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First Paxil Birth Defect Trial May Pave Way For 600 Others Pending Against GSK

UPDATED: February 5, 2020

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Although approximately 600 product liability lawsuits have been filed against GlaxoSmithKline (GSK) alleging that its antidepressant drug, Paxil (paroxetine), caused hundreds of birth defects and that the pharmaceutical giant failed to warn consumers about the drug's side effects, the first trial getting underway in Philadelphia, Pennsylvania may pave the way for others – and everyone is watching.

Paxil litigation

The first Paxil lawsuit to go to trial involves Michelle David who blames GSK's Paxil for causing life-threatening heart defects in her son Lyam Kilker, 3. She says that she was prescribed Paxil during the first trimester of her pregnancy to treat mild anxiety. Her son was born with defects including two holes in his heart and underwent multiple surgeries within six months of his birth.

Her lawyer – as well as many others – allege that GSK documents show that the drug manufacturer knew that Paxil could increase the risk of birth defects as far back as 1980 and that the company didn't sufficiently research the drug before or after it went on the market.

Drug litigation attorneys allege that GSK destroyed data from animal studies, withheld safety reports which showed adverse outcomes and actually crafted studies that would avoid triggering adverse results and stronger warnings – something for which other drug manufacturers have also been accused.

Paxil linked to many birth defects

Paxil has been linked to a variety of birth defects – including cardiac (heart), pulmonary (lung), neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull), infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward) and anal atresia (complete or partial closure of the anus).

GSK & FDA warnings

In September 2005, GSK issued two letters to doctors and healthcare professionals warning of links between Paxil use and abdominal birth defects and cranial birth defects. The U.S. Food & Drug Administration (FDA) issued a Public Health Advisory in December 2005 about the risk of heart birth defects and another in July 2006 warning of the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) by mothers taking Paxil and other SSRI antidepressants such as Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline).

Everyone is watching to see the results of this first Paxil trial. Interestingly, the judge has already denied GSK's motion not to allow punitive damages in the case and a judge in another ongoing case has ordered GSK to surrender damaging evidence which may show that GSK sought to influence researchers and may have buried negative studies so that the FDA wouldn't require stronger Paxil warnings.

If you've been injured by Paxil, contact an experienced drug litigation attorney for a free case review. You may be entitled to compensation for your injuries.

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