Lawsuits and FDA expert panel continue to question the safety of testosterone therapy

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by Eric Pearson

Evelyn Calvillo lost her husband to the use of the popular testosterone supplement AndroGel, according to the lawsuit she has filed. Calvillo alleges that the companies behind the testosterone supplement failed to adequately warn people like her husband about the potential for serious testosterone side effects. Calvillo is one of many plaintiffs alleging the drug companies failed to properly warn about the risk of strokes and heart attacks posed by testosterone therapy.

Calvillo’s suit was filed in a California state court against Abbott Laboratories Inc., the manufacturer of AndroGel, as well as AbbVie Inc. and McKesson Corp., a pharmaceutical distributor based in the California. AbbVie removed the case to federal court, arguing that the California defendant McKesson Corp. was not a proper defendant. AbbVie was also attempting to have the case transferred to the federal multi-district proceedings now pending in Illinois for testosterone therapy cases.

However, the federal court has rejected AbbVie’s argument and ordered the case be sent back to state court. Calvillo noted that products liability law in California holds distributors as well as manufacturers strictly liable for defective products. According to the federal court, AbbVie failed to provide any facts demonstrating that McKesson was not a proper party to the action. Accordingly, the case was remanded to California state court for trial rather than being transferred to the federal MDL in Illinois.

Calvillo’s suit is just one of hundreds of lawsuits that have been filed around the country regarding adverse effects of testosterone therapy. So far, more than 200 federal lawsuits filed on behalf of men or their survivors alleging heart attacks, blood clots, strokes and deaths as a result of using testosterone replacement therapy products have been consolidated for pre-trial purposes in the Northern Illinois federal court before U.S. District Judge Matthew F. Kennelly.

The FDA has announced an investigation into the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products based on the publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. The first publication was an observational study of older men in the U.S. Veteran Affairs health system published in JAMA in November 2013. (Vigen R, O’Donnell CI, Baron AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310(17):1829-1836). The men in the study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. The study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.

The second study referenced by the FDA was Finkle, William D., et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One 9.1 (2014): e85805. This study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy. This study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack

Most recently, an FDA expert panel voted overwhelmingly to have testosterone labels updated to include the fact that testosterone has not been proven as appropriate to treat conditions associated with aging and the natural dip in testosterone levels that result. The panel noted there was little evidence that testosterone replacement therapy effectively treats normally sagging levels of the hormone in aging males. The panel also expressed the need for increased caution in order to avoid needless testosterone side effects. Given the studies that have indicated the risk of heart problems, the panel also voted to require new clinical trials for safety for at least some types of testosterone therapy.

Heygood, Orr & Pearson and pharmaceutical claims

Despite the best efforts of the FDA and other health organizations, tens of thousands of patients are serious injured each year by dangerous drugs or medical devices. Sadly, many of these cases could have been prevented if the manufacturers of these goods had designed and developed their products to meet safety standards that are mandated by federal law. At Heygood, Orr & Pearson, we believe that when drugmakers fail to properly warn patients about risk of complications from prescription drugs and other pharmaceutical products, they should be held responsible for their negligent actions in a court of law.

We have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. From dangerous fentanyl pain patches to defective hip and knee implant devices to Yaz, Actos, Avandia and Accutane, we have made it a career priority to hold drug manufacturers accountable and responsible for their actions. Our law firm has represented patients and their loved ones in numerous lawsuits involving complications caused by prescription drugs and has secured verdicts and settlements for our clients totaling more than $200 million.

If you or a loved one was prescribed testosterone drugs or therapy and suffered a heart attack or stroke, you may be entitled to compensation. To receive a free consultation about your case and learn more about your legal rights, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out our free case evaluation form located on this website.