Lawsuit Against GSK'S Paxil Claims Drug Causes Birth Defects Even Though It Is Promoted As Safe


(Law.Com) -An Ohio woman has filed a product liability suit against the manufacturer of Paxil, claiming the antidepressant that she took during pregnancy caused severe birth defects.
Kathryn Kiker filed the suit against SmithKline Beecham Corp., doing business as GlaxoSmithKline (GSK), on March 11 in the U.S. District Court of the Eastern District of Pennsylvania.

The suit also names Kiker’s minor child, identified as C.S., as a plaintiff. The child has been diagnosed with infant respiratory distress syndrome and ventricular septal defect (VSD) from which he continues to suffer, the suit states.
The plaintiff cites several causes of action in the suit against GSK, including negligence, failure to warn, breach of express and implied warranties and fraud.
Kiker is suing for an unspecified amount of past and future general damages and economic damages, earnings losses, medical expenses, punitive damages, attorneys’ fees and costs.
Paxil is one of the brand names used by GSK to market the drug “paroxetine,” which is a member of a class of drugs known as “selective serotonin reuptake inhibitors.” The suit says Paxil was first approved in the United States by the Federal Drug Administration (FDA) in 1992 to treat depression in adults, but has never been approved for use with pregnant women.
Kiker contends she took Paxil as prescribed by her physician while pregnant with C.S., who was born in 2001 with birth defects. Kiker asserts that at the time she was pregnant, GSK knew through its studies and reports that Paxil was associated with a significant increased risk of cardiac birth defects in babies whose mothers ingested Paxil during pregnancy.
Despite this knowledge, GSK promoted Paxil to pregnant women and suggested it was safer than other drugs on the market such as Prozac and Zoloft. “None of this was true,” the suit says.
“These marketing misrepresentations were done to give a false impression of both the safety and efficacy of the drug to the medical community, prescribing doctors and patients,” according to the lawsuit.
In 2012, the suit states, the U.S. Department of Justice announced that GSK would plead guilty and pay a $3 billion fine to resolve federal civil and criminal inquiries arising from GSK’s illegal promotion of some of its products, including Paxil, and its failure to report safety data.
Laura Castro is a contributing writer for The National Law Journal

http://dswoodopines.blogspot.com/2014/03/lawsuit-against-gsks-paxil...

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