Low Testosterone

Dangerous Drugs & Devices

What Is Low Testosterone?

Since the 1950s, testosterone supplements have been approved for use by men who experience low testosterone because of a birth defect; chemotherapy; or a disorder of the testicles, pituitary gland or brain. Since testosterone levels naturally become lower as men age, these supplements are only approved for men with an actual medical condition. Some of the effects of low testosterone levels include weight gain, loss of muscle, decreased sexual performance or general lack of energy, but none of these are considered medical conditions when associated with aging and do not require treatment.

Since 2000, the pharmaceutical companies which manufacture testosterone replacement drugs actively tried to create a market to sell these drugs to more and more men. They began advertising campaigns about a “condition” called “Low T” or Low Testosterone. The expected natural effects of lower testosterone have been characterized as a disorder, and men were encouraged to seek treatment. In fact, testosterone replacement therapy is being used by nearly 3% of men over the age of 40—very few of whom have an actual medical condition! Androgel is the most popular prescription product, but these therapies are also sold as:

  • Testim
  • Androderm
  • Axiron
  • Bio-T-Gel
  • Delatestryl
  • Dep-Testosterone
  • Fortesta
  • Striant
  • Testopel

The economic impact on Low T prescriptions is estimated at $3 billion.

What Are The Potential Injuries?

After at least two studies showed a link between testosterone therapy and an increased risk of heart attack in men over the age of 65, the Food and Drug Administration issued a safety alert for anyone using these drugs for non-medical reasons. One study showed that risk of stroke, heart attack and death were increased by 30%. Another study showed that men over 65 had twice the likelihood of heart attack within three months of going on Low T drugs. Other complications include blood clots, deep vein thrombosis and aggressive behavior. When applied topically, others can be exposed, and thereby impacted by these drugs.

What Is The Legal Status?

Lawsuits are being filed against the makers of these drugs for recklessly marketing to men who were simply experiencing the natural effects of aging. The serious side effects of increased risks of heart attack, stroke and death were not listed in the prescription materials. The Federal Drug Administration has now intervened and, as of March 2015, the manufacturers are required to post warnings of potentially fatal side effects of using the drugs.

What Is The Legal Outlook?

Many lawsuits have been filed across the country by individuals or their families who took these drugs and suffered the negative side effects. Most lawsuits are being filed against Abbvie, the maker of Androgel, but the other companies that marketed similar testosterone therapies are likely to join Abbvie as defendants.

Individuals who are filing lawsuits suffered different injuries and outcomes, but many will have common aspects of their cases. Given this, a Multi-District Litigation (MDL) has been created for the Low T mass tort lawsuit so that proceedings can be coordinated and consolidated. Lawsuits that have been filed around the country will be brought into the MDL, although cases will remain individual.

If you or a family member had a heart attack, blood clot, pulmonary embolism, stroke, or deep venous thrombosis after taking Androgel or any other testosterone therapy, contact Oxner + Permar for a free consultation.