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GSK faces products liability claim by woman alleging birth defects from Paxil

By Jon Campisi | Mar 12, 2014

Bryan f. aylstock

An Ohio woman claims in a newly filed products liability suit that her child

was born with infant respiratory distress syndrome and a ventricular septal defect, diagnoses she blames on the fact that she took the antidepressant drug Paxil during pregnancy.

Kathryn Kiker, who resides in Columbus, OH, is suing drugmaker GlaxoSmithKline over claims that her child’s birth defects are directly attributed to the defendant’s medication.

The medication “paroxetine,” which is marketed under the brand name Paxil, is a selective serotonin reuptake inhibitor that was first approved for use in the United States by the Food and Drug Administration back in 1992 for the treatment of depression in adults.

The drug, however, has never been approved by the FDA for use by pregnant women, the lawsuit claims.

The plaintiff says her family physician prescribed her the pharmaceutical, which she continued to ingest while she was pregnant with her child, identified in the suit only as “C.S.”

She gave birth to C.S. in the spring of 2001, records show.

“At the time Paxil was prescribed to Mrs. Kiker, GSK knew through pre-market studies and post-marketing studies and reports that Paxil was associated with a significant increased risk of cardiac birth defects in babies whose mothers ingested Paxil during pregnancy,” the complaint reads. “Notwithstanding this knowledge, GSK aggressively and actively promoted Paxil for use with pregnant women.”

The drug company, the lawsuit alleges, encouraged its sales force to promote Paxil to pregnant women and touted the medication as being a safer alternative to other similar drugs for women who were pregnant.

“Indeed, GSK even suggested that Paxil was safer and more efficacious than other SSRIs on the market, such as Prozac and Zoloft,” the complaint states. “In fact, none of this was true.”

The defendant’s “illegal and improper” marketing of drugs such as Paxil were done to give a “false impression of both the safety and efficacy of the drug to the medical community, prescribing doctors and patients,” the lawsuit says.

The complaint goes on to allege that GSK did not begin to inform doctors of the serious risk associated with Paxil until September 2005, when third party research was released showing the association between Paxil and cardiac birth defects.

The complaint says that prior to Kiker’s pregnancy with C.S., the defendant had the “knowledge, the means and the duty to provide the medical community and the consuming public with a stronger warning regarding the association between Paxil and birth defects through all means necessary including but not limited to labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements and promotional materials, etc. GSK breached this duty.”

The suit contains counts of negligence and negligence per se, negligent pharmaco-vigilance, strict liability, failure to warn, breach of express and implied warranties, fraud, negligent infliction of emotional distress, negligent design, negligent misrepresentation, and violations of unfair trade practices and consumer protection laws.

The plaintiff seeks unspecified past and future general damages and economic damages, earnings losses, medical expenses, punitive damages, attorneys’ fees and costs.

The plaintiff is being represented by attorneys Bryan F. Aylstock and R. Jason Richards of the Pensacola, FL firm Aylstock, Witkin, Kreis & Overholtz.


The federal case number is 2:14-cv-01445-CMR.

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