From BLOOMBERG NEWS  Androgel Pump

By Andrew Harris  Feb 5, 2014 2:34 PM CT

Abbott Laboratories (ABT) and AbbVie Inc., the company it spun off last year, hid the dangers of using the testosterone replacement drug AndroGel, five men claimed in lawsuits.

Their complaints, filed in the federal court in Chicago yesterday, came four days after the U.S. Food and Drug Administration said it will re-examine the safety of testosterone replacement drugs after two studies showed a higher risk of heart attacks and strokes in men who use them.

The men range in age from 50 to 63, according to their complaints. Three claim they had heart attacks after they started using AndroGel, and a fourth said he had a stroke. The fifth man said he had a mini-stroke.

Abbott and AbbVie “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs, “while downplaying known adverse and serious health risks,” according to the complaints.

The men accuse Abbott, which marketed the drug from 2010 through 2012, and prescription drug-maker AbbVie of concealing knowledge that AndroGel had a “serious propensity” to harm.

The market for testosterone-replacing drugs, which include AndroGel and Axiron, made by Eli Lilly (LLY) & Co., is worth $1.6 billion. Indianapolis-based Eli Lilly is not named in the lawsuits.

Raises Risk

Adelle Infante, a spokeswoman for North Chicago-based AbbVie, did not immediately reply to voice-mail messages for comment on the filings. Scott Stoffel, a spokesman for Abbott Park, Illinois-based Abbott Labs, declined to immediately comment.

Each complaint was filed by the same two law firms, Alton, Illinois-based Simmons Browder Gianaris Angelides & Barnerd LLC and Morelli Alters Ratner LLP in New York. Their clients are seeking unspecified damages.

A study released in November of more than 8,000 men treated in the Veterans Health Administration found testosterone therapy raised the risk of heart attack, stroke and dying by 29 percent. Testosterone worsens sleep apnea and is linked to atherosclerosis and coronary plaque, the study found without identifying reasons why.

Prescriptions for the supplements rose more than fivefold to 5.3 million in 2011 from 2000, the authors said. The products are only FDA-approved for men who lack or have low testosterone levels in conjunction with a medical condition, the agency said.

The FDA advised patients to talk to their doctors.

The cases are Aurecchia v. AbbVie Inc. (ABBV), 14-cv-00772; Benn v. AbbVie, 14-cv-00774; Gallagher v. AbbVie Inc., 14-cv-00776; Marino v. AbbVie Inc., 14-cv-00777 and Myers v. AbbVie Inc., 14-cv-00780; U.S. District Court, Northern District of Illinois (Chicago).

To contact the reporter on this story: Andrew Harris in federal court in Chicago at aharris16@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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The product liability lawyers at Taylor Martino, P.C. are currently evaluating potential lawsuits involving testosterone supplements, such as the prescription topical treatments Androgel, Testim and Axiron.  Testosterone Replacement Therapy (TRT) products for men have been linked to an increased risk of death, heart attack and stroke.  Researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use.  Furthermore, men who started the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke, or die as men who entered the study with established coronary artery disease.  Testosterone therapy, such as the prescription topical treatments Androgel, Testim and Axiron, are used to help boost testosterone levels in men who have a deficiency of the male hormone.  Symptoms of low testosterone include decreased libido and low energy.

To review a potential case for yourself, a friend, or family member with the lawyers at Taylor Martino, P.C., request a free claim evaluation by calling 1-800-256-7728 or simply complete the free evaluation form to the right.”

 

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