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The family of a teenager who committed suicide in 2002 after taking the antidepressant drug Paxil is not barred from suing the manufacturer, because the U.S. Food and Drug Administration had not yet taken any position on whether there was a link between the use of such drugs by pediatric patients and an increased risk of suicidality, a federal judge has ruled.
In his 55-page opinion in Knipe v. SmithKline Beecham, Senior U.S. District Judge Ronald L. Buckwalter of the Eastern District of Pennsylvania concluded that a jury must decide whether the drug manufacturer "indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling."
Buckwalter rejected arguments by SmithKline's defense team that the suit was pre-empted by FDA regulations which, at the time, did not call for suicide warnings for pediatric patients on drugs known as SSRIs, or selective serotonin reuptake inhibitors.
To see the entire article from Law.com, click here.
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