If you’ve been harmed by a prescription drug that was given to you for off-label use – in other words, for a reason that hasn’t been cleared or approved by the FDA – the parties involved in getting the medication into your hands may be liable for damages. From the pharmaceutical company and its sales reps to the physician to the pharmacy, these professionals have an obligation to ensure that medications are only distributed for intended use. Similarly, if you were given a prescription for an approved use but were not warned of risks and side effects, the parties who failed to warn you may also owe you compensation for any damages you suffered.
Unfortunately, marketing prescription drugs for off-label use is not an unusual occurrence, and with the prevalence of television commercials and other advertisements, consumers are saturated with messaging that stands to put them at risk. Pharmaceutical companies that manufacture medications for testosterone therapy claim that the drugs treat erectile dysfunction, increase sperm count, increase libido, and even enhance sexual ability, although these uses have not been approved by the FDA.
Testosterone is a male hormone that is produced in the testicles and regulated in the brain. Testosterone is responsible for facial hair, muscle mass, sperm production, and other male sexual characteristics. Testosterone naturally decreases by 0.5-1% per year after a man reaches the age of 40.
Men who suffer from low testosterone may benefit from testosterone replacement therapy, although there are significant cardiovascular and other risks associated with the drugs. But many men seek testosterone therapy for symptoms that are common to aging, rather than for actual disease, and experience severe side effects as a result. Doctors have been cautioning against the use of these dangerous drugs as a means to regain youthful energy and sex drive, but to little avail, as the advertisements promise a seeming fountain of male sexual youth.
Thanks to the blitz of commercials and advertising by manufacturers of the drugs used in testosterone therapy, men are self-diagnosing low testosterone based on vague and common symptoms, such as decreased energy and sex drive. Believing that they have a condition that requires testosterone therapy, they seek out drugs such as AndroGel, Fortesta, Androderm, Testim, Axiron, Testopel, Delatestryl, and Striant to correct these symptoms. In actuality, many of these men are not actually suffering from a disease that indicates the need for testosterone therapy and are placing themselves at significant risk of potentially fatal side effects because pharmaceutical marketers have convinced them that these drugs are the solution to their troubles.
The message being delivered is that that if you are a man who is tired, bored, stressed out, and have a low libido, etc. – a vague list of symptoms which are common among middle-aged and older men – then you probably have Low-T and would benefit from their drug offerings.
The FDA has approved these medications to treat specific diseases related to low testosterone, but using them to treat symptoms of age-related decreasing testosterone levels constitutes off-label use. The FDA has focused more attention on the misuse of these prescriptions due to recent studies and evidence pointing to an increased risk of serious cardiovascular risks, including heart attack and stroke, as well as prostate cancer, deep vein thrombosis, blood clots, and death.
In addition to the risks noted above, the following side effects may also be caused by Low-T therapy: hypertension; leg pain, swelling, and redness; decreased sperm count; gynecomastia; sleep apnea; acne; high cholesterol; high red blood cell count; and abnormal erections.
A study published by the New England Journal of Medicine in 2010 also found that these adverse side effects occurred twice as often in men over the age of 65, and cardiovascular events were also significantly more frequent in that age group. A different study in men over 65 had to be discontinued altogether because the participants suffered too many serious side effects. Yet another study reported a two-fold increase in heart attack risk in the first 90 days of use among men over 65, as well as a two- to three-fold risk factor for men under 65 with a history of heart disease.
In 2014, five men between the ages of 50-63 sued Abbott Laboratories and AbbVie, Inc. for injuries sustained due to the use of AndroGel. Three of the men suffered heart attacks, and two suffered strokes. According to the complaints, the companies “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs, “while downplaying known adverse and serious health risks,” Bloomberg reported.
Despite the fact that several studies have shown that men who use testosterone replacement therapy increase their risk of these potentially deadly side effects, only half of men on the therapy actually have hypogonadism, and nearly 25% were never tested before receiving a prescription.
Also at risk of damage from testosterone medications are women and children who may have secondary exposure by contact with male patients who are using the drugs. Merely coming into contact with the product at an unwashed application site or unwashed clothing of someone who is using the drug can cause pronounced sexual changes, such as enlarged genitalia, early development of pubic hair in children, increased erections and libido, aggressive behaviour, advanced bone age, and increased acne and body hair in women. The application sites must be covered with clothing to protect others from accidental exposure, and application sites must be washed before skin-to-skin contact.
If you or your loved one have undergone testosterone replacement therapy and suffered side effects and you were not warned of these severe side effects prior to use, we will review your case at no cost to determine if you or your loved one may be eligible for compensation for injuries, medical bills, lost income, pain, and suffering. Many who have suffered severe side effects from these drugs are coming forward to seek justice and appropriate compensation.
To arrange a free evaluation of your case and explore your legal options, call Macaluso & Fafinski today at 718.364.4000 (in the Bronx) or212.480.9000 (from elsewhere in New York), or simply fill out our convenient online form, and we will respond as soon as possible. The offices of Macaluso & Fafinski are conveniently located to serve the five-borough area and its residents.