Testosterone Replacement Therapy (TRT)

  • Testosterone Replacement Therapy Medical Record Review & Outsourcing Services

Testosterone Replacement Therapy (TRT) is a hormone replacement therapy which has evolved in recent years; within a short period of time it reached its highest level of prescriptions in the US. When the testes fail to produce an adequate amount of testosterone and/or to conduct normal spermatogenesis, the result is hypogonadism also called ‘low t.’ In 2015, the Food and Drug Administration (FDA) approved TRT to treat male hypogonadism due to disorders of the testicles, pituitary gland, or brain. The FDA stated that the benefit and safety of testosterone was not established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. As the onset of normal effects of aging could be delayed or lessened with TRT prescription, the FDA became aware that testosterone was being used extensively in attempts to relieve symptoms in men with low testosterone for no apparent reason other than aging.

Testosterone is made available in forms like topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. 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.

Popular brand names include: Andriol, Androderm, AndroGel, Axiron, Delatestryl, Depo-Testosterone, Intrinsa, Nebido, Omnadren, Primoteston, Sustanon, Testim, TestoGel, TestoPatch, Testoviron, and Tostran.

Studies show that there is 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 Safety Warnings:

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  

 

  • 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.

 

Legal Updates:

Defendants: AbbVie, Inc., Actavis, Inc., Auxilium Pharmaceuticals, Inc., Eli Lilly & Company, Endo Pharmaceuticals, Inc. (Endo), GlaxoSmithKline, LLC (GSK), and affiliated entities.

Defendant Law Firm:

AbbVie is represented by Shook Hardy Bacon LLP, Goldman Ismail Tomaselli Brennan & Baum LLP, Greenberg Traurig LLP, Dechert LLP, Phillips Lytle LLP, Kirkland & Ellis LLP, Butler Snow LLP.

Auxilium is represented by Arnold & Porter Kaye Scholer LLP.

Allegations:

Lawsuits filed alleged the plaintiff suffered heart attacks, strokes and blood clots as a result of using the low- t drugs. They further claim strict liability, failure to warn, negligence, breach of implied warranty, breach of express warranty, fraud, negligent misrepresentation.

Defendants' Liaison Counsel: Scott P. Glauberman - Winston & Strawn/ David M.; Bernick - Dechert LLP

Plaintiffs' Steering Committee

Ronald Johnson, Jr - Schachter, Hendy & Johnson PSC

Trent B. Miracle - Simmons Hanly Conroy

Christopher A. Seeger - SEEGER WEISS LLP

Martin D. Crump - Davis Crump, PC

T. Matthew Leckman - Pogust Braslow & Millrood, LLC

Lawrence J. Gornick - Kaiser Gornick, LLP

Matthew Teague - Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.,

Gregory S. Spizer - Anapol Schwartz

Frank Petosa - Morgan & Morgan, P.A.

Kristine K. Kraft - Schlichter, Bogard & Denton, LLP

Elwood C. Stevens, Jr. -Domengeaux, Wright, Roy & Edwards, L.L.C.

Christopher V. Tisi - Ashcraft & Gerel, LLP

Arnold Levin - Levin, Fishbein, Sedran & Berman

Alex H. MacDonald - Macdonald, Rothweiler, Eisenberg, LLP

Mark A. Hoffman - Ross Feller Casey, LLP

Dawn M. Barrios - Barrios, Kingsdorf & Casteix, LLP

Derriel C. McCorvey - The Law Office Of Derriel Mccorvey

Roger W. Orlando - The Orlando Firm, P.C.

Rachel Abrams - Levin Simes

W. Mark Lanier - The Lanier Law Firm PC

David S. Ratner - Morelli, Alters, Ratner LLP

Yvonne M. Flaherty - Lockridge Grindal Nauen P.l.l.P.

Dianne M. Nast - Nastlaw LLC

Kathleen Chavez - Foote, Mielke, Chavez & O'neil LLC

Brian J. Perkins - Meyers & Flowers

Myron Cherry - Myron M. Cherry & Associates

Lawsuit Status:

June 2014: The U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated proceedings for all testosterone lawsuits as part of multidistrict litigation docket 2545 (MDL) in the Northern District of Illinois, to be presided by U.S. District Judge Matthew Kennelly.

As of September 2018, more than 6,500 lawsuits were filed by men across the country blaming testosterone replacement drug makers of alleged injuries. Of these, nearly 4,200 involve AbbVie's AndroGel and about 500 involved Eli Lilly’s Axiron.

Important Verdicts & Settlements

January 3, 2018: Eli Lilly the maker of Axiron announced a global settlement for all the Axiron cases filed against it in the MDL, a month before the start of its first bellwether trial, resulting in the cancellation of two upcoming trial dates in January and March by Judge Kennelly.

March 28, 2018: AbbVie was ordered by a federal jury to pay $3.2 million to the plaintiff who claims he suffered a heart attack while using AndroGel. The jury awarded $200,000 compensatory damages and $3 million in punitive damages to the plaintiff. The plaintiff had been awarded $150 million in punitive damages in July 2017. However, post-trial motions resulted in the dismissal of the verdict by U.S. District Judge Matthew Kennelly of the Northern District of Illinois, on finding that the jury’s decision was “logically incompatible” with the evidence presented at trial; he further ordered a retrial.

June 14, 2018: Jury Favors AbbVie in the Fifth TRT Bellwether Trial over claims that its AndroGel caused a Plaintiff Rowley’s  deep vein thrombosis (DVT).

June 2018: Auxilium, a subsidiary of Endo International PLC, announced it had signed a master settlement agreement resolving all testosterone product liability claims linked to its drug Testim, without  requiring to admit liability or wrongdoing with a tentative settlement value around $200 million for about 1,300 lawsuits.

June 29, 2018: Actavis announces settling about 500 Androderm cases filed against it.

July 2, 2018: AbbVie and its partner Besins Healthcare Inc., were ordered to pay $448 million in an antitrust lawsuit filed by the Federal Trade Commission in 2014 accusing them of filing baseless patent infringement lawsuits in 2011.

September 2018: Abbvie & its subsidiaries Abbott Laboratories, Solvay Pharmaceuticals Inc. and Unimed Pharmaceuticals LLC would enter a global settlement phase under confidential terms.

Evidence:

  • 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 Testosterone Replacement Therapy (TRT) 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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