Testosterone Therapy Lawsuit - Heart attack, stroke and death Attorney

Testosterone Replacement Therapy

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Testosterone treatments may be linked to an increased risk of heart attack, stroke and death. If you or a loved one used a non-generic testosterone replacement treatment and suffered from one of these injuries, you should seek legal counsel immediately.

Many men who experience fatigue, decreased sexual virility and other signs of aging turn to testosterone replacement treatments like Testim and AndroGel to help reverse the natural decline of testosterone, thereby improving sex drive, building muscle mass and increasing bone density. However, mounting research has identified an increased risk of life-threatening side effects, like heart attack and stroke, among older men with pre-existing heart conditions receiving testosterone therapy, and even among young men with no prior heart problems. If you have undergone testosterone replacement therapy, and you have since suffered a potentially fatal side effect, like heart attack or stroke, consult an experienced attorney today to discuss your legal options. You may have grounds to file a testosterone therapy lawsuit against the drug manufacturing company, in order to pursue financial compensation for your losses.

TRT Alternatives for Low Testosterone Levels

The amount of testosterone naturally produced by the male body begins to decrease around the age of 40, and many older men struggle at this point with health issues like osteoporosis, psychological symptoms, and a loss of muscle mass and coordination. Some of these men turn to testosterone therapy to improve their sex drive and treat erectile dysfunction, and once hormone replacement therapy is initiated, the patient usually undergoes lifelong treatment. However, in light of the risk of potentially life-threatening side effects that have been linked to popular low-T drugs, many older men are looking for safer alternatives to hormone replacement therapy to treat low testosterone levels, including the following natural testosterone boosters:

  • Getting a good night’s sleep
  • Losing excess weight
  • Getting enough zinc
  • Reducing sugar intake
  • Getting plenty of exercise
  • Ensuring you are getting the right nutrients
  • Reducing stress levels

What are Testosterone Treatments?

Testosterone therapy, also called low-T treatment or testosterone replacement therapy (TRT), is a type of medical treatment typically prescribed to men diagnosed with a condition known as male hypogonadism, or low testosterone levels due to the underproduction of sperm or testosterone, or both, by the testes. Testosterone products come in different forms, including pills, gels, topical creams, skin patches and injections, and while most low-T treatments are available only with a prescription, some are sold over-the-counter at drug stores and health food stores, and a few of the medications claim to be all-natural.

There are two types of testosterone replacement therapy: bioidentical hormones and synthetic hormones. AndroGel and a number of other low-T products contain bioidentical hormones, which mean they match the hormones naturally found in the body, while synthetic hormones are altered from their original chemical makeup, and do not match the hormones made by the body. Among the most popular treatments for low testosterone levels are the following:

  • AndroGel (topical gel) – AbbVie Inc.
  • Androderm (skin patch) – Actavis
  • Axiron (underarm liquid/cream) – Lilly USA
  • Aveed (intramuscular injection) – Endo Pharmaceuticals
  • Bio-T-Gel (topical gel) – Teva Pharmaceuticals
  • Delatestryl (injection) – Endo Pharmaceuticals
  • Depo-Testosterone (injection) – Unigen Life Sciences
  • Fortesta (topical gel) – Endo Pharmaceuticals
  • Natesto (nasal spray) – Trimel Pharmaceuticals
  • Striant (tablet absorbed through gums) – Auxilium Pharmaceuticals
  • Testim (topical gel) – Auxilium Pharmaceuticals
  • Testopel (subcutaneous pellet) – Auxilium Pharmaceuticals
  • Vogelxo (topical gel) – Upsher-Smith Laboratories

Although low-T drugs like AndroGel, Axiron and Testim have only been approved by the FDA for the treatment of hypogonadism, many healthy men are prescribed the medications “off-label,” to reverse signs of the natural aging process, such as fatigue, decreased sex drive, loss of muscle mass and erectile dysfunction problems. Despite the fact that the products have never been approved for these uses, their manufacturing companies continue to market low-T drugs as “miracle” products that can improve a man’s strength, vitality and sex drive.

Possible Side Effects Leading to a TRT Side Effect Lawsuit

Although testosterone replacement therapy has been shown to successfully address low testosterone levels in men with hypogonadism, a growing body of research indicates that the medications may also contribute to serious medical consequences. A growing number of studies have linked testosterone replacement therapy to an increased risk of the following side effects:

  • Heart attack
  • Blood clots
  • Pulmonary embolism
  • Stroke
  • Venous thromboembolism
  • Irregular heartbeat
  • Decreased sperm production
  • Lifetime commitment to low-T products
  • Prostate cancer
  • Deep vein thrombosis
  • Death

This risk of potentially fatal side effects is particularly alarming, considering the high percentage of men who use low-T drugs like AndroGel and Testim off-label to simply combat the natural signs of aging, without an actual medical need.

Link Between Testosterone Therapy and Side Effects

Testosterone therapy has become increasingly popular in recent years, as more and more men seek medical help for low testosterone levels, and medications like AndroGel, Testim and Androderm brought in more than $1.9 billion in sales in 2012 alone. Unfortunately, a number of recent studies have identified an increased risk of serious side effects among men undergoing testosterone replacement therapy, including heart attacks, strokes and death.

According to one important study, published in the Journal of the American Medical Association, prescription testosterone medications were associated with an increased risk of heart attack, stroke and death for older men with certain pre-existing heart problems. In the second study, published in the journal PLOSOne, researchers found a two-times increased risk of heart attack for younger men with heart disease, and for men over the age of 65 with no prior heart conditions.

It was after reviewing the findings of these two testosterone treatment studies that the U.S. Food and Drug Administration (FDA) finally issued a warning about the alleged risk of side effects linked to testosterone replacement therapy, and announced its decision to investigate these potentially dangerous treatments. The agency announced in January 2014 that it would “continue to evaluate the information from these studies and other available data,” in order to determine whether regulatory action is necessary.

Lawsuits Against TRT for Heart Attack, Stroke, Death and Other Side Effects

February 2014 – Five men between the ages of 50 and 63 sue Abbott Laboratories and AbbVie, alleging injuries caused by the companies’ AndroGel low-T product. According to the claim, three of the men suffered heart attacks and two suffered strokes.
March 2014 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) receives a motion to consolidate all federal testosterone lawsuits in federal court in Illinois.
March 2014 – A man who suffered a stroke after using the testosterone gel AndroGel files a lawsuit against the manufacturing company in the U.S. District Court for the Northern District of Illinois.
March 2014 – The makers of the low-T gel Testim face a lawsuit filed on behalf of a man who suffered a stroke after using the testosterone product.
May 2014 – One of the first lawsuits involving the testosterone product Fortesta is filed in Pennsylvania against Endo Pharmaceuticals and Prostrakan Group PLC.
June 2014 – The JPML consolidates all low-T therapy lawsuits filed in federal courts across the country in the U.S. District Court for the Northern District of Illinois, before Judge Matthew F. Kennelly.
June 2014 – A man from Texas files a product liability lawsuit against AbbVie, alleging that the company’s AndroGel testosterone gel caused him to suffer a heart attack.
July 2014 – Attorneys in Canada file two class action lawsuits against the makers of Delatestryl testosterone injection and AndroGel testosterone gel.
August 2014 – A testosterone replacement therapy lawsuit has been filed on behalf of a California man who used Depo-Testosterone and suffered major cardiovascular problems.
October 2014 – A man who used Axiron and subsequently suffered a heart attack files a TRT lawsuit against Eli Lilly & Co.
May 2015 – A man from New York files a testosterone therapy lawsuit after developing blood clots in his legs that were allegedly linked to the injection Depo-Testosterone.

FDA, TRT and Adverse Medical Complications

January 2014 – The FDA issues a safety announcement indicating that it is “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” The agency also warns that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”

February 2014 – The consumer advocacy group Public Citizen urges federal regulators to add a black box warning to the labels of testosterone products, warning about the risk of cardiovascular side effects.

April 2014 – The European Medicines Agency launches a review of testosterone replacement therapy, demanding marketing information from the manufacturing companies.

June 2014 – The FDA issues a safety communication requiring the makers of testosterone products to include warnings on their drug labels about the risk of blood clots in the veins, known as venous thromboembolism.

July 2014 – Health Canada warns about a “growing body of evidence” tying testosterone products to heart problems, including heart attack, stroke, blood clots in the legs or lungs, and an irregular heart rhythm.

September 2014 – An FDA report published ahead of an advisory panel meeting indicates that there is little evidence of any benefit from TRT in aging men, and that the safety risks are unclear.

September 2014 – An FDA panel votes in favor of restricting the labels of testosterone products, indicating that the drugs are only intended for patients diagnosed with hypogonadism.

April 2015 – A safety communication released by the FDA asks the makers of testosterone treatments to stop marketing the products for age-related “Low T,” begin studying the long-term risks of the products, and add warnings to the labels about the risk of heart attacks and strokes.

Testosterone Replacement Therapy Studies

August 2005 – The Journal of Urology publishes research suggesting that men undergoing testosterone treatment may be at risk of developing prostate cancer within months to a few years after beginning TRT therapy.

June 2010 – A study published in the New England Journal of Medicine indicates that older men with limitations in mobility and a high prevalence of chronic disease are more likely to suffer heart attacks and other major cardiac events from testosterone treatment. During the study, one man died from what researchers say was likely a heart attack brought on by testosterone use.

April 2013 – The journal Clinical and Applied Thrombosis/Hemostasis publishes a study indicating that blood clots may develop as soon as one month after beginning testosterone replacement therapy.

April 2013 – A study published in the journal BioMed Central suggests that low-T treatments increase the risk of cardiovascular-related events in users.

June 2013 – A study published in JAMA Internal Medicine indicates that, between 2001 and 2011, the use of low-T treatments among men ages 40 and older increased more than three-fold. According to the researchers, by 2011, nearly one in 25 men in their 60s, and nearly one in 40 men in their 40s, were taking some form of hormone replacement therapy.

June 2013 – Dr. Adriane Fugh-Berman of Georgetown University Medical Center tells USA Today that testosterone replacement therapy “offers no proven benefits for healthy men,” adding that “Low T syndrome is invented by pharmaceutical companies to sell treatment products.”

November 2013 – The Journal of the American Medical Association publishes a study indicating that men aged 60 and older using low-T drugs may have a 30% increased risk of stroke, heart attack and death.

November 2013 – Addressing the practice of drug companies marketing hormone replacement therapies for off-label uses, Dr. Lisa Schwartz, professor at the Dartmouth Institute for Health Policy and Clinical Practice, tells the New York Times, “We’re giving people hormones that we don’t know they need for a disease that we don’t know they have, and we don’t know if it’ll help them or harm them.”

January 2014 – Research conducted by UCLA and the National Cancer Institute, and published in the medical journal PLoS One, finds that men over the age of 65, and younger men with pre-existing heart disease, have a two-times increased risk of suffering a heart attack after the first 90 days of TRT.

April 2014 – A professor at the University of Washington Harborview Medical Center publishes an editorial in The Lancet Diabetes & Endocrinology, calling for new clinical trials studying the safety and effectiveness of testosterone therapy.

October 2014 – A study led by Professor Maarten Bosland from the University of Chicago’s College of Medicine indicates that rats exposed to a carcinogen did not develop cancer, while 10-18% of rats exposed to testosterone did.

January 2015 – The journal Pharmacotherapy publishes a study linking first-time use of testosterone products to a 41% greater risk of heart attack, compared to non-users, and higher risks for men with coronary artery disease.

May 2015 – A study published in the Journal of the American Medical Association suggests that testosterone injections, like Depo-Testosterone, may increase a man’s risk of suffering stroke, heart attack or death, compared to topical gels like AndroGel, which are absorbed slowly through the skin.

August 2015 – The Journal of the American Medical Association publishes research indicating that testosterone therapy does not appear to improve sexual health or overall quality of life.

Why We Think Manufacturing Companies Should Be Held Liable for TRT Side Effects

Since 2000, more than one million men have had their testosterone levels tested, and half a million began using testosterone replacement therapy. Today, four times as many men are using low-T medications than in 2000, and this has raised red flags about the possible risks of off-label testosterone treatment. At the same time, while side effects of testosterone replacement therapy are more frequently noted in patients over the age of 65, more and more cases are arising in which young men are suffering severe complications after undergoing TRT. In light of these findings, a growing number of product liability lawsuits are being brought against the makers of testosterone products, alleging that:

  • The manufacturing companies designed and sold defective medications
  • The makers of low-T treatments failed to properly research the long-term risks of testosterone treatments
  • Testosterone treatments have been misrepresented as safe and effective, despite causing serious and potentially life-threatening side effects
  • The makers of low-T drugs used aggressive marketing and advertising techniques to convince men to discuss testosterone replacement therapy with their doctors
  • The manufacturing companies failed to provide consumers and doctors with adequate warnings about the potential for low-T drugs to cause heart attacks, strokes, death and other major side effects in users
  • The makers of low-T products marketed the treatments for off-label uses not approved by the FDA

What should you do? If you have suffered heart attack, stroke or another side effect, you should contact a lawyer as soon as possible to discuss filing a testosterone therapy lawsuit.

More than five million prescriptions have been written in the United States for testosterone treatments, and, as more men become aware of the potential health risks associated with testosterone therapy, victims are holding the manufacturers of these prescription drugs accountable for their products. If you or a loved one has been adversely affected by side effects of testosterone replacement therapy, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a reputable lawyer who has experience handling testosterone treatment lawsuits. With a qualified attorney on your side, you can protect your legal rights and seek fair and timely reimbursement for your injuries, medical expenses, and pain and suffering.

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