TRT (Testosterone Replacement Therapy)

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Testosterone Replacement Therapy (TRT) is a hormone replacement therapy which has evolved in recent years and within a short period of time, it has reached to its highest level of prescriptions in the US. The Food and Drug Administration (FDA) had approved TRT to treat male hypogonadism which means low testosterone levels due to disorders of the testicles, pituitary gland, or brain. Testosterone is made available in forms like topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. TRT may also be prescribed to lessen the effects or delay the onset of normal male aging.

The manufacturers involved are AbbVie, Actavis, Inc. (formerly Watson Pharmaceuticals), Eli Lilly and Company, Teva Pharmaceuticals, Pharmacia & Upjohn Company, Endo Pharmaceuticals, Columbia Laboratories, Auxilium Pharmaceuticals.

Studies show that there is an evidence of an increased risk of heart attack or stroke associated with testosterone use especially for AndroGel, Testosterone Therapies.

Serious Alleged Injuries may include:

  • Acute Myocardial Infarction
  • Stroke
  • Transient ischemic attacks ("mini-strokes")
  • Venous thromboembolism (VTE)- DVT and PE
  • Prostate cancer
  • Coronary artery disease
  • Death

FDA Approved Medications used for treatment of low testosterone include

ANDRODERM DITATE-DS TESTOPEL
ANDROGEL FORTESTA TESTOSTERONE
ANDROID 10 METANDREN TESTOSTERONE CYPIONATE
ANDROID 25 METHYLTESTOSTERONE TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE
ANDROID 5 NATESTO TESTOSTERONE ENANTHATE
AVEED ORETON TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
AXIRON ORETON METHYL TESTOSTERONE PROPIONATE
DELATESTRYL STRIANT TESTRED
DEPO-TESTADIOL TESTIM VIRILON
DEPO-TESTOSTERONE TESTODERM VOGELXO
  TESTODERM TTS  

FDA SAFETY WARNINGS:

 

  • May 7, 2009, the FDA announced the requirement for two testosterone replacement gels, AndroGel and Testim, to carry a black-box warning — the FDA’s strongest warning — for secondary exposure in children.
  • On January 31, 2014, the FDA released a Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued. The revised labels clarify the approved uses of these medications and include information about a possible increased risk of heart attacks and strokes in patients taking testosterone.
  • On June 19, 2014, the FDA required manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.
  • On March 3, 2015, the FDA announced the requirement for labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.
  • October 25, 2016, the FDA approved class-wide labeling changes for all prescription testosterone products, adding a new warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.

 

Lawsuit Allegations:

Approximately 1,000 men filed lawsuits in February 2014 related to testosterone therapy in which most of the lawsuits filed have been brought against AbbVie, the makers of AndroGel, which is the most widely used and heavily marketed testosterone replacement therapy.

Nearly 7,000+ Testosterone lawsuits have been filed against drug manufacturers including AbbVie Inc., Auxilium Pharmaceuticals, and Endo Pharmaceuticals Inc. as part of multidistrict litigation docket 4525 (MDL) in the Northern District of Illinois, presided by  U.S. District Judge Matthew Kennelly, formed in June 2014.

Allegations: Strict Liability/Failure to Warn, Negligence, Breach of Implied Warranty, Breach of Express Warranty, Fraud, Negligent Misrepresentation

Bellwether trials are in progress as of November 2017 with mixed verdicts announced.

Evidences:

  • Indication of usage in Medical Records
  • Evaluation of Risk and Confounding factors from Past Medical History
  • Indication of Usage in Pharmacy Records
  • Images of the product
  • Duration/Formulation of usage
  • Follow-up complications and their treatment after initiation of therapy in medical records

Medical Record Review and claim validation of TRT (Testosterone Replacement Therapy) case should take approximately 8 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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