Testim Gel Lawsuit Filed Over Wrongful Death From Testosterone Therapy

The makers of Testim gel face a wrongful death lawsuit brought by the children of a Louisiana man, who suffered a fatal heart attack that was allegedly caused by side effects of the testosterone replacement therapy.

The complaint (PDF) was filed by the family of John B. Peuler against Auxilium Pharmaceuticals, Inc. on March 21, in the U.S. District Court for the Eastern District of Louisiana, joining a growing number of similar testosterone therapy lawsuits filed nationwide in recent weeks.

Testim gel is one of the more popular prescription treatments for men suffering testosterone deficiency, which is commonly marketed as “Low T.” Together with AndroGel, AndroDerm, Axiron and other testosterone therapy drugs, annual sales for the medications have reached $2 billion in recent years.

According to recent studies, side effects of Testim gel and other treatments may increase men’s risk of suffering a heart attack, stroke, blood clot or sudden death. According to allegations raised by Peuler’s family and others throughout the U.S., the manufacturers of testosterone therapy have failed to adequately warn consumers and the medical community about the potential risks associated with the treatments.

Peuler was 61 years old when he suffered a fatal heart attack on March 22, 2013. According to allegations raised in the lawsuit filed by his children, Jeffrey D. Peuler and Jennifer P. Gillen, he began using Testim testosterone gel about a year earlier, and had no prior history of blood clots, diabetes, strokes or significant cardiovascular problems before using the medication.

The complaint describes Testim gel as defective and unreasonably dangerous, indicating that the drug maker engaged in aggressive marketing campaigns that misrepresented the safety of the testosterone treatment.

Auxilium allegedly engaged in misleading advertising campaigns “designed to convince men that they suffered from low testosterone,” suggesting that various symptoms associated with a number of other conditions may be caused by low testosterone, such as listlessness, increased body fat and moodiness.

Testosterone Heart Concerns

Testim gel and other testosterone therapies are approved by the FDA for the treatment of medically low testosterone levels caused by a medical condition, such as hypogonadism. It was first estimated that the rare condition only affects about 1 million men nationwide. Now the drugs are being sold to many times that number of men, following “disease awareness” campaigns by Auxilium and other drug makers, which encourage men to talk to their doctors about low testosterone levels, which are often a normal part of the aging process.

Hypogonadism can cause excessively low or no testosterone production. Low testosterone caused by this ailment can be confirmed through medical testing. However, a recent study found that 25% of men prescribed the drugs never had their testosterone tested, and that doctors have often prescribed the drugs in recent years for “lifestyle reasons,” treating symptoms associated with the natural reduction of testosterone that all men experience as they age.

While concerns about the potential link between heart attacks and testosterone treatments have existed for years, a study published in November 2013 by the Journal of the American Medical Association(JAMA) confirmed that testosterone products were linked to increased risks of heart attacks, strokes and deathamong older men with certain pre-existing heart conditions.

The JAMA study was followed by a report published by the medical journal PLoSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems. The researchers estimated that for every 1,000 men over the age of 65 who uses AndroGel or another TRT product, 11.52 may suffer a heart attack. That compares to only 5.27 men per 1,000 who do not use testosterone.

On January 31, the FDA announced that it has launched an investigation into the heart safety of testosterone therapy. The agency says it is not yet ready to say that testosterone products cause cardiovascular problems.

Last month, the grassroots consumer protection group Public Citizen criticized the agency for that stance in the face of the evidence and called for a Black Box warning on all testosterone products alerting men to the risk of heart attacks and strokes.

Several dozen similar AndroGel lawsuits have been filed against AbbVie, Inc., the manufacturer of the most widely used testosterone treatment. Amid the mounting litigation, a motion was filed earlier this month seeking to consolidated the lawsuits before one judge, as part of an AndroGel MDL, or multidistrict litigation.

It is widely expected that there will ultimately be several thousand lawsuits filed nationwide by testosterone therapy lawyers reviewing cases on behalf of men who suffered a heart attack, stroke, blood clot or sudden death after using Testim, AndroGel, Axiron or another “low T” treatment.