In the federal multidistrict litigation (MDL), testosterone litigation, there are 1,100 cases filed against all manufacturers, and 714 Androgel lawsuits against Abbvie.
In June 2014, all federal testosterone lawsuits were centralized as part of a single MDL, for coordinated pretrial proceedings.
U.S. District Judge Matthew Kennelly is presiding over the coordinated pretrial proceedings in the lawsuits out of the Northern District of Illinois
Testosterone Allegations Ramping Up
The complaints blame the drug makers for failing to warn men that side effects of testosterone replacement therapy may increase the risk of a heart attack, stroke, pulmonary embolism, and deep vein thrombosis.
There has been a big increase in the filings over the past four months, especially involving AbbVie’s Androgel product, which is the most popular testosterone replacement medication available.
According to many experts, there will be thousands of cases filed by men who suffered serious and catastrophic injuries.
Androgel Bellwether Cases
Judge Kennelly has ordered some Androgel cases to go before juries, known as “bellwether” cases, with a series of six trials scheduled between October 2016 and April 2017.
Testosterone Litigation Status Update
AbbVie currently faces a serious number of Androgel lawsuits, which claim that the drug maker recklessly promoted the medications without adequately warning patients and the doctors.
Similar testosterone drug allegations have also been filed against manufacturers of similar products, including Testim, Axiron, AndroDerm and other “Low T” gels, creams, patches, injections and other treatments.
The testosterone MDL includes claims against the major testosterone manufacturers and have resulted in Axiron, Testim, Androderm and Depo-Testosterone lawsuits.
A separate bellwether track has been established for early test trials involving other testosterone drugs, which are not expected to begin until at least mid-2017.
These early trial dates are beneficial in mass tort defective pharmaceutical and product liability medical device cases to help the parties determine how juries may respond to similar evidence and testimony that is presented throughout the litigation.
Androgel Heart Risks
Recent medical studies have indicated potential cardiovascular risks associated with Androgel side effects, following the publication of several studies and recent FDA advisory panel meetings convened to evaluate what regulatory actions may be necessary to protect consumers.
In November 2013, a study published in the Journal of the American Medical Association (JAMA) linked testosterone to higher rates of heart attacks, strokes, and death among older men with certain pre-existing heart problems.
In January 2014 article in the medical journal PLOSOne, found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.
FDA Testosterone Investigation
The FDA launched its own testosterone investigation, indicating that the agency is reviewing the cardiovascular risks among men taking any approved testosterone drugs to determine what regulatory actions may be necessary.
Two FDA advisory committees met in 2014 to evaluate the available data and voted overwhelmingly to recommend that the drug manufacturers be forced to conduct additional clinical trials to evaluate the potential heart risks.
The panels also recommended that the FDA restrict use of the widely used medications to men actually suffering from testosterone deficiencies caused by hypogonadism or another medical condition.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.