The Trial Lawyer Fall 2017 - Page 55

Case Background The plaintiff, 54-year-old Jesse Mitchell of Portland, Oregon, began taking Androgel in 2007. AbbVie promoted Androgel with catch-phrases such as “Is it Low T?” and “T it Up!” and marketing the product to middle-aged and older men as a treatment for low energy and libido. The controversy over the ad campaign stemmed from the fact that the drug was FDA-approved only for primary or secondary hypogonadism, rare conditions in which the body fails to produce testosterone. It was never approved as a testosterone replacement for men whose levels decline naturally with age. Lead counsel Troy Rafferty of Levin, Papantonio, Mitchell, Rafferty & Proctor pointed out, “[AbbVie] didn’t properly warn of the risks. They were promoting it for uses that hadn’t been proven safe and effective. As a result, Mr. Mitchell had a heart attack that nearly killed him.” Jesse Mitchell suffered his near-fatal heart attack in 2012, a little over four years after he started using Androgel. He and his wife filed their lawsuit in 2014. It was the first such case to go to trial. Arguments For The Defense Counsel for the defense argued that heart attacks are one of the leading causes of premature death in the U.S. They further claimed there was never sufficient evidence of links between Androgel and cardiac arrest, despite an extensive, 2,352 page adverse event report from the FDA on 6,292 cases involving their client’s product — in which cardiac failure or stress was mentioned a total of 108 times, as well as a sizable number of scientific studies published prior to Mr. Mitchell’s heart attack. An early study, funded by the federal government and published in the New England Journal of Medicine in 2010, had to be terminated after a large number of participants suffered heart attacks and other serious cardiac events. AbbVie’s attorneys also pointed out that Mitchell suffered from a number of medical conditions that might have contributed to his heart attack. In addition to obesity, hypertension, high cholesterol and a family history of heart disease, Mitchell was a long-time smoker. Defense counsel David Bernick argued, “Together, these risk factors are completely sufficient to cause a heart attack.” The Trial Lawyer x 53