More Than 1,000 Testosterone Lawsuits Filed

Chicago, ILThe number of testosterone lawsuits alleging men suffered serious testosterone side effects has increased, with more than 1,380 sitting in a multidistrict litigation (MDL) in Illinois, according to court documents. The lawsuits allege men suffered serious adverse effects after taking testosterone therapy, with some lawsuits filed alleging the therapy was responsible for heart attack and stroke

According to documents from the Judicial Panel on Multidistrict Litigation (4/15/15), there are 1,382 lawsuits currently sitting in MDL 2545 (In Re: Testosterone Replacement Therapy Products Liability Litigation) in the Northern District of Illinois before Judge Kennelly. That’s up from March 16, 2015, when there were 1,172 lawsuits included in the MDL.

A conference regarding discovery was held on April 21, 2015.

The plaintiffs who filed the lawsuits allege they suffered health problems, including heart attack and stroke, as a result of taking testosterone. According to Forbes (4/6/15), the first lawsuit is scheduled to start trial in the fall of 2016. At issue is not just the drugs’ side effects but the fact that they were being marketed for a condition that the Food and Drug Administration (FDA) does not recognize as a medical disease and for which they were not approved to treat, argues a plaintiff’s lawyer.

It is not illegal for doctors to prescribe medication off-label, but it is illegal for drug companies to market their drugs for unapproved uses. Essentially, plaintiffs’ attorneys tell Forbes that Low T is a fictitious condition made up by marketing departments in drug companies. Testosterone is approved to treat hypogonadism, which is a decline in hormones linked to a patient’s disease or injury.

Lawsuits allege that the drugmakers aggressively marketed testosterone to the public, using many natural symptoms of aging as evidence of the fictitious condition “Low T.”

The FDA has now answered concerns about testosterone products, issuing a safety communication on March 3, 2015. That safety communication notes that manufacturers of prescription testosterone products must change their labels to show the approved uses for testosterone. The label change must also warn about the increased risk of heart attack and stroke.

“FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the FDA wrote. “The benefits and safety of this use have not been established.”

The FDA did note that there is a possible increased risk of cardiovascular problems while using testosterone, although results of studies have been contradictory.