Articles Posted in Testosterone Replacement Therapy

Thousands of cases are pending against manufacturers of testosterone replacement therapy drugs, including GlaxoSmithKline and Auxilium. Lawsuits allege that manufacturers failed to warn the public and physicians of potentially life-threatening side effects, such as heart attacks and strokes, and that the drugs were marketed aggressively to target younger patients, for whom the drugs have little to no benefit. What are the Risks?

Dangerous side effects associated with testosterone replacement therapies, such as Androgel, Axiron, Testim, and Fortesta, include:

• heart attack;

Just about every pharmaceutical has some kind of negative side effect. The general rule of thumb is; don’t use a medication unless the benefits outweigh the risks. But what if you don’t know what the risks are?

A man who claimed that the manufacturer of a testosterone replacement drug was negligent in not informing him of associated risks, recently received a jury award of more than $3 million. According to the lawsuit, the plaintiff, Jesse Mitchell, used AndroGel for nearly five years until suffering a heart attack in 2012. Mitchell claims that the drug’s manufacturer, Abbvie, failed to provide adequate warnings about the risks linked to AndroGel. The lawsuit alleged strict liability, fraudulent misrepresentation and negligence. Although the jury did not agree with all of Mitchell’s claims, they did agree that Abbvie was negligent.

What is Strict Liability?

To win a case based on negligence, you have to be able to show that the defendant was at fault, whereas strict liability claims do not require proof of fault. Consider a dog bite, for example. In strict liability states, a dog’s owner is responsible for any injuries caused by the dog, whether or not the owner was negligent. If, for instance, the victim was bitten when he reached over a fence to pet the dog, the owner may still be liable because the dog is “unreasonably dangerous.”

Apparently, in the AndroGel case, the jury found that Abbvie acted negligently, but did not regard AndroGel as an unreasonably dangerous pharmaceutical. A Boston personal injury lawyer can help you determine how to proceed if you’ve been injured by a defective medication, dog bite, or in any type of accident.

A Second Chance

This was actually the second round of trials for Jesse Mitchell in his lawsuit against Abbvie. In the first trial, he was awarded $150 million by the jury, but the judge threw out the verdict, calling it “logically incompatible.” In this most recent trial, the jury awarded $200,000 in economic and non-economic damages and $3 million in punitive damages.

Other Harmful Drugs and Devices

It seems that every day there is another new prescription drug or medical device in the news for harming patients. Here are just a few of the dangerous drugs and devices that have made headlines in the past year:

• Xarelto: An anticoagulant (blood thinner) linked to excessive bleeding.
• Invokana: A medication for type 2 diabetes linked to multiple health problems, including a potentially-deadly condition called ketoacidosis.
• All-metal hip implants: Originally touted as more durable than their all-plastic counterparts, all-metal hip implants may rub together, releasing metal debris into the body.
• Transvaginal mesh: Intended to remedy pelvic organ prolapse or stress incontinence in women, transvaginal mesh devices have been associated with severe pain, organ perforation and other serious medical complications.

A MA drug injury lawyer can help you recover damages if you’ve been harmed by a defective or dangerous medication. Continue reading

Testosterone is a naturally occurring hormone produced in the human body.  This hormone is mainly produced in the testicles of men and is responsible for sperm production, a man’s sex drive, and building muscle and bone mass.  Testosterone production tends to naturally decrease as men age.  As a result, men can experience various symptoms if testosterone levels decrease below a normal range.  Low testosterone, also called low T or hypogonadism, can often be mistaken as a natural part of aging.  Typical symptoms include low sex drive, difficulty achieving erection, low semen volume, hair loss, fatigue and lack of energy, loss of muscle mass, increase in body fat, decrease in bone mass, and mood changes.  Common treatment for symptomatic low T is testosterone replacement therapy.  This treatment helps many men with clinically proven low levels of testosterone to feel “normal” again, i.e. normal sex drive, able to maintain erection, etc.  However, drug manufacturers have participated in aggressive direct-to-consumer advertising urging men to seek treatment for low testosterone when they likely do not need it.  In these cases, the risks of the treatment typically far outweigh the benefits.

Although testosterone replacement therapy has been shown to reduce the symptoms of low T, there have also been many reported side effects that can be life threatening.  Recently, studies have shown data that suggests some patients taking testosterone supplements delivered as a gel, patch, injection, implant or pill may face an increased risk of cardiovascular problems.   A November 2013 study in the Journal of the American Medical Association (JAMA) suggested that men with certain preexisting heart issues may be up to 29 percent more likely to die, suffer a heart attack or stroke while taking some form of testosterone supplements.   This is not the first study that has shown evidence linking increased cardiovascular risks and testosterone treatments.  In 2009, a study funded by the National Institute of Health examined 200 older men with a high incidence of heart disease.  The men who were also receiving testosterone therapy were found to have a significant spike in the rate of heart attacks.  Researchers decided to cancel the study early due to these findings.  A January 2014 study by PLoS One, a medical journal, found that men over the age of 65 and younger men with pre-existing heart disease might actually face a two-fold increase of risk of heart attacks associated with testosterone treatments.  Collectively, these studies prompted the FDA to issue a drug safety communication in March 2015 revealing that new warning labels will be added to low testosterone drugs regarding the possible increased risk of cardiovascular complications.  The warnings would also reiterate that the drugs should only be used to treat clinically proven hypogonadism.  Continue reading

Low testosterone therapy has been increasingly prescribed in recent years, resulting in billions of dollars of contributions to the pharmaceutical industry. This type of hormone treatment is typically used in men with low testosterone levels who suffer from decreased libido, low energy, lack of motivation, depression, and irritability. However, recent studies show that potentially dangerous consequences may arise as a result of low testosterone therapies, which include gels, patches, injections, and implants.

Over 2,000 lawsuits have been filed against numerous drug companies manufacturing “Low T,” including Auxilium and Endo Pharmaceuticals. The latest is a 2015 wrongful death suit filed in Illinois against the makers of AndroGel, AbbVie, Inc. The plaintiff claims that exposure to the gel triggered a heart attack that resulted in her husband’s death. She alleges that AbbVie is guilty of:

• Negligent design of a defective drug
• Not warning consumers of potential dangers
• Mis-representing the safety of the drug.

While courts await 2016 trials, anyone participating in or potentially injured by low testosterone therapies should be aware of the risks. Continue reading

In recent years, the effects of testosterone replacement therapy (TRT) have been widely debated. Since the early 2000’s, TRT has been used to treat men, generally over 40 years of age, who produce low levels of testosterone. It has become extremely popular as an all-encompassing antidote for symptoms including low energy and low libido. While TRT seems to be a cure-all that promotes bone-health and aids in diabetes prevention, skeptics are challenging its safety. A recent study reveals that TRT use may pose an increased risk for cardiovascular disease in men over 65 and younger men with a history of heart issues. In 2014, the Food and Drug Administration announced plans to reassess the risk factors and safety of testosterone treatments, including stroke and heart attack potential. If you or a loved one has been affected by testosterone replacement therapy, understanding the Continue reading

Testosterone replacement therapy has grown into a billion dollar industry and is only expected to continue to thrive in the coming years. As the prescriptions have come pouring in, so have the reports of severe side effects caused by the relatively new medication. While it has long been known that Low-T medications can be harmful to women and children, several more recent studies have shown significant signs that the treatment may be linked to increased risk of heart attack. Studies such as one published in renowned science journal PLoS One have shown compelling evidence that Low T medications such as Androgel may triple the risk of a heart attack in men under 65 within 90 days of starting treatment. Those who have suffered a heart attack while taking the medication are urged to consult a Massachusetts Personal Injury Attorney right away.

There have been so many cases that the FDA is now looking into the safety of Low-T treatment drugs. According to Bloomberg News, the “U.S. Food and Drug Administration said it will re-examine the safety of testosterone replacement drugs after two studies showed a higher risk of heart attacks and strokes in men who use them.” The National Cancer institute conducted a study of 65,000 patients in which both patients older and younger than 65 years of age were twice as likely to suffer a heart attack or other cardiac issues. “When the study compared these men to a separate group of patients taking Viagra and Cialis, the men on the erectile dysfunction drugs patients did not experience more heart attacks,” according to forthepeople.com Continue reading

A new study presented at the 2014 Genitourinary Cancers Symposium showed that testosterone therapies do not have any links to prostate cancer; an original concern for medical professionals.

According to an article sourced from the National Trial Lawyers, the study used information from several cancer registries to study the risk of prostate cancer in males using androgen-replacement drugs. Androgen replacement and other testosterone therapies are commonly used to remedy male hormonal issues-specifically for men who wish to build greater muscle mass, reduce body fat, and improve health and sex drive. The U.S. Food and Drug Administration has approved hormonal therapy as a beneficial treatment for patients suffering low t-levels as a result of coinciding medical issues, but has not approved testosterone therapy as safe for men without an existing medical condition. Testosterone replacement is typically administered in the form of prescription transdermal gels, creams, pellets, patches, and injections. Common testosterone therapy products include: Androgel, Andoderm, Axirom, Bio-T-Gel, Foretesa, and Testim.

But while many of these treatments are safe for use, there remain some serious risks. Hormone changes have the possibility of influencing certain tissues and organs, including the prostate, and therefore medical professionals had previously speculated that androgen and testosterone could increase the risk of developing prostate cancers. This study, though, found no link between androgen-replacement therapies and prostate cancer.
Continue reading

A recent study published in PLos One, the Public Library of Science Journal, is linking testosterone therapies to stroke, heart attack, and related deaths in older males. According to the findings, the heart attack risks went up significantly in men older than 65, as well as those under that age with a history of heart disease.

If you think that your heart condition, heart attack, or stroke may have been caused from testosterone therapy, please contact our Boston defective medications lawyers today. You may have reason to pursue a Massachusetts products liability case.

Funded by the National Cancer Institute and the Intramural Research Program, the study looked at approximately 56,000 middle-aged and older men who took testosterone therapies for over 90 day. UCLA Fielding School of Public Health Professor Sander Greenland, who specializes in epidemiology, led the study. He and his team, which included experts from Consolidated Research Inc. and the National Cancer Institute, found that not only did heart attack rates more than double in males over 65 that took a testosterone prescription but the risk more than tripled in men who were 75 or older.