On June 6, 2014, the United States Judicial Panel on Multidistrict Litigation (“Panel”) decided to consolidate in the federal court in Chicago about 45 federal testosterone replacement drug cases pending throughout the United States against Abbott Laboratories (“Abbott”) and AbbVie Inc. involving the testosterone replacement drug AndroGel. Abbott had formed AbbVie in January 2013 to handle the commercial rights and responsibilities involving AndroGel in the United States.
Abbott and AbbeVie have been accused of engaging in a $80 million television marketing campaign beginning in 2012 to promote AndroGel for use in treating “Low T” (low testosterone level in men) allegedly associated with low energy and loss of sex drive in men, that hid the risks associated with testosterone replacement drugs. Other testosterone replacement drugs are manufactured by Pfizer Inc. and Actavis Inc., which opposed the consolidation, as well as by other pharmaceutical companies. The Panel decided that the consolidation of the testosterone cases in Chicago was appropriate because the cases involve common questions of fact and the consolidation of the cases in Chicago would promote efficiency in resolving the cases.
The FDA’s Warnings Regarding Testosterone Replacement Drugs
On January 31, 2014, the FDA issued a Safety Announcement to alert the public that it was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products based on the results of two recent studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
The FDA stated, however, that it had not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death and it advised that patients taking prescribed testosterone products should not stop taking the drugs without first discussing it with their health care professionals.
One study cited by the FDA was an observational study published in November 2013 involving older men in the U.S. Veteran Affairs health system who had low serum testosterone and were undergoing imaging of the blood vessels of the heart to assess for coronary artery disease. The study found a 30% increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.
The other study was also an observational study. That study found a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription of a testosterone boosting drug and a two-fold to three-fold increased risk of heart attack in the first 90 days following the first prescription for men less than 65 years old who had a pre-existing history of heart disease. (The study found no increased risk of heart attack for men under 65 who had no history of heart disease who filled a prescription for testosterone.)
If you or a loved one were prescribed a testosterone replacement (testosterone therapy) drug that you or your loved one took and later you or your loved one had a stroke, had a heart attack, or died, you should promptly consult with a testosterone replacement lawyer (drug claim lawyer) who may investigate your testosterone drug claim for you and assist you with filing a testosterone drug case, if appropriate.
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