Archive for February 9th, 2010

FDA cracks down on misleading drug promotions

The economic pressures  that are placed upon the pharmaceutical industry  as a result of competition, increased reporting requirements, research and development pressures and regulatory compliance have resulted in a very aggressive  strategy by some companies when it comes to promoting their products. When a consumer reads,  views  or hears claims about a drugs application or efficacy the consumer  is led to believe that these claims are supported and sanctioned by the FDA. Very often this is not the case.

According to a new report published  in Forbes magazine, the FDA has taken a much more aggressive posture since Pres. Obama came into office. According to Forbes,Thomas Abrams, who heads up the FDA division that oversees drug marketing, freely admits it. His group sent 41 enforcement letters in 2009, up from just 21 the year before. And so far this year–just the month of January–it has dispatched another nine, with plans to continue that pace through 2010.”We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Abrams says in an interview with Reuters. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or healthcare professionals misled.”

It’s not unexpected, considering that FDA Commissioner Margaret Hamburg has pledged to increase the agency’s enforcement presence. And she’s promised to streamline processes that slowed down regulatory action. That streamlining has already had an effect at DDMAC, Abrams said; his division has changed its procedures so that warning letters go out more quickly. “We are inspired by Dr. Hamburg’s enforcement initiative and have taken it to heart,” he told the news service. “I personally am thrilled with it.”

This updated surveillance  is good news for the consumer.

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$17 million verdict against Honeywell & Abex

Yesterday  an Illinois jury handed down a surprising verdict against two former asbestos product manufacturers. According to the attorneys involved in the case, the verdict was returned on the novel liability theory of corporate conspiracy. Typically this means that the factfinder determined that the defendants acted in concert with one another and caused the plaintiffs injury.  This is different than a typical mesothelioma product liability case where the verdict is based upon a failure to warn about a particular product manufactured or sold by the defendant.

In this case, the plaintiff,Jayne Menssen, is 65 years old, widowed, and has no children. She was exposed to asbestos from 1967-1969 when she worked as a secretary at the UNARCO plant in Bloomington, IL.  The jury returned the following verdict:

$3,500,000 compensatory
$4,370,000 punitives against Abex
$10,000,000 punitives against Honeywell

Congratulations  to my friends ,Lisa Corwin & Jim Wydler,  who represented the plaintiff  for this extraordinary result.

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