New York Testosterone Low-T Lawyer

Androgel, Axiron, Fortesta, Testim, Delatestryl, Striant, Androderm and Testopel Liability Attorneys in New York

Have you or a loved one experienced a heart attack, deep vein thrombosis, pulmonary embolism or stroke while using a testosterone medication? Litigation and lawsuits have commenced based upon recent medical studies showing a greatly increased risk of a heart attack (myocardial infarction) occurring in users of testosterone prescriptions. Our firm's senior litigation partner, Paul D. Rheingold, has represented thousands of clients and gained millions of dollars in verdicts and settlements for other prescription hormone drugs.

The New York testosterone lawyers of Giuffra, have a dedicated team of lawyers and legal staff individually handling claims. In other hormone-related drug product liability litigation, we have represented clients from many states.

The Dangers of Low-T Prescription Medication with Testosterone

We allege that the risks of Low-T testosterone drugs were not adequately communicated to users, and that the product exposes men to heightened risk of:

  • Heart Attack (myocardial infarction)
  • Stroke
  • Blood clots
  • Thrombosis
  • Pulmonary embolism
  • DVT (Deep Vein Thrombosis)
  • Death

Could There Be Liability against Testosterone Drug Companies Based on Over-Promotion or Direct-to-Consumer Advertising?

Testosterone supplementation is approved by the FDA only to treat specific diseases due to having low levels of testosterone. Any prescribing or use for general alleged health benefits in persons is therefore an "off label" use. This happens, in part, due to print and media ads blanketing magazines and cable television. The great majority of prescriptions currently are for such off label uses. Even more disturbing is that a large number of users have not even had the blood test to determine if in fact they have low levels of testosterone! The FDA on January 31, 2014, issued a Safety Announcement that it was investigating cases of heart attack, stroke and death in men who had been using testosterone medication. The basis for this intervention was recent articles linking testosterone supplementation to these conditions. For example, the University of Florida mined data from an insurer, looking at the rate of heart attack within 90 days of the use of testosterone. They found that in men over 65 the risk more than doubled, compared to the control group. In men under 65, who had risk factors for a heart attack, the risk was between double and triple!

At Rheingold Giuffra Ruffo & Plotkin LLP, we have been serving the legal needs of people throughout New York and across the nation for over 30 years. We handle a wide range of complex cases involving drugs containing hormones. Our attorneys are experienced litigators with a long track record of success, winning settlements and jury awards for our clients. We are happy to answer any questions you may have, and help you explore your legal options.

Testosterone Lawsuits Transferred to Multi District Litigation

Federal lawsuits filed against manufacturers of Low-T testosterone drug manufacturers have been consolidated in the U.S. District Court for the Northern District of Illinois. Lawsuits are transferred upon the determination of the U.S. Judicial Panel on Multidistrict Litigation. Judge Matthew F. Kennelly will preside over the litigation.

This is an important step in the resolution of these claims. We have resolved hundreds of MDL cases and look forward to helping you resolve your Testosterone case.

Contact Us for a Case Evaluation

Have you or someone close to you suffered from the use of Androgel, Axiron, Fortesta, Testim, Delatestryl, Striant, Androderm or Testopel?

Please contact us today online or by telephone at (888) 260-0473 to speak with an experienced New York drug liability law firm.

Our law office is conveniently located in a brownstone in Midtown Manhattan located at 113 East 37th Street.

For more information, please visit our drugs and medical devices information center.

CDRH New Update

FDA MedWatch - Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke

[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]

ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone.

Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.

BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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