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AndroGel May Cause Cardiac Events in Men
A lawsuit has been filed for the prescription drug AndroGel, which is manufactured, sold, distributed and promoted by the AbbVie Inc. and Abbot Laboratories Inc. (hereinafter jointly “Defendants” or “AbbVie”) as a testosterone replacement therapy. It is alleged that Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism and a condition they referred to as “low testosterone,” when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events. AndroGel causes the hematocrit level to increase, thereby thickening the blood. This effect, if not monitored and controlled properly, can lead to life threatening cardiac events, strokes and thrombolytic events. Defendants failed to adequately warn physicians about the risks associated with the AndroGel and the monitoring required to ensure their patients’ safety. Defendants engaged in aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for AndroGel. Further, Defendants engaged in an aggressive unbranded “disease awareness” campaign to alert men that they might be suffering from “low T” or “low testosterone.” According to the industry-leading Androgen Deficiency in Adult Males (“ADAM”) or “Is it Low T?” quiz, the symptoms of “Low T” include being “sad or grumpy,” “experiencing deterioration in the ability to play sports,” and “falling asleep after dinner.” Available at: http://www.isitlowt.com/do-you-have-low-t/low-t-quiz. Most doctors agree that these symptoms can be caused by an abundance of factors, the most prominent of which is the natural aging process. As a result of this “disease mongering,” as termed by Dr. Adriene Fugh-Berman of Georgetown University Medical Center, diagnoses of “Low T” have increased exponentially. This has directly related to AndroGel’s sales increasing to over $1.37 billion per year. However, consumers of AndroGel were misled as to the drug’s safety and efficacy, and as a result have suffered injuries including life-threatening cardiac events, strokes, and thrombolytic events.
By way of background, Unimed Pharmaceuticals Inc. originally developed AndroGel and sought FDA approval in 1999. Before the drug was approved by the FDA in 2000, Solvay Pharmaceuticals Inc. acquired Unimed Pharmaceuticals, Inc. and subsequently brought AndroGel to market. In 2010, Defendant Abbott Laboratories, Inc. acquired Solvay’s pharmaceutical division which included AndroGel. Then in 2013, Abbott created AbbVie, a company composed of Abbott’s former proprietary pharmaceutical business, which included AndroGel.
Hypogonadism is a specific and recognized condition of the endocrine system, which in men may involve the severely diminished production or nonproduction of testosterone. In 1999, when Unimed Pharmaceuticals Inc., one of the Defendants’ predecessor companies, asked for FDA approval of AndroGel, it asserted that hypogonadism was estimated to affect approximately “one million American men.” In 2000, when the FDA approved AndroGel, the company announced that the market was “four to five million American men.” By 2003, the number increased to “up to 20 million men.” However, a study published in the Journal of the American Medical Association (“JAMA”) in August 2013 entitled “Trends in Androgen Prescribing in the United States, 2001 – 2011” indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.
Defendants coordinated a massive advertising campaign designed to convince men that they suffered from low testosterone. Defendants orchestrated a national disease awareness media blitz that purported to educate male consumers about the signs of low testosterone. The marketing campaign consisted of television advertisements, promotional literature placed in healthcare providers’ offices and distributed to potential AndroGel users, and online media including the unbranded website “IsItLowT.com.” The television advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the “symptoms” of low testosterone. These “symptoms” include listlessness, increased body fat, and moodiness—all general symptoms that are often a result of aging, weight gain, or lifestyle, rather than low testosterone. Defendants’ national education campaign included the creation and continued operation of the website www.IsItLowT.com. The website asserts that millions of otherwise healthy men experience low testosterone and encourages male visitors to “Take the ‘Is it Low T’ Quiz.” The “Is it Low T” quiz asks men if they have experienced potential signs of low testosterone, including “Have you experienced a recent deterioration in your ability to play sports?”, “Are you falling asleep after dinner?”, “Are you sad and/or grumpy?”, and “Do you have a lack of energy?”
Dr. John Morley, director of endocrinology and geriatrics at the St. Louis University School of Medicine, developed this quiz at the behest of Dutch pharmaceutical company Organon BioSciences, in exchange for a $40,000 grant to his university. The pharmaceutical company instructed Dr. Morley, “Don’t make it too long and make it somewhat sexy.” Dr. Morely drafted the questionnaire in 20 minutes in the bathroom, scribbling the questions on toilet paper and giving them to his secretary the next day to type up. Dr. Morely admits that he has “no trouble calling it a crappy questionnaire” and that it is “not ideal.” This is the “Low T Quiz” used on the “IsItLowT” website. Natasha Singer, Selling that New-Man Feeling, Nov. 23, 2013, N.Y. TIMES.
Since the FDA approved AndroGel, Defendants have also sought to convince primary care physicians that low testosterone levels are widely under-diagnosed, and that conditions associated with normal aging could be caused by low testosterone levels. While running its disease awareness campaign, Defendants promote their product AndroGel as an easy to use topical testosterone replacement therapy. Defendants contrast their product’s at-home topical application with less convenient prescription testosterone injections, which require frequent doctor visits. Defendants convinced millions of men to discuss testosterone replacement therapy with their doctors, and consumers and their physicians relied on Defendants’ promises of safety and ease. Although prescription testosterone replacement therapy had been available for years, millions of men who had never been prescribed testosterone flocked to their doctors and pharmacies. What consumers received, however, were not safe drugs, but a product which causes life-threatening problems, including strokes, heart attacks, pulmonary embolisms and blood clots.
Defendants successfully created a robust and previously nonexistent market for their drug. Defendant Abbott Laboratories spent $80 million promoting AndroGel in 2012. The company also spent millions on its unbranded marketing including commercials and its websites, www.IsItLowT.com and www.DriveForFive.com, sites which recommend that men have regular checkups with their physicians and five regular tests done: including cholesterol, blood pressure, blood sugar, prostate-specific antigen, and testosterone. Defendants’ advertising paid off in a return of $1.4 billion in sales during the past year, making AndroGel the biggest selling androgen drug in the United States. Sales of replacement therapies have more than doubled since 2006, and are expected to triple to $5 billion by 2017, according to forecasts by Global Industry Analysts. Shannon Pettypiece, Are Testosterone Drugs the Next Viagra?, May 10, 2012, Bloomberg Businessweek, available at: http://www.businessweek.com/articles/2012-05-10/are-testosterone-drugs-the-next-viagra.
In early 2013, Medical Marketing & Media named two AbbVie executives as “the all-star large pharma marketing team of the year” for promotions of AndroGel and unbranded efforts to advance low T. See Singer, Selling That New-Man Feeling, supra; See also, Larry Dobrow, All-star large pharma marketing team of the year: Androgel. Jan. 2, 2013, Medical Marketing & Media, available at: http://www.mmm-online.com/all-star-large-pharma-marketing-team-of-the-year-androgel/article/273242/. The marketing program sought to create the image and belief by consumers and physicians that low testosterone affected a large number of men in the United States and that the use of AndroGel is safe for human use, even though Defendants knew these to be false, and even though Defendants had no reasonable grounds to believe them to be true. There have been a number of studies associating testosterone use in men with an increased risk of heart attacks and strokes.
In 2010, a New England Journal of Medicine Study entitled “Adverse Events Associated with Testosterone Administration” was discontinued after an exceedingly high number of men in the testosterone group suffered adverse events. In November of 2013, a JAMA study was released entitled “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels” which indicated that testosterone therapy raised the risk of death, heart attack and stroke by about 30%. On January 29, 2014, a study was released in PLOS ONE entitled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” which indicated that testosterone use doubled the risk of heart attacks in men over sixty five years old and men younger than sixty five with a previous diagnosis of heart disease.
The Food and Drug Administration approved AndroGel 1% on February 28, 2000 for the treatment of adult males who have low or no testosterone (AndroGel 1.62% was approved in April, 2011). After FDA approval, AndroGel was widely advertised and marketed by Defendant as a safe and effective testosterone replacement therapy. AndroGel, is a hydroalcoholic gel containing testosterone in either 1% or 1.62%, applied to the chest, arms or stomach and enters the body through transdermal absorption. The AndroGel 1.62% product also contains isopropyl myristate as an ointment and ethanol for absorption enhancement. Testosterone is a primary androgenic hormone responsible for normal growth, development of the male sex organs, and maintenance of secondary sex characteristics.
The hormone plays a role in sperm production, fat distribution, maintenance of muscle strength and mass, and sex drive. In men, testosterone levels normally begin a gradual decline after the age of thirty. The average testosterone levels for most men range from 300 to 1,000 nanograms per deciliter of blood. However, testosterone levels can fluctuate greatly depending on many factors, including sleep, time of day, and medication. Resultantly, many men who may have testosterone levels below 300 ng/dl on one day will have normal testosterone levels the next.
AndroGel may produce undesirable side effects to patients who use the drug, including but not limited to, myocardial infarction, stroke, pulmonary embolism and death. In some patient populations, AndroGel use may increase the incidence of adverse events and death by over 500%. In addition to the above, AndroGel has been linked to several severe and life changing medical disorders in both users and those who come into physical contact with users or the unwashed clothes of someone who applied AndroGel. Patients taking AndroGel may experience enlarged prostates and increased serum prostate-specific antigen levels. Secondary exposure to AndroGel can cause side effects in others. In 2009 the FDA issued a black box warning for AndroGel prescriptions, advising patients of reported virilization in children who were secondarily exposed to the gel. Testosterone may also cause physical changes in women exposed to the drug and cause fetal damage with pregnant women who come into secondary contact with AndroGel.
Defendants’ marketing strategy beginning in 2000 has been to aggressively market and sell their products by misleading potential users about the prevalence and symptoms of low testosterone and by failing to protect users from serious dangers that Defendants knew or should have known to result from use of its products. Defendants successfully marketed AndroGel by undertaking a “disease awareness” marketing campaign. This campaign sought to create a consumer perception that low testosterone is prevalent among U.S. men and that symptoms previously associated with other physical and mental conditions, such as aging, stress, depression, and lethargy were actually attributable to “Low-T.” AbbVie’s advertising program, sought to create the image and belief by consumers and their physicians that the use of AndroGel was a safe method of alleviating their symptoms, had few side effects and would not interfere with their daily lives, even though Defendants knew or should have known these to be false, and even though the Defendants had no reasonable grounds to believe them to be true.
Defendants purposefully downplayed, understated and outright ignored the health hazards and risks associated with using AndroGel. Defendants deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes, and manipulating hypogonadism statistics to suggest widespread disease prevalence, while downplaying known adverse and serious health effects. Defendants concealed material relevant information from potential AndroGel users and minimized user and prescriber concern regarding the safety of AndroGel. In particular, in the warnings Defendants give in their commercials, online and print advertisements, Defendants fail to mention any potential risk of cardiac event, stroke, pulmonary embolism or other dangerous side effects related to blood clotting and falsely represents that AbbVie adequately tested AndroGel for all likely side effects. The Defendants also fail to warn and instruct regarding the importance of adequate monitoring of hematocrit levels. As a result of Defendants’ advertising and marketing, and representations about its product, men in the United States pervasively seek out prescriptions for AndroGel. If Plaintiff had known the risks and dangers associated with AndroGel, the Plaintiff would not have taken AndroGel and consequently would not have been subject to its serious side effects.
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