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Fortesta Lawsuit Filed Over Heart Attack from Testosterone Gel

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A Georgia man has filed a product liability lawsuit against the makers of Foresta gel, alleging that side effects of the testosterone replacement therapy (TRT) caused him to suffer a heart attack. 

The complaint was filed last week by Demetric Taylor in the Philadelphia Court of Common Pleas against Prostrakan, the manufacturers of Fortesta testosterone gel, claiming that the company failed to warn about an increased risk of heart attacks and other cardiovascular problems associated with use of the “low T” treatment.

The case is one of a growing number of testosterone gel heart attack lawsuits filed in recent months, which allege that manufacturers of Foresta, AndroGel, Testim, Axiron and other popular treatments have aggressively marketed treatments for “low testosterone”, while withholding important safety information from men and the medical community.

Over the past decade, sales of testosterone replacement drugs have increased more than five fold, growing to account for more than $2 billion a year in sales as a result of direct-to-consumer advertisements that many critics indicate has caused widespread overuse of the medications among men with no real medical need.

Foresta and other testosterone gels are designed to treat men with a diagnosed testosterone deficiency associated with a medical condition, such as hypogonadism, which was once considered a “niche” treatment. However, according to allegations raised by Taylor and a growing number of other men throughout the U.S., manufacturers have encouraged men to seek testosterone gel treatments if they are experiencing any number of vague symptoms, such as grumpiness, fatigue or lack of energy, which are often associated with the natural lowering of testosterone levels as all men age.

Testosterone Heart Concerns

A growing number of Foresta lawsuits, AndroGel lawsuits, Testim lawsuits and Axiron lawsuits have been filed this year, after concerns about the link between heart attacks and testosterone drugs surfaced.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) suggested that side effects of low T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by a study published in the medical journal PLOSOne in January 2014, which found that low T treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

In response to the findings, the FDA launched a safety review of all testosterone replacement therapy on January 31, leading to multiple media reports about the potential risk and lawyers advertising for potential claims.

In February 2014, the Endocrine Society also called for large-scale scientific studies to help doctors better understand the potential risk of heart attacks and other cardiovascular injuries that may be caused by testosterone treatments. The Society indicated that until evidence of the heart safety is confirmed, patients should be made aware of the potential risk of cardiovascular events and urged doctors to follow clinical practice guidelines to ensure appropriate prescribing of testosterone.

Testosterone Litigation

There are currently several hundred testosterone lawsuits filed throughout the U.S., with many expecting that thousands of cases will ultimately be brought on behalf of men who allegedly suffered a heart attack, stroke, blood clot or other injury after using the medications.

While most of the current cases involve the use of AndroGel, which accounts for about 60% of the market, other cases have been filed against manufacturers of other products, including other gels, creams, patches and injections.

In late March 2014, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to centralize all federal AndroGel cases in one court to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and courts.

Another group of plaintiffs filed a second motion several weeks later, seeking to consolidate all testosterone drug lawsuits as part of an industry-wide MDL, regardless of which specific medications were used in the case. The motion pointed out that many plaintiffs have used several different testosterone treatments, and all of the cases will involve common questions of fact and law.

The JPML meets on May 29 to hear oral arguments for and against consolidation of the testosterone litigation.

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