Glaxo Settles Paxil Off-Label Marketing To Kids Lawsuit

As I note in another post, I am utterly exhausted, so I'll defer to classic cut-and-paste methods:

From the Minneapolis Star-Tribune:

"In a settlement approved Tuesday in U.S. District Court in Minneapolis, British drugmaker GlaxoSmithKline agreed to pay $40 million to reimburse health plans that paid for children and adolescents to receive the antidepressant Paxil.

"The agreement brings to a close the long-standing class-action litigation against Glaxo, which was sued for allegedly withholding negative information about the safety and efficacy of Paxil for teenagers and children. In 2007, Glaxo agreed to pay $63.9 million to consumers in another class-action settlement. In both cases Glaxo did not admit wrongdoing. "

I'm not up to speed on the history of other Paxil lawsuits, but a combined $103.9 million strikes me as a fairly significant amount. I wonder if the infamous Paxil Study 329 played a part in this case.

From the main law firm in the case:

"Baum, Hedlund, Aristei & Goldman originated the class actions and litigated the heart of the case based on internal GSK (GlaxoSmithKline) documents showing that GSK promoted Paxil as an effective medication for children and adolescents despite internal communications acknowledging that Paxil’s pediatric depression clinical trials failed to out-perform sugar pills, yet had higher suicidality rates than sugar pills. Notwithstanding, GSK promoted Paxil as being 'remarkably safe and effective' for depressed children.

"Paxil was never approved for children, so there were no explicit warnings for pediatric use on Paxil’s warning label. Thus, the prescription and sale of Paxil to children was all 'off label,' which is permitted, but with severe restrictions on such 'off-label' promotion and marketing.

"'Off-label marketing of drugs is prohibited, with limited exceptions that allow scientific trial results to be presented as long as they are truthful and accurate,' stated Michael Baum, senior partner at Baum, Hedlund, Aristei & Goldman. 'Here GSK should not have promoted Paxil for kids’ use when GSK’s own pediatric clinical trials showed Paxil was no more effective than sugar pills and, in fact, caused pediatric Paxil patients to experience increased suicidality. Litigation like this helps remove the incentive for drug companies to take advantage of the off-label marketing loophole.'"

I'll believe it when I see it.

I suspect there will be more coverage of this case later today. I'll add more to this if it makes sense.