Androgel Lawsuit Filed Over Myocardial Infarction from Testosterone Gel

A Texas man is one of the latest to file a lawsuit against the makers Androgel, alleging that side effects of the testosterone gel caused him to suffer a myocardial infarction and that the manufacturer mislead consumers into believing the drug was safe.

The complaint (PDF) was filed by David Lyon in the U.S. District Court for the Northern District of Illinois on June 2, claiming that AbbVie, Inc. and Abbott Laboratories withheld important information from consumers and the medical community about the risk of heart attacks and other health problems from Androgel.

Lyon indicates that he was employed as an Executive Assistant to the Vice President of a large multi-national corporation when he was precribed Androgel in January 2005, for symptoms the 72 year old attributed to low testosterone. He indicates that he had no prior history of cardiac problems until he suffered a significant myocardial infarction from Androgel in November 2005, which allegedly caused severe injuries that impact his personal and professional life.

The case is the latest in a growing number of Androgel lawsuits filed by men throughout the country who have suffered heart attacks, strokes, blood clots and other life-threatening injuries that were allegedly caused by the popular testosterone gel.

Like other claims, Lyon’s complaint accuses AbbVie of duping men with essentially a made-up disease that they called “Low-T” by conflating the normal side effects of aging, like fatigue and lowered libido, with a very real, and very rare, condition known as hypogonadism, which causes abnormally low testosterone levels.

The lawsuit alleges that AbbVie then convinced men that blood tests should be obtained to decide whether they need testosterone replacement therapy (TRT), although the medical community generally recognizes that such tests are unreliable in determining whether someone is suffering from testosterone deficiency.

Lyon is pursuing claims for failure to warn, breach of warranty, negligence, fraud, negligent misrepresentation, and seeks compensatory and punitive damages.

Testosterone Litigation

A growing number of testosterone lawsuits have been filed in recent months against AbbVie and makers of other similar drugs, coming after a series of studies that have highlighted the link between testosterone and cardiovascular risks.

In November 2013, a study published in JAMA suggested that side effects of low T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by a study published in the medical journal PLOSOne in January 2014, which found that low T 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.

In response to the findings, the FDA launched a safety review of all testosterone replacement therapy on January 31, leading to multiple media reports about the potential risk and lawyers advertising for potential claims.

Most of the lawsuits filed to date have involved injuries associated with the use of AndroGel, which is a testosterone gel spray manufactured and sold by AbbVie. However, a growing number of other cases are being filed by men who suffered injuries following use Axiron and other testosterone products, including Testim, Foresta, AndroDerm and others.

In late March, a group of plaintiffs filed a motion to centralize all AndroGel lawsuits before one U.S. District Judge, as part of an MDL or Multidistrict Litigation. However, earlier this month, a second motion was filed calling for all testosterone drug lawsuits to be centralized as part of one consolidated proceeding during pretrial litigation, to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

The U.S. Judicial Panel on Multidistrict Litigation (JPML), which oversees MDL consolidations, heard oral arguments over the AndroGel consolidation motion on May 29. It is expected to issue a ruling in the near future.