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AbbVie 91 articles

Testosterone lawsuits blame makers for failing to warn of drug’s risks

AbbVie won the latest testosterone side effects lawsuit alleging its testosterone replacement therapy AndroGel caused a man to suffer debilitating blood clots, but the two previous plaintiffs wins with verdicts totaling nearly $300 million suggest the fight has only just begun. AbbVie’s AndroGel has enjoyed the lion’s share of sales in the once-booming testosterone replacement therapy market. The hormone treatment was approved by the Food and Drug Administration (FDA) in 2000 for the treatment of hypogonadism, a condition in which there is a testosterone deficiency due to a genetic defect, illness or trauma. But AbbVie began aggressively promoting the drug ... Read More

AndroGel’s label did not warn of cardiovascular risks

AbbVie Inc., never mentioned on the safety label of its testosterone replacement therapy AndroGel that users were at an increased risk of cardiovascular events, including blood clots like those that lodged in the lungs of a man suing the drug company, his attorneys said in opening arguments to an Illinois federal jury this week. Robert Nolte’s case is the third bellwether trial AbbVie has faced in a multidistrict litigation of consisting of about 7,500 cases of men alleging testosterone treatment makers did not adequately warn doctors or consumers that their products were linked to an increased risk of heart attacks, ... Read More

Judge orders new trial in testosterone MDL, overturns verdict

The $150 million verdict awarded in the first bellwether trial alleging AbbVie Inc., fraudulently misrepresented its testosterone replacement therapy AndroGel was tossed out by an Illinois federal judge last week and a new trial ordered. U.S. District Judge Matthew Kennelly said the jury’s verdict was “internally inconsistent” because jurors awarded punitive damages based on the misrepresentation claim, but did not award compensatory damages because they did not find the drug company liable for the plaintiff’s injury. “Of course, it would violate the precepts of logic to assert simultaneously that a party has been damaged and not been damaged,” Judge Kennelly ... Read More

Eli Lilly announces settlement agreement of testosterone side effects cases

A month before facing its first bellwether trial in a multidistrict litigation involving testosterone side effects, Eli Lilly& Co., announced it had reached a global settlement in all cases filed against it. The drug company faced claims that the company failed to warn that its testosterone replacement therapy Axiron could cause potentially deadly heart attacks, strokes and blood clots. The pharmaceutical company told U.S. District Judge Matthew Kennelly that it had entered into a memorandum of understanding. As a result, Judge Kennelly canceled two upcoming trial dates – in January and March – involving Axiron. The trials involved the case ... Read More

Auxilium escapes verdict in testosterone side effects trial

Auxilium Pharmaceuticals Inc., maker of the testosterone replacement therapy Testim, escaped a verdict in the first bellwether trial blaming Testim for a man’s heart attack. This marks the first victory in multidistrict litigation (MDL) over testosterone side effects that names several testosterone manufacturers. The first two bellwether trials were against AbbVie Inc., makers of AndroGel, and resulted in combined $290 million in verdicts. The seven-day trial focused on the case of Steve Holtsclaw, who claimed he was prescribed Testim after complaining to his doctor about chronic fatigue. Months after treatment, Holtsclaw suffered a heart attack. He since learned that studies ... Read More

Testim benefits not worth the heart attack, patient says

Steve Holtsclaw’s heart attack in 2014 weighs on his mind daily. He’s more emotional now, and constantly wonders, “How much longer have I got?” the 62-year-old man told an Illinois federal jury during the first bellwether trial in a multidistrict litigation (MDL) involving cardiovascular risks with Auxilium Pharmaceuticals Inc.’s testosterone replacement therapy Testim. Holtsclaw was prescribed Testim in 2013 after complaining to his doctor about chronic fatigue. A blood test showed his testosterone levels were low. Months later, Holtsclaw suffered a heart attack. He received two stents and was put on several medications to help prevent a second heart attack. ... Read More

Opening arguments begin in latest testosterone trial

The Food and Drug Administration (FDA) repeatedly rejected Auxilium Pharmaceuticals Inc.’s requests to expand the indication of its testosterone replacement therapy Testim to include age-related drops in testosterone, yet the drug company continued to market its product for age-related symptoms, attorneys for Steve Holtsclaw said during opening arguments. As a result, Holtsclaw trusted the product was safe, but realized the error of his ways when he suffered a heart attack seven months after starting the hormone therapy. Holtsclaw’s lawsuit is the first bellwether to reach trial against Auxilium in a multidistrict litigation that names numerous manufacturers of testosterone treatments. Two ... Read More

Depo-Testosterone users want to sue Pfizer over heart risks

More than 1,000 people alleging Pfizer Inc., failed to warn that its Depo-Testosterone treatment could cause cardiovascular events, asked the Seventh Circuit to let them sue the drug maker. The plaintiffs were part of a multidistrict litigation (MDL) in Illinois federal court naming several testosterone replacement therapy makers. But, U.S. District Judge Matthew Kennelly dismissed their lawsuits after finding that the failure-to-warm claims against Pfizer for its Depo-Testosterone were preempted by the Food, Drug and Cosmetic Act and Food and Drug Administration (FDA) regulations, which bar generic drug manufacturers from altering their products’ labels once they’re approved. Plaintiffs argued that ... Read More

Teva launches generic Axiron despite heart risks

Teva Pharmaceuticals Ltd., announced it has launched CII, a generic version of the testosterone replacement therapy Axiron, a topical solution of the prescription medication used to treat adult males with low levels of testosterone due to injury, disease or defect. “We are pleased with the result in the district court, which has helped Teva add yet another product to our industry-leading generic portfolio, providing savings to our customers and to patients,” said Andy Boyer, Teva’s President and CEO, Global Generic Medicines, North America. Axiron is manufactured by Eli Lilly and Co., and has annual sales of about $247 million in ... Read More

Testosterone products not effective for so-called Low T, possibly dangerous

As men age, their testosterone levels drop. Their muscle mass declines, they start feeling tired more easily, and they begin to lose interest in sex or in sexual performance. A few years ago, ads for testosterone replacement therapies encouraged men to ask their doctors if they were candidates for testosterone treatment for their so-called Low T. The products, the ads claimed, could reverse those bothersome symptoms. But medical science has since revealed that testosterone supplementation for age-related drops in testosterone levels is not only unnecessary, it can be dangerous. Despite this, testosterone manufacturers like AbbVie, makers of the top selling testosterone treatment ... Read More