Testosterone Litigation Is Moving Forward

Plaintiffs who have filed testosterone product lawsuits as part of the multidistrict litigation (MDL) in an Illinois federal court have now surpassed 2,700. These lawsuits in the MDL claim that testosterone replacement therapy made by companies such as AbbVie are mass-produced and sold that led men taking them to suffer serious and fatal health problems including stroke, heart attack, and death. Recently, U.S. District Judge Matthew Kennelly, who is overseeing the federal AndroGel litigation, has allotted a case management order authorizing that AbbVie produce documents on safety information and clinical trials regarding AndroGel. He also updated the process for plaintiffs to request a waiver of service for newly filed complaints.

AndroGel Bellwether Trials 

In 2014 and 2015, the testosterone litigation increased rapidly from only a dozen AndroGel complaints filed throughout the federal and state court systems to several thousand cases concerning many different low-t drugs. By far, most of the lawsuits filed have been brought against AbbVie, the creators of AndroGel, which is the most broadly used and heavily marketed testosterone replacement therapy [1].

Testosterone product companies gross billions of dollars annually, and it is estimated that over two million men use low-t products each year. These products essentially are used as a replacement therapy in men with specific hypogonadal conditions associated with deficient or absent testosterone. The absence of testosterone is due to specific disease conditions such as Klinefelter’s disease, pituitary injury, etc. However, data has shown that the products are marketed for middle-aged to elderly men with “low-t”. Current product labeling does not include “age-related hypogonadism” or “aging”; on the other hand, current labeling may unintentionally imply such use by including: “idiopathic gonadotropic or LHRH deficiency”. This is a physiologic condition that occurs in older men and is usually sustained from a pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low-t serum concentrations, but have gonadotropins in the normal or low range.

Current drug development is not capable of providing data that would support use for “age-related hypogonadism” and is not meant to support it. The two main obstacles in indicating such use in labeling is the fact that it is unclear whether signs and symptoms in aging men purported to reflect hypogonadism (e.g., fatigue, diminished sexual desire, muscular weakness) are a direct result of “low-t” as well as the fact that the clinical benefit and safety of testosterone replacement for “age-related hypogonadism” has not been demonstrated by substantial evidence from adequate and well-controlled clinical studies [2].

Regardless of their popularity, however, testosterone therapy products have been shown to pose substantial health risks to those who use them and several studies have linked low-t therapy to heightened risk of cardiovascular problems.

  • An article published in November 2013 for JAMA by a grouping of doctors tested the association of testosterone therapy with mortality, myocardial infarction (heart attack), and stoke in men with low testosterone levels. With the rate of testosterone therapy increasing and the effects of said therapy on cardiovascular outcomes and mortality are in its infant phases, it’s dangerous to take dosages without knowing the side effects. In this clinical trial that tested the association between testosterone therapy (TRT) and all-cause mortality, myocardial infarction (MI), or stroke among male veterans who underwent coronary angiography and had a low serum testosterone level, the use of TRT was associated with increased risk of adverse outcomes. These findings may inform the discussion about the potential risks of testosterone therapy [3].
  • An additional study published by a group of researchers tested the risk of non-fatal myocardial infarction following testosterone therapy prescription in men. They concluded that among men 65+, there was a two-fold increased risk in the possibility of MI in the 90 days after filing an initial testosterone therapy (TT) prescription. The pattern of risk is determined by the supply of testosterone due to the effect of the drug. Among the older men, the two-fold increased risk was associated TT prescription regardless of cardiovascular disease history. More relevant perhaps is the rapid increase with age in the prevalence of diagnosed and undiagnosed coronary artery disease reported from autopsy studies, both overall and among accidental victims, so that advanced age may be a more sensitive indicator of coronary disease prevalence than prior diagnoses. Overall, their findings appear consistent with a higher frequency of thrombotic events following TT prescription among men with more extensive coronary vascular disease. The evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular-related events–including non-fatal myocardial infarction–in men [4].

Testosterone Lawsuits

The defendants in these cases currently include Abbott, AbbVie, Auxilium Pharmaceuticals, Pfizer, and Pharmacia & Upjohn. The panel for the MDL issued an order that stated: “All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedents) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions will share factual questions regarding general causation and the background science regarding the role of testosterone in the aging body as well as involve common regulatory issues in light of the FDA’s recent actions.”

There are already concerns about the risks that TT therapies pose for older men. According to a report from Washington Times, Boston University School of Medicine researchers stopped a study of testosterone therapy use in older men in 2010. Compared with subjects taking a placebo, men taking the TT drugs were five times as likely to experience severe heart problems such as congestive heart failure.

Some critics are concerned that there is no proof that the drugs benefit healthy men. In particular, some doctors feel there should be more agreement about what constitutes a normal testosterone level. Since testosterone therapies are not proven treatments, they caution that risks may outweigh benefits for healthy men. Continually, in June 2013, Dr. Adriane Fugh-Berman of Georgetown University Medical Center told USA Today that TT “offers no proven benefits for healthy men. Low-Tt syndrome is invented by pharmaceutical companies to sell treatment products.” [5]

Dolman Law Group

Testosterone replacement therapy is anticipated to benefit the regulation of hormone levels in men with medically low testosterone. The U.S. Food and Drug Administration has stated that testosterone products should not be used in men who are experiencing reduced testosterone due to aging. However, many men who have filed testosterone therapy lawsuits claim that products like AndroGel and Testim were purposefully marketed toward aging men. Additionally, testosterone lawsuits allege that manufacturers failed to effectively test their products’ safety, and in some cases concealed or downplayed the cardiovascular risks of testosterone therapy.

Although the FDA and pharmaceutical giants are trying to make up for lost time, that doesn’t mean the damage that’s already occurred can be swept under the rug when the market for TRT drugs are at an all-time high.

Contact the Litigation Team at Dolman Law Group for help with TT products

If you or anyone you know is suffering from cardiac issues after using testosterone replacement therapy products, please call the attorneys at Dolman Law Group whom thoroughly know about the defective drugs and deceptive marketing tactics of big pharma manufacturers. Call (727) 853-6275 today.

Dolman Law Group
5435 Main Street
New Port Richey, FL 34652
(727) 853-6275

https://www.dolmanlaw.com/legal-services/defective-medication-attorneys/

References:

[1] http://topclassactions.com/lawsuit-settlements/lawsuit-news/228226-testosterone-litigation-proceeds-as-low-t-drug-lawsuits-increase/
[2]http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/reproductivehealthdrugsadvisorycommittee/ucm416461.pdf
[3] http://www.ncbi.nlm.nih.gov/pubmed/24193080
[4] http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805
[5] http://www.drugwatch.com/testosterone/lawsuit/

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