miércoles, 4 de octubre de 2017

"Is it Low T?" / Se cayó la testosterona...a multas.

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AbbVie took a damaging hit Monday as the first verdict from a series of bellwether AndroGel cases went against the drugmaker to the tune of $150 million. 

Jurors decided after hearing weeks of testimony that AbbVie isn’t responsible for plaintiff Jesse Mitchell’s 2012 heart attack, nor was it negligent. But the drugmaker did fraudulently misrepresent its product, the jury concluded. And that was worth $150 million in punitive damages for Mitchell and his legal team.

Ver:
USA: "low-T" problem...deceptive marketing 

That "fraudulent misrepresentation" decision echoes critics who've put AbbVie and other testosterone drugmakers under fire for aggressively marketing their meds. Mitchell’s case was one of about 6,000 grouped in federal court in Chicago, all alleging that the companies pushed testosterone drugs off-label and put patients at unnecessary risk. 

AndroGel itself broke the blockbuster barrier, fueled in part by campaigns that urged men to have their testosterone levels checked. 


Ver: 
AbbVie faces first of thousands of men suing over AndroGel testosterone drug 

Following the verdict, Mitchell’s attorney Troy Rafferty said in a statement the decision “sends a very strong message to AbbVie, that its conduct in improperly marketing this drug to millions of off-label patients was wrong and warranted severe punishment.” 

Mr. Mitchell was given his day in court and AbbVie was made to answer for its conduct that ultimately, nearly killed him,” Rafferty continued. 

AbbVie sees things differently. A spokesperson told FiercePharma the jury “found that Androgel did not cause any damage. We expect the punitive damage award will not stand.” 

Speaking with Bloomberg, Duke University law professor Neil Vidmar said the award will likely not survive an appeal because of a U.S. Supreme Court ruling that requires punitive damages to be based on reasonable actual damages.

Mitchell used AndroGel from 2008 to 2012 after seeing TV ads for the testosterone drug, according to his 2014 lawsuit. He suffered a heart attack in 2012, the suit says. If he had been warned of the med’s risks, he wouldn’t have opted to use the drug, according to the document. 

The suit alleged AndroGelcauses serious medical problems, including life-threatening cardiac events, strokes, and thrombolytic events.” Mitchell’s case was selected as an early "bellwether" trial to highlight each side’s legal strengths and weaknesses.

Ver:
Testosterona: Advertencia de riesgo cardíaco / Black box warning


Going forward, the jury’s decision could affect settlement negotiations. A series of testosterone drug bellwether trials are set to start in the coming months, according to the Illinois federal court’s website. 

Previously, the first testosterone bellwether case, filed by plaintiff Jeffrey Konrad, ended in a mistrial after a week because of a lead plaintiff's attorney's health problems, according to the National Law Journal. That trial is now set to start in September. 
 
AbbVie launched its first testosterone awareness campaign in 2008 to change men's attitudes toward testing and treatment.

Ver:

Todo sobre "Is it Low T?"en PHARMACOSERÍAS

 "Is it Low T?" targeted middle-aged consumers with complaints about weight, muscle tone and sexual satisfaction, promoting Low-T therapy as a way to boost energy levels and improve their day-to-day lives. 
The company's AndroGel remains a top-selling testosterone therapy. (Ver)

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