Men who regularly use Androgel and other testosterone-lowering treatments may be at risk of suffering a testosterone heart attack or other similar heart problems, according to new warnings by federal health officials. Many men have thus filed testosterone heart lawsuits seeking compensation for possible heart attacks, strokes and similar cardiovascular complications supposedly caused by the use of testosterone therapy. The FDA has warned that the use of testosterone drugs could result in increased blood pressure and increased risk of heart disease. The warnings are the latest in a string of studies highlighting the potentially fatal effects of high levels of testosterone in men.
There have been a number of lawsuits involving low-to drugs since at least the late 1980s. These lawsuits, however, are becoming more common now that the FDA has begun publicly acknowledging the adverse health effects of testosterone. Testosterone is commonly used to treat a number of conditions, including low sperm count in men and male pattern baldness. In the past, plaintiffs filing testosterone heart lawsuits had little legal recourse because the Food and Drug Administration refused to allow the manufacturers of testosterone drugs to include warning labels on the drugs about the dangers of excessive usage. Now, some plaintiffs are filing lawsuits with the help of an attorney who is representing them in a personal injury lawsuit.
According to the FDA, the main reason the agency has cited testosterone heart attack lawsuit plaintiffs for using unapproved drugs is the fact that they frequently used the drugs despite knowledge of their negative side effects. Even so, the FDA did not include these as among the approved drugs to treat low testosterone levels in men. Plaintiffs usually cite the false marketing of the drug as a primary reason for their lawsuit. The false marketing refers to the company’s efforts to convince consumers that using the drugs will stimulate bone growth and lead to increased muscle mass. However, studies have shown that there is no scientific evidence linking testosterone therapy to increased muscle mass. Other studies have shown that there is no increase in the amount of muscle mass among body builders who have taken testosterone.
While these androgel lawsuits are new, the lawsuit history makes clear that the FDA did not take the side effects of testosterone therapy into consideration. The FDA did not issue safety warnings about the risks of the drugs to men like cardiovascular disease, sleep apnea and osteoporosis. The court found that the manufacturer of binaural beats was aware of the risk of these side effects in the context of the treatment for sleep apnea. Despite this, the manufacturer marketed its product as a safe solution to high blood pressure by including it in a variety of over-the-counter medications. The FDA did not require binaural beats manufacturers to include warnings about the potential dangerous side effects to women like breast cancer and infertility.
The plaintiffs’ lawyer, David deflecto, explains that these plaintiffs have suffered from various conditions such as congestive heart failure, persistent leg pain, shortness of breath, depression, anxiety, sexual dysfunction and cognitive impairment. He says that these are very serious side effects. The pending case is likely to be decided on the basis of these facts alone. The lawsuit seeks compensation for these patients from the manufacturer of the drug. If the defendant manufacturer is found to have negligently advertised the safety of the drug, or failed to warn the public about the serious side effects associated with binaural beats, then the manufacturer may be liable for punitive damages.
In recent years, the Food and Drug Administration has been sued by thousands of people who have been harmed by defective drugs. As the number of testosterone lawsuits continue to rise, the FDA may have to reconsider the regulations governing the sale of such prescription drugs. Prohibiting these lawsuits is one way that the FDA can protect itself from being forced to foot the bill for medical malpractice settlements that result from injuries caused by these drugs.