First bellwether trial for 'low-T' treatment could have ramifications for Lilly

June 5, 2017

A series of trials regarding the use of testosterone replacement drugs is set to begin Monday that could act as bellwethers for some 500 lawsuits filed against Indianapolis-based Eli Lilly and Co. and its therapy Axiron.

Consolidated in federal court in Chicago, nearly 7,000 lawsuits are pending against pharmaceutical makers and their testosterone replacement treatments, with the first several reserved for maker AbbVie Inc. and its AndroGel. The lawsuits filed against Lilly have been consolidated with the larger group including AbbVie.

As so-called bethwether cases, the results are expected to provide the players with a sense of how juries will consider evidence and could potentially lead to settlements in a wide swath of cases. Bellwether trials focusing specifically on Axiron are expected after AndroGel proceedings.

The early cases, of course, boil down to the personal stories of plaintiffs. For example, Brian DeMatteo said he hoped AndroGel would give him more energy when he started taking the testosterone-replacement medicine in 2010. Instead, he claims, the drug led to 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 can in the first trial over the medicine slated to begin Monday.
AbbVie has suffered as sales of AndroGel -- once a top-seller -- have slid after regulators called for tougher warning labels.

On Monday, the company faces the first of 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 are among the cases consolidated in Chicago federal court.

The first trial involves a Tennessee traffic consultant, Konrad, whose lawyers 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 the former subsidiary.

“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 and Co., of hiding or downplaying their products’ risk for blood clots and other serious injuries and violating federal law with aggressive marketing campaigns. AndroGel has been tied to fatal heart attacks in at least four cases.

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.

Lilly has the exclusive license to market the drug, which was developed by Acrux of West Melbourne, Australia. Axiron had global sales of $29.3 million in the second quarter of 2016. The drug, a topical solution of testosterone, is marketed to men who have a deficiency or absence of testosterone. It is applied by an underarm applicator.

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 nearly 30 percent.

Lawyers for Konrad said 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.

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 in an interview.

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.”

Consolidating cases in one court is believed to speed litigation and promote efficiency.


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