Photographer: Daniel Acker/Bloomberg

AbbVie Testosterone Gel Faces Scrutiny as First Trial Begins

  • Company has denied claims gel causes strokes and heart attacks
  • Drug’s ‘Low-T’ marketing campaign criticized by patients

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 AbbVie executives 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.

Approved Uses

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.

AbbVie, based in North Chicago, Illinois, was spun off in 2013 from Abbott Laboratories, and a spokesman for that drugmaker said liability for AndroGel suits lies with AbbVie.

“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.

Faced with lower AndroGel sales, AbbVie is also fighting to fend off patent challenges to its blockbuster arthritis drug Humira, which accounts for almost two-thirds of the company’s revenue. 

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.

Safety Warnings

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.

AbbVie took a testosterone treatment regulators approved for use by a small group of patients and wrongfully pitched it to millions of men seeking to fight off the effects of aging, Konrad’s lawyer, Chris Seeger, told jurors in his opening statement Monday. “AndroGel was approved for one condition and marketed for another’’ even though the company knew it posed increased risk of heart attacks and strokes, he said.

Test Cases

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.

The initial trials are test cases for the company to gauge the reaction of juries to determine if and when to settle, said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.

“Once the folks at AbbVie gets a sense of its exposure to these claims, then they can start to figure out what it’s going to take to come up with a settlement to resolve them,” Tobias said.

DeMatteo said he’s angry that AbbVie continues to sell the testosterone gel even after receiving reports it can cause life-altering injuries. The businessman was forced to close his computer-security firm after his stroke because the wheelchair made traveling to client sites too difficult.

“I can’t believe there are still men out there using this stuff,” said DeMatteo. “Why would you take the chance of using something that could land you in a wheelchair for the rest of your life? It doesn’t make any sense to me.”

The consolidated case is In Re AndroGel Products Liability Litigation, MDL No. 2545, U.S. District Court, Northern District of Illinois (Chicago).

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