs can cause heart attack, stroke, blood clots and sudden death — serious medical problems for which the companies allegedly failed to provide adequate warnings.
AndroGel is the testosterone product most often named in lawsuits. AbbVie Inc. manufactures AndroGel. AbbVie’s parent company, Abbott Laboratories, bought AndroGel from Solvay in 2010 and is also named in lawsuits.
Other brands named in lawsuits include Pfizer’s Depo-Testosterone, Eli Lilly & Co.’s Axiron, Endo Pharmaceutical’s Foresta and Auxilium Pharmaceuticals Inc.’s Testim. Actavis Inc. also faces lawsuits over its testosterone gel, Androderm.
Men who suffered heart suffered heart attack, stroke, pulmonary embolism or deep vein thrombosis may be eligible for compensation if they used any of the following testosterone products:
|AndroGel||AbbVie Inc.; Abbott Laboratories Inc.; AbbVie Products; Unimed; Solvay; Besins Inc.; Besins S.A.|
|Depo-Testosterone||Pfizer Inc.; Pharmacia & Upjohn Inc.|
|Testim||Auxilium Pharmaceuticals Inc.; GlaxoSmithKline; Endo Pharmaceuticals|
|Testopel||Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals|
|Striant||Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals|
|Androderm||Actavis Inc., Actavis Pharma Inc., ALU, and Anda, Inc.|
AndroGel is the most widely used type of testosterone replacement therapy. The drug brought in $1.15 billion in sales in 2012 alone. Sales in 2016 were $675 million.
AndroGel lawsuits say manufacturers Abbott and AbbVie “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs “while downplaying known adverse and serious health risks,” Bloomberg reported.
One of the men who sued AbbVie was then-54-year-old Michael Gallagher of Virginia. He suffered myocardial infarction, congestive heart failure and other injuries after being prescribed the gel. He had no history of cardiac problems before taking the prescription drug. Gallagher claims he started AndroGel therapy after the defendants’ advertisements led him to attribute symptoms to low testosterone.
Several manufacturers of testosterone drugs are facing lawsuits in court filed by men who suffered heart attacks, blood clots and strokes. Pfizer and Pharmacia & Upjohn Co. are no exception.
In September 2014, Alvaro Roman Gutierrez took his case to court after using Depo-Testosterone and suffering heart problems he blames on the drug. He accuses Pfizer of “disease mongering” by downplaying the risks of the drug and exaggerating its benefits.
“As a direct and proximate result of the plaintiff’s use of Depo-Testosterone, also known as Testosterone Cypionate, and plaintiff’s reliance on defendants’ representations regarding the character and quality of the products and defendants’ failure to comply with federal requirements, plaintiff suffered serious physical injury, harm, damages and economic loss and will continue to suffer such harm, damages and economic loss in the future,” Gutierrez says in his complaint.
The complaint also says the drugmaker had a duty to warn the public and did not. Pfizer denies any wrongdoing and stands by its drug.
“We do not believe that the cases against Pfizer have merit, and we intend to defend these cases vigorously in court”
Pfizer is accustomed to fighting hormone drug lawsuits. In 2012, it paid $896 million to women who said their breast cancer was caused by the drug. Some doctors warn that testosterone might follow the same path as estrogen therapy.
In 2015, Judge Kennelly dismissed more than 1,000 lawsuits involving Depo-T. A federal appeals court upheld that ruling in February 2018.
AbbVie Inc. was the first testosterone manufacturer on trial. Judge Kennelly, the Illinois federal judge overseeing the MDL, identified about a half-dozen AbbVie cases for bellwether trials, which are test cases intended to try a widely contested issue.
The first four cases in the bellwether trials involve plaintiff claims that AndroGel caused myocardial infraction (heart attack) or stroke. The second group is made up of cases that allege blood clot injury, including pulmonary embolism and deep vein thrombosis.
In December 2017, Eli Lilly and Co. settled about 400 cases that were part of the federal MDL. Details of the tentative settlement were not immediately disclosed. The cases involved people who claimed they were injured by the drug Axiron.
Also, in January 2018, Endo’s Auxilium Pharmaceuticals settled a lawsuit filed in state court in Philadelphia by a man who said his stroke was caused by the drug Testim. The parties didn’t release details of that resolution either.
In February 2018, Endo International, Auxilium and GlaxoSmithKline reached a tentative settlement with more than 500 plaintiffs. Details of the settlement were being worked out and were not made public.
Judge Kennelly had appointed Randi Ellis as the MDL’s settlement master in March 2017. Kennelly ordered Ellis to meet with both sides to discuss settlement. Ellis is an attorney who is frequently called upon to facilitate settlements.
The attention surrounding testosterone lawsuits is on the federal multidistrict litigation in Illinois.
All federal testosterone lawsuits have been consolidated and transferred to the MDL as a way of conserving time and resources.
Although testosterone class actions are not in the forefront right now, an MDL can lead to a class action.
Several studies have assessed the safety of testosterone products and found increased risk of heart attack, stroke and blood clots. As a result, the FDA has launched investigations into the products and now requires manufacturers include warnings about these risks on the products’ labels.
After one FDA safety announcement in 2014, five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel. The plaintiffs’ ages range from 50 to 63. Three of the men suffered heart attacks, and two suffered strokes. Scores of lawsuits followed.
Studies published as recently as February 2017 link testosterone products to serious and even deadly side effects, including heart attack, blood clots and stroke.
Drug companies that manufacture testosterone replacement drugs like AndroGel heavily market their products promising a better quality of life for men. It’s not uncommon for several television ads to air during football games and shows that target men. Many of these direct-to-consumer ads attributed symptoms associated with aging, such as fatigue and loss of libido, to Low T.
Advertisements for AndroGel, for example, popped up soon after the 2000 FDA approval of the product and became more and more prevalent over time. AbbVie spent $75.6 million on direct-to-consumer marketing for AndroGel in 2012 and $67.9 million in 2013, according to data from market-researcher Kantar Media.
Aggressive marketing tactics such as these have been criticized for allegedly luring otherwise healthy aging men to testosterone. Direct-to-consumer marketing campaigns promote testosterone as a way of regaining youthful levels of energy, sex drive, strength and muscle mass while downplaying potential side effects.
The FDA, however, approved testosterone only to treat specific medical conditions that lead to a drop in testosterone levels in men. But more and more men are using the drugs off-label to treat a wide range of symptoms related to the aging process, such as energy loss, decreased muscle mass and reduced libido.
Drugmakers often try to increase profits by creating new, unproven uses to piggyback on existing FDA approvals, putting patients at risk by making misleading statements about the drugs’ safety and effectiveness for those unapproved purposes.
It appears makers of testosterone therapies put a new twist on this marketing scheme. Manufacturers like Eli Lilly & Co. and Abbott Laboratories are riding on the successful marketing of Viagra and other erectile dysfunction treatments to encourage men to ask their doctors about testosterone replacement.
Websites and TV ads show middle-aged men longing to rejoin sporting activities and ask men if they’ve lost their energy. Direct-to-consumer marketing quizzes set men up to believe that natural signs of aging point to a testosterone deficiency.
However, the FDA warns that “the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.” And recent clinical trials found that testosterone did not have an effect on memory or cognitive abilities in older men.
While the controversy continues, it’s clear that drugmakers are reaping the rewards of successful marketing of testosterone treatments. But at least one Low-T drugmaker has reportedly come under fire for its marketing practices.
According to a report by McClatchy, a whistleblower lawsuit filed in federal court in Texas alleges that Solvay Pharmaceuticals, formerly Unimed Pharmaceuticals, used improper sales practices to market AndroGel.
The FDA approved AndroGel to treat hypogonadism, but the drugmaker allegedly recruited doctors to help AndroGel “ride (the) coattails of Viagra” by encouraging them to screen patients seeking Viagra for low testosterone. A former sales manager involved in the lawsuit attributes AndroGel’s high sales to the company’s decision to promote the drug for off-label uses even though it isn’t approved to treat erectile dysfunction (ED) like Viagra is.
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