Testosterone Replacement Therapy
Sales of testosterone supplements in the form of gels, injections, pellets, pills, and patches have skyrocketed in recent years leading to a multi-billion dollar industry with millions of prescriptions written each year in the U.S. Testosterone replacement therapy is approved specifically for the treatment of abnormally low testosterone levels (often referred to as “low T”) confirmed by lab testing. However, due to a loophole in FDA regulations, testosterone supplements are often prescribed off-label to men who complain of common symptoms such as feeling irritable, tired, sluggish, or have problems with sexual function. Legitimate safety questions exist regarding testosterone replacement, and users should understand the potential risks and consider alternatives before boosting testosterone levels. According to Dr. Carl Pallais, an endocrinologist and Assistant Professor of Medicine at Harvard Medical School, "Because of marketing, men have been flooded with information about the potential benefit of fixing low testosterone, but not with the potential costs. Men should be much more mindful of the possible long-term complications."
Recent medical literature suggests that middle-aged and older men who take prescription testosterone supplements may be putting themselves at increased risk of heart attack, strokes or death. On January 31, 2014, the FDA announced it would begin investigating whether there is an increased risk of heart attacks, stroke, and death in men using testosterone products. This decision came after a large new study published in January 2014 found that prescription testosterone raised the risk of heart attacks in older men and in middle-aged men with a history of heart disease. The study tracked 56,000 men around the country who used testosterone products between 2008-2010. Study data showed the men had double the rate of heart attacks in the months after starting testosterone replacement therapy compared to the year before starting testosterone replacement.
As our Tampa testosterone lawyers know, this is not the first study in recent months that has highlighted a growing safety concern. A study published in November 2013 in the Journal of the American Medical Association studied 8,000 male veterans during the years 2005-2011 and found a 30% increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone replacement therapy compared to those not taking testosterone. The difference could be seen even after researchers factored in age, pre-existing heart disease, and other various factors.
Another study published by the New England Journal of Medicine in June 2010 found a higher rate of adverse cardiovascular events, such as increased heart attacks, heart rhythm disturbances, and elevated blood pressure among men who received testosterone versus men who received placebo. For health and safety reasons, researchers discontinued the study.
Common Brand-Name Testosterone Medication Include:
Testosterone Litigation Proceedings
Claims involving testosterone are considered a “mass tort.” Mass tort claims involve numerous injured persons harmed by the same product or event. Previous examples of mass tort claims include recalled hip implants, or recalled drug products like Vioxx, the diet drug combination fen-phen, or hormone replacement therapy (HRT) litigation, just to name a few. Events like exploding airbags, airline crashes, and oil spills are considered mass torts.
Mass torts are not the same as a “class action” which is a common misconception. In many instances a mass tort is litigated in what is called multi-district litigation (MDL). This type of centralized litigation is not the same as a class action. Unlike a class action, individual lawsuits filed all across the United States remain stand-alone lawsuits, but they will be transferred to one jurisdiction and assigned to one federal court judge. Product liability cases are often good candidates for MDL because they involve a large number of people similarly injured by a particular product. The MDL process is a mechanism that allows the pretrial procedures of numerous similar cases to be consolidated before a single judge, with the intention of avoiding inconsistent rulings, completing generic discovery and conserving the resources of the parties involved. In the Summer of 2014, the Judicial Panel on Multi-District Litigation (JPMDL) chose the Honorable Matthew F. Kennelly, a federal court judge in the United States District Court for the Northern District of Illinois to preside over the Testosterone Replacement Therapy Products Liability Litigation MDL proceedings.
The experienced mass tort attorneys at Alley, Clark & Greiwe are presently investigating and litigating claims of injured men to be included in the federal court proceedings in Illinois. For nearly three decades, our attorneys have successfully represented thousands of injured persons in Tampa and throughout the State of Florida in various complex product liability and mass tort claims against the makers of dangerous drugs and unsafe medical products. These cases have involved claims against diet drug manufacturers, hormone replacement therapy, big tobacco, breast implant manufacturers, as well as claims involving Baycol, Vioxx, Bextra, ProtoGen bladder slings, and various manufacturers of hip and knee implants.
Tampa Testosterone Attorneys
If you or someone you know suffered a heart attack, stroke, or death while using prescription testosterone products, please contact Alley, Clark & Greiwe for a free consultation regarding your legal rights.
Helpful Resources Regarding Testosterone Replacement Therapy
- Click here to view FDA bulletin from January 31, 2014
- Click here to read the joint PLOS ONE medical study published in January 2014
- Click here to read the JAMA medical study from November 2013
- Click here to read the NEJM medical study from January 2010