National class action lawsuit adds to growing number of similar court procedures in the United States, after study finds testosterone replacement products for older men can increase chances of heart attacks and death.
For Norman Wise, it all started with an ad on television talking about “Low-T”, or low testosterone syndrome, and its blockbuster drug AndroGel. The commercial promised to help older men who suffer from low sex drive, erectile dysfunction, decreased energy, reduced muscle mass and anemia.
“The commercial was describing something called Low-t and my symptoms were very similar to what was being expressed, just low energy, general apathy. What I was feeling fit what was advertised.”
– Norman Wise, plaintiff
His family doctor prescribed him the testosterone-replacement drug manufactured by Abbott Laboratories. The topical gel contains male hormone testosterone, which is absorbed by the body through the skin.
After using AndroGel for about a month, Norman says he did not feel any different. Until the evening of October 9th, 2013, when he felt a searing pain across his body during his regular workout routine.
Within hours, he was rushed to the ER and underwent emergency surgery. Doctors told Monika that her fit 68 year-old husband, with no family history of heart disease, was having a heart attack.
After months of painful recovery, life will never be the same for the once happily-retired snowbirds. Their days are now filled with doctors’ appointments and constant naps for Norman. The many adventures that he and his wife had planned are cancelled, and they can’t get travel insurance because of his condition.
“My heart was damaged so badly that I was diagnosed twice with congestive heart failure. Doctors are telling me my heart was damaged substantially.”
– Norman Wise, plaintiff
“Misrepresentation and disease-mongering”
The Wises allege that AndroGel-maker Abbott Laboratories is responsible for Norman’s heart attack on October 9th, 2013.
In a 45-page class action lawsuit filed June 25th, they claim neither they nor their family doctor was aware of the risks of heart damage associated with the use of the drug.
They claim Abbott Laboratories “misrepresented that AndroGel is a safe and effective treatment for so-called ‘low-T’ when in fact the drug causes serious medical problems, including life-treathening cardiac arrest.”
The lawsuit demands half a million dollars in damages for each plaintiff that was prescribed AndroGel, plus $60 million in exemplary damages to be paid by Abbott Laboratories. There is also mention of compensation for family members.
A growing trend
This case is part of a growing trend involving many pharmaceutical companies behind the controversial marketing campaign “Low-T”, that has made testosterone replacement drugs more popular than ever in Canada and the United States.
Launched in 2011, the AndroGel campaign urged older men to get their testosterone tested if they lacked energy or had a low sex drive. It also included mailouts to doctors and a new website. Soon, men were flocking to their family doctors and the number of prescriptions increased substantially.
One study estimated the number of American men being treated for “Low T” more than tripled from 2001 to 2011, with results similar for Canadians.
The “Low-T” wave hit a wall in January 2014, when a study published by the Journal of American Medical Association found that older men taking testosterone replacement drugs have up to 30 per cent more chances to suffer heart attacks, blood clots and death.
Underdiagnosed and overprescribed?
In a safety announcement, the U.S. Food and Drug Administration (FDA) announced it was investigating the use of these drugs and stipulated that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”
That’s precisely the problem, says Norman and Monika Wise’s lawyer, Matthew Bear. He explains that Norman was never properly diagnosed with hypogonadism, the medical condition drugs like AndroGel are supposed to treat. “Low-T is really just a disease that the drug companies made up, which stands up for low testosterone,” adds Bear.
“Because of the very aggressive marketing that they [pharmaceutical companies] do, most of the men who take these drugs don’t even have the health condition [hypogonadism] these products are suppose to treat. So not only do most of the men taking it don’t really need it, but the warnings are also inadequate.”
– Lawyer Matthew Bear, McKenzie Lake Lawyers LLP
Dozens of lawsuits in the US
AndroGel might soon become part of many lawyers’ vocabulary as class actions multiply. In the United States, 45 cases have been filed against Abbott Laboratories (and its new research-based pharmaceutical division AbbVie) by men who claim they suffered strokes, heart attacks and blood clots after using the drug.
In Canada, Lawyer Matthew Bear says he has received “dozens of calls” from men who want to join the first class action lawsuit in the country against the makers of AndroGel.
Meanwhile, Abbott Canada confirmed they have received the lawsuit and issued the following statement:
“AndroGel has more than 10 years of clinical and post-marketing data, with therapeutic risks documented in the prescribing labels. Abbott encourages discussion between physicians and patients that leads to proper diagnosis based on symptoms, lab tests and a patient’s other health needs.”
– Abbott Canada statement (August 6th 2014)
In its Second-Quarter 2014 Financial Results, AbbVie notes that AndroGel sales in the United States are down 15.6 percent from the prior year quarter, telling investors this is a “notable slowdown in the market, with overall prescriptions down more than 20 percent in recent months. We expect these market trends to continue.”
The lawsuit must first be certified by a judge, which could take up to a year according to lawyer Matthew Bear.
The allegations have yet to be proven in court.