Low testosterone treatments have been hailed as the fountain of youth for many men seeking to revitalize their energy and vitality. But men who suffered cardiac incidents, such as heart attack or stroke, after taking low testosterone drugs are filing lawsuits, claiming pharmaceutical negligence and failure to warn patients of potentially life-threatening side effects.
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Many testosterone manufacturers are now facing lawsuits claiming they have misrepresented their products by marketing to men without medically low testosterone (the only FDA-approved use for TRT) and misleading patients about the health benefits of low T therapies. In 2014, the FDA issued a statement that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition” such as hypogonadism. But many plaintiffs claim that misleading marketing claims resulted in the off-label use of these prescriptions.
Plaintiffs claim that marketing sensationalizes men’s fear of aging by asking purposefully misleading and vague questions. Androgel’s website asked questions such as “Do you have low energy?” on its Low Testosterone Symptoms Quiz page, which has since been removed from the site.
Men who took low T drugs and suffered a cardiac event are claiming that companies did not warn patients about the possible adverse effects of the drug. Continued studies on the health risks of low T drugs prompted the FDA to issue a March 2015 communication that low T therapies should not be used for the “treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”
The 2013 study Testosterone in Older Men with Mobility Limitations trial on men 65 years or older was stopped early because of increased cardiovascular events in the treatment group. According to research conducted in 2013, there was a twofold increase in the relative risk of myocardial infarctions (i.e., heart attacks) within 90 days after starting TRT in men who had heart disease the year prior. The risk in men over 65 was even greater according to examined medical records of over 55,000 men.
The FDA now requires labels to clarify usage and include a warning of possible cardiac risk including stroke and heart attack.
As of July 2015, more than 2,000 lawsuits have been filed against pharmaceutical companies alleging that men were not properly warned about possible side effects. The suits have been combined into a multidistrict litigation suit (MDL 2545) in Illinois presided over by Judge Matthew F. Kennelly. Consolidating suits does not undermine the individual importance of each claim; it simply acknowledges that each suit shares a similar set of allegations. A similar consolidation of cases occurred against the makers of the popular diet pill Fen-Phen, which paid out $3.75 billion to plaintiffs who suffered heart valve complications, according to the New York Times.
Even as early as 2003, pharmaceutical companies had come under fire for allegations of false advertising, even having a False Claims Act suit filed by two former employees. Solvay (now AbbVie Pharmaceutical) fired employee John King after he voiced concerns about the marketing materials for AndroGel in 2002. Tammy Drummond who also questioned marketing tactics and King’s release was also fired in 2002. As a result, the two filed a whistle-blowing lawsuit claiming “retaliation,” “false claims” and “alleged fraud” by Solvay.
Lawsuits allege that both marketing and warning labels failed to effectively warn of potential health risks and complications. Low T drugs are for use only in men with clinically low testosterone supported by blood work but many plaintiffs in testosterone lawsuits allege a drug company’s failure to warn caused an avoidable health risk or complications. According to one suit, a victim was “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.” (Case No. 2:14-cv-06026 in United States District Court for the Central District of California).
Plaintiffs also allege that marketing tactics misled users into off-label use of the drug. Claims include that campaigns used vague language (such as “do you have low energy?”) and misleading imagery that targeted younger men with no clinical hypogonadism.
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