androgel lawsuit

“Low T” Lawsuits Have New Order Ruling by Federal Court Addressing State Court Coordination

heart-attack.On January 7th, a new order was issued on January 7th by the US federal court in regards to the state court testosterone lawsuit proceedings and the twin claims currently being dealt with in many different state courts. The order states that a number of attorneys who represent the plaintiffs must now act as the same with state proceedings held in Illinois, Missouri, Pennsylvania, California and Indiana and also for other state cases that happen in the future. This order may result in settlements ended faster for men injured by these drugs.

An estimated 620 – and growing – “Low T” therapy lawsuits have been filed in the Northern District of Illinois defending men who claim to have suffered strokes, heart attacks, life-threatening cardiovascular events, deep vein thrombosis and pulmonary embolism as a result of their treatment. At the top of the list, the plaintiffs allege that the manufacturers of the prescribed drugs concealed their potentially adverse side effects from the public and did nothing to  warn doctors and physicians about the risks so they could inform patients. The plaintiffs also propose that sales of the medications were driven by misleading multi-million dollar marketing claims by pharmaceutical companies that drilled into minds that the drugs were remedies for male aging symptoms. Those claims have now injured healthy men that used the drugs without true medical need and did not have hypogonadism.

Court documents uncover that the “Low T” drug therapy litigation has been getting stronger since January of 2014 when the FDA published a safety announcement stating they were seriously investigating the drugs in question.

ANY OF THE FOLLOWING TESTOSTERONE REPLACEMENT DRUGS COULD BE HARMFUL:

There are a variety of products on the market including gels, patches, pills and injections.

  • AndroGel®
  • Androderm®
  • Android 10®
  • Android 25®
  • Axiron®
  • Fortesta®
  • Bio-T-Gel®
  • Delatestryl®
  • Depo-Testosterone®
  • Methyltestosterone®
  • Striant®
  • Testim®
  • Testopel®
  • Testosterone
  • Cypionate®
  • Enanthate®
  • Testred®

FDA advisors have instructed the prescription labels be updated to reflect that the medications have indeed not been proved to lessen muscle loss, fatigue, low libido and other male aging symptoms. The FDA advisors also require manufacturers to conduct heart-related side effect studies on their drugs.

We will see many more lawsuits filed in 2015.

 

 

 

 

The Truth About Low Testosterone in Men

Heart attack striking a young man.jpgUnderstand the potential risks and consider alternatives before boosting your hormones indefinitely.

Millions of American men use a prescription testosterone gel or injection to restore normal levels of the manly hormone. The ongoing pharmaceutical marketing campaigns promise that treating “low T” this way can make men feel more alert, energetic, mentally sharp, and sexually functional. However, legitimate safety concerns linger. For example, in November 2013 a study in The Journal of the American Medical Association reported new evidence that some older men on testosterone could face higher cardiac risks. A 30% increased risk of death, heart attack, and stoke, to be exact.

“Because of the marketing, men have been flooded with information about the potential benefit of fixing low testosterone, but not with the potential costs,” says Dr. Carl Pallais, an endocrinologist and assistant professor of medicine at Harvard Medical School. “Men should be much more mindful of the possible long-term complications.”

The Low-T Explosion

A loophole in FDA regulations allows pharmaceutical marketers the ability to urge men to talk to their doctors if they have certain “possible signs” of testosterone deficiency. Virtually everybody asks about this now because the direct-to-consumer marketing is so aggressive. Tons of men who would never have asked about it before started to do so when they saw ads that say ‘Do you feel tired?’

Just being tired isn’t enough to get a testosterone prescription. If a man has significant symptoms, they’ll need to have a lab test. In most men, the testosterone level is normal.

If a man’s testosterone looks below the normal range, there is a good chance he could end up on hormone supplements—often indefinitely. There is a bit of a testosterone trap. Men get started on testosterone replacement and they feel better, but then it’s hard to come off of it. On treatment, the body stops making testosterone. Men can often feel a big difference when they stop therapy because their body’s testosterone production has not yet recovered.

This wouldn’t matter so much if we were sure that long-term hormone therapy is safe, but some experts worry that low-T therapy is exposing men to small risks that could add up to harm over time.

What are the risks?

A relatively small number of men experience immediate side effects of testosterone supplementation, such as acne, disturbed breathing while sleeping, breast swelling or tenderness, or swelling in the ankles. Doctors also watch out for high red blood cell counts, which could increase the risk of clotting.

From 2001 to 2011, the number of men receiving testosterone therapy tripled. Over the recent years, lawsuits started being filed over cases involving men with serious side effects using “Low T” therapy, such as the popular Androgel. The side effects profiles are different for each drug, but there are some potential dangers common to all them:

  • Sleep apnea
  • Increased risk of prostate cancer
  • Stroke
  • Sudden cardiac death
  • Heart attack
  • Deep vein thrombosis
  • Pulmonary embolism
  • Acne
  • Breast enlargement
  • Anemia

What does the FDA say?

One year ago (January 2014), the FDA made an official safety announcement through their website that made clear that the agency would be investigating the link between heart attack and death with FDA-approved testosterone products. The risk of cardiovascular issues led consumer advocacy groups to call for a black-box warning on all testosterone drug packages and have petitioned the FDA to require manufacturers to do so.

Take a cautious approach

A large, definitive trial for hormone treatment of men is still to come. Until then, here is how to take a cautious approach to testosterone therapy.

Take stock of your health first

Unhappy couple in bedroomHave you considered other reasons why you may be experiencing fatigue, low sex drive, and other symptoms attributable to low testosterone? For example, do you eat a balanced, nutritious diet? Do you exercise regularly? Do you sleep well? Address these factors before turning to hormone therapy.

If your sex life is not what it used to be, have you ruled out relationship or psychological issues that could be contributing?

If erectile dysfunction has caused you to suspect “low T” as the culprit, consider that there are other factors that can also cause erectile dysfunction.

Get an accurate assessment

Inaccurate or misinterpreted test results can either falsely diagnose or miss a case of testosterone deficiency. Your testosterone level should be measured between 7 am and 10 am, when it’s at its peak. Confirm a low reading with a second test on a different day. It may require multiple measurements and careful interpretation to establish bioavailable testosterone, or the amount of the hormone that is able to have effects on the body. Consider getting a second opinion from an endocrinologist.

Be mindful of unknown risks

Approach testosterone therapy with caution: especially if you are at high risk for prostate cancer; have severe urinary symptoms from prostate enlargement; or have diagnosed heart disease, a previous heart attack, or multiple risk factors for heart problems.

Ask your doctor to explain the various side effects for the different formulations of testosterone, such as gels, patches, and injections. Know what to look for if something goes wrong.