AbbVie testosterone gel faces scrutiny as first trial begins
Brian DeMatteo said he hoped AbbVie Inc.'s AndroGel would give him more energy when he started taking the testosterone-replacement medicine in 2010. Instead, he claims, the drug put him in a wheelchair.
The 64-year-old Boston businessman blames AndroGel for a spinal stroke that left him a paraplegic suffering from chronic pain in 2012.
"I was the kind of guy who was always out playing tennis or surfing," DeMatteo said in an interview. "You can't do that kind of stuff in a wheelchair."
DeMatteo and thousands of other men who used AndroGel are looking to hold executives of North Chicago-based AbbVie responsible for their strokes and heart attacks. DeMatteo can't press his claims just yet but Tennessee resident Jeffrey Konrad is making his case to a jury in the first trial over the medicine that started Monday.
AbbVie has suffered as sales of AndroGel - once a top-seller - have slid after regulators called for tougher warning labels. The company faces more than 4,100 lawsuits by men like DeMatteo who claim AndroGel was responsible for their health problems, which range from blood clots to heart attacks. While DeMatteo's trial date hasn't been set, his case is among those consolidated in Chicago federal court.
Lawyers for Konrad, a Tennessee traffic consultant, declined to make him available for comment. The 56-year-old had a heart attack after using AndroGel for two months in 2010. AbbVie, which has denied the allegations, said in court filings that Konrad recuperated and had returned to running long-distance races. The company called the attack "relatively mild" and blamed Konrad's other ailments for his condition.
"We believe our disease education and marketing of AndroGel have adhered strictly to FDA-approved uses and are in full compliance with applicable standards," Toni Haubert, an AbbVie spokeswoman, said in an emailed statement.
The consolidated lawsuits accuse AbbVie and other makers of testosterone-replacement medicines, including Eli Lilly & Co., of hiding or downplaying their products' risk for blood clots and violating federal law with aggressive marketing campaigns. AndroGel has been tied to fatal heart attacks in at least four cases.
Indianapolis-based Lilly is facing more than 500 suits over its Axiron product. Mark Taylor, a spokesman, didn't respond to a request for comment about suits targeting the drugmaker's testosterone gel.
AbbVie has been specifically targeted for allegedly launching an $80 million marketing campaign in 2012 to promote AndroGel for a condition known as "Low T" - low testosterone. Television ads promised immediate benefits for men suffering from low energy and lack of sexual drive, according to court filings.
The FDA approved the drug only for men who suffer from hypogonadism, a severe loss of testosterone, rather than the natural decline of the hormone through aging. Regulators moved to strengthen safety warnings in 2015 after a study suggested testosterone-replacement medicines hiked risks of heart attacks and strokes by almost 30 percent.
Lawyers for Konrad said in court filings that had he and his doctors known the true risks of the drug, he would never have used AndroGel. Konrad is seeking unspecified damages for medical bills, and pain and suffering in addition to punitive damages to punish the company's behavior.
The drugmaker contends in the filings that it "made no misrepresentations about the safety or effectiveness of AndroGel to Mr. Konrad or his doctor" and that the FDA signed off on the medicine's warnings.
AbbVie properly developed and marketed AndroGel and didn't engage in "corporate misconduct,'' David Bernick, one of the drugmaker's lawyers, told jurors in his opening statement Monday. "The FDA set the rules of the marketplace and we followed those rules," he said.
Bernick also dismissed Konrad's claims that it was the testosterone medicine that caused his heart attack, saying the patient's own doctors never found a link between the product and the incident.