LOW-T
In February 2014, the first case involving AndroGel, a testosterone replacement therapy, was filed against AbbVie Inc., Abbott Laboratories and Eli Lilly and Company (“Defendants”) in the United States District Court for the Northern District of Illinois. One month later, Hon. Matthew F. Kennelly ordered that over 30 lawsuits be consolidated in the same court for coordinated or consolidated pretrial proceedings.
- About Low-T
Androgen replacement therapy, often referred to as testosterone replacement therapy, is used to treat hypogonadism, or low testosterone (low-T), a disease in which a problem with the sex glands results in the body’s inability to produce normal amounts of testosterone. This can be diagnosed with a blood test. Signs and symptoms associated with low testosterone include increased body fat, lethargy, reduced muscle mass, poor erectile function, low libido, reduced sexual activity, depression, moodiness, hair loss, gynecomastia, decreased bone density and sleep disturbances. High blood pressure, high cholesterol levels and cardiovascular problems have also been linked to low testosterone.
According to Bloomberg, the market for the testosterone-replacing drugs AndroGel and Axiron, manufactured by Eli Lilly (Abbott Laboratories owned AbbVie until January 1, 2014), is $1.6 billion annually. In 2012, Abbot Laboratories spent $80 million promoting AndroGel and millions more on its unbranded marketing to increase the awareness of low testosterone. Other testosterone replacement therapy drugs include AndroDerm manufactured by Actavis Pharma, Inc. and Testim manufactured by Auxillium Pharmaceuticals.
On January 1, 2014, the FDA issued an alert urging healthcare professionals and patients to report any side effects arising from prescription testosterone products and announced that it would be evaluating the risk of stroke, heart attack and death in men that had taken FDA-approved testosterone products.
On March 2015, the FDA announced that all testosterone replacement therapies must have their labels updated after the agency reviewed several studies that suggested men using the “low T” therapies are at an increased risk for heart attacks and strokes. In a drug safety communication on March 3, 2015, the agency noted that the treatments have been overprescribed to men suffering from low testosterone due to aging, rather than a related medical issue. Therefore, the FDA said that the makers of these drugs must update their labels to include these risks and clarify the only approved use for the prescriptions. Furthermore, the FDA warned doctors to only prescribe these treatments to men who have had medical tests performed verifying that their low testosterone levels are the result of hypogonadism or another medical issue.
- Studies
On January 29, 2013, a study conducted by a group of researchers at the U.S National Cancer Institute and the University of California, Los Angeles was published, which revealed that some men have an increased risk of suffering heart attacks while using prescription testosterone therapies. The study of approximately 56,000 patients found that men over the age of 65, as well as patients younger than 65 with a history of heart disease, had twice the rate of heart attacks in the three months after beginning testosterone therapy when compared to the year prior to treatment. The study also addressed whether these men were at a greater risk for cardiac problems due to an increase in libido caused by higher testosterone levels. When the study compared these men to a separate group of patients taking Viagra and Cialis, the men on the erectile dysfunction drugs patients did not experience more heart attacks.
A 2009 federally-funded research study intended to address whether testosterone gels could help older men build muscle was stopped after researchers noticed that some of the study’s participants were suffering heart attacks and other cardiac problems, further supporting the link between testosterone therapy and heart risks.
Another study published in the Journal of the American Medical Association (JAMA) had similar results, finding that older men had a 29% increase in stroke, heart attack and death when undergoing testosterone therapy. Researchers said the study warranted cautious testosterone prescribing and additional investigation. Researchers reported that men who used testosterone were 30 percent more likely to have a heart attack or stroke or to die during a three-year period than men with low hormone levels who didn't take the supplements. The study’s 3,000 participants averaged 60 years of age and most of the men (hormone users and non-users) had other health problems including high blood pressure, unhealthy cholesterol and diabetes. Further, participants who began the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke, or die as men who entered the study with established coronary artery disease.
Also, according to the Endocrine Society's Journal of Clinical Endocrinology & Metabolism, men who have low testosterone and Type 2 diabetes face a greater risk of developing atherosclerosis—a condition where plaque builds up in the arteries—than men who have diabetes and normal testosterone levels, Authors of the study, titled “Low Testosterone Concentration and Atherosclerotic Disease Markers in Male Patients with Type 2 Diabetes,” recommend that testosterone treatment should be reserved for men with clinical symptoms of hypogonadism and consistently low levels of testosterone. The Society also has called for large-scale, well-controlled trials to assess the long-term cardiovascular risks associated with testosterone therapy.
A study titled Testosterone Therapy and Myocardial Infarction (January 2014) published by the Public Library of Science in conjunction with the University of Florida and the National Cancer Institute shows an association between testosterone therapy (TT) and cardiovascular disease. The researchers also noted that testosterone therapy is increasing despite the fact that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of myocardial infarction shortly after they begin testosterone therapy is substantially increased. The study reported that increased risk of heart attack among young men with prior heart disease is a “particular public health concern, as about 10 percent of the men in our study under age 65 years with a [testosterone therapy] prescription had a history of heart disease.”
Research is continually being conducted on the effects of low testosterone drugs. In the August 20th, 2015 edition of the New England Journal of Medicine (NEJM), FDA officials wrote that there is still “no proof” that testosterone supplements are safe or effective.
- Claims
In this litigation, the plaintiffs allege that AndroGel caused serious medical problems, including life threatening cardiac events, strokes and thrombolytic events, and that Defendants misrepresented and continue to misrepresent that AndroGel is safe and free from serious side effects, fraudulently concealing these facts from the public. Accordingly, it is claimed that the use of AndroGel can increase the risks of myocardial infarctions and death by over 500% in some patient populations. The drug has also been linked to adverse medical events for those who are secondarily exposed to the gel, such as physical changes in women and fetal damage to pregnant women.
Plaintiffs further contend that Defendants engaged in aggressive marketing and advertising for AndroGel and unbranded “disease awareness” campaigns designed to convince men that they might be suffering from low testosterone and to convince primary care physicians that low testosterone levels are under-diagnosed. One of these campaigns included a quiz that Dr. John Morley developed for pharmaceutical company, Organon BioSciences, in exchange for a $40,000 grant to his university. Morley was instructed to make the quiz short and “somewhat sexy,” but even Morley admitted the quiz was “crappy” and “not ideal.”
Plaintiffs assert that Defendants engaged in “disease mongering” by turning ordinary life experiences like moodiness, lethargy and increased body fat into a disease requiring medical treatment, when these symptoms could be caused by a number of different things, such as the natural aging process, weight gain or lifestyle choices. Defendants allegedly concealed material relevant information from consumers, falsely represented that they adequately tested the drug for all potential side effects and deliberately downplayed the risks associated with AndroGel.
The plaintiffs are seeking compensatory damages based on the following causes of action: failure to warn; negligence; breach of implied warranty; breach of express warranty; fraud; and negligent misrepresentation. Plaintiffs is also asking for punitive damages based on Defendants’ actions, which they claim were outrageous, willful and malicious and made with a conscious disregard for the rights of AndroGel users.