Federal Testosterone Drug Lawsuits Consolidation on the Horizon as More Studies Link Low-T Drugs to Significant Risk of Heart Attack

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Low-T Lawsuits Requested to be Consolidated in ILA growing number of testosterone drug lawsuits have recently been filed in U.S. federal courts against various manufacturers of testosterone replacement therapies (or low-T therapies), like testosterone gels, patches and injections. This snowballing low-T drug injury litigation has likely been spurred, at least in part, by some recent studies that have linked the use of low-T therapies to an increased risk of serious health complications – namely, heart attack and stroke.

In fact, two low-T drug studies that were published in the November 2013 Journal of the American Medical Association (JAMA) have reported that some men who use testosterone replacement therapies have a substantially higher risk of sustaining potentially fatal complications. The details of these studies are as follows:

Low-T Drug Study 1- Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels
Published: November 06, 2013, JAMA
Lead Researchers & Affiliations: Rebecca Vigen, M.D., M.S.C.S., of the University of Texas at Southwestern Medical Center, Dallas and colleagues
Synopsis: This observational study reportedly focused on men who were around 60 years old and who were being treated by the Veterans Health Administration. Researchers running this study ultimately concluded that the men who had been using low-T drugs had about a 25.7 percent risk of heart attack, stroke and death versus 19.9 percent found in the control group. Many physicians came to the defense of Testosterone therapy after the publication, notably Jen Landa, M.D. the Chief Medical Officer of Body Logic MD.
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Low-T Drug Study 2: Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
Published: January 02, 2014, PLOS one
Lead Researchers & Affiliations: Rebecca Vigen, M.D., M.S.C.S., of the University of Texas at Southwestern Medical Center, Dallas and colleagues
Synopsis: This study, which was also observational in nature, reportedly focused on men who were 65 years old and older, as well as younger men who had underlying heart conditions. These researchers found that, while men who were 65 years old or older had about a twofold risk of sustaining a heart attack within the first 90 days of using testosterone replacement therapies, the risk of heart attack for men who were younger than 65, had pre-existing heart conditions and were using low-T drugs approximately tripled within the first 90 days of using these drugs.
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Low-T Drug Studies’ Findings Spark FDA Investigation

The findings of these low-T drug studies have not only been the likely cause for the increased number of testosterone drug injury lawsuits filed in federal courts. They have also played a role in the FDA’s recent announcement that it will be conducting its own in-depth investigation into the reported links between the use of low-T drugs, and the increased risk of serious health complications.

On January 31, 2014, the FDA officially announced that it would be initiating a testosterone drug investigation, stating in this announcement that the agency has “decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”  Among the specific low-T drugs the FDA named as being part of its investigation were Axiron (made by Eli Lilly & Co.), AndroGel (made by AbbVie Inc.) and Androderm (made by Actavis plc). The FDA also explained in this announcement that it would report its final conclusions and recommendations regarding the alleged serious risks associated with the use of low-T drugs once it has completed its investigation.

If the results of the FDA’s low-T drug investigation backup the findings of the two recently published studies regarding the significant risk of heart attack associated with the use of testosterone drugs, the number of low-T drug injury lawsuits will likely continue to climb.

Consolidation Request Pending:

71 cases have been officially filed at the date of this writing, with thousands more promised to be underway by the 35 plaintiff’s firms handling the cases.

On 4/25, a motion was filed with the JPML requesting consolidation in the Northern
District of Illinois to be presided over by Judge Matthew F. Kennelly.

 Sources:

fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384225.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

aboutlawsuits.com/wp-content/uploads/2014-04-25-Testosterone-MDL-Response.pdf

photograph: “Federal Plaza, Kluczynski Federal Building and Dirksen United States Courthouse, Chicago, Illinois” by Ken Lund

Topics:  Drug Manufacturers, FDA, Healthcare, Heart Attacks, Investigations, Prescription Drugs

Published In: Personal Injury Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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