About 7,000 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 (FDA).
The lawsuits, which involve the makers of popular products such as AndroGel and Depo-Testosterone, are consolidated into a multidistrict litigation (MDL) in the Northern District of Illinois. MDL is a special federal legal procedure intended to speed up the process of handling complex cases.
Of the 236 MDL dockets, the testosterone MDL is especially complicated, with the sixth most pending actions, according to the U.S. Judicial Panel on Multidistrict Litigation’s February 2017 MDL statistics report.
The first manufacturer on trial will be AbbVie Inc., whose product AndroGel is the most widely used type of testosterone replacement therapy. The drug brought in $1.15 billion in sales in 2012 alone.
U.S. Judge Matthew F. 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.
Plaintiffs say AbbVie:
- Misrepresented AndroGel as a safe and effective treatment for hypogonadism — the drastic decline in hormone levels caused by injury or disease — despite causing serious side effects.
- Used “aggressive, award-winning direct-to-consumer and physician marketing campaigns” to convince men to discuss testosterone therapy with their doctors.
- Engaged in “disease mongering” to increase sales instead of adequately warning consumers about AndroGel’s risks.
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. The cases include:
Jeffrey Konrad v. AbbVie Inc.
Plaintiffs: Jeffrey and Jana Konrad
Alleged injury: Heart attack
Date of alleged injury: July 9, 2010
Dates of alleged AndroGel use: May 2010 – June 2010
Current age: 56
Age at injury: 49
Age at first prescription: 49
Jesse Mitchell v. AbbVie
Plaintiff: Jesse Mitchell
Alleged injury: Heart attack
Date of alleged injury: November 18, 2012
Dates of alleged AndroGel use: December 2007 – November 2012
Current age: 53
Age at injury: 49
Age at first prescription: 44
Edward Cribbs v. AbbVie
Plaintiff: Edward Cribbs
Alleged injury: Heart attack
Date of alleged injury: May 25, 2012
Dates of alleged AndroGel use: March 2010 – April 2014
Current age: 66
Age at injury: 61
Age at first prescription: 59
Cecile Frost v. AbbVie
Plaintiff: Cecile Frost
Alleged injury: Stroke
Date of alleged injury: February 21, 2013
Dates of alleged AndroGel use: January 2012 – February 2013
Current age: 64
Age at injury: 59
Age at first prescription: 58
Arthur Myers v. AbbVie
Plaintiff: Arthur Myers
Alleged injury: Pulmonary embolism
Date of alleged injury: February 7, 2008>
Dates of alleged AndroGel use: June 2003 – August 2008
Current age: 51
Age at injury: 42
Age at first prescription: 37
Robert Nolte v. AbbVie
Plaintiff: Robert Nolte
Alleged injury: Pulmonary embolism
Date of alleged injury: November 1, 2012
Dates of alleged AndroGel use: August 2012 – December 2012
Current age: 77
Age at injury: 72
Age at first prescription: 72
Robert Rowley v. AbbVie
Plaintiff: Robert Rowley
Alleged injury: Deep vein thrombosis
Date of alleged injury: April 27, 2013
Dates of alleged AndroGel use: April 2012 – April 2013
Current age: 71
Age at injury: 67
Age at first prescription: 66
FDA Investigation Spurs Testosterone Lawsuits
Slated for June 5, 2017, the first of six bellwether trials comes nearly four years after men initially began filing testosterone lawsuits.
The FDA announced on January 31, 2014, that it was “investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.”
The following month, 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.
One of the men was then-54-year-old Michael Gallagher of Virginia who 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.
According to the complaints, 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.
This was just one of scores of lawsuits filed around the same time.
In March 2014, the multidistrict litigation panel received a motion to consolidate all federal testosterone lawsuits, including the AndroGel lawsuits, in federal court in Illinois. The panel in June 2014 ordered that 45 actions pending in four districts be consolidated and moved to the Northern District of Illinois.
In issuing its order, the panel stated: “All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions will share factual questions regarding general causation and the background science regarding the role of testosterone in the aging body … as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.”
Since then, the number of actions in the MDL has surpassed 7,000, according to the U.S. District Court Northern District of Illinois website. Defendants named in the lawsuits include AbbVie Inc.; Abbott Laboratories Inc.; Pharmacia & Upjohn Inc.; Pfizer Inc.; Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals Inc.; Eli Lilly & Co. and Actavis Inc.
Testosterone MDL Timeline
The FDA announced it was “investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.”
Five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel.
The multidistrict litigation panel received a motion to consolidate all federal testosterone lawsuits, including the AndroGel lawsuits, in federal court in Illinois.
The panel ordered 45 actions pending in four districts be consolidated and moved to the Northern District of Illinois.
The court appointed attorneys to serve in leadership roles in the multidistrict litigation.
The court designated attorneys who will serve in leadership roles throughout the rest of the litigation.
U.S. Judge Matthew F. Kennelly selected AbbVie cases for bellwether trials.
The first AbbVie bellwether trial is scheduled to start.
The second AbbVie bellwether trial is scheduled to start.
The third AbbVie bellwether trial is scheduled to start.
The fourth AbbVie bellwether trial is scheduled to start.
The fifth AbbVie bellwether trial is scheduled to start.
The sixth AbbVie bellwether trial is scheduled to start.
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 spokesman Steven Danehy said in a statement.
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.
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.
The New Viagra
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.
Testosterone: ‘The Fountain of Youth’
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.
Marketing efforts suggest decreased energy levels are caused by Low T rather than by aging or any number of other factors. Once this energy–Low T connection is made, consumers are persuaded to visit their doctors seeking Low T therapy to help them regain vitality.
Eli Lilly & Co., AbbVie and other testosterone product manufacturers face criticism for these and other tactics. They created a $1.6 billion market for testosterone replacement drugs, and critics say they haven’t done enough to inform consumers and doctors about potential risks. Drugmakers have a legal duty to warn consumers and doctors about any known risks associated with their drugs.
Recipe for Pharmaceutical Negligence
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.
Details about Unimed Pharmaceuticals:
- In 1999, it reportedly projected treating a market of 1 million men for hypogonadism.
- By the time the drug was approved in 2000, it estimated its market at up to 5 million men.
- By 2003, corporate managers had reportedly expanded that number to 20 million men. (There are an estimated 116 million adult men in the U.S.)
- Abbott Laboratories is AndroGel’s current owner.
- Serious health risks and aggressive marketing for off-label purposes frequently form a recipe for negligence and widespread pharmaceutical injuries.
- Pharmaceutical companies that hurry to market a drug without proper approvals often end up accused of inadequate testing or concealing risks.
- When they fail to protect consumers and warn about those risks, they may be held legally liable for any injuries that result from their negligence.
- U.S. Judicial Panel on Multidistrict Litigation. (2017, February 15). MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-February-15-2017.pdf
- U.S. District Court in Northern District of Illinois. (n.d.). MDL 2545. Retrieved from http://www.ilnd.uscourts.gov/mdl-details.aspx?UGlDS1bLxpRHyfdf3l5DJQ==
- Wasserman, E. (n.d.). AndroGel. Retrieved from http://www.fiercepharma.com/special-report/androgel
- Lexis Legal News. (2016, August 5). Testosterone MDL Judge Picks 1st 8 AndroGel Bellwether Cases. Retrieved from http://www.lexislegalnews.com/articles/10329/testosterone-mdl-judge-picks-1st-8-androgel-bellwether-cases
- U.S. District Court in Northern District of Illinois. (2017, February 27). Joint Submission Regarding AbbVie-Only Bellwether Trial Sequence. Retrieved from http://www.aboutlawsuits.com/wp-content/uploads/2017-02-27-AbbVie-Case-Report.pdf
- U.S. Judicial Panel on Multidistrict Litigation. (2014, June 6). Transfer Order. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2545-Initial_Transfer-05-14.pdf
- Vigen, R. et al. (2013, November 6). Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels. Retrieved from http://jama.jamanetwork.com/article.aspx?articleID=1764051
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- Beck, M. (2013, November 5). Testosterone Therapy Tied to Heart Risks. Retrieved from http://online.wsj.com/news/articles/SB10001424052702303661404579180294201174958
- Reuters. (2013, November 5). Testosterone treatments may increase risk of heart problems in men: study. Retrieved from http://www.nydailynews.com/life-style/health/testosterone-linked-heart-risks-men-study-article-1.1507645
- Perrone, M. (2012, September 10). Testosterone boosters sell to millions. Retrieved from http://www.washingtontimes.com/news/2012/sep/10/testosterone-boosters-sell-to-millions/?page=all
- Ungar, L. (2013, June 12). Popular 'low T' therapy divides the medical field. Retrieved from http://www.usatoday.com/story/news/2013/06/12/health-low-testosterone-therapy/2417333/
- Finkle, W. D. et al. (2014, January 29). Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. Retrieved from http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805
- Healy, M. (2014, January 29). Testosterone prescriptions linked to heart attack. Retrieved from http://www.latimes.com/science/sciencenow/la-sci-sn-testosterone-heart-attack-20140129-story.html
- FDA.gov. (2015, March 3). FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm436259.htm