The stakes for drug makers selling testosterone gel therapies just got a little higher as an insurance company – Medical Mutual of Ohio – has filed suit against a number of testosterone gel manufacturers alleging RICO conspiracy claims. RICO is the Federal Racketeer Influenced and Corrupt Organization Act, most commonly known for actions against organized crime syndicates and other mob activity.
You can read a copy of the RICO complaint here.
The conspiracy lawsuit claims that the drug companies conspired to falsely and deceptively oversell the usefulness of testosterone replacement therapy drugs while failing to warn about the severe and sometimes deadly side effects. Medical Mutual of Ohio also claims the drug companies unlawfully promoted the testosterone drugs for use on patients not approved by the Food and Drug Administration (FDA).
“What was once a rare condition was suddenly said to affect up to 40 percent of middle-aged men, according to repected ‘thought leaders’ – specialist urologists and endocrinologists at teaching university hospitals – many of whom were in fact on one or more of defendants’ respective payrolls as consultants, speakers, and/or researchers. Defendants’ respective unlawful marketing schemes directly convinced patients, physicians, and TPPs that hypogonadism was vastly underdiagnosed and undertreated, directly causing prescriptions for [testosterone replacement therapy] drugs to increase 170% from 1999 to 2002.”
– Medical Mutual of Ohio Complaint
What’s At Issue in the Conspiracy Lawsuit?
The conspiracy lawsuit is really about the selling of the disease. Take, for example, the testosterone propaganda site IsItLowT.com.
The site is funded by pharmaceutical giant AbbVie (recently spun off from Abbott Labs). AbbVie sells the most popular testosterone replacement drug, AndroGel, which makes it more than one billion dollars each year.
But you would never know that AbbVie or AndroGel has anything to do with the Is It Low T? web site. There’s no mention of AndroGel at all.
Why? The company is selling the disease in order to market the cure.
And the site provides a handy little quiz so you can self-diagnose and ask your doctor about this “disease.” But it turns out that this handy little quiz was created in 20 minutes while the author,Dr. John E. Morley, was in the bathroom (yes, in the bathroom for 20 minutes) and
Testosterone supplements, like AndroGel, have been approved only to treat a very specific condition – hypogonadism – along with documented low testosterone levels.
“None of the testosterone products have indications for weight loss, increasing energy or improving mood,” said Andrea Fischer, a spokeswoman for the F.D.A.
But “unbranded” advertisements like the “Is It Low T” web site are not subject to strict FDA scrutiny.
Testosterone Gel Health Risks and Side Effects
Earlier this year, a panel of experts strongly urged the FDA to impose strict limitations on the off-label use of testosterone replacement gels in order to avoid prescribing testosterone to millions of men who have no medical need for the drugs.
The panel voted 20-1 in recommending label changes to the FDA.
The expert panel also identified several noted health risks – including increased risk of heart attack and stroke.
The panel was also asked to sift through the evidence for safety risks. It concluded that the evidence of heart problems was mixed, and all but one of its members voted to require clinical trials for safety for at least some types of testosterone therapy.
A 2010 clinical trial found an elevated risk of heart attacks and strokes among men who took testosterone.
– Sabrina Tavernise at The New York Times
In fact, the risk of heart attack and stroke was so great, the study was canceled as a result.
Another study, by William D. Finkle and others – was published in January 2014. The Finkle study examined more than 55,000 men and looked at the rate of heart attack within 90 days of starting testosterone replacement therapy. Finkle found that testosterone replacement doubled the risk of heart attack in men over 65 years old and tripled the risk of heart attack in men with a prior history of heart problems. An earlier study, published in the November 2013 edition of the Journal of the American Medical Association (JAMA) also found that testosterone gel therapy resulted in a substantially increased risk for heart attack and stroke in men over 65.
Individual Testosterone Lawsuits Filed
There have been a number of lawsuits filed involving men who have experienced heart attack or other heart-related events after taking AndroGel. Hundreds of additional lawsuits are expected across the country. The attorneys at Langdon & Emison are currently investigating and evaluating these claims. Contact us for a free evaluation of your case. You can also download our free e-book, which takes a closer look at the development of testosterone replacement gels and the serious side effects that have been documented in recent studies.
- Insurance Company Files Large RICO Class Action Targeting Low-Testosterone Therapies: Claims Manufacturers Invented “Low-T” and Duped Payors Into Paying Billions [Thomas Sullivan at Policy and Medicine]
© Copyright 2014 Brett A. Emison
Follow @BrettEmison on Twitter.
Brett Emison is currently a partner at Langdon & Emison, a firm dedicated to helping injured victims across the country from their primary office near Kansas City. Mainly focusing on catastrophic injury and death cases as well as complex mass tort and dangerous drug cases, Mr. Emison often deals with automotive defects, automobile crashes, railroad crossing accidents (train accidents), trucking accidents, dangerous and defective drugs, defective medical devices.