Doctors prescribe testosterone replacement therapy drugs, medications and treatments to treat low testosterone in millions of men in the U.S. each year, with annual sales exceeding $2 billion. These products may be in the form of injection, gel, implant, patch or pill. Some of the more common treatments for low testosterone are or have been Androderm, AndroGel, Android, Androxy, Axiron, Bio-T Gel, Delatestryl, Depo-Testosterone, Fortesta, Methitest, Striant, Testim and Testopel.
Men experience low testosterone levels from either a disease known as hypogonadism, in which the body is unable to produce normal amounts of testosterone, or merely be due to normal aging, where testosterone levels start gradually declining after men reach the age of 30. Common symptoms of low testosterone levels include muscle loss, lower strength, fatigue, depression, low libido, erectile dysfunction, infertility, osteporosis or hair loss. Although the U.S. Food and Drug Administration (FDA) approved testosterone replacement therapy products only to treat hypogonadism, men seek to use these products for non-medical reasons including increasing physical development and performance or counteracting the natural aging process.
Testosterone Replacement Therapy Studies
A November 2013 study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association revealed a potential 30% increased risk of stroke, heart attack, and death in a test group that had been prescribed testosterone therapy.
A second study in January 2014 reported a doubling of the risk of heart attack among both men aged 65 years and older and men aged less than 65 years old with a pre-existing history of heart disease, within 90 days following their first testosterone therapy prescription.
FDA Drug Safety Communications
After several studies linking testosterone replacement therapy products to increased risks of stroke, heart attack or death, the FDA issued several drug safety communications warning of the dangers of testosterone replacement therapy products, particularly for uses other than hypogonadism.
On January 31, 2014, based upon the above studies, the U.S. Food & Drug Administration (FDA) announced it would be investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone therapy products.
On June 19, 2014, given reports of venous blood clots, the FDA required testosterone therapy product manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins (venous thromboembolism), including deep vein thrombosis and pulmonary embolism.
On March 3, 2015, the FDA issued a drug safety communication which, among other directives:
- Concluded that there was a possible increased cardiovascular risk associated with testosterone use
- Cautioned that prescription testosterone products were approved only for men suffering hypogonadism as confirmed by laboratory testing, and that the benefit and safety of testosterone products were not established for the treatment of low testosterone levels due to aging
- Required manufacturers of all approved prescription testosterone products to change their labeling to clarify the approved uses of testosterone therapy products and add information about a possible increased risk of heart attacks and strokes associated with testosterone use
- Required manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products.
Further, the FDA required manufacturers of all approved prescription testosterone products to (i) change their labeling to clarify the approved uses of testosterone therapy products and add information about a possible increased risk of heart attacks and strokes associated with testosterone use, and (ii) conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products.
Testosterone Replacement Therapy Side Effects, Injuries and Risks
Regardless of the effectiveness of testosterone replacement therapy, taking drugs, medications or treatments such as Androderm, AndroGel, Android, Androxy, Axiron, Bio-T Gel, Delatestryl, Depo-Testosterone, Fortesta, Methitest, Striant, Testim and Testopel may lead to the following conditions ranging from serious side effects to life-threatening injuries:
- Heart attack and other cardiovascular defects
- Blood clot
- Pulmonary embolism
- Deep vein thrombosis
- Abnormal red blood count increase (polycythemia)
- Prostate cancer or enlargement
- Sleep apnea
- Testiclular shrinkage or softening
- Lowered sperm count
- Acne or other skin reactions
- Hair loss
- Enlarged breasts (gynecomastia)
- Reduced sex drive or impotence
- Erectile dysfunction
- Weakened bones (osteoporosis) leading to fracture
- Loss of muscle mass
- Increase in body fat
- Fluid retention
- Depression, irritability and/or inability to concentrate
- Mood changes
- Hot flashes
The following signs and symptoms may indicate a testosterone replacement therapy drug-related blood clot, which could lead to stroke, heart attack or death:
- Chest pain (pressure, fullness, squeezing)
- Pain extending to shoulder, arm, back or jaw
- Shortness of breath
- Rapid heartbeat
- Pain, tenderness or numbness in face, arm or leg
- Sudden difficulty speaking or understanding speech (aphasia)
- Sudden blurred, double or decreased vision
- Skin discoloration
Certain types of testosterone replacement therapy drugs, medications and treatments may accidentally expose women and children to the product. Testosterone side effects on women and children may include premature puberty, changes to sexual organs and body hair distribution, osteoporosis, heightened libido or aggressive behavior.
Testosterone Replacement Therapy Lawsuits
Many users of testosterone replacement therapy drugs, medications and treatments have filed federal lawsuits across the United States against pharmaceutical manufacturers. These lawsuits seek damages for injuries including heart attack, stroke, blood clot, pulmonary embolism, deep vein thrombosis (DVT), and death. Many of the complaints allege that testosterone replacement therapy product manufacturers:
- Failed to adequately research the risk of stroke or heart attack from testosterone therapy, especially among men with pre-existing cardiovascular conditions
- Recklessly and aggressively marketed testosterone treatments in misleading advertisements which created a “disease” (“Low T”) based upon general symptoms and natural issues, prompting otherwise healthy men to seek prescription medications
- Withheld information and failed to adequately warn consumers and the medical community about heart attack risks despite having knowledge of possible side effects
Lawsuit defendants include, AbbVie, Pfizer, Eli Lilly and Co., Endo Pharmaceuticals, Auxilium Pharmaceuticals, Actavis U.S. and Teva Pharmaceutical, Valeant Pharmaceuticals, Upsher-Smith Laboratories and Impax Laborarories.
Testosterone Replacement Therapy Damages
Patients or families of patients who have suffered injuries from testosterone replacement therapy drugs, medications or treatments such as Androderm, AndroGel, Android, Androxy, Axiron, Bio-T Gel, Delatestryl, Depo-Testosterone, Fortesta, Methitest, Striant, Testim and Testopel, may be entitled to compensation for the following:
- Doctor visits
- Medical tests
- Past, current and future medical expenses
- Medical monitoring
- Physical therapy
- Pain and suffering – physical, mental and emotional distress
- Lost wages and income
- Diminished earning capacity
- Home modifications
- Nursing or caregiving services
- Damages to spousal relationship (loss of consortium)
- Wrongful death
- Funeral costs
- Punitive damages
Factors used to determine damage awards at trial or settlement amounts for injuries caused by testosterone replacement therapy drugs, medications or treatments include:
- Nature and extent of injury
- Physical, mental and emotional effects of complications
- Past and future pain and mental anguish
- Amount of any past and future medical expenses
- Amount of lost wages or earning capacity
Testosterone Replacement Therapy Multidistrict Litigation (MDL)
In June 2014, the Judicial Panel on Multidistrict Litigation approved consolidation of all testosterone replacement therapy cases in federal courts across the country into a single multidistrict litigation (MDL) taking place in United States District Court, Northern District of Illinois before Judge Matthew F. Kennelly (In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545). The MDL was approved to streamline all of the litigations against testosterone product manufacturers to allow for common pre-trial procedures, with each plaintiff’s case remaining independent as opposed to the grouping of plaintiffs into one lawsuit as is the case in a class action. Creation of the MDL simplifies complex litigation of similar cases against a common defendant and gives plaintiffs a strong group bargaining position against large corporate defendants in order to obtain a favorable settlement for all plaintiffs.
Testosterone Replacement Therapy Bellwether Trials
A bellwether trial is a preliminary, or “test” trial ordered by the federal court overseeing an MDL. These trials test jury reaction to a case or cases selected as representative of the MDL plaintiff pool. The outcome of an MDL’s bellwether trials may encourage an appropriate group settlement of all cases consolidated under that MDL, as large plaintiff verdicts may prompt defendants to consider settlement instead of incurring the risk of additional legal fees, court costs and judgments.
Judge Kennelly recently asked plaintiffs and defendants to each select eight Androgel lawsuits involving a blood clot injury and another eight cases concerning heart attacks and cardiovascular injuries. Each of these lawsuits name AbbVie — the manufacturer of AndroGel — as the defendant. The first bellwether ended in a mistrial. The second ended with a $150 million jury verdict against AbbVie. Jury selection for the third trial started on September 18th, with three additional bellwethers scheduled.
What You Should Do If You Have, or a Family Member Has, Taken Testosterone Replacement Therapy Drugs, Medications or Treatments
Consult your doctor
If you or a family member have taken a testosterone replacement therapy drug, medication or treatment, whether or not you or your family member has suffered side effects or related conditions, you should schedule an appointment with your doctor to treat any side effects or injuries and prevent any potential complications.
Do not communicate with testosterone manufacturers or pharmaceutical companies
Please note that you or your family member who has taken a testosterone replacement therapy drug, medication or treatment should not:
- Provide any information to testosterone manufacturers or pharmaceutical companies, as it may be used against you or your family member in a future lawsuit
- Accept any compensation or sign any waivers or releases offered by testosterone manufacturers or pharmaceutical companies, as you or your family member may be prevented from filing a lawsuit for damages suffered from a testosterone replacement therapy drug, medication or treatment other product in the future
Though testosterone manufacturers or pharmaceutical companies may offer the prospect of fast recovery of compensation through a claims process, your best chance to recover money for damages is through participation in the existing multidistrict litigation (MDL). Manufacturers’ reimbursement claims processes may limit compensation and not cover future medical treatments, disability, pain and suffering, lost wages, loss of consortium or future medical expenses.
Be aware of the statute of limitations
The statute of limitations related to all product liability cases affects the time within which you may file a lawsuit for damages suffered from testosterone replacement therapy drugs, medications or treatments. Therefore, it is important that a lawsuit for injuries suffered from any testosterone replacement therapy drug, medication or treatment be started as soon as possible to avoid your lawsuit being rejected by the court because it is filed later than the law allows.