LAWSUITS NEWS & LEGAL INFORMATION

Low-T Testosterone Heart Risk Lawsuit FAQ

What are testosterone therapy side effects?

Testosterone drugs are associated with serious side effects including deep vein thrombosis (DVT), pulmonary embolism, stroke and heart attack. People who have heart, kidney or liver disease are more at risk for worsening heart failure, and increased prostate cancer risk.

What side effects are attorneys investigating?

Attorneys are accepting testosterone injury claims involving DVT, heart attack and pulmonary embolism - a blockage in a lung artery. Pulmonary embolism, or emboli, appear to be the biggest problem, but all testosterone therapy claims are potentially life-threatening.

How can testosterone therapy be associated with heart issues and other serious side effects?

Taking testosterone causes the body to produce more red blood cells, and these blood cells tend to coagulate, causing the blood to thicken. Coagulation makes it more difficult for blood to flow, which can lead to high blood pressure and heart problems. Because older men may have narrow arteries due to old age or disease, they are particularly at risk.

What are testosterone manufacturers accused of?

Testosterone manufacturers have been accused of placing profits before the safety and health of consumers by:

• Failing to adequately research the risk of stroke or heart attack from testosterone therapy, especially among men with cardiovascular disease, high cholesterol, blocked arteries, diabetes, obesity and other prior heart problems.

• Recklessly marketing testosterone treatments in direct-to-consumer advertisements that encourage otherwise healthy men to take medications for “Low T” if they are experiencing general symptoms such as lack of energy, weight gain, decreased sex drive and other natural issues men experience as they age.

When did the FDA approve testosterone therapy and to whom?

The FDA approved AndroGel, which makes up about 80 percent of the testosterone therapy market, in 2000. AndroGel was only approved to treat hypogonadism, a condition of the endocrine system that typically involves severely diminished production or non-production of testosterone.

Is the FDA warning users of serious side effects?

Yes, but only recently. A black box warning was issued in 2009 regarding the risks of secondary exposure to testosterone in children and women that can occur with the use of testosterone gel in men. The FDA announced in January 2014 that it would investigate the risk of heart attack, stroke and death in men using prescription testosterone - after it reviewed a number of studies linking testosterone therapy with heart issues.

Attorneys believe there is very likely a failure to warn consumers of potential testosterone side effects such as heart attack.

What do studies say about testosterone side effects?

In 2010, a study at Boston University was discontinued when researchers concluded the risk for heart attack among their subjects was five times the normal rate. JAMA (Journal of the American Medical Association November 2013) has linked the hormone to serious side effects, including testosterone death. A study titled Testosterone Therapy and Myocardial Infarction (January 2014) also shows an association between testosterone therapy.

Interestingly, studies funded by pharmaceutical companies have concluded there is no increased risk of adverse cardiovascular events associated with testosterone drugs such as AndroGel.

Why is there concern about testosterone now?

Recent FDA warnings, medical reports and studies have alerted testosterone users to heart issues. And testosterone therapy has increased nearly 500 percent in the past two decades, despite the fact that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of heart problems shortly after they begin testosterone therapy is substantially increased.

Reasons for the increased use include direct consumer advertising of testosterone products to baby boomers, many of whom are retired. As well, middle-aged men have been targeted by the manufacturers promising increased vitality and health benefits.

Have testosterone makers been accused of inappropriate off-label marketing or false advertising?

The FDA only approved testosterone therapy for men with hypogonadism - a condition in which the body doesn’t produce enough testosterone. However, testosterone manufacturers such as AbbVie aggressively market AndroGel by telling men the following: “If you're bored, stressed or aging normally, you probably have Low T symptoms: grumpiness, less energy, lower libido and ‘falling asleep after dinner.’" These “symptoms” are also associated with the natural process of aging.

In 2000, the FDA told AbbVie that “claims and representation that suggest that AndroGel is indicated for men with ‘age-associated’ hypogonadism or ‘andropause’ are misleading.”

What brands are being investigated and what about generic medications?

Attorneys are only focusing on brand-name testosterone drugs such as AndroGel and Testim for now, mainly due to an ongoing battle in Supreme Court regarding generic drugs that don’t require the same warnings as prescription medications. (See other testosterone treatments for a thorough list of brand names).

Is there a testosterone class action?

No. Testosterone cases will be lawsuits coordinated nationally and called mass torts, which will allow the court to handle some parts of the case on a group basis, but each individual’s case will be considered on its own merits. Attorneys believe that AndroGel lawsuits will likely proceed on an individual basis because many plaintiffs have suffered substantial injury and financial losses.

Have testosterone lawsuits been filed?

Yes. As of February 2014, a number of AndroGel and Testim (both gel treatment for testosterone replacement) lawsuits have been filed. A recent lawsuit filed against AbbVie Inc. and Abbott Laboratories Inc alleges its AndroGel product caused hematocrit level to increase, thereby thickening the blood and led to pulmonary embolism.

How much time do I have to file an AndroGel lawsuit?

States differ in their statute of limitations. Attorneys advise men who have suffered DVT, pulmonary embolism or heart attack, or their families to inquire about testosterone lawsuit time limits sooner than later.