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Androgel Lawsuits

androgelIf you are a man in your 40’s, 50’s, 60’s, or 70’s and are promised boundless energy, renewed vitality, and a terrific sex life just by rubbing a gel into your skin once a day,  chances are you’d ask where you get in line. That is the promise that the makers of Androgel made to male consumers who hoped to once again be the man they were in their 20’s by taking this testosterone-replacement drug.

Developed by the Belgian drug company Solvay Pharmaceuticals, Androgel was approved by the FDA in 2010 as a therapy for men whose bodies were not naturally producing adequate testosterone levels. It didn’t take long for U.S. based Abbott Laboratories to see the potential marketing bonanza in Androgel, and Abbott and its subsidiary AbbVie bought the drug from Solvay in 2010.

Testosterone levels decrease naturally in men after 30 years of age

Abbott seized on the fact that testosterone, which is produced naturally in the body and powers a male’s sex drive and general sense of physical strength and well-being, also naturally dips about 1% a year sometime after males hit their 30’s. The telltale symptoms of decreased testosterone levels, also termed hypogonadism, would include lower sperm counts, lack of vitality and muscle strength, and weight gain. The FDA gave its approval for testosterone replacement drugs such as Androgel to counter these symptoms.

The deception issue, alleged in hundreds of Androgel lawsuits, arose when Abbott indiscriminately and aggressively marketed Androgel to men with naturally decreasing testosterone levels causing prescriptions to be written needlessly to men who were simply aging normally. Abbott’s marketing hook was to tout Androgel as a “lifestyle” drug and proverbial sexual fountain of youth. Where there are large profits to be found, there’s generally a drug company willing to supply the demand, even if the drug company has to create the demand.

“Lifestyle drug” reaches blockbuster sales levels

Androgel, the most popular “Low T” supplement on the market in the U.S., is a synthetic testosterone suspended in a gel formulation and applied topically once daily and released over 24 hours into the system. Normal testosterone levels in men range from 298 to 1043 ng/dl. Androgel and other “Low T” testosterone replacement drugs supplement a man’s existing testosterone levels to reach into that normal range.

Abbott’s wager on men’s positive response to Androgel in hopes of achieving “past glory” has been  rewarded many times over and continues to generate phenomenal profits for Abbott. What were once modest but profitable sales revenues of a little over $300 million in 2002 leaped 600% by 2012 to almost $2 billion in testosterone therapy sales.

The Endocrine Society published a study in the January 2014 issue of their Journal of Clinical Endocrinology & Metabolism. The findings support that males with normal testosterone levels are being needlessly prescribed testosterone treatments despite the risk of serious cardiovascular side effects from Low T drugs.

Increase in heart attacks, strokes, and death found in certain profiles

The American Medical Association previously published a study in the November 2013 of JAMA reporting that Androgel and other Low T therapies raised the risk in certain male profiles of incurring serious cardiovascular injuries by 29%. This AMA study prompted the FDA to release its own findings in January 2014 that the risk of heart attack in young men with pre-existing heart disease was doubled with the use of Androgel and other Low T drugs. The same study reported that there was also a doubled risk of heart attack for men over 65, even without any previous heart disease.

FDA fails to add black box warning to testosterone products

The FDA said in June that it would now require manufacturers to provide warnings on Low T labels regarding the risk of venous blood clots (occurring in a vein), also referred to as venous thromboembolism (VTE). At the same time, it refused to mandate a black box warning that these same drugs could cause severe cardiovascular injuries including strokes, heart attacks, even sudden death. In addition, there is evidence that Androgel and its drug class can cause prostate cancer, reduced sperm count, edema, and gynecomastia (enlarged male breasts)

The founder of the Canadian consumer advocacy group Public Citizen, Dr. Sydney Wolf, issued a statement in response to the FDA’s refusal to add a black box warning to Low T therapies. He said “…the FDA is more sensitive to pressure from doctors dispensing more than 7 million prescriptions of testosterone in the past year and from the companies selling billions of dollars of testosterone products during the past year than Canadian regulators.”

Androgel lawsuits may eventually reach into the thousands

The number of testosterone therapy lawsuits alleging serious cardiovascular side effects filed nationwide on behalf of Androgel victims continues to rise. According to the latest case list released by the JPML, there are currently at least 260 federal testosterone lawsuits centralized in a multidistrict litigation in the Northern District of Illinois before Judge Matthew Kennelly.

The Androgel lawsuits involve claims that victims suffered an assortment of serious injuries including strokes, heart attacks, pulmonary thrombosis, deep vein thrombosis, and death by not receiving adequate warnings about Androgel’s potential risks. The suits also allege that the defendants Abbott Labs and AbbVie failed to adequately research the drugs before embarking on a massive marketing campaign to an unsuspecting public.

Bellwether trials to begin October 2016 – April 2017

In an attempt to clear the impending logjam of testosterone claims, Judge Kennelly has outlined a tentative schedule of bellwether trials which are designed to give both the plaintiffs and the defendant an opportunity to see how their evidence and testimony plays out in front of a live jury. The results of these trials are not binding on any other Androgel lawsuits but may be instrumental in creating an atmosphere in which the parties may settle equitably before forcing hundreds of individual trials.

Low T therapy litigation

An experienced product liability attorney can clarify what rights a victim has who has been harmed by Androgel.

To receive compensation, a victim of Androgel or other Low T supplements must prove that the drug manufacturer is at fault. In a case where the allegation is that the manufacturer failed to warn the public about the risks of taking the drug, the following must be proved:

  • The manufacturer sold the drug in the usual course of its business
  • The drug was defective in that it was unreasonably dangerous, even when used correctly
  • The manufacturer did not adequately warn users of the drug’s danger
  • The victim took the drug in the way that was anticipated.
  • The victim’s injury was directly caused by the manufacturer selling the drug without providing adequate warning

An Androgel victim should contact a testosterone attorney immediately so as not to miss the statute of limitations deadline.

Compensation for dangerous drug side effects can include:

  • Past and future medical bills
  • Pain and suffering
  • Lost wages
  • Reduced earning capacity


  1. Cleveland Plain Dealer, Testosterone side effects prompt FDA's attention to prescription warnings: Healthy Cleveland
  2. Bloomberg, Abbott Labs Testosterone Suits Consolidated in Chicago