Testosterone therapy treatment
Over 1,300 men have filed testosterone therapy lawsuits against manufacturers of drugs like AndroGel, Testim, and Depo-Axiron. Plaintiffs claim they took the drugs and then suffered from serious side effects like heart attack and stroke—side effects they say the manufacturers failed to provide adequate warnings about.
These plaintiffs have evidence to back up their claims. A number of studies have indicated that when men take testosterone replacement products, they increase their risk of cardiovascular problems. Because of the scientific evidence, the FDA issued a safety communication in January 2014, indicating that they were investigating the risks. They advised patients and doctors to report any side effects involving these drugs to the FDA’s MedWatch program.
The Pittsburgh testosterone attorneys at Chaffin Luhana are currently representing men who have taken these drugs and then suffered serious side effects. If you live in the Ohio Valley area and have had your life turned upside down because of testosterone therapy drugs, contact us today for a free initial consultation.
Testosterone Approved Only for the Treatment of Hypogonadism
The FDA approved testosterone replacement drugs strictly for the treatment of “hypogonadism,” which is a medical condition. Men with hypogonadism do not produce enough of the male hormone testosterone because of a problem with the pituitary gland or the testicles that leaves the body unable to produce normal amounts.
Hypogonadism is diagnosed by a doctor via a series of blood tests that measure levels of testosterone. Doctors typically conduct several tests as the amount of the hormone in a man’s body can fluctuate during the day.
Recent studies, however, have discovered that many men are taking testosterone when they haven’t been diagnosed with hypogonadism. A 2014 study published in the Journal of Clinical Endocrinology & Metabolism, for example, reported that 40.2 percent of U.S. men did not have a testosterone test in the 180 days before beginning therapy, and 50 percent had only one test.
Researchers concluded that “high rates of inadequate laboratory testing” was found prior to initiating therapy in both U.S and U.K. men.
Plaintiffs who have filed testosterone lawsuits against drug manufacturers claim that these manufacturers engaged in an aggressive marketing campaign to convince men that they needed testosterone for typical symptoms of aging like reduced muscle mass, fatigue, and low sex drive.
Typical testosterone replacement advertisements advised men to talk to their doctor about supposed “symptoms” of low testosterone, which were said to include listlessness, increased body fat, and moodiness—all symptoms that are more likely to be caused by aging and lifestyle rather than low testosterone.
Doctors expressed their concerns in a New York Times article. “The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” Dr. Joel Finkelstein, associate professor at Harvard Medical School, told the Times. “The problem is that no one has proved it works and we don’t know the risks.”
Studies Indicate Testosterone Heart Attack Risk
A couple of concerning studies published in 2013 and 2014 raised concerns about the risks associated with testosterone replacement therapy. The first appeared in the scientific journal JAMA. Researchers looked at data from over 1,200 men who started taking testosterone therapy after undergoing a coronary angiography. They found that these men were at a significant increased risk of heart attack and stroke. They were so concerned, in fact, that they stopped the study prematurely.
The second appeared in the scientific journal PloS One. Researchers examined data from a large health-care database, zeroing in on men who started testosterone therapy and then suffered a heart attack within 90 days. They compared these results with the rate of heart attacks in men one year prior to the initial prescription.
They found that in men 65 and older, the use of testosterone therapy doubled the risk of heart attack. In younger men with a family history of heart disease, it increased by three times the risk of suffering from a heart attack.
These two studies raised red flags in the medical industry. On January 31, 2014, the FDA released a public safety communication alerting patients and doctors to the potential risks. They announced that they were investigating the potential link between these drugs and adverse cardiovascular events, and they asked doctors and patients to report any side effects to the FDA’s MedWatch program.
In March 2015, the FDA released a follow-up communication noting that testosterone product labels had been updated. The revised labels include a warning about a “possible increased risk of heart attacks and strokes in patients taking testosterone.”
Plaintiffs who have filed testosterone therapy lawsuits claim that the manufacturers had a responsibility to include such warnings on the product labels long ago.
Types of Testosterone Therapy Side Effects
Men taking testosterone replacement drugs may be at risk for the following serious side effects:
• Heart attack
• Transient ischemic attacks (mini-strokes)
• Blood clots
• Pulmonary embolism
• Congestive heart failure
In addition to these serious effects, most testosterone drugs also carry a risk of transfer to women and children. Skin-to-skin contact can result in the following symptoms:
• Increased acne and body hair in women
• Enlarged genitals
• Early development of pubic hair in children
• Increased libido
• Increased erections
• Bone problems in children
Products that may lead to these side effects include:
• Androderm-Watson Labs
• Android 10-Valeant Pharm Intl
• Android 25-Valeant Pharm Intl
• Axiron-Eli Lilly and Co.
• Delatestryl-Endo Pharms
• Depo-Testosterone-Pharmacia and Upjohn Inc.
• Fortesta-Endo Pharms
• Striant-Actient Pharms
• Testopel-Actient Pharms
• Testosterone Cypionate-Watson Labs, Paddock LLC
• Testosterone Enanthate-Watson Labs, Paddock LLC
• Testred-Valeant Pharm Intl
Testosterone Therapy Lawsuits
After the FDA issued its 2014 safety communication, more men became aware of the potential drug–heart attack link. In February 2014, watchdog group Public Citizen sent a letter to the FDA petitioning them to add a “black-box” warning to all testosterone-containing drugs to alert doctors and patients to the increased risks of cardiovascular dangers.
“[T]he rapidly accumulating evidence from both randomized, placebo controlled trials and from observational studies,” the group wrote, “make it clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”
Men who had taken these drugs and then suffered from these serious effects began to put two-and-two together. Over the past few years, the number of testosterone lawsuits filed in state courts began to climb. Then, in June 2014, in response to the growing litigation, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all federal testosterone lawsuits be consolidated into one court in the Northern District of Illinois.
Consolidation makes it more convenient for all parties to engage in pre-trial proceedings. The testosterone MDL will make things like discovery and coordination more efficient, and will also reduce the risk of conflicting rulings. The goal is to prepare a representative sample of cases to go to trial. These initial “bellwether trials” are conducted to gauge the potential response of juries to the evidence. In many cases, they can facilitate future settlements and speed up the resolution of a large number of lawsuits.
A Pittsburgh Testosterone Lawyer Can Help
If you or a loved one suffered a heart attack, stroke, blood clot, or other related serious event after taking testosterone therapy drugs, the Pittsburgh attorneys at Chaffin Luhana LLP may be able to help. We understand that manufacturers like AbbVie, Endo, and others are responsible for making sure their products are safe before releasing them on the market. A lack of proper warning labels on the drugs puts many patients at risk, and companies should be held liable for such failures.
Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio, and will give you an initial consultation for free. Contact us today.